Enzolytics, Inc. Announces Expansion of Production of Its Monoclonal Antibody Therapeutics and Marketing of IPF Immune™

COLLEGE STATION, TX / ACCESSWIRE / November 16, 2022 / Enzolytics, Inc. (OTC PINK: ENZC) 

Enzolytics, Inc. is a drug development company committed to the commercialization of its multiple proprietary therapeutics for the treatment of debilitating infectious diseases. The Company’s proprietary technologies include therapeutics for treating HIV and monoclonal antibodies for infectious diseases including HIV, SARS-CoV-2, and numerous other viruses in both humans and animals, and the production of over-the-counter nutritional supplements.

Planned Expansion of the Company’s Monoclonal Antibodies 

Enzolytics is focused on the production of anti-HIV therapeutics and monoclonal antibodies to treat viruses that affect humans. At the same time, the Company is applying its technology to address viruses that affect animals. The Company’s primary therapeutics in progress include the following.

ITV-1 anti-HIV Therapeutic

ITV-1 is an anti-HIV therapeutic produced under patents invented by the Company’s CSO, Harry Zhabilov, U.S. Patent Nos. 8,066,982 and 7,479,538. These and all patents relating to all Company technologies and products are exclusively licensed to the Company. No other company or individual has an ownership right or license in any Company related patent. Patent Office records verify this fact.

The Company has announced the completion of the first phase of the animal toxicology studies on its ITV-1 anti-HIV therapeutic and continues to progress with the GLP Compliant Repeat Dose Toxicity Study. https://www.nasdaq.com/press-release/enzolytics-reports-successful-completion-of-an-mtd-tolerability-study-of-its-itv-1. Upon completion of final Toxicity Study by BTS Pharma under GLP conditions, the Company expects to be able to make ITV-1 available in the countries in Africa, including Rwanda, the Democratic Republic of Congo, Angola, Kenya, and South Africa. The Company sees this as significant for individuals in Africa recognizing that out of the 34 million HIV-positive people worldwide, 69% live in sub-Saharan Africa. There are roughly 23.8 million infected persons in all of Africa. 40% of those infected with HIV in Africa do not have any access to any treatment for the virus. In addition, 91% of the world's HIV-positive children are in Africa.

Prior successful Clinical Trials of the Company’s ITV-1 treatment were completed earlier under the Bulgarian Drug Agency requirements. The Company moving forward to complete further clinical trials to fulfill the European Medicines Agency (EMA) requirements to launch the therapy in the EU followed by seeking FDA approval for use in North America. The Company is finalizing a comprehensive clinical development plan based on the prior clinical trials completed earlier, preparing a CMC non-clinical Gap analysis, and a necessary EU Regulatory Strategy.

Thereafter, CMC and GMP Requirements for EMA and FDA will be completed, followed by production of ITV-1 as per EMA and FDA requirements and a Fast-Tracked Clinical Trial to fulfill EMA and FDA requirements. ITV-1 has been successfully produced and has been earlier successfully clinically tested in human trials under the Bulgarian Drug Agency requirements.

In the prior clinical trials of ITV-1, the following beneficial results were established:

 ITV-1 inhibits the infection of CD4 T-cells by HIV.
• Use resulted in an increase in the patient's CD4/CD8 index.
• CD4 T-cell counts were raised to healthier levels, with a 68% increase in CD4+T-lymphocytes.
• HIV viral loads were reduced. Tests showed an 80.5% drop in viral loads.
• Use resulted in a decrease in the absolute number and the relative percent of CD8 lymphocytes.
• Use replaces or complements current anti-retroviral therapies.
• ITV-1 was less toxic than anti-retroviral and would be less costly.
• ITV-1 was unaffected by HIV mutations that can hamper anti-retroviral therapies (HAART).
• ITV-1 demonstrated a good effect on opportunistic infections.
• ITV-1 had good compatibility with other anti-retroviral drugs.
• There was good tolerance without any side effects.
• ITV-1 use boosted the immune system to fight HIV infections.

Monoclonal Antibodies against HIV and the CoronaVirus

Acquired Immunodeficiency Syndrome (AIDS) is considered to be one of the most serious and chronic diseases, caused by the human immunodeficiency virus (HIV). The prevalence of HIV is souring at a significant rate. According to the World Health Organization (WHO), an estimated 34 million individuals are currently living with the HIV virus. Due to increased awareness among people, there is now an increase in testing which has led to a surge in demand for HIV medications.

Today, there is no cure for HIV. The virus and its disease are treated by administering antiretroviral (ARV) drugs that do not cure and must be taken for life. The global HIV drug market size was $28.79 Billion in 2020. Even though sales rise was moderated during the height of the COVID pandemic, a steady growth of 5.7% in 2020 occurred. The market is expected to grow from $30.46 Billion in 2021 to $45.58 Billion in 2028. The rise in CAGR is attributable to this market's demand and growth, returning to pre-pandemic levels once the pandemic subsides. https://www.fortunebusinessinsights.com/industry-reports/hiv-aids-drugs-market-101115.

To address this need, the Company is focused on both the production of its ITV-1 therapeutic and producing multiple anti-HIV monoclonal antibodies using its proprietary methodology. 
The Company's primary anti-HIV monoclonal antibody has been produced and successfully tested in vitro against multiple strains of the virus where it demonstrated complete efficacy. The recombinant form of the parent antibody (necessary for patient therapy) has been successfully produced for the Company by Samsung Biologics. This recombinant antibody is currently undergoing efficacy testing in Europe and has shown significant activity even against drug-resistant HIV strains. Studies have confirmed the dual tropic activity of the HIV monoclonal Antibody-Clone 3. For HIV to be infectious, there is a requirement of specific binding between the virus envelope protein and the human CD4 cell at two receptor sites on the CD4 cell and the chemokine co-receptors CXCR4 and/or CCR5 (on gp41).

The Company’s Clone 3 Antibody interrupts the binding of the virus transmembrane gp41 to the human CD4 cells via blocking of binding to the 2nd co-receptor—to both the CCR5 and the CXCR4 receptors—on the CD4 cell surface. Because Clone 3 is dual-tropic, it consequently prevents HIV infection by abrogating the essential infectivity process which requires the fusion between the viral membrane and the CD4 cell membrane.

The success of an anti-HIV monoclonal antibody would be significant. The objective is to have a therapy that would not require lifelong use as is the case for antiretrovirals, the only available therapeutic treatment for HIV treatment. The statistics for HIV are alarming.
• Of the 34 million individuals living with the HIV virus today, only 66% had access to antiretroviral treatment - leaving 34% with no treatment.
• 1.7 million people become newly infected with HIV each year.
• 1 million people die yearly from AIDS-related illnesses. 2,700 die each day - over 300 are children (almost twice the number who die from cancer).
• 32.7 million people have died from AIDS-related illnesses since the start of the pandemic.

Antiretroviral drugs have significant drawbacks.
• They do not cure a patient and must be taken for life.
• They are extremely expensive.
◦ The cost of Biktarvy by Gilead is $90,000 per year.
◦ The cost of Cabenuva by ViiV Healthcare is $48,000 per year.
◦ The cost of Dolutegravir/tenofovir is $46,000 per year.
◦ It is well recognized (even by the producers of these drugs - as is publicly revealed in advertisements for the drugs) that these antiretroviral drugs cause serious damage over time to the heart and the kidneys, decrease bone density and contribute to Vitamin D deficiency. These are only some of the potential negative side effects attributed to the therapies.
• HIV infections are most treatable during their earlier stages, and patients cannot take antiretrovirals during earlier stages since drug resistance often develops.
• Limited or no treatment options exist when viral load and CD4 cell counts are at their worst, i.e., AIDS.
Thus, the need for alternative treatment is critical. A successful treatment using multiple monoclonal antibodies offers the hope for a therapeutic cure at a fraction of the current treatment cost.

U.S. Product Launch Scheduled for IPF Immune™

The Company’s nutritional supplement IPF Immune™ will be available in the U.S. market this month. The Company’s IPF Immune™, produced under U.S. Patent No. 8,309,072, invented by the Company CSO, Harry Zhabilov, and exclusively licensed to the Company, will now be available to consumers in the U.S. “We have met with buyers from some of the most sought-after retailers in the country. We are working to add retail outlets to make it easy for consumers to find IPF Immune™,” said Harry Zhabilov, CSO of Enzolytics. The Company has high expectations for this product, in view of the strength of the dietary supplement industry. The average American spends almost $100 per trip on vitamins and supplements. The U.S. vitamin and supplement industry currently totals $35.6 Billion in 2022 while the global sector is worth $151.9 billion. Older Americans from the Greatest Generation and Baby Boomers spend the most per purchase on dietary supplements, $129.58 and $111.59, respectively. Gen X totals $82.06 and Millennials are at $62.73. 

Enzolytics IPF Immune™

“It is obvious that Americans take vitamins and supplements for health reasons,” Mr. Zhabilov said. “Dietary supplement usage has been increasing for years, but the pandemic forced everyone to focus more on their health.” During the health crisis, consumers started searching for vitamins and supplements that would support their immune systems. Enzolytics IPF Immune™ is a nutritional supplement that is taken orally. “In the coming months, we will be working hard promoting IPF Immune™ to consumers and retailers,” Mr. Zhabilov said. “Retailers know consumer interest in dietary supplements has been increasing. Consumers want to take a proactive approach to their health, which is why they are turning to dietary supplements,” he added. “Retailers are taking note of this trend.”

The Company is also investigating the sale and distribution of IPF Immune™ in foreign countries. The Company is focused on sales in the U.S., Latin America, and Europe. The Latin American nutritional supplements market was valued at US $48.10 Billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 8.1% from 2022 to 2030. The increasing consumer awareness regarding personal health and well-being is one of the key drivers of the market, with 77 percent of U.S. adults taking dietary supplements. The Company's IPF Immune™ product is expected to command a meaningful market share as an effective nutritional supplement.

The Company is Now Deploying its Monoclonal Antibody Technology for the Treatment of Animal Viruses.

While the Company's focus is on producing monoclonal antibodies for treating human viruses, the Company is now applying its technology in the production of monoclonal antibodies against animal viruses, including Feline Leukemia Virus (FeLV) and Feline Immunodeficiency Virus (FIV). The Company has analyzed, using Artificial Intelligence (AI), epitopes of these viruses and have identified conserved sites against which targeting monoclonal antibodies are being developed. The Company has also analyzed epitopes of the Equine Infectious Anemia Virus, Koala Retrovirus, Elephant Endotheliotropic Herpes Virus (EEHV), Avian Flu Swine Flu, and others. This analysis has revealed the conserved immutable sites on these viruses against which monoclonal antibody production is planned.

 Targeting the conserved sites discovered by Enzolytics allows the production of a therapeutic that will not be rendered ineffective due to mutation (variants) of the virus. Even a “variant form of the virus” will contain the immutable targeted sites. Targeting immutable sites avoids the ineffectiveness that is experienced when a therapeutics or vaccine targets a site that has mutated.
Enzolytics is combining its technology in a collaboration with Abveris, a division of Twist Bioscience Corporation, for the application of the Company’s methodology to produce monoclonal antibodies against human and animal viruses. The collaboration makes possible the combination of the synergistic technologies of the two companies in producing monoclonal antibodies against numerous pathogenic viruses. https://www.nasdaq.com/press-release/enzolytics-inc.-announces-collaboration-with-abveris-to-discover-monoclonal.

This process of producing monoclonal antibodies for the treatment of FeLV and FIV is proceeding with the objective of producing antibodies for the treatment of Feline Leukemia Virus and Feline Immunodeficiency Virus, viruses that are one of the most common infectious diseases in cats. There are more than 150 million cats in the U.S. and over 25% of households in America own cats. These Feline viruses affect 3% of the cat population in the United States, resulting in over 4 million cats suffering from these viruses. This same problem exists around the world. Production of monoclonal antibodies targeting these viruses will be more direct and the time to treatment will be significantly less than is the case required for monoclonal antibodies developed for the treatment of individuals. The Company has initiated discussions with animal health providers who express an interest in this technology and its end product.

 The production of these monoclonal antibodies begins in the Company’s lab located at the Texas A&M University Institute for Preclinical Studies [https://tips.tamu.edu/]. The lab uses the Company's proprietary methodology for producing fully human monoclonal antibodies which target conserved, immutable sites on the viruses, thereby avoiding ineffectiveness due to virus mutation.

The methodology implemented by the Company to produce monoclonal antibodies is proprietary and the subject of pending international patent applications. In the initial process step, Artificial Intelligence (computer analysis - AI) is used to identify conserved, immutable epitopes on the target virus utilizing Enzolytics' proprietary AI platform. In the AI initial analysis process step, the sequences (structure) of virus isolates are analyzed. From that analysis, epitopes (target sites) are identified which are conserved across all isolates curated. The Company production process is then employed to produce monoclonal antibodies targeting these identified conserved sites.

As a part of this process, 3 Dimensional models of these conserved targets are generated, and the targets may be analyzed for linearity, accessibility by antibodies, and neutralizability by antibodies. Then Enzolytics produces multiple broadly neutralizing antibodies targeting these multiple conserved, immutable epitopes on the targeted virus.

Enzolytics' methodology for producing monoclonal antibodies is unique and innovative, unlike those employed by other biotech companies. In the case of a monoclonal antibody to treat an animal virus, the Company's antibodies are produced from animal "immune-B cells", obtained from convalescent animals who have recovered from the target virus. The Company's monoclonal antibodies are then developed directly where the original antibody affinity and specificity are maintained, and the chances of immunogenicity are minimized.

Enzolytics’ Focus on Intellectual Property (I.P)

“As Enzolytics advances its science and clinical products, the Company continues to build a robust Intellectual Property portfolio”, said Gaurav Chandra, MD, the Company COO. “The focus is on gaining competitive advantage through an aggressive patent strategy.” This comprehensive program is described in detail in the Company's Press release of March 25, 2022, and on the Company New page of its website (https://enzolytics.com/company-news/).

Charles Cotropia, the Company CEO, said, “The international patent system is an optimum way for a small biotech company to lay claim, for a 20-year period dating back to an early priority date, to significant intellectual property even before or without bringing the therapeutic to market. The filing of a patent application serves as a constructive reduction to practice of the subject matter described in the application. In this way, we are taking every opportunity to cover the waterfront on all of the viruses we are fully analyzing.”

The Company is the exclusive worldwide licensee of each of the patents and applications covering its technologies. Any assertions by others to the contrary are false claims. The company’s patent portfolio ownership if verified in Patent Office records. These patents include:
1. Fully human anti-HIV monoclonal antibodies and vaccines covered by PCT Patent Application No. PCT/US2022/020682. The Company's pending PCT patent application cover the multiple highly conserved antigens and epitopes of the HIV virus that can be used in vaccines and to produce bindings proteins (e.g., monoclonal antibodies) for detecting, treating, preventing, or reducing the risk of HIV infection
2. Anti-Corona Virus monoclonal antibodies and vaccine covered by PCT Patent Application No. PCT/US2022/016926. The Company's pending PCT patent application claims the 19 highly conserved antigens and epitopes of SARS-CoV-2 that can be used in vaccines and to produce bindings proteins (e.g., monoclonal antibodies) for detecting, treating, preventing, or reducing the risk of SARS-CoV-2 infection. In these applications, the Company has claimed its discoveries including the use of these identified conserved epitopes for (1) use in any diagnostics to identify whether a person has HIV or the CoronaVirus, (2) producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus, and (3) producing a vaccine against HIV or the CoronaVirus.
3. Artificial intelligence platform for use in diagnosing COVID-19 and HIV covered by PCT Patent Applications. The Company's patent claims cover the use of any one identified epitope or any combination of any of the multiple identified epitopes in any of the following ways:
• For producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus.
• For producing a vaccine against HIV or the CoronaVirus.
• For producing related prophylactic/therapeutic methods relating to the epitopes/antigens.
• For use in any diagnostic test to identify whether a person has HIV or the CoronaVirus.
4. The Company will file patent applications on its discovery leading to the production of monoclonal antibodies against Feline Leukemia Virus (FeLV) and Feline Immunodeficiency Virus (FIV) and other animal viruses.
5. ITV-1 - a clinically tested anti-HIV therapy is covered by U.S. Patent Nos. 8,066,982 and 7,479,538. The final production process requires Company proprietary technology.
6. IPF Immune™ - a currently marketed immune supplement, is covered by U.S. Patent No. 8,309,072. The patent covers using an Irreversibly inactivated Pepsin fragment which has significant benefit as an immune supplement.

These issued patents cover the Company’s ITV-1 anti-HIV therapeutic and IPF Immune™. Supplemental patent applications are planned to cover improvements of ITV-1 and IPF Immune.

The PCT patent applications covering the anti-HIV and anti-Coronavirus monoclonal antibodies and the AI platform have received an initial PCT Patent Office review. In the anti-HIV PCT application, PCT/US2022/020682, “Human Immunodeficiency Virus (HIV) Antigens and Epitopes and Proteins That Bind Thereto”, the first PCT Patent Office search report found that inventions claimed were both novel and inventive and thus the Company is assured of the issuance in the final country prosecutions.
 
In the PCT/US2022/016926 application, “Coronavirus Antigens and Epitopes and Proteins That Bind Thereto”, in the first examination, not all of the 39 claims were examined. Examined claims were found to be inventive though not novel. The prior art references cited in reaching the conclusion of lack of novelty clearly do not disclosure or suggest the claimed target epitopes and thus the Company is confident that in the numerous countries in which the application will be finally prosecuted (each country having its own standard as to patentability), patent coverage will be granted. It is a regular occurrence that claims may be initially objected to but later allowed after argument and submission of relevant evidence to the Patent Office. This is particularly the case where not all the filed claims were the subject of any review and where the cited references do not disclose the epitope sequences claimed as is the case in this application. The 39 separate patent claims submitted in this application are drafted to cover varying inventions (1) the discovered highly conserved antigens and epitopes (sites) on the virus, (2) antibodies that bind to the disclosed antigens and epitopes, (3) vaccines based on the antigens, (4) methods of treating, preventing, or reducing the risks of infection with the antigens or binding proteins, and (5) methods and kits for detecting or diagnosing infection by using the antigens or binding proteins.
 
The Company fully expects that the patent claims sought in these applications will be issued in the U.S. and the foreign countries in which they will be advanced. The Company intends to prosecute the applications in all major countries around the world. The life for any patent issued is 20 years from the effective priority date.
 
Charles Cotropia, the Company CEO, said: “The breadth of patent coverage that is sought and expected is extremely far-reaching based on the discovery of the critical target epitope sites necessary to most effectively neutralize these viruses. The Company has identified conserved epitopes using its AI platform on multiple viruses other than HIV and CoronaVirus, namely including HIV-2, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Small-Pox, Ebola Virus, Tetanus, Diphtheria, HTLV-1/2, Rabies, Herpes zoster, Varicella zoster, Anthrax, Mason-Pfizer monkey virus (MPMV) and Visna virus (VISNA). These findings will also be the subject of protection through international patents. Our patent portfolio will be extensive”.

Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or any comparable regulatory agencies elsewhere in the world.

While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of its therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.

Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.

Enzolytics Inc. Announces Collaboration with Abveris to Discover Monoclonal Antibodies.

COLLEGE STATION, TX / ACCESSWIRE / September -16, 2022/ Enzolytics, Inc. (OTC Markets "ENZC" or the "Company"). 

Enzolytics, Inc. announces a collaboration with Abveris, a division of Twist Bioscience Corporation, to discover fully human monoclonal antibodies against multiple viruses. Abveris applies advanced immunization methods combined with B cell screening and hybridoma-based antibody discovery technologies to provide comprehensive gene-to-antibody discovery services.

The collaboration makes possible the combination of the synergistic technologies of the two companies in discovering monoclonal antibodies against numerous pathogenic viruses. Under the terms of the collaboration, Abveris (also known as Twist Boston) will utilize human patient donor peripheral blood mononuclear cell (PBMC) samples and peptide screening tools provided by Enzolytics to perform rapid B cell screening and identify antigen-binding antibodies for further characterization by Enzolytics. The companies will initially focus on discovering antibodies targeting SARS-CoV-2. 

Enzolytics’ focus is on producing fully human monoclonal antibodies targeting multiple viral infectious diseases, including SARS-CoV-2, HIV-1, Feline Leukemia virus, and Feline Immunodeficiency virus. The Company's antibodies are produced from human "immune-B cells" obtained from convalescent individuals who have recovered from the target virus. The Company’s Artificial Intelligence (AI) platform is used to identify highly conserved, immutable target sites on viruses. Production of antibodies targeting these conserved sites on the viruses will result in the production of antibodies that are not rendered ineffective by virus mutation. These fully human monoclonal antibodies have the original antibody affinity and specificity and minimized chances of immunogenicity. 

This collaboration allows Enzolytics to significantly expedite the production of monoclonal antibodies against the numerous human and animal viruses which Enzolytics has analyzed using its AI platform. 

"We have been impressed by Abveris' track record of discovering and delivering therapeutic antibodies," said Dr. Gaurav Chandra, Chief Operating Officer of Enzolytics. "To efficiently block COVID-19 infections and transmission, we need to get high levels of secretory IgA, reflecting mucosal immunity. Abveris will identify promising monoclonal antibody candidates via function-forward, high-resolution screening under expedited timelines.

This partnership with Abveris complements our efforts to significantly expand our antibody portfolio. We look forward to collaborating with Abveris to move us closer to our goal of expediently developing therapies for both human and veterinary use."

ITV-1 anti-HIV Therapeutic

August 22, 2022

The Company’s ITV-1 anti-HIV therapeutic is in production and the Company is proceeding with steps to advance it through approval under the European Medicines Act (EMA). Toxicology studies are ongoing and near completion in the Company’s partnering California lab. The results of these tests will be reported as they are completed. Simultaneously, the ITV-1 therapeutic is proceeding through the necessary multi-stage production process in the Company’s partnering lab in Europe. The current ongoing production of ITV-1 will be used in clinical trials conducted under the EMA guidelines. Early production of ITV-1 will be submitted to health care entities in Africa, where testing and use of the therapeutics are expected to be made possible before EMA approval.

To meet EMA requirements, the Company has engaged European medical specialists to guide the therapeutics through the EMA process. The Company's Board Advisor, Dr. Lachezar Ivanov, and the Company CSO Harry Zhabilov, in conjunction with medical field advisors in Europe, are managing this process for introducing ITV-1 to E.U. countries under the EMA.

The Company is also focused on providing its anti-HIV therapeutics to the African continent due to the tremendous need in African countries for effective and affordable treatment. The Company plans to make ITV-1 available in countries in Africa, including Rwanda, the Democratic Republic of Congo, Angola, Kenya, and South Africa and the Company is coordinating the introduction of ITV-1 for use in these countries as soon as possible. This is significant, recognizing that out of the 39 million HIV-positive people worldwide, 69% live in sub-Saharan Africa. There are roughly 23.8 million infected persons in all of Africa. In addition, 91% of the world's HIV-positive children live in Africa. More than 45% of the African population who have HIV do not have any access to the anti-retroviral treatment used in other countries to treat but not cure HIV.

The beneficial effects of ITV-1 are significant and will be complimentary to other treatments but at a lower cost and available to the over 45% of infected individuals in Africa who have no access to any treatment, including antiretrovirals which are used in other countries around the world for treating HIV patients.

Positive Therapeutic Effects of ITV-1

Prior European clinical trials have demonstrated the following beneficial effects of ITV-1.

  • ITV-1 inhibits the infection of CD4 T-cells by HIV.
  • It reduces HIV viral loads.
  • Replaces or complements current anti-retroviral therapies.
  • It is potentially less costly and much less toxic.
  • It may be effective as a periodic therapy instead of a daily one.
  • It is unaffected by HIV mutations that can hamper anti-retroviral therapies (HAART).
  • Tests have shown an 80.5% drop in viral loads.
  • It raises CD4 T-cell counts to healthier levels, with a 68% increase in CD4+T-lymphocytes.
  • Use achieved an increase in the CD4/CD8 index.
  • It demonstrated an excellent effect on opportunistic infections.
  • It had good compatibility with other anti-retroviral drugs.
  • There was good tolerance without any side effects.
  • Use resulted in a decrease in the absolute number and the relative percent of CD8 lymphocytes.
  • It boosts the immune system to fight HIV infections.

ITV-1 has benefits that anti-retrovirals do not and may be used in situations where anti-retrovirals are not appropriate.

  • Anti-retroviral therapies have serious side effects. In addition, they do not cure a patient.
  • HIV infections are most treatable during their earlier stages, and patients cannot take antiretrovirals during earlier stages since drug resistance often develops.
  • There are limited or few treatment options available when viral load and CD4 cell counts are at their worst, i.e., AIDS.

The Company’s IPF Immune ™ dietary supplement

Enzolytics IPF Immune™ will be available in numerous sales outlets throughout the U.S. Delays in producing sufficient quantiles for the market are being addressed. These delays have provided time for increasing production capability to meet demand. The company’s market research has indicated significant demand for IPF Immune™.

The nutritional supplement market is large and growing annually. The global dietary supplements market was valued at $151.9 Billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 8.9% from 2022 to 2030. Over the forecast period, increasing consumer awareness of personal health and wellbeing is expected to be a key driving factor for dietary supplements. In addition, increasing dependence on supplements to fulfill the nutrient requirements owing to their high convenience is expected to drive the market upwardly over the forecast period. The U.S. market for dietary supplements leads the North American market and matches the European market.

The Company is making plans for the sale of the IPF Immune™ product in numerous countries in Europe, Latin America, Australia, and Canada. These plans include engaging with promoters and distribution representatives in these countries. Just like in the U.S., each country's nutritional supplement market is large and growing rapidly. In addition, because the product is produced in Europe, providing the product to European markets will be easier and less expensive, providing a more significant profit margin to the Company.

Regarding marketing, the Company has engaged a marketing specialty firm that will use "computer analytics" to target individuals who are specifically searching for a nutrition supplement with the properties of IPF Immune™. Such focus will greatly increase sales of this new product while reducing advertising costs.

Production of Monoclonal Antibodies

Enzolytics' U.S. lab at the A&M Institute for Preclinical Studies is focused on producing fully human monoclonal antibodies targeting multiple infectious disease​s​, including SARS-CoV-2, HIV-1, Feline Leukemia virus and Feline Immunodeficiency virus. The lab uses the Company's proprietary methodology for producing fully human monoclonal antibodies which target conserved, immutable sites on the viruses, thereby avoiding ineffectiveness due to virus mutation.

The methodology implemented by the Company to produce monoclonal antibodies is proprietary and the subject of pending international patent applications. In the initial process step, Artificial Intelligence (computer analysis - A.I.) is used to identify conserved, immutable epitopes on the target virus utilizing Enzolytics' proprietary A.I. platform invented by Dr. Gaurav Chandra the Company COO. In the A.I. initial analysis step, the sequences (structure) of over 2 million Coronavirus isolates have been analyzed. From that analysis, 19 epitopes (target sites) have been identified as immutable and conserved across all 2 million isolates. The Company production process is then employed to produce monoclonal antibodies targeting these identified conserved sites.

As a part of this process, 3 Dimensional models of these conserved targets are generated, and the targets are analyzed for linearity, accessibility by antibodies, and neutralizability by antibodies. Then Enzolytics’ scientists produce multiple broadly neutralizing antibodies targeting these multiple conserved, immutable epitopes on the targeted virus.

Enzolytics' methodology for producing monoclonal antibodies is innovative, unlike those employed by other biotech companies. The Company's antibodies are produced from human "immune-B cells," obtained from convalescent individuals who have recovered from the target virus. The Company's monoclonal antibodies are not "humanized" but are fully human monoclonal antibodies where the original antibody affinity and specificity are maintained, and the chances of immunogenicity are minimized.

The team then produces broadly neutralizing antibodies using various techniques. The Company is partnering with a biotech company with specialized capabilities for accelerating process steps to speed production. This new strategy will allow the Company to reduce the time to completion significantly. In addition to the already produced anti-HIV monoclonal antibody Clone 3, the Company is focused on producing monoclonal antibodies for treating HIV-1, SARS-CoV-2, SARS-CoV-2, Feline Leukemia Virus (FeLV), and Feline Immunodeficiency Virus (FIV). However, the Company has identified the conserved and immutable epitope sites on 20 human and animal viruses, against which it plans to produce monoclonal antibodies for the treatment of those viruses.

This production process is highly technical and time-consuming. The process begins by creating the target epitopes identified using A.I. as sites fully conserved across millions of epitopes of the targeted virus. Then, the antibody creation process is conducted such that the produced antibodies are designed to neutralize by binding to these “Achilles heel” sites on the targeted virus.

Once produced, the monoclonal antibodies are tested for binding and neutralizing activity. These characteristics are confirmed by the Company's partnering laboratories, Genscript Labs, and the University of Strasbourg, France. After confirming antibody activity, the Company's CDMO partner Samsung Biologics produces recombinant antibodies in their proprietary, FDA-approved stable CHO cell line suitable for Clinical Application. https://www.bloomberg.com/press-releases/2021-10-07/enzolytics-inc-and-samsung-biologics-announce-development-and-manufacturing-agreement-for-anti-hiv-and-anti-sars-cov-2.

The plans are in place to proceed with animal studies to demonstrate the in-vivo efficacy of the monoclonal antibodies in partnership with European partners.

There is a significant role for mucosal immunity and secretory as well as circulating IgA antibodies in COVID-19. Therefore, Enzolytics focus on mucosal immunity for COVID-19. Enzolytics firmly believe that mucosal immunity can be exploited for beneficial diagnostic, therapeutic, or prophylactic purposes.

Enzolytics has created Class switched IgA1/2 Clone 3 Antibodies. This therapy will expectedly provide a protective immunological defense against an initial exposure to HIV virus at mucosal surfaces, such as occurs in the passage of the virus from mother to child through maternal breastfeeding. HIV mucosal infection plays a critical role in virus transmission and AIDS pathogenesis, affecting mucosal surfaces of the gastrointestinal tract early on by depleting CD4+ T helper cells independently of the virus transmission route. Although current anti-retroviral therapy helps control HIV infection in most patients, it cannot eradicate the virus from the human host. Therefore, the development and use of HIV microbicides (i.e., topical pre-exposure prophylaxis) have become the most promising approach to preventing HIV transmission. Thus, the development of Class switched Clone 3 IgA1/IgA2 is highly significant.

Enzolytics is collaborating with companies to produce monoclonal antibodies for Feline Leukemia Virus (FeLV) and Feline Immunodeficiency Virus (FIV). Enzolytics has already identified a partner for the monoclonal antibodies targeting Feline Leukemia Virus (FeLV) and Feline Immunodeficiency Virus.

Enzolytics Patent Portfolio and Strategy

As of August 19, 2022, the Company has three (3) pending Patent Cooperation Treaty (PCT) Patent applications covering its fully human monoclonal antibodies targeting the CoronaVirus and HIV. Additional patent applications are being prepared to cover the numerous viruses against which the Company plans to produce monoclonal antibodies.

In the first PCT Patent Office Official Action on the Company’s International Patent Application covering its discovery and exclusive claim to conserved antigens and epitopes of the HIV virus, the PCT International Search Report concluded that inventions claimed therein are novel and inventive and thus will expectedly be issued in final international patents. The Company’s International Patent application covers (1) the discovered highly conserved antigens and epitopes (sites) on the HIV virus, (2) antibodies that bind to the disclosed antigens and epitopes, (3) vaccines based on the antigens, (4) methods of treating, preventing, or reducing the risks of HIV infection with the antigens or binding proteins, and (5) methods and kits for detecting or diagnosing infection by HIV using the antigens or binding proteins. 

The Company discovered the claimed virus sites through computer analysis (Artificial Intelligence (A.I.)), wherein tens of thousands of HIV isolates were curated to identify these critical, conserved, immutable epitopes on the virus. These sites are now claimed as patentable based on their novel specificity and the finding that they are conserved on the HIV virus. This is significant in that by producing antibodies that attack these conserved, immutable sites, the virus can be neutralized rather than unaffected due to virus mutation that avoids the therapeutic.

The Company is producing fully human monoclonal antibodies against these claimed sites. The International Patent Office has now confirmed these discoveries to be novel and inventive, capable of being patented and claimed exclusively for a 20-year term in every member country under the Patent Cooperation Treat in which the Company pursues these claims.

Due to the novel nature of the Company’s discoveries, the Company fully expects the same favorable results in the PCT Patent Office for its pending applications covering epitopes (binding sites) on the CoronaVirus (covering all variants), on the Monkeypox Virus, and on numerous animal viruses, namely Feline Leukemia Virus (FeLV), Feline Immunodeficiency Virus (FIV), Elephant Endotheliotropic Virus, Equine Infectious Anemia, and Koala Retrovirus. The Company fully expects the issuance of multiple international patents covering these discoveries.

The Company's PCT applications also cover the identification of highly conserved antigens and epitopes of these viruses that can be used in the production of antibodies and the production of vaccines for treating, preventing, or reducing the risks of infections caused by these viruses.

The patents also cover the discovery of using these identified antigens and epitopes as targets for detecting and diagnosing viral infection. This is a significant development since these patents cover treatment and prevention and target detecting and diagnosing infections for all viruses pursued by Enzolytics.

In the Company's unique process, computer analysis (A.I.) was used to identify conserved, immutable epitopes on the target virus utilizing Enzolytics' proprietary A.I. platform invented by Dr. Gaurav Chandra, the Company COO. The sequences (structure) of over 87,500 HIV isolates were analyzed in the initial A.I. step for HIV, and for the Coronavirus, over 2 million SARS-CoV-2 virus isolates were curated. In the case of HIV, eight (8) epitopes (target sites) were identified and claimed in the Company's PCT application. As a part of this process, 3 Dimensional models of these conserved targets were generated, and the targets were analyzed for linearity, accessibility by antibodies, and neutralizability by antibodies. From this, Enzolytics' scientists are producing multiple broadly neutralizing antibodies targeting these multiple conserved, immutable epitopes on the targeted virus. As a result, the monoclonal antibodies produced against these targets will be universal, durable, broadly neutralizing, and unaffected by virus mutation. In the case of SARS-CoV-2, nineteen (19) conserved sites were identified and are claimed in the Company's pending PCT applications.

The Company considers the forthcoming patent protection highly significant in view of the following facts:

  • For a monoclonal antibody to be effective (that is, to be fully capable of neutralizing a virus), it must target an immutable site on the virus. Otherwise, a virus mutation will render the therapeutic ineffective.
  • The Company has analyzed over 2 million Coronavirus isolates and over 87,000 HIV isolates and has identified 19 conserved sites (98 to 99% conserved) on the Coronavirus and 8 conserved sites on the HIV virus.
  • The Company's patent claims cover these findings. From the most recent PCT International Patent Office Action, claims have been recognized as novel and Inventive. They thus can be expected to issue in the U.S. and many foreign countries pursued. The Company claims the use of anyone identified epitope or any combination of any of the multiple identified epitopes in any of the following ways:
    • For producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus.
    • For producing a vaccine against HIV or the CoronaVirus.
    • For producing related prophylactic/therapeutic methods relating to the epitopes/antigens.
    • For use in any diagnostic test to identify whether a person has HIV or the Coronavirus.

To accelerate and fully execute the successful production of the multiple monoclonal antibodies, the subject of the Company's intellectual property (specifically the numerous monoclonal antibodies (mAbs) targeting both human and animal viruses), the Company continuously engages with numerous entities to accelerate its progress toward production, testing, and delivery of successful therapeutics. Entities with whom the Company is working include other Biotech Companies having:

  • Technology and processes for accelerating the production of monoclonal antibodies that target critical virus sites identified by the Company using its A.I. platform. The Company has identified critical conserved target sites on 20 viruses, including human and animal viruses, and is engaging with biotech companies having expertise in accelerating the production of such antibodies.
  • Related, synergistic or complimentary therapeutics and business structure for the purpose of potential combination with other biotech entities.
  • Expertise in providing specialized peptides having precise amino acid sequences corresponding to the precise target sites on both the Coronavirus and HIV viruses which are then used in the Company’s Texas lab against which mAbs are being produced. This strategy accelerates the production of the mAbs for further development.
  • Specialized cell sorting technology that is complementary to the process used in the Company’s lab to accelerate production of mAbs for advancing production.
  • Expertise in hybridoma production techniques for producing mAbs using hybridoma methodologies complementary to the process used in the Company's lab.
  • Animal trials centers, both in the U.S. and abroad, for the preparation of animal trials.
  • Promotional entities with specialized expertise in targeting large funding sources for the purpose of raising the substantial funds needed for the production of the recombinant mAbs necessary for future trials and for conducting animal trials.

As to each of these entities and those with whom the Company currently works on an ongoing basis, the Company has entered into NDAs (Nondisclosure Agreements) necessary to preserve and protect the Company plans and intellectual property being discussed and exchanged between the parties. These contractual restrictions are critical for the Company and its partners. Maintenance of strict confidentiality is essential to preserving intellectual property rights (patent rights) which are now being sought and will be sought in the future. Premature disclosure of information can bar the right to seek patent protection at a later date. The Company is not able to share specific details regarding arrangements regarding these NDAs.

The term of these NDAs is not time limited. The term extends until the later of five (5) years from the Effective Date or "until such time as the proprietary information is publicly known and made generally available". This provision is necessary because under Patent Laws an issued patent may be invalidated where the patent is filed subsequent to public disclosure of the invention claimed. In view of this limitation, the Company makes no public disclosure of information subject to NDAs and inventions covered by them. Additionally, certain technical information shared with companies with whom the Company has entered into an NDA may not be included in a patent application, but rather the subject technical information is maintained as Company confidential ("secret") indefinitely. Also, in these Agreements, the parties generally agree not to reveal the names of the contracting parties for a specified period.

The Company is very confident in its Artificial Intelligence empowered Intellectual Property Portfolio. It has allowed the Company to claim exclusive rights on an international stage covering critical target sites on numerous human and animal viruses. This places the Company on an equal level with the largest biotech companies in that the Company is the first to identify and patent critical sites on many human and animal viruses. This same technology and strategy are being implemented by the Company on new viruses, human or animal. The Company identified the conserved sites on the Monkeypox Virus even before the World Health Organization declared it a global health emergency last week.

The Company believes that its extensive patent portfolio will provide a return on investment through partnering or licensing technology covered by multiple international patents.

Enzolytics Artificial Intelligence Platform 

Enzolytics has a wholly owned Artificial Intelligence platform that:

1. Permits early drug discovery and development
2. Builds an Intellectual Property Portfolio
3. Provides for strategic entry into the personalized medicine market

The Artificial Intelligence platform is being built under the leadership of Dr. Gaurav Chandra., the Company’s COO. The Healthcare A.I. market is expected to be $34 Billion in 5 years. This platform makes possible:

1. Creation of an artificial intelligence platform for Genomic Surveillance and monitoring of virus epidemiology
2. Application of A.I. to analyze the amino acid sequences of the targeted viruses to identify conserved immutable and neutralizable sites on the targeted viruses.
3. A comprehensive A.I. protocol for the production of monoclonal antibodies, including implementing A.I. Analysis of existing viruses and any new virus immediately upon its emergence globally.
4. Collaboration with biotechnology companies and veterinary institutions in early drug discovery and development programs, increasing safety, efficacy, and probability of success.
5. An envisioned consortium to assess the effects of Genetics, Nutrition, and Human Microbiome on infectious diseases, mental health disorders, and chronic medical diseases.
6. Collaboration with technology companies to offer solutions with Global Pandemic Preparedness

Enzolytics A.I. platform is unique because it has been driving the Company’s discoveries and drug development. A.I. has helped Enzolytics move beyond big pharma's monoclonal antibody discovery and development. As a result, Enzolytics continues to forge ahead with the immediate strategy to identify novel biomarkers and therapeutic targets, design innovative diagnostic and prognostics tests, and expand the Company's Patent portfolio. Enzolytics' long-term plan is to be a serious contender in the personalized medicine market. Enzolytics continues to partner with technology, genetics, diagnostic and regulatory companies with that strategy in each of these areas:

1. Artificial Intelligence Platform for Genomic Surveillance and monitoring of virus epidemiology 

2. Application of A.I. to analyze the amino acid sequences of the targeted viruses to identify conserved immutable and neutralizable sites on the targeted viruses. An extensive A.I. analysis of 2.8 million SARS-CoV-2 isolates confirmed the 19 immutable sites to be conserved in ALL Variants of Concern and Variants of Interest. The Company's Artificial Intelligence platform has been used to build 3D Models of all the 19 conserved targets. The analysis of the SARS-CoV-2 spike protein revealed that all epitopes identified by the Company are linear on the spike proteins, accessible by antibodies, neutralizable, and unaffected by mutations. An extensive A.I. analysis of 87,500 HIV isolates and confirmed 8 immutable sites on the HIV virus. A.I. confirmed the KLIC amino acid binding site sequences targeted by the Company's primary anti-HIV monoclonal antibody is 100% conserved. The KLIC binding site on the HIV virus has remained unchanged for decades, as confirmed by the Company's analysis of the Los Alamos National Database of HIV sequences. This means that even mutations of the HIV virus will contain this neutralizable site, and virus escape will not occur in treatment with the Company's anti-HIV antibody.

3. A comprehensive A.I. protocol for producing monoclonal antibodies, including implementing A.I. analysis of existing viruses and any new virus immediately upon its emergence globally. Dr. Chandra discusses the significance of this protocol in an article published in The Yuan on December 20, 2021. https://www.the-yuan.com/191/AI-Provides-Key-to-Pandemic-Preparedness.html

4. Collaboration with biotechnology companies and veterinary institutions in early drug discovery and development programs, increasing safety, efficacy, and probability of success. A joint paper published by Enzolytics in conjunction with Intel Corporation provides more details regarding this collaboration. https://www.intel.com/content/www/us/en/healthcare-it/resources/enzolytics-whitepaper.html

5. Enzolytics A.I. Human Microbiome Consortium.

A.I. is a significant driver for advancing healthcare. Understanding the Human Microbiome will be pivotal to that transformation, to unlock the potential of the Human Microbiome by utilizing Artificial Intelligence.

Enzolytics is building on the consortium to utilize A.I. to assess the effects of nutrition, genetics, and the human microbiome on diseases. This is a part of the Company's long-term strategy to enter the personalized medicine market and build a strong I.P. portfolio.

1. Build prediction models for infectious diseases (preferably COVID), mental health disorders, and chronic medical diseases.

2. Identify biomarkers for infectious diseases and chronic medical diseases.

3. Identify novel targets and clear intervention strategies for infectious and chronic medical diseases.

A.I. Driven Diagnostics

Enzolytics is developing Artificial Intelligence for use in in-vitro diagnostic tests that diagnose viral diseases based on the presence of the conserved sites that remain unaffected by mutations. Enzolytics has identified conserved targets for many infectious diseases for humans and animals. The Company has identified conserved targets for Monkey Pox, SARS-CoV-2, HIV, rabies, influenza A, influenza B, HTLV1, Herpes, Smallpox, Ebola, Equine Infectious Anemia, Feline leukemia virus, Feline immunodeficiency virus, and Koala Retrovirus. The Company published information regarding these findings in its Press Release on February 21, 2022. https://www.accesswire.com/viewarticle.aspx?id=689605.

Documented studies show better clinical outcomes and delayed progression of diseases if patients have the antibodies to the conserved targets. Enzolytics is working on prognostic tests utilizing A.I. to predict the immune response before receiving viral therapy. This will allow physicians to understand if a patient will respond to a particular antiviral treatment. More information on this technology has been presented by Dr. Chandra, the Company's COO, published in The Yuan on April 4, 2022. https://www.the-yuan.com/269/AI-Driven-Diagnostics-Transform-Healthcare.html.

Enzolytics Advisory Board

Enzolytics continues to build a strong Advisory Board to support Enzolytics' leadership team in achieving the Company's goals and mission. In addition, the Company's Advisory Board is instrumental in fostering innovation and interfacing with potential biotech partners both in the U.S. and abroad.

Company Programs Funding

Given the large number of therapeutics being advanced by Enzolytics, the Company is focused on raising the necessary funds for the production and sale in the U.S. and abroad of IPF Immune™, final development of its anti-HIV ITV-1 therapeutic, accelerating the development of multiple monoclonal antibodies for human therapy, and production of animal monoclonal antibodies. The Company’s audit is being finalized, and the Company fully expects to be able to acquire the funding necessary to complete its multiple programs.

Enzolytics Announces the International Patent Office Search Report finding Novelty and Inventiveness in the Company’s Pending International Patent Application Covering its anti-HIV Monoclonal Antibodies.

COLLEGE STATION, TX / ACCESSWIRE / July 28, 2022 / Enzolytics, Inc.

(OTC Markets "ENZC" or the "Company"). In the first Official Action on the Company’s International Patent Application covering its discovery and exclusive claim to conserved antigens and epitopes of the HIV virus, the PCT International Search Report concluded that inventions claimed therein are novel and inventive and thus will expectedly be issued in final international patents.

The Company’s International Patent application covers (1) the discovered highly conserved antigens and epitopes (sites) on the HIV virus, (2) antibodies that bind to the disclosed antigens and epitopes, (3) vaccines based on the antigens, (4) methods of treating, preventing, or reducing the risks of HIV infection with the antigens or binding proteins, and (5) methods and kits for detecting or diagnosing infection by HIV using the antigens or binding proteins.

The claimed virus sites were discovered by the Company through computer analysis (Artificial Intelligence (AI)), wherein tens of thousands of HIV isolates were curated to identify these critical, conserved, immutable epitopes on the virus. These sites are now claimed as patentable based on their novel specificity and the finding that they are conserved on the HIV virus. This is significant in that by producing antibodies that attack these conserved, immutable sites, the virus can be neutralized rather than be unaffected as a result of virus mutation that avoids the therapeutic.

The Company is producing fully human monoclonal antibodies against these claimed sites. These discoveries have now been confirmed by the International Patent Office to be novel and inventive, capable of being patented and claimed exclusively for a 20-year term in every member country under the Patent Cooperation Treat in which the Company pursues these claims.

The Company expects the same favorable results in the PCT Patent Office for its pending applications covering epitopes (binding sites) on the CoronaVirus (covering all variants), on the Monkeypox Virus, and on numerous animal viruses, namely Feline Leukemia Virus (FeLV), Feline Immunodeficiency Virus (FIV), Elephant Endotheliotropic Virus, Equine Infectious Anemia, and Koala Retrovirus. The Company fully expects the issuance of multiple international patents covering these discoveries.

The Company's PCT applications also cover the identification of highly conserved antigens and epitopes of these viruses that can be used in the production of treating antibodies, and the production of vaccines for treating, preventing, or reducing the risks of infections caused by these viruses.

The patents also cover the discovery of using these identified antigens and epitopes as targets for detecting and diagnosing viral infection. This is a significant development since these patents cover not only treatment and prevention but also targets for detection and diagnosis of infections for all viruses being pursued by Enzolytics.

In the Company’s unique process, computer analysis (AI) was used to identify conserved, immutable epitopes on the target virus utilizing Enzolytics' proprietary AI platform invented by Dr. Gaurav Chandra, the Company COO. The sequences (structure) of over 87,500 HIV isolates were analyzed in the initial AI step for HIV, and for the Coronavirus, over 2 Million SARS-CoV-2 virus isolates were curated. In the case of HIV, eight (8) epitopes (target sites) were identified and claimed in the Company’s PCT application. As a part of this process, 3 Dimensional models of these conserved targets were generated, and the targets were analyzed for linearity, accessibility by antibodies, and neutralizability by antibodies. From this, Enzolytics' scientists are producing multiple broadly neutralizing antibodies targeting these multiple conserved, immutable epitopes on the targeted virus. The monoclonal antibodies produced against these targets will expectedly be universal, durable, broadly neutralizing, and unaffected by virus mutation. In the case of SARS-CoV-2, nineteen (19) conserved sites were identified and are claimed in the Company’s pending PCT applications.

The Company considers the forthcoming patent protection highly significant in view of the following facts:

  • For a monoclonal antibody to be effective (that is to be fully capable of neutralizing a virus), it must target an immutable site on the virus. Otherwise, a virus mutation will render the therapeutic ineffective.
  • The Company has analyzed over 2 Million Coronavirus isolates and over 87,000 HIV isolates and has identified 19 conserved sites (98 to 99% conserved) on the Coronavirus and 8 conserved sites on the HIV virus.
  • The Company’s patent claims cover these findings and from the most recent PCT International Patent Office Action, claims have been recognized as novel and Inventive and thus can be expected to issue in the U.S, and many foreign countries pursued. The Company claims the use of any one identified epitope or any combination of any of the multiple identified epitopes in any of the following ways:
    • For producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus.
    • For producing a vaccine against HIV or the CoronaVirus.
    • For producing related prophylactic/therapeutic methods relating to the epitopes/antigens.
    • For use in any diagnostic test to identify whether a person has HIV or the Coronavirus.

Enzolytics' methodology for producing monoclonal antibodies is unique and innovative, unlike those employed by other biotech companies. The Company's antibodies are produced from human "immune-B cells," obtained from convalescent individuals (or animals in the case of veterinarian monoclonal antibodies) who have recovered from the target virus. The Company's monoclonal antibodies are not "humanized" but are fully human monoclonal antibodies where the original antibody affinity and specificity are maintained, and the chances of immunogenicity are minimized.

To accelerate and fully execute in the successful production of the multiple monoclonal antibodies the subject of the Company’s intellectual property (specifically the numerous monoclonal antibodies (mAbs) targeting both human and animal viruses), the Company continuously engages with numerous entities to accomplish the successful goal of production, testing and delivery of successful therapeutics. Entities with whom the Company is working includes other Biotech Companies having:

  • Technology and processes in related, synergistic or complimentary therapeutics and business structure for the purpose of potential combination.
  • Expertise in providing specialized peptides having precise amino acid sequences corresponding to the precise target sites on both the Coronavirus and HIV viruses which are then used in the Company’s Texas lab against which mAbs are being produced. This strategy accelerates the production of the mAbs for further development.
  • Specialized cell soring technology that is complementary to the process used in the Company’s lab to accelerate production of mAbs for advancing production.
  • Expertise in hybridoma production techniques for production of mAbs using hybridoma methodologies that are complementary to the process used in the Company’s lab.
  • Animal trials centers, both in the U.S. and abroad, for preparation of animal trials.
  • Promotional entities with specialized expertise in targeting large funding sources for the purpose of raising the substantial funds needed for the production of the recombinant mAbs necessary for future trials and for conducting animal trials.

As to each of these entities, and those with whom the Company currently works on an ongoing basis, the Company has entered into NDA’s (Nondisclosure Agreements) necessary to preserve and protect the Company plans and intellectual property being discussed and exchanged between the parties. These contractual restrictions are critical for the Company and its partners. Maintenance of strict confidentiality is absolutely essential to preserving intellectual property rights (patent rights) which are now being sought and which will be sought in the future. Premature disclose of information may and generally does bar the right to successfully seek patent protection at a later date. The Company is not able to share specific information regarding arrangements regarding these NDA’s.

Charles Cotropia, the company CEO, said, "We are very confident in our Artificial Intelligence empowered Intellectual Patent Portfolio. It has allowed us to claim exclusive rights on an international stage covering critical target sites on numerous human and animal viruses. This places our relatively small company on an equal level with the largest biotech companies in that we are the first to identify and patent critical sites on these many human and animal viruses. This same technology and strategy is being implemented by the Company continuously on new viruses, human or animal. We note that we have identified the conserved sites on the Monkeypox Virus even before the World Health Organization declared it a global health emergency last week. An extensive patent portfolio will provide a return on investment through partnering or licensing technology covered by multiple international patents."

Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC.

While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of its therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.

Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.

Company Contact:
Enzolytics, Inc.
Texas A&M Institute for Preclinical Studies
Enzolytics, Inc.
800 Raymond Stotzer Parkway
College Station, Texas 77843-4478

Enzolytics Announces the Discovery of Conserved

Target Sites on the Monkeypox virus.

COLLEGE STATION, TX / ACCESSWIRE / June 21, 2022 / Enzolytics, Inc.

(OTC Markets "ENZC" or the "Company") today announced it has identified conserved, immutable sites (epitopes) on the Monkeypox virus. These discoveries are a part of Enzolytics' continuing efforts to address future healthcare needs in pandemics using its Comprehensive Artificial Intelligence (AI) protocol for producing Monoclonal Antibodies, including implementing AI analysis of existing viruses and any new virus immediately upon its emergence globally.

The Chief Operating Officer, Dr. Gaurav Chandra, said, "We continue to make rapid strides with our Artificial Intelligence Platform. Our unique AI platform has been driving the Company's discoveries and drug development. Enzolytics has a robust Artificial Intelligence Platform for genomic surveillance and monitoring of viral epidemiology that is used to identify conserved targets for produced Monoclonal Antibodies. The Company's Artificial Intelligence platform has also been used to build AI-generated 3D Models of all the conserved targets. The analysis of these conserved sequences revealed that all epitopes identified by the Company are linear, accessible by antibodies, and unaffected by mutations. Therefore, Monoclonal Antibodies produced against these targets will expectedly be universal, durable, broadly neutralizing, and unaffected by virus mutation."

Monkeypox is a zoonotic orthopoxvirus that incidentally causes disease in humans similar to smallpox, although with notably lower mortality. Two types (West African-usually, seen in Nigeria, and Central African-usually, seen in the Congo River Basin) have a higher case fatality rate, approx. 10.6%. Between 1 January to 15 June 2022, a cumulative total of 2103 laboratory confirmed cases, one probable case, and one death have been reported to WHO from 42 countries.

The public health risk could become high if this virus exploits the opportunity to establish itself as a human pathogen and spreads to groups at higher risk of severe diseases such as young children and immunosuppressed persons. According to a WHO risk assessment issued 06/12/22, "immediate action from countries is required to control further spread among groups at risk, prevent spread to the general population and avert the establishment of Monkeypox as a clinical condition and public health problem in currently non-endemic countries.”

The vaccines available to combat Monkeypox have significant drawbacks that many other therapies do not. The smallpox vaccine is approximately 85% effective in preventing infection in close contacts and lessening the severity of the disease, but this vaccine has a significant side effect profile (including post vaccinal CNS disease, progressive vaccinia, and most commonly urticarial rashes), as it is a live vaccinia virus and cannot be used in populations most at risk from Monkeypox. It may be especially risky for infants or women who are pregnant or immunocompromised individuals or those with HIV.

Speaking on the role of Monoclonal Antibodies in targeting conserved sequences for Monkeypox, Dr. Suraj Saggar, an Advisory Board Member, said, “Monkeypox is a DNA virus and is less prone to random mutations during replication versus an RNA virus-like SARS-Cov2. The current virus outbreak reveals only minor genetic variations compared to strains first collected in the 1970s. However, if the virus becomes endemic in Europe and N. America, the pool of those infected becomes much more significant. In addition, the chances of mutation increase compared to when endemicity was constrained to Central/West Africa. Currently, the U.S. government agency CBRN (Chemical Biological Radiologic and Nuclear) Medical Countermeasures is looking at Monoclonal Antibodies for Monkeypox. Enzolytics will be ready to create Monoclonal Antibodies for Monkeypox if the situation requires it.” As with all of the significant discoveries made by the Company, Enzolytics is preparing patent applications to cover the identified neutralizable, immutable sequences and their use in the creation of anti-Monkeypox Monoclonal Antibodies, vaccines, and diagnostic tests.

The Company is making continuous progress on its many programs and therapeutics. The Company CEO, Charles Cotropia, said, “We have many collaborative partners with whom we work daily and are focused on expanding that list so that we can achieve, as soon as possible, our many therapeutic goals.”

About Enzolytics, Inc.
Enzolytics, Inc. is a drug development company committed to commercializing its proprietary proteins and monoclonal antibodies to treat debilitating infectious diseases. The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. In addition, its proprietary methodology, covered in its pending U.S./PCT Patent Application for producing fully human monoclonal antibodies, is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the CoronaVirus (SARS-CoV-2) and HTLV-1.

Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.

While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of its therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.
Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.

I.R. contact:
TEN Associates, LLC
Tom Nelson, CEO
(480) 326-8577

Company Contact:
Enzolytics, Inc.
Texas A&M Institute for Preclinical Studies
Enzolytics, Inc.
800 Raymond Stotzer Parkway
College Station, Texas 77843-4478

Enzolytics, Inc. Reports Progress and Future Plans

COLLEGE STATION, TX / ACCESSWIRE / April 25, 2022 / Enzolytics, Inc. (OTC PINK: ENZC)(https://enzolytics.com/).

Enzolytics continues to make significant progress in its multiple therapeutic platforms and outlines here the technical aspects of the implementation of those programs and the Company’s plans for the future.

Enzolytics Texas Laboratory 
Texas A&M University Institute for Preclinical Studies 

Enzolytics’ primary U.S. lab is focused on the production of fully human monoclonal antibodies targeting multiple infectious disease​s​, including SARS-CoV-2 and HIV-1. The lab uses the Company’s proprietary methodology for producing fully human monoclonal antibodies which target conserved, immutable sites on the viruses, thereby avoiding ineffectiveness due to virus mutation.

 The lab is located on the campus of Texas A&M University in the University’s ​Texas ​Institute for Preclinical Studies [https://tips.tamu.edu/] and is led by the Company’s Chief Science Officer, Dr. Joseph Cotropia.  Dr. Cotropia is assisted by multiple scientists with significant experience in the technology relating to production of monoclonal antibodies.

 The methodology implemented by the Company to produce monoclonal antibodies is proprietary and the subject of pending international patent applications. In the initial process step, Artificial Intelligence (computer analysis - A.I.) is used to identify conserved, immutable epitopes on the target virus utilizing Enzolytics' proprietary A.I. platform invented by Dr. Gaurav Chandra, the Company COO. In the A.I. initial analysis process step, the sequences (structure) of over 2 million Coronavirus isolates have been analyzed. From that analysis, 19 epitopes (target sites) have been identified as being immutable and conserved across all 2 million isolates curated. The Company production process is then employed to produce monoclonal antibodies targeting these identified conserved sites.

 As a part of this process, 3 Dimensional models of these conserved targets are generated, and the targets are analyzed for linearity, accessibility by antibodies, and neutralizability by antibodies. Then Enzolytics’ scientists produce multiple broadly neutralizing antibodies targeting these multiple conserved, immutable epitopes on the targeted virus.

 Enzolytics’ methodology for producing monoclonal antibodies is unique and innovative, unlike those employed by other biotech companies. The Company’s antibodies are produced from human “immune-B cells”, obtained from convalescent individuals who have recovered from the target virus. The Company’s monoclonal antibodies are not “humanized” antibodies but rather are fully human monoclonal antibodies where the original antibody affinity and specificity are maintained, and the chances of immunogenicity are minimized.

 The team then produces broadly neutralizing antibodies using three techniques:  1) Hybridomas, 2) Fluorescent Antibody Cell Sorting (FACS) technology, and 3) Phage Display technique. Currently, the laboratory is focused on the production of monoclonal antibodies for treatment of HIV-1, SARS-CoV-2, Feline Leukemia Virus (FeLV), and Feline Immunodeficiency Virus (FIV).

 This production process is highly technical, laborious and time consuming. The process begins by creating the target epitopes that have been identified using A.I. as sites that are fully conserved across millions of epitopes of the targeted virus. Then, the antibody creation process begins with millions of cells from the donor’s peripheral blood and follows a process where over a period of many months, the million cells are processed to identify a single cell line that produces a single monoclonal antibody that binds to the single targeted epitope that is a conserved site on the subject virus.

 Once produced, the monoclonal antibodies are then tested for binding activity and neutralizing activity. These characteristics are confirmed, by the Company’s partnering laboratories, Genscript Labs and the University of Strasbourg, France, respectively. After the final confirmation of antibody activity, the Company’s CDMO partner Samsung Biologics produces the recombinant antibodies in their proprietary, FDA approved stable CHO cell line suitable for Clinical Application. https://www.bloomberg.com/press-releases/2021-10-07/enzolytics-inc-and-samsung-biologics-announce-development-and-manufacturing-agreement-for-anti-hiv-and-anti-sars-cov-2.

Upon completion of these steps, animal and then clinical trials will be conducted.

 Enzolytics Laboratory
Dallas, Texas

Positive Therapeutic Effects of ITV-1

The following beneficial effects of ITV-1 have been demonstrated in clinical trials in Europe.

  • ITV-1 inhibits the infection of CD4 T-cells by HIV.
  • It reduces HIV viral loads.
  • Replaces or complements current anti-retroviral therapies.
  • It is potentially less costly and much less toxic.
  • It may be effective as a periodic therapy instead of a daily one.
  • It is unaffected by HIV mutations that can hamper anti-retroviral therapies (HAART).
  • Tests have shown an 80.5% drop in viral loads.  
  • It raises CD4 T-cell counts to healthier levels, a 68% increase in CD4+T-lymphocytes.  
  • Use achieved an increase in the CD4/CD8 index. 
  • It demonstrated good effect on opportunistic infections. 
  • It had good compatibility with other anti-retroviral drugs. 
  • There was good tolerance without any side effects. 
  • Use resulted in a decrease in the absolute number and the relative percent of CD8 lymphocytes 
  • It boosts the immune system to fight HIV infections.

ITV-1 has benefits that antiretrovirals do not and may be used in situations where antiretrovirals are not appropriate.

  • Anti-retroviral therapies have serious side effects. They do not cure a patient.
  • HIV infections are most treatable during their earlier stages, and patients cannot take antiretrovirals during earlier stages since drug resistance often develops.
  • There are limited or few treatment options available when viral load and CD4 cell counts are at their worst, i.e., AIDS.

ITV-1 Production for Sale

Upon completion of scheduled toxicology studies, the ITV-1 therapeutic will be made available in the countries in Africa, including Rwanda, the Democratic Republic of Congo, Angola, Kenya and South Africa. Dr. Chandra is coordinating the introduction of ITV-1 for individuals in Africa. This is significant, recognizing that out of the 34 million HIV-positive people worldwide, 69% live in sub-Saharan Africa. There are roughly 23.8 million infected persons in all of Africa. In addition, 91% of the world's HIV-positive children live in Africa.

Prior successful Clinical Trials were completed earlier under the Bulgarian Drug Agency requirements. The Company plans to complete further clinical trials to fulfill EMA requirements to launch the therapy in the EU followed by seeking FDA approval for use in North America.

The Company has engaged Scendea (https://www.biospace.com/article/enzolytics-reports-its-engagement-of-scendea-usa-inc-a-leading-international-product-development-and-regulatory-consulting-group-to-guide-the-progress-toward-clinical-trials-and-market-approval-for-its-itv-1-anti-hiv-therapeutic/) to assist in introducing ITV-1 to EU countries through the EMA and to North America through FDA. Scendea (https://www.scendea.com) is a leading product development and regulatory consulting group serving the pharmaceutical and biotechnology industry. Scendea’s service will focus on reducing time-to-market and minimizing development costs. Scendea's team offers strategic and operational support in quality/CMC, non-clinical/toxicology, clinical/medical, and regulatory, guiding the Company's ITV-1 therapy efficiently to market approval.

In the approval process, Scendea’s critical role is finalizing a comprehensive clinical development plan based on the prior clinical trials completed earlier, preparing a CMC non-clinical Gap analysis, and a necessary EU Regulatory Strategy.

Thereafter, CMC and GMP Requirements for FDA and EMA will be completed under the direction of Eurofin, followed by production of ITV-1 as per EMA and FDA requirements and Fast-Tracked Clinical Trial to fulfill EMA and FDA requirements 

ITV-1 and HIV Monoclonal Antibodies Sales Potential
Acquired Immunodeficiency Syndrome (AIDS) is considered to be one of the most serious and chronic diseases, caused by the human immunodeficiency virus (HIV). The prevalence of HIV is souring at a significant rate. According to the World Health Organization (WHO), an estimated 34 million individuals are currently living with the HIV virus. Due to an increased awareness among people, there is now an increase in testing which has led to a surge in demand for HIV medications. 

Today, there is no cure for HIV. The virus and its disease are treated by administering antiretroviral (ARV) drugs that  do not cure and must be taken for life. The global HIV antiretroviral drugs market was $30.46 Billion in 2021 and is expected to rise to $45.58 billion in 2028, at a CAGR of 5.9% in the forecast period, 2021-2028.

The global HIV drug market size was $28.79 Billion in 2020. Even though sales rise was moderated during the height of the COVID pandemic, a steady growth of 5.7% in 2020 occurred. The market is expected to grow from $30.46 Billion in 2021 to $45.58 Billion in 2028. The rise in CAGR is attributable to this market's demand and growth, returning to pre-pandemic levels once the pandemic subsides. https://www.fortunebusinessinsights.com/industry-reports/hiv-aids-drugs-market-101115.

To address this dire situation, the Company is focused on both the production of its ITV-1 therapeutic and producing multiple anti-HIV monoclonal antibodies using its proprietary methodology as described above in this report. The Company’s ITV-1 has been successfully tested in clinical trials and the Company is initiating production.

The Company’s primary anti-HIV monoclonal antibody has been produced and successfully tested in vitro against multiple strains of the virus where it shows complete efficacy. The recombinant form of the parent antibody (necessary for patient therapy) has been successfully produced for the Company by Samsung Biologics. This recombinant antibody is currently undergoing efficacy testing in Europe. 

The Companies A.I. analysis, coupled with the ability to produce targeted monoclonal antibodies, allows the Company to produce effective antibodies against multiple viruses, both human and animal. With this focus, A.I. analysis has been completed on each of the following viruses in preparation for production of anti-monoclonal antibodies for use in treatment of these human and animal viruses: HIV-2, SARS-CoV-2, H1N1 Influenza, HTLV1 & HTLV2, Influenza A and B, Herpes Simplex I & II, Anthrax, Smallpox, Equine Infectious Anemia Virus, Feline Leukemia Virus, Feline Immunodeficiency Virus, Elephant Endotheliotropic Virus.

 The statistics for HIV are alarming.

  • Of the 34 Million individuals living with the HIV virus today, only 66% had access to antiretroviral treatment – leaving 34% with no treatment.
  • 1.7 million people become newly infected with HIV each year.
  • 1 Million people die yearly from AIDS-related illnesses. 2,700 die each day – over 300 are children (almost twice the number who die from cancer).
  • 32.7 million people have died from AIDS-related illnesses since the start of the pandemic.

Antiretroviral drugs have significant drawbacks.

  • They do not cure a patient and must be taken for life
  • They are extremely expensive.
    • The cost of Biktarvy by Gilead is $42,635 per year.
    • The cost of Dovato by ViiV Healthcare/GSK is $27,540 per year.
    • The cost of Dolutegravir/tenofovir is $48,000 per year.
    • It is well recognized (even by the producers of these drugs – as is publicly revealed in advertisements for the drugs) that these antiretroviral drugs cause serious damage over time to the heart and the kidneys, they decrease bone density, and they contribute to Vitamin D deficiency. These are only some of the potential negative side effects attributed to the therapies.
  • HIV infections are most treatable during their earlier stages, and patients cannot take antiretrovirals during earlier stages since drug resistance often develops.
  • Limited or no treatment options exist when viral load and CD4 cell counts are at their worst, i.e., AIDS.
  • The reason these ARV drugs do not cure is because they do not act on the virus in the same way that our ITV-1 therapeutics or our a monoclonal antibody can. In the case of using monoclonal antibodies, our technology is to produce monoclonal antibodies that target immutable, conserved epitopes on the virus so that a therapeutic cure may be achieved.

    The same is true with regard to the CoronaVirus. Because the virus mutates and will continue to mutate, to defeat it, it is imperative to produce therapeutics (in our case monoclonal antibodies) that target conserved, an immutable epitope on the virus (that is always present even in a mutant of the virus).

    To achieve such a therapy is not simple. The NIH in conjunction with Vaccine Research Center tried for years to produce a successful anti-HIV monoclonal antibody and failed. In clinical trials, their VRC01 and VRC02 monoclonal antibodies were found to fail due to “virus escape”, a euphuism for the fact that the antibody targeted a site that mutated and rendered the therapy ineffective.

    Due to the enormity of the HIV pandemic, it is understandable that a successful therapeutic that would replace the exorbitant cost of antiretrovirals, and would be affordable for the 34% of the 34 Million infected HIV individuals who have no access to treatment, would have enormous potential.

    An independent national consulting firm has calculated projected Earnings (Profit) from a successful HIV Monoclonal Antibody therapy. This analysis examined the expected potential profits from 2 perspectives: (1) considering sales only to North America and Western Europe and (2) considering sales to the major markets including North America, Western and Central Europe, Eastern Europe and Central Asia, South and Southeast Asia and Latin America. 

    An appropriate market for the Company's therapy includes the regions referred to as the "Major Markets," including North America, Western and Central Europe, Eastern Europe and Central Asia, South and Southeast Asia, and Latin America; wherein there are 10.6 million HIV positive individuals. Assuming a penetration rate of 1% rising to a maximum of 15% over five years, profit from making treatment available to these 10.6 million HIV-positive individuals in the 7 major world markets would be $105 Billion in the first 11 years. http://bioclonetics.com/profit-potential.html.

    An HIV vaccine against HIV has a much broader application and would produce significantly larger profits. 

    It should be noted that the above-referenced financial analysis focused only on what was termed the Major Markets and did not include expected sales in countries in Africa. However, providing anti-HIV therapeutics to Africa is a prime focus of the Company for a number of reasons. The Company’s therapeutics may be produced economically and supplied at a cost that would be optimum for the African continent. The African situation as to the HIV pandemic is a significant humanitarian issue and at the same time a significant opportunity for the Company to play a key role in addressing this humanitarian crisis.

    • Of the global total of 34 Million individuals living with HIV today, the vast majority—an estimated 23.5 Million or 69 percent—live in Sub-Saharan Africa. Of those infected, 8 Million, or 34%, receive no anti-retroviral treatment.
    • A 2020 preliminary analysis of data from 37 countries (mainly from South Africa) revealed that controlling for other factors, people with HIV were 30% more likely to die from COVID-19 among those hospitalized with the disease.
    • The popular anti-retroviral Biktarvy by Gilead costs $42,635 per year. 
    • The ARV Dovato by ViiV Healthcare/GSK costs is $27,540 per year.
    • The ARV Dolutegravir/tenofovir costs $48,000 per year.

    The Company plans to provide its ITV-1 therapeutic to countries on the African continent and this is expected to be achieved prior to full EMA approval for use in Europe.

    Enzolytics Artificial Intelligence Platform 

    Enzolytics has a wholly owned Artificial Intelligence platform that drives:

    1. Early Drug Discovery and Development
    2. Builds Intellectual Property Portfolio
    3. Strategic entry into the personalized medicine market

    The Artificial Intelligence platform is being built under the leadership of Dr. Gaurav Chandra., the Company’s COO. The Healthcare A.I. market is expected to be 34 billion USD in 5 years. Enzolytics A.I. platform is unique because it has been driving the Company’s discoveries and Drug development. A.I. has helped Enzolytics move beyond big pharma's monoclonal antibody discovery and development. As a result, Enzolytics continues to forge ahead with the immediate strategy to identify novel biomarkers and therapeutic targets, design innovative diagnostic and prognostics tests, and expand the Company’s Patent portfolio. Enzolytics' long-term plan is to be a serious contender in the personalized medicine market. Enzolytics continues to partner with technology, genetics, diagnostic and regulatory companies with that strategy in each of these areas:

    1. Artificial Intelligence Platform for Genomic Surveillance and monitoring of virus epidemiology 
    2. Application of A.I. to analyze the amino acid sequences of the targeted viruses to identify conserved immutable and neutralizable sites on the targeted viruses. An extensive A.I. analysis of 2.8 million SARS-CoV-2 isolates confirmed the 19 immutable sites to be conserved in ALL Variants of Concern and Variants of Interest. The Company's Artificial Intelligence platform has been used to build 3D Models of all the 19 conserved targets. The analysis of the SARS-CoV-2 spike protein revealed that all epitopes identified by the Company are linear on the spike proteins, accessible by antibodies, neutralizable, and unaffected by mutations. An extensive A.I. analysis of 87,500 HIV isolates and confirmed 8 immutable sites on the HIV virus. A.I. confirmed the KLIC amino acid binding site sequences targeted by the Company’s primary anti-HIV monoclonal antibody is 100% conserved. The KLIC binding site on the HIV virus has remained unchanged in the past decades as confirmed by the Company’s analysis of the Los Alamos National Database of HIV sequences. This means that even mutations of the HIV virus will contain this neutralizable site and virus escape will not occur in treatment with the Company’s anti-HIV antibody.
    3. A comprehensive A.I. protocol for producing Monoclonal Antibodies, including implementing A.I. analysis of existing viruses and any new virus immediately upon its emergence globally. The significance of this protocol is discussed by Dr. Chandra in an article published in The Yuan on December 20, 2021. https://www.the-yuan.com/191/AI-Provides-Key-to-Pandemic-Preparedness.html
    4. Collaboration with biotechnology companies and veterinary institutions in early drug discovery and development programs, increasing safety, efficacy, and probability of success. A joint paper published by Enzolytics in conjunction with Intel Corporation provides more details regarding this collaboration. https://www.intel.com/content/www/us/en/healthcare-it/resources/enzolytics-whitepaper.html
    5. Enzolytics A.I. Human Microbiome Consortium.

    A.I. is a significant driver for advancing healthcare, and understanding the Human Microbiome will be pivotal to that transformation, to unlock the potential of the Human Microbiome by utilizing Artificial Intelligence.

    Enzolytics is building on the consortium to utilize A.I. to assess the effects of nutrition, genetics, and the human microbiome on diseases. This is a part of the Company's long-term strategy to enter the personalized medicine market and build a strong I.P. portfolio.

    1. Build prediction models for infectious diseases (preferably COVID), mental health disorders, and chronic medical diseases.
    2. Identify biomarkers for infectious diseases and chronic medical diseases.
    3. Identify novel targets and clear intervention strategies for infectious diseases and chronic medical diseases.

    A.I. Driven Diagnostics 

    Enzolytics is developing Artificial Intelligence for use in in-vitro diagnostic tests that diagnose viral diseases based on the presence of the conserved sites that remain unaffected by mutations. Enzolytics has identified conserved targets for many infectious diseases for humans and animals. The Company has identified conserved targets for SARS-CoV-2, HIV, rabies, influenza A, influenza B, HTLV1, Herpes, Smallpox, Ebola, Equine Infectious Anemia, Feline leukemia virus, Feline immunodeficiency virus, and Koala Retrovirus. More information has been published by the Company in its Press Release of February 21, 2022. https://www.accesswire.com/viewarticle.aspx?id=689605

    Documented studies show better clinical outcomes and delayed progression of diseases if patients have the antibodies to the conserved targets. Enzolytics is working on prognostic tests utilizing A.I. to predict the immune response before receiving viral therapy. This will allow physicians to understand if a patient will respond to a particular antiviral treatment. More information on this technology has been presented by Dr. Chandra, the Company’s COO, published in The Yuan on April 4, 2022. https://www.the-yuan.com/269/AI-Driven-Diagnostics-Transform-Healthcare.html

    Intellectual Property (I.P). Portfolio 

    As Enzolytics advances its multiple scientific endeavors and clinical products, the Company continues to build a robust Intellectual Property portfolio. The focus is on gaining competitive advantage through an aggressive patent strategy. This comprehensive program is described in detail in the Company’s Press release of March 25, 2022 and on the Company New page of its website (https://enzolytics.com/company-news/). The highlights of the Company’s intellectual property are listed:

    1. ITV-1 – a clinically tested anti-HIV therapy covered by U.S. Patent Nos. 8,066,982 and 7,479,538. See attached pdf document.
    2. IPF Immune™ – a currently marketed immune booster covered by U.S. Patent No. 8,309,072.
    3. Fully human anti-HIV monoclonal antibodies and vaccines are covered by PCT Patent Application No. PCT/US/018672.
    4. Anti-Corona Virus monoclonal antibodies and vaccine covered by PCT Patent Application No. PCT/US/014916. The Company’s pending PCT patent applications cover the 19 highly conserved antigens and epitopes of SARS-CoV-2 that can be used in vaccines and to produce bindings proteins (e.g., antibodies) for detecting, treating, preventing, or reducing the risk of SARS-CoV-2 infection.
    In these applications, the Company has claimed its discoveries including the use of these identified conserved epitopes for (1) for use in any diagnostics to identify whether a person has HIV or the CoronaVirus, (2) for producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus, and (3) for producing a vaccine against HIV or the CoronaVirus.
    5. Artificial intelligence platform for use in diagnosing COVID-19 and HIV covered by PCT Patent Application Nos. PCT/US/020682 and PCT/US/014936. (The Company's patent claims cover the use of any one identified epitope, or any combination of any of the multiple identified epitopes in any of the following ways:

    • For producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus.
    • For producing a vaccine against HIV or the CoronaVirus.
    • For producing related prophylactic/therapeutic methods relating to the epitopes/antigens.
    • For use in any diagnostic test to identify whether a person has HIV or the CoronaVirus.

    Enzolytics Advisory Board

    Enzolytics continues to build a strong Advisory Board to support Enzolytics’ leadership team in achieving the Company’s goals and mission. The Company’s Advisory Board is instrumental in fostering innovation and interfacing with potential biotech partners both in the U.S. and abroad. 

    Enzolytics recently brought on board Dr. Suraj Kumar Saggar as an Advisory Board Member. https://www.biospace.com/article/releases/enzolytics-inc-announces-new-advisory-board-member/. Dr. Saggar brings to the Company his vast experience as a physician and healthcare research professional with an established track record of exceptional performance in healthcare operations, clinical trials, and regulatory compliance. He is a dynamic leader, physician, and healthcare research professional, and his vast experience and expertise, based on his background as an accomplished infectious disease specialist spanning two decades, will be a great asset to the Company. He complements the Company’s team of experienced scientists and advisors and adds a unique set of skills and background, given his accomplished career in infectious diseases.

    Enzolytics has also added Dr. Lachezar Bogomilov Ivanov to its Advisory Board. (https://www.parliament.bg/en/MP/1016 ). Dr. Ivanov acquired degrees in internal medicine from the ESPU-Sofia (European Society for Paediatric Urology) and the Medical Academy in Sofia.  He holds a Master's degree in health management. He has worked as a physician at the Razgrad Municipal Hospital in the field of obstetrics and gynecology.  He has served at the Military Medical Academy in Sofia as a physician with a specialty in anesthesiology, intensive care and pulmonology. Dr. Ivanov has also served as a member of Bulgarian National Assembly and as a member of Parliament. He has training in the fields of health services administration, marketing and promotion. He has served in positions coordinating initiations between the United States and Bulgaria relating to health care issues. 

    Dr. Ivanov brings significant academic and medical practice experience, and an understanding of the clinical practices in Bulgaria, and will guide the Clinical Trials for the Company’s ITV-1 therapeutic in accordance with EMA requirements.

    Enzolytics, Inc.

    Company contact:
    Enzolytics, Inc.
    2000 North Central Expressway
    Plano, Texas 75074

    Texas A&M Institute for Preclinical Studies 
    Enzolytics, Inc.
    800 Raymond Stotzer Parkway
    College Station, Texas 77843

    ENZOLYTICS HIGHLIGHTS ITS COMPREHENSIVE PCT PATENT APPLICATIONS COVERING DISCOVERED CONSERVED TARGET EPITOPES ON THE SARS-CoV-2 AND HIV VIRUSES

    March 25, 2022 / Enzolytics, Inc. (OTC PINK: ENZC) (https://enzolytics.com/

    In submissions under the Patent Cooperation Treaty (PCT), Enzolytics, Inc. has pending international patent applications covering the use of any of its discovered numerous conserved Coronavirus epitopes or conserved HIV epitopes in the production of monoclonal antibodies, the production of vaccines or use in diagnostic tests for detecting the viruses in patients.

    The applications are pending as Patent Cooperation Treaty (PCT) applications which allow the Company to prosecute the applications both in the U.S. and in all PCT member countries. The applications identify and claim the conserved, immutable sites on the SARS-CoV-2 virus and HIV virus that have been identified by the Company through its Artificial Intelligence (AI) technology. These applications, and their significance, are based on the following findings by the Company.

    By using computer analysis (AI), the Company has analyzed over 2 Million different isolates of the Coronavirus. From that analysis, the Company identified 19 conserved, immutable sites (epitopes) on the virus. The 19 conserved sequences identified on the isolates analyzed have been identified on the basis that they are 98.71% to 99.29% conserved over the entirety of the over 2 Million CoronaVirus isolates which have been analyzed by the Company using AI.

    Additionally, the Company has analyzed over 100,000 HIV isolates using AI and has identified 9 conserved sites, some with over 98% conserved sequences.

    In its PCT Patent Applications, the Company has claimed its discoveries including the use of these identified conserved epitopes for (1) producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus, (2) producing a vaccine against HIV or the CoronaVirus, or (3) for use in any diagnostics to identify whether a person has HIV or the CoronaVirus.

    The Company considers these filings significant because:

    • For a monoclonal antibody to be effective (that is to be fully capable of neutralizing a virus), it must target an immutable site on the virus. Otherwise, a virus mutation will render the therapeutic ineffective.
    • The Company has analyzed over 2 Million Coronavirus isolates and over 100,000 HIV isolates and have identified 19 conserved sites (98 to 99% conserved) on the Coronavirus and 9 conserved sites on the HIV virus.
    • The Company’s patent claims cover these findings in a number of ways, claiming the use of any one identified epitope or any combination of any of the multiple identified epitopes in any of the following ways:
      • For producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus.
      • For producing a vaccine against HIV or the CoronaVirus.
      • For producing related prophylactic/therapeutic methods relating to the epitopes/antigens.
      • For use in any diagnostic test to identify whether a person has HIV or the CoronaVirus.

    The Company fully expects that the patent claims sought in these applications will be issued in the U.S. and the foreign countries in which they are filed. And the Company intends to prosecute the applications in all major countries around the world. The life for any patent issued is 20 years from the effective priority date. In the case of the Company’s applications, the priority dates are early in the pandemic time frame, as the Company was alert to the need for and significance of making the discoveries found. Use of any of the 19 Coronavirus epitopes or any of the 9 HIV epitopes in the production of a therapeutic, vaccine or diagnostic will be covered by the issued patents. 

    Charles Cotropia, the Company CEO, said: “The breadth of patent coverage that is sought and expected is extremely far-reaching based on the discovery of the critical target epitope sites necessary to effectively neutralize these viruses. The Company has also identified conserved epitopes using its AI platform on multiple other viruses, including HIV-2, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Small-Pox, Ebola Virus, Tetanus, Diphtheria, HTLV-1/2, Rabies, Herpes zoster, Varicella zoster, Anthrax, Mason-Pfizer monkey virus (MPMV) and Visna virus (VISNA). These findings will also be protected by patent coverage.”

    “The Company is also now focused on therapeutics for veterinarian treatment, namely the production of treatments for the Horse Equine Infectious Virus, Chicken Anemia Virus, Cat Feline Leukemia Virus, Feline Immunodeficiency Virus, Koala Retrovirus (KoRV), and Elephant Endotheliotropic Herpesvirus (EEHV). Patent coverage will be obtained on discovered conserved epitopes for these animal viruses, and specifically on the use of any of the discovered epitopes/antigens in producing therapies, any vaccines or related prophylactic/therapeutic method relating to the identified epitope/antigens and on diagnostics.”

    Numerous mutants have arisen during the CoronaVirus pandemic and monoclonal antibodies produced by pharma have failed as a result of the mutation of the virus. As recently as early this year, anti-COVID-19 monoclonal antibodies produced by Regeneron and Eli Lilly were found ineffective against the Omicron variant and their use was discontinued. 

    Charles Cotropia said, “It can be concluded that Eli Lilly's ‘bamlanivimab’ monoclonal, that has been pulled from the market, did not target one of the conserved 19 epitopes covered in our discovery of conserved sites and covered in our patent application.”

    “Similarly, in 2014 through 2016, the NIH funded the development of anti-HIV monoclonal antibodies VRC01 and VRC02 but these antibodies failed due to what the NIH called ‘virus escape’. ‘Virus escape’ is a euphemism for the fact that antibodies targeted a mutable site on the virus. Enzolytics’ focus is on producing monoclonal antibodies that target immutable sites to avoid ‘virus escape’.”

    Targeting the conserved sites discovered by Enzolytics allows the production of a therapeutic that will not be rendered ineffective due to mutation (variants) of the virus. In other words, even a “variant form of the virus” will contain the immutable targeted sites. Targeting immutable sites avoids the ineffectiveness that is experienced when a therapeutics or vaccine targets a site that has mutated.

    This capability is highly significant in that experts agree that even though effective vaccines have been developed and deployed, it is expected the CoronaVirus will be with us going into the future, with a resurgence year to year. Thus, therapeutics to treat the virus will be necessary for the future. And the same applies for all other viruses.

    Charles Cotropia said, “We are confident in our discoveries. The patent system is an optimum way for a small biotech company to lay claim, for a 20-year period dating back to an early priority date, to such significant intellectual property even before or without bringing the therapeutic to market. The filing of a patent application serves as constructive reduction to practice of the subject matter described in the application. In this way, we are taking every opportunity to cover the waterfront on all of the viruses we are fully analyzing. This is a step that big pharma has not taken but one we have.”

    About Enzolytics, Inc.

    Enzolytics, Inc. is a drug development company committed to commercializing its proprietary proteins and monoclonal antibodies to treat debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), covered by U.S. Patent Nos. 8,066,982 and 7,479,538. Studies have shown it to be effective in treating HIV/AIDS. ITV-1 has also been shown to modulate the immune system.

    The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. In addition, its proprietary methodology, covered in its pending U.S. Patent Application for producing fully human monoclonal antibodies, is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the CoronaVirus (SARS-CoV-2) and HTLV-1.

    Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.

    While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of its therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.

    Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.

    I.R. contact:
    TEN Associates, LLC
    Tom Nelson, CEO
    (480) 326-8577

    Company Contact:
    Enzolytics, Inc.
    2000 North Central Expressway
    Plano, Texas 75074

    Texas A&M Institute for Preclinical Studies 
    Enzolytics, Inc.
    800 Raymond Stotzer Parkway
    College Station, Texas 77843

    DR. SURAJ KUMAR SAGGAR JOINS ENZOLYTICS AS A MEMBER OF ITS ADVISORY BOARD

    Enzolytics, Inc. (OTC PINK: ENZC) announces the addition of Dr. Suraj Kumar Saggar to its Advisory Board. Dr. Saggar brings to the Company his vast experience as a physician and healthcare research professional with an established track record of exceptional performance in healthcare operations, clinical trials, and regulatory compliance.

    Charles Cotropia, CEO of Enzolytics, said, “We are very excited to have Dr. Suraj Kumar Saggar join our Advisory Board. He is a dynamic leader, physician, and healthcare research professional and his vast experience and expertise, based on his background as an accomplished infectious disease specialist spanning two decades, will be a great asset to the Company. He complements our team of experienced scientists and advisors and adds a unique set of skills and background, given his accomplished career in infectious diseases.”

    Dr. Saggar is a well-known infectious disease expert, and his appointment is a significant step toward Enzolytics’ growth as it advances multiple therapeutics toward clinical trials and patient application. Dr. Saggar credentials speak for themselves. He is an experienced physician and healthcare research professional with expertise in healthcare operations, clinical trials, and regulatory compliance. Dr. Saggar is an expert in diagnosing and treating the full spectrum of infectious diseases, from influenza, varicella, MRSA, and bacterial skin infections to complex issues such as tuberculosis, HIV, Zika, Dengue Lyme, and SARS-CoV-2.

    Dr. Saggar has served on staff at Holy Name Medical Center in Teaneck, New Jersey since 2007 and currently serves as the Chief of the Department of Infectious Disease, Medical Director of the Institute for Clinical Research, and is the chair of Infection Prevention at Holy Name. He also has a private medical practice.

    Dr. Saggar is also an adjunct clinical associate professor at Touro College of Osteopathic Medicine in New York City. He earned his undergraduate degree at the University of Richmond and medical degree at the Philadelphia College of Osteopathic Medicine. He completed his internal medicine residency and fellowship in infectious diseases at Saint Michael's Medical Center in Newark, New Jersey. He is board-certified in Internal Medicine and Infectious Disease and is a Fellow of the Infectious Disease Society of America.

    Dr. Saggar has conducted clinical research at the National Institute of Health and as a Merck Research Fellow. He is currently a primary investigator in several ongoing trials of COVID-19 therapeutics and numerous other clinical trials involving all aspects of clinical medicine. In addition, he is on the speaker's bureau of AbbVie Pharmaceutical and Regeneron and regularly lectures for Grand Rounds and to medical students and residents.

    Dr. Saggar has regularly been featured on CNN and Fox Business News discussing various aspects of the COVID-19 pandemic. In addition, he periodically discusses up-to-the-minute health information, new research findings, and the latest advances in health screenings and medical technology.

    Dr. Saggar will also provide guidance to the Company in its development of its Artificial Intelligence (A.I.) Platform which includes the planned use of A.I. Analysis to identify immutable sites on viruses, 3D Modeling of the epitopes to establish linearity, neutralizing potential, and accessibility to antibodies and for assessing the effects of nutrition, genetics, and microbiome on diseases.

    The Company and its technology will be greatly strengthened with Dr. Saggar’s participation and counsel.

    Enzolytics, Inc.’s Wholly Owned Subsidiary Virogentics, Inc.
    Reports Progress on the Delivery of its ITV-1 Anti-HIV
    Therapeutic for Use by Patients in African Regions

    COLLEGE STATION, TX / ACCESSWIRE / March 14, 2022 / Enzolytics, Inc. (OTC PINK: ENZC) (https://enzolytics.com/) Enzolytics’ (“ENZC”) wholly owned subsidiary Virogentics, Inc. (the “Subsidiary”) today announced its progress toward the production and use of its ITV-1, anti-HIV immunotherapy treatment in the Central and Eastern regions of Africa for patients with HIV/AIDS.

    The steps necessary for the production and delivery of the Company’s anti-HIV therapy in these regions are in progress. Toxicology, pharmacodynamic and pharmacokinetic studies (toxicology studies) of the immunotherapy are planned, a prerequisite to use of the immunotherapy in certain African countries where the therapies will be used. These toxicology studies will also be used in the Company’s progress toward clinical trials necessary for EMA approval. The ITV-1 therapeutic has succeeded in clinical trials earlier and the Company is planning additional trials leading to EMA approved. As that approval is underway, the ITV-1 therapeutic will be provided to the Central and Eastern regions of Africa once toxicology studies are completed.

    The Company, led by its CSO Harry Zhabilov and advisor Professor Dr. Luchezar Ivanov, is guiding the production in Eastern Europe using the Company’s patented proprietary technology and production process. The Company has commitments for the production of an initial quantity for use in two African hospitals. A follow-on production will be provided to treat a larger group of HIV/AIDS patients followed by a much larger commitment, potentially to treat 30,000 patients.

    While the healthcare focus for the last 2 years has been on the COVID-19 pandemic, the HIV pandemic has continued unabated. Over 16 million people are infected with HIV, with approximately 10% being children. There are 1.7 Million new cases each year and approximately 1 Million deaths. Over 50% of the world-wide patients with HIV/AIDS are located in Africa.

    The only therapy for treating infected patients is antirational (ARV) drugs, but these drugs are not available to 27% of those infected. The ARV therapies which are available cause substantial side effects and are expensive. The ARV therapy Biktarvy produced by Gilead costs $42,635 per year. The global HIV market is estimated to be over $30 billion this year and is expected to grow to over $36 billion globally by 2027.

    The Company sees this as a massive market opportunity with room for improved therapies and recognizing that 27% of those infected with HIV do not have access to any ARV therapy.

    Enzolytics Announces Its New Technology For Entry Into The In-vitro Diagnostics Market

    February 21, 2022 / Enzolytics, Inc. (OTC PINK: ENZC) (https://enzolytics.com/) announces its plans for entry into the diagnostics market. Enzolytics has filed a comprehensive U.S. and foreign Patent Cooperation Treaty (PCT) Patent Application covering its invention of a novel, innovative technology for improved diagnostics. The PCT Application covers the Company’s identification of highly conserved antigens and epitopes of SARS-CoV-2 that can be used in vaccines and to produce bindings proteins (e.g., antibodies) for treating, preventing, or reducing the risks of infections caused by β-coronaviruses such as SARS-CoV-2. The patent also covers the discovery of using these identified antigens and epitopes as targets for detecting and diagnosing SARS-CoV-2 infection.
    The Company's Artificial Intelligence platform has been used to build 3D Models of the conserved targets. The analysis of the SARS-CoV-2 spike protein revealed that all epitopes identified by the Company are linear on the spike proteins, accessible by antibodies, neutralizable, and unaffected by mutations.
    The Company’s finding provides the basis for addressing the challenge posed by the fast evolution of SARS-CoV-2 variants having mutations in their genomic and protein sequences, which have precluded the development of effective methods for accurately detecting infection. The effect of mutations on a test's performance may be influenced by several factors, including the sequence of the variant (including the number, identity, and location of mutations), the design of the test, and the prevalence of the variant in the population. For example, tests with single targets are more likely to fail to detect new variants. On the other hand, tests with multiple targets (e.g., a PCR test designed to detect more than one section of the SARS-CoV-2 genome or an antigen test intended to detect more than one region of the spike protein) can more accurately detect new variants. For example, a molecular test able to detect other variants is expected to fail to detect the SARS-CoV-2 Omicron variant (B.1.1.529) due to a nine-nucleotide deletion in the N-gene, spanning positions 28370-28362, while a two-target antigen test able to detect other variants is expected to fail to detect the Omicron variant due to deletions at amino acid positions 69-70 and mutations at nucleotide positions 23599.
    Enzolytics is developing tests that diagnose SARS-CoV-2 based on the presence of the conserved sites that remain unaffected by mutations. Using its Artificial Intelligence technology, all the conserved sites identified by the Company have remained present in all of the variants of concern and variants of interest.
    Enzolytics is currently working with diagnostic companies with track records for taking this technology and the tests produced under it through regulatory approval, leading to patient use.
    The global in-vitro diagnostics market was valued at the approximately U.S. $68.41 Billion in 2020. The market value is expected to increase to the U.S. $91.25 Billion in revenue in 2026, with a CAGR of 4. 90% over the forecast period.
    The COVID-19 pandemic turned attention to in-vitro diagnostics. As a result, there is an increasing demand for IVD kits and reagents for the rapid and accurate diagnosis of SARS-CoV-2 virus infection among the global population. The outbreak of COVID-19 is expected to positively impact the market studied, as in-vitro diagnostics involves the testing of various biological samples. This is expected to aid the diagnosis of infectious diseases, such as COVID-19. Therefore, testing remains a crucial step in controlling the COVID-19 pandemic. As a result, there is an increased push for faster, reliable, and accurate diagnosis of SARS-CoV-2. The Company’s new technology addresses this need.
    This new technology is supplemental and additive to the Company's multiple technology platforms, which include:
    The Company’s development of ITV-1 therapeutic for treating HIV.
    The Company’s production of anti- HIV Monoclonal Antibodies. 
    The Company’s production of anti-SARS CoV-2 Monoclonal Antibodies.
    The Company’s planned production of Monoclonal Antibodies addressing animal viruses such as the Equine Infectious Anemia Virus, Feline Leukemia Virus, Feline Immunodeficiency Virus, Equine Herpesvirus (EHV), Koala Retrovirus (KoRV), and the Elephant Endotheliotropic Herpesvirus (EEHV).
    The Company’s Artificial Intelligence (A.I.) Platform including:
    A.I. Analysis to identify immutable sites. 3D Modelling of the epitopes to establish linearity, neutralizing potential, and accessibility to antibodies.
    A.I. to assess the effects of nutrition, genetics, and microbiome on diseases to: 
    • Build prediction models for infectious diseases (preferably COVID), mental health disorders, and chronic medical diseases.
    • Identify biomarkers for infectious diseases and chronic medical diseases.
    • Identify novel targets and clear intervention strategies for infectious diseases and chronic medical diseases.
    A.I. Platform for genomic surveillance, monitoring of viral epidemiology.
    Enzolytics, Inc.

    I.R. contact:
    TEN Associates, LLC
    Tom Nelson, CEO
    (480) 326-8577

    Company Contact:
    Enzolytics, Inc.
    2000 North Central Expressway
    Plano, TX 75074

    ENZOLYTICS REPORTS ITS ENGAGEMENT OF SCENDEA USA, INC., A LEADING INTERNATIONAL PRODUCT DEVELOPMENT AND REGULATORY CONSULTING GROUP, TO GUIDE THE PROGRESS TOWARD CLINICAL TRIALS AND MARKET APPROVAL FOR ITS ITV-1 ANTI-HIV THERAPEUTIC

    COLLEGE STATION, TX December 29, 2021 / Enzolytics, Inc. has engaged Scendea USA, Inc. (www.scendea.com), the leading international product development and regulatory consulting group, to advance its anti-HIV therapeutic ITV-1 to production, clinical trials, and market approval under both the European Medicines Act (EMA) and the U.S. FDA regulatory process.

    Scendea is a leading product development and regulatory consulting group serving the pharmaceutical and biotechnology industry. Scendea’s service will focus on reducing time-to-market and minimizing development costs. Scendea's team offers strategic and operational support in quality/CMC, non-clinical/toxicology, clinical/medical, and regulatory, guiding the Company’s product ITV-1 efficiently to market approval.

    Scendea’s critical role in the approval process is one of finalizing a comprehensive clinical development plan based on the prior clinical trials completed earlier, preparing a CMC non-clinical Gap analysis, and a necessary EU Regulatory Strategy.

    Enzolytics Inc. currently has in place engagements for the product production by Danhson (https://danhson.bg/en/) and clinical trials at Clinic Design (https://clinicdesign.eu/) to advance its anti-HIV therapeutic ITV-1 to the final stage of regulatory approval by the European Medicines Agency (EMA), leading to patient use authorization. Additionally, Scendea will also assist with the FDA approval process to expeditiously introduce ITV-1 to the North American market. 

    About Enzolytics, Inc.

    Enzolytics, Inc. is a drug development company committed to the commercialization of its proprietary proteins and monoclonal antibodies for the treatment of debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), covered by U.S. Patent Nos. 8,066,982 and 7,479,538. Studies have shown it to be effective in treating HIV/AIDS. IPF is the active component of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has also been shown to modulate the immune system.

    The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including the CoronaVirus, HIV, HTLV-1, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology, covered in pending U.S. Patent Application Ser. No. 63/245,122 for producing fully human monoclonal antibodies, is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the Coronavirus (SARS-CoV-2) and HTLV-1.

    Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.

    While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy its therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.

    Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.

    I.R. contact:

    TEN Associates, LLC

    Tom Nelson, CEO

    (480) 326-8577

    Investor Relations Contact

    Company Contact:

    Enzolytics, Inc.

    2000 North Central Expressway

    Plano, TX 75074

    and

    Research Center

    Enzolytics, Inc.

    Texas A&M University

    Institute for Preclinical Studies

    College Station, TX 77843-44

    SOURCE: Enzolytics, Inc.

    ENZOLYTICS ANNOUNCES PROGRESS AS IT RECOGNIZES WORLD AIDS DAY

    COLLEGE STATION, TX: December 2, 2021 / Enzolytics wishes to recognize and acknowledge World AIDS Day — a day to call attention to the continued need for a more effective treatment for HIV, including successful treatments for the growing number of individuals living longer with HIV.

    Approximately 1.2 million people in the U.S. and 37.7 million people in the world have HIV, yet the only treatment available is antiretrovirals (ARVs), which do not cure, are tremendously expensive, are only available to 60% of those infected, and have significant long-term side effects. Additionally, those with HIV are living longer than in earlier years of the pandemic. Because almost ½ of those with HIV are now 50 or older and approximately 1 in 6 new diagnoses of HIV occur in this age group, people aging with HIV can face treatment-related challenges, such as drug interactions between HIV medicines and medicines used for other conditions. Because older individuals are more likely not to be diagnosed with HIV, a delayed diagnosis means treatment is also delayed, resulting in HIV potentially causing more damage to the immune system. Additionally, data suggest that untreated HIV is resulting in the development of SARS-CoV-2 variants. In this regard, the Company’s technology remains focused on both HIV and SARS-CoV-2.

    The Company’s technologies focus on a definitive therapy for treating HIV compared to the current treatment using ARVs. Specifically, the Company is advancing two platforms, one being a clinically tested, patented, antiviral therapeutic, known as ITV-1, that has shown significant effectiveness in treating patients with HIV/AIDS. This therapeutic is complementary to the Company's development of fully human monoclonal antibodies that target and neutralize the virus. Experts in the field have consistently acknowledged that a cure for HIV will require the administration of "multiple, broadly neutralizing monoclonal antibodies." Just as multiple anti-CoronaVirus monoclonal antibodies are now widely recognized as successful in treating those with COVID-19, the same will be true for anti-HIV monoclonal antibodies. But to be successful, such antibodies must be “broadly neutralizing” – that is, they must target conserved, immutable sites not subject to mutant strains of the HIV virus. This is exactly the focus of the Company’s technology.

    A.I. PLATFORM SUCCESS

    To enhance its production of effective anti-HIV monoclonal antibodies, the Company has employed Artificial Intelligence (A.I.), using computer analysis to curate (analyze) the amino acid sequences of targeted viruses to identify the conserved, immutable, and neutralizable target sites (epitopes) on viruses. Once identified, the Company uses its proprietary technology to produce fully human monoclonal antibodies that target these identified immutable sites – thereby producing a therapeutic that does not fail due to virus mutations – known as virus escape. Additionally, these identified target sites may be used to develop more effective vaccines – a vaccine development methodology significantly different than mRNA vaccine production.

    Using Artificial Intelligence, Enzolytics has identified immutable conserved epitopes for numerous viruses and is focused on producing monoclonal antibodies targeting these sites.  The company has fully analyzed over 87,000 HIV isolates using A.I. and over 2 million COVID-19 isolates to identify conserved epitopes. Antibodies are being produced targeting these conserved sites.

    The Company has also now completed its analysis of isolates of the Omicron Variant and has confirmed that the conserved epitopes previously identified by the Company are also fully conserved in the Omicron Variant. Thus, it is critical that monoclonal antibodies be produced that target the conserved epitopes on the CoronaVirus identified by the Company using its A.I. analysis. These identified conserved sites are also confirmed as existing in each of the now known “Variants of Concern” and “Variants of Interest”. These conserved epitope sites on the CoronaVirus are claimed in the Company’s now pending patent applications filed early in 2020.

    The far-reaching nature of the Company’s A.I. analysis is seen by noting that in addition to curating isolates of HIV and COVID-19, the Company has fully analyzed each of the following viruses and identified the conserved epitopes on the viruses: HTLV-1, H10N3, Influenza A, and B, H1N1 influenza, Respiratory syncytial virus (RSV), Ebola, Small-Pox, Tetanus, Diphtheria, Rabies, Herpes zoster, Varicella zoster, Anthrax, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, Feline Immunodeficiency virus, Small Ruminant Lentivirus, and Koala retrovirus. The Company's future efforts are the production of monoclonal antibodies targeting these virus sites.

    The Company’s A.I. is significant for the following reasons:

     

    • The A.I. platform incorporates genomic surveillance and monitoring of virus epidemiology. The Enzolytics AI team is working on a comprehensive Artificial Intelligence protocol to analyze existing viruses and any new virus immediately upon its emergence globally.
    • Enzolytics also utilizes A.I. to assess the effects of Genetics, Nutrition, and the Human Microbiome on infectious diseases, mental health disorders, and chronic medical diseases. The purpose of this focus is to:
      • Build prediction models for infectious diseases, mental health disorders, and chronic medical diseases.
      • Identify biomarkers for infectious diseases, mental health disorders, and chronic medical diseases.
      • Identify novel targets and clear intervention strategies for infectious diseases, mental health disorders, and chronic medical diseases.

    This is part of Enzolytics' strategic effort to expand to the personalized medicine market and increase its Intellectual Property portfolio. The Company’s Chief Operating Officer, Dr. Gaurav Chandra, has described the role of Artificial Intelligence in understanding the microbiome, leading to biomarkers, innovative diagnostic tools, and novel treatment strategies in diseases in an article "Demystifying the Human Microbiome using Artificial Intelligence" recently published in the Yuan (https://www.the-yuan.com/177/Demystifying-the-Human-Microbiome-Using-AI.html).

    HIV THERAPEUTICS

    Addressing the HIV pandemic, the Company has two expectedly complementary therapeutics directed to the effective treatment of HIV. One therapeutic, ITV-1, a patented antiviral peptide that has been clinically tested, is a suspension of Inactivated Pepsin Fragment (IPF), a purified extract of porcine pepsin. This therapeutic has been shown to strengthen the immune system and has been tested in HIV patients in clinical trials with significant beneficial results. [https://enzolytics.com/proprietary-therapeutics/]. Currently, the Company is working with European Medicines Agency (EMA) consultants in marshaling the extensive prior clinical trial and technical data for application in advancing this therapeutic under the EMA for approval for use in European Union countries. Additionally, the Company is engaged with preclinical, product production, and clinical trial companies to meet EMA requirements and approval.

    The Company has recently received an invitation for the immediate application of this therapeutic in regions where EMA approval is not required. Accordingly, the production of ITV-1 for this purpose is moving forward.

    The second therapeutic for treating HIV, namely the Company’s primary anti-HIV monoclonal antibody, is now being produced in the recombinant form (a form necessary for patient treatment) at Samsung Biologics. Samsung Biologics provides end-to-end CDMO services from cell line development, clinical drug substance, and drug product manufacturing services to support IND filings for Anti-HIV Monoclonal Antibody Therapy for the treatment of HIV. This development is in progress, and final production is expected in the near term. The Company notes that this anti-HIV mAb targets an immutable site on the HIV virus.

    SARS-COV-2 THERAPEUTICS

    Addressing the COVID-19 pandemic, the Company is producing monoclonal antibodies targeting conserved sites on the SARS-CoV-2 virus identified using Artificial Intelligence. The conserved targets are found in all variants of concern – including the COVID-19 Omicron variant. Thus, the monoclonal antibodies being produced by the Company, due to the conserved nature of the targeted epitopes, are expected to be effective against current and future variants of the COVID-19 virus.

    The Company is using multiple processes to accelerate the production of these monoclonal antibodies. As acknowledged by experts in the field, numerous monoclonal antibodies are needed for effective therapy. By using accelerated technology systems now employed by the Company, namely hybridoma technology, Phage Display, antigen-specific single B cell sorting, and monoclonal antibody (mAb) cloning platforms, the desired antibodies may be produced in shorter time frames. In addition, the Company has a strong working relationship with Samsung Biologics, which provides end-to-end CDMO services from cell line development, clinical drug substance, and drug product manufacturing services to support IND filings for Anti-SARS-CoV-2 Antibody Therapy for the treatment of SARS-CoV-2.

    About Enzolytics, Inc.

    Enzolytics, Inc. is a drug development company committed to commercializing its proprietary proteins and monoclonal antibodies for the treatment of debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), covered by U.S. Patent Nos. 8,066,982 and 7,479,538. Studies have shown it to be effective in treating HIV/AIDS. IPF is the active component of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has also been shown to modulate the immune system.

    The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology, covered in pending U.S. Patent Application Ser. No. 63/245,122 for producing fully human monoclonal antibodies, is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the Coronavirus (SARS-CoV-2) and HTLV-1.

    Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.

    While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of its therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.

    Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.

    I.R. contact:
    TEN Associates, LLC
    Tom Nelson, CEO
    (480) 326-8577
    Investor Relations Contact

    Company Contact:
    Enzolytics, Inc.
    2000 North Central Expressway
    Plano, TX 75074
    and
    Research Center
    Enzolytics, Inc.
    Texas A&M University
    Institute for Preclinical Studies
    College Station, TX 77843-44
    SOURCE: Enzolytics, Inc.

     

    Enzolytics, Inc. Announces Production and Sale in North America of “Enzolytics IPF Immune”, a Tested Immune Modulator based on U.S. Patent No.8,309,072

    COLLEGE STATION, TX / ACCESSWIRE / November 17, 2021/ Enzolytics, Inc. (OTC PINK: ENZC) (https://enzolytics.com/) has announced planned production and sale in the U.S. and North America of “Enzolytics IPF Immune,” a liquid nutritional supplement that is an immune modulator that benefits the immune system by fortifying it against infections and supporting the body’s antioxidant defense. The active components in the supplement have been registered with the FDA for use in the U.S. under NDI reg. no. 1083. The product will be produced and sold by the Company pursuant to its license under U.S. Patent No. 8,309,072 (the ‘072 Patent).

    This ‘072 Patent, entitled “Irreversibly-Inactivated Pepsinogen Fragments for Modulating Immune Function,” covers the use of Irreversibly Inactivated Pepsin Fragments (IPF), which has been shown in tests to perform an immune-modulating function. The primary IPF ingredient is a complex platform that modulates the immune system and may be used alone or as a concomitant therapy for a variety of diseases. The IPF active substance in the product is derived from pepsin from the mucosa, and the method of its extraction and application is the subject of the licensed ‘072 Patent invented by the Company’s Chief Scientific Officer Harry Zhabilov. The immune modulator is made from purified and lyophilized pepsin containing a polypeptide chain of 327 amino acid residues and one phosphoric acid residue. Using a proprietary method, a peptide chain of 36 amino acids – (IPF) is isolated and made available in a ready-to-use liquid form.

    In tests, this therapeutic has demonstrated significant beneficial effects for various diseases, whether used alone or as a concomitant therapy, by bolstering the immune system. The irreversible pepsin fraction (IPF) in Enzolytics IPF Immune effectively inhibits the infectious HSV-1 viral progeny without toxicity to cells. The viral yield in tested subjects was also reduced. In addition, IPF, based on HSV-1 and CoV-Sars-2 reports, has shown antiviral effects.

    The Company’s 15-year license to the ‘072 patent grants to Enzolytics marketing rights in all U.S. states, territories, provinces, North American countries, and Australia. The company is moving forward with the production of the product and with nationwide distribution throughout the licensed territory.

    The Company Chief Scientific Officer, Harry Zhabilov, stated: “We see this product as significant to our focus on providing effective therapeutics for treating infectious diseases and are proud to bring to the U.S. and North American markets a product that has been tested and previously successfully marketed abroad. Over many years, I have been intimately involved in its invention, development, and prior testing. To be able to bring it to the North American continent is a meaningful achievement of which we are extremely proud.”

    The Company CEO, Charles Cotropia, stated: “The North America dietary supplements market size is large, valued at over $50 Billion in 2020 and expected to grow at a compound annual growth rate of 5.6% over each of the next 5 years. Consumers are increasingly aware of the significance of personal health and wellbeing, and this awareness is driving the market.

    Enzolytics IPF Immune will play a significant role in this space, and due to its beneficial effects, it will be well received. It is a significant addition to the multiple therapeutics our company is producing.”

    Enzolytics, Inc. Announces Program for Creation of Multiple Monoclonal Antibodies for Veterinary application Utilizing Hybridoma and Phage Display Technology

    COLLEGE STATION, TX / ACCESSWIRE / November 8, 2021 / Enzolytics, Inc. (OTC PINK: ENZC) (https://enzolytics.com/) has announced a coherent protocol that it is executing to meet the Company's objective of producing monoclonal antibodies for a veterinary application utilizing Hybridoma and Phage Display Technologies.

    The Company’s defined protocol includes:

    • Application of computer analysis (Artificial Intelligence – A.I.) to curate (analyze) the amino acid sequences of targeted viruses to identify the conserved, immutable, and neutralizable target sites (epitopes) on targeted viruses. Enzolytics has accomplished this goal for HIV, the Coronavirus, HTLV-1, as well as for H10N3, Influenza A, and B, H1N1 influenza, Respiratory syncytial virus (RSV), Ebola, Small-Pox, Tetanus, Diphtheria, Rabies, Herpes zoster, Varicella zoster, Anthrax, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, Feline Immunodeficiency virus, Small Ruminant Lentivirus, and Koala retrovirus.
      • The new protocol includes implementing A.I. analysis of existing viruses (or mutants thereof) and on any new virus immediately upon its emergence anywhere in the world.
      • The A.I. analysis identifies the conserved, immutable, and neutralizable target sites on the subject virus. It provides for the production of multiple monoclonal antibodies, each targeting an immutable epitope for administering combination therapy.
    • Creation of cell lines to produce monoclonal antibodies targeting each identified conserved virus site (epitope). In this step, multiple broadly neutralizing antibodies are being produced targeting multiple conserved, immutable epitopes on the targeted virus.
      • The Company utilizes both the Hybridoma Technology and the Phage Display for producing Monoclonal Antibodies for veterinary use.

    Enzolytics utilizes Hybridoma Technology by creating hybrid cell lines called "hybridomas" by combining a specific antibody-producing lymphocyte B cell with a myeloma cell that can grow in tissue culture. Hybridoma produces antibodies that have single specificity to the conserved epitopes identified by Artificial Intelligence.

    Enzolytics is also utilizing Phage Display technology for production of Monoclonal Antibodies. Phage Display technology offers a significant advantage: it provides a means to identify target-binding proteins from a library of millions of different proteins without the need to screen each molecule individually. Phage display vaccines are made by expressing multiple copies of an antigen on the surface of immunogenic phage particles, thereby eliciting a powerful and effective immune response.

    According to the Chief Operating Officer, Dr. Gaurav Chandra, "We are utilizing Phage Display techniques for production of our Monoclonal Antibodies since the Phages are very suitable for vaccine design due to higher stability under severe environmental conditions. Additionally, they are less expensive, have potent adjuvant capacities and offer an expedited process for vaccine development. Phage Vaccines have efficient immunostimulatory effects and present a high safety profile. As a result, Enzolytics is focusing on Phage-based Vaccines for various infectious diseases. Our Phage Display techniques can be used to create novel molecules that can lead to breakthroughs in technology and medicine."

    The monoclonal antibodies for veterinary use at Enzolytics are being created in three phases.

    Phase 1

    Feline Immunodeficiency virus
    Feline Leukemia virus
    Equine Infectious Anemia virus
    Small Ruminant Lentivirus
    SARS-CoV-2 for Wild Animals

    Phase 2

    Koala retrovirus
    Elephant Endotheliotropic Herpesvirus
    Camel Pox
    Avian Flu
    Swine flu
    Falcon Herpesvirus

    Phase 3

    Striped dolphin morbillivirus
    Phocine distemper virus

    The Company is actively exploring proposals for collaborations and partnerships with U.S. and foreign veterinary companies for their monoclonal antibodies for veterinary use.

    Enzolytics Inc. and Samsung Biologics Announce Development and Manufacturing Agreement for Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibody Therapy – October 7

    • Enzolytics Inc. to leverage Samsung Biologics’ development and manufacturing expertise to advance both Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibody Therapy to IND.
    • Samsung Biologics to offer a seamless, end-to-end CDMO service with support from its San Francisco R&D Center.

    California, U.S. and Incheon, S. Korea, October 7, 2021 – Samsung Biologics (KRX: 207940. K.S.), a leading contract development and manufacturing organization and Enzolytics, a drug development company committed to commercializing multiple proprietary therapeutics to treat debilitating infectious diseases, announced the signing of a strategic CDMO partnership agreement.

    Under the terms of the agreement, Samsung Biologics will provide end-to-end CDMO services from cell line development, clinical drug substance, and drug product manufacturing services to support IND filings for Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibody Therapy for the treatment of HIV and SARS-CoV-2. In addition, there will be continuing discussions for other Monoclonal Antibodies being developed by Enzolytics.

    The Enzolytics protocol offers the opportunity to implement A.I. analysis and provides a platform for creating multiple fully human Monoclonal Antibodies targeting conserved immutable sites on the virus and offering a cure for these viruses. A stable cell line will be manufactured with support from Samsung Biologics' R&D Center in San Francisco. Its related clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea.

    “Partnering with Enzolytics reinforces the value of our fully integrated, end-to-end business model, which is designed to meet the unique needs and goals of our biotech clients,” said John Rim, CEO of Samsung Biologics. “We look forward to providing comprehensive services and professional support for the manufacturing of this important class of Monoclonal Antibody therapeutics for the treatment of HIV and SARS-CoV-2, helping to accelerate the process of drug development to IND filing and bring these life-saving products to patients.”

    "The collaboration with Samsung Biologics is a significant milestone for Enzolytics' Artificial Intelligence enabled Monoclonal Antibody Platform.  We chose to partner with Samsung Biologics because of Samsung Biologics' extensive experience and expertise in developing, producing, and manufacturing Monoclonal Antibodies for Infectious Diseases and Oncology.” said Dr. Gaurav Chandra, Chief Operating Officer Research and Development at Enzolytics. “This partnership marks a pivotal milestone for Enzolytics to significantly advance the clinical development of our universal, durable, broadly neutralizing Monoclonal Antibodies and reduce time to the clinic and offer the much-needed treatment for patients."

    About Enzolytics Inc.

    Enzolytics Inc. is a drug development company committed to commercializing its multiple proprietary therapeutics to treat debilitating infectious diseases. The Company's patented ITV-1 therapeutic suspension of Inactivated Pepsin Fraction (IPF), which studies have shown effectively treats HIV/AIDS. IPF is the active component of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has also been shown to modulate the immune system. Additionally, the Company has proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, Coronavirus, HTLV-1, Influenza A, and B, H10N3, H1N1 influenza, Respiratory syncytial virus (RSV), Ebola, Small-Pox, Herpes zoster, Varicella zoster, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, and Koala retrovirus.

    Enzolytics Safe Harbor Statement

    This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.

    About Samsung Biologics Co., Ltd.

    Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com

    Samsung Biologics Forward-Looking Statement

    This press release contains certain statements that constitute forward-looking statements, including statements that describe Samsung Biologics' objectives, plans or goals. All such forward-looking statements, and the assumptions on which they are based, are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. There can be no assurance that the results and events contemplated by the forward-looking statements contained herein will in fact occur. Except as required by law, Samsung Biologics will not update any forward-looking statements to reflect material developments that may occur after the date of this press release.

    Enzolytics Investor Relations Contact:

    Title: Ten Associates, LLC

    Name: Tom Nelson

    Contact Info: Enzolytics, Inc.
    2000 North Central Expressway
    Plano, TX 75074 USA

    Samsung Biologics Contact:

    Senior Director of Global Public Relations
    Claire Kim

    cair.kim@samsung.com

    National HIV/AIDS and Aging Awareness Day – September 18

    COLLEGE STATION, TX September 18, 2021 / Enzolytics wishes to recognize and highlight National HIV/AIDS and Aging Awareness Day—a day to call attention to the growing number of people living longer with HIV and to aging-related challenges of HIV prevention, testing, treatment, and care.

    Those with HIV are living longer than in earlier years of the pandemic. Because almost ½ of those with HIV are now 50 or older and approximately 1 in 6 new diagnoses of HIV occur in this age group, people aging with HIV can face treatment-related challenges, such as drug interactions between HIV medicines and medicines used for other conditions. Additionally, because older individuals are more likely not to be diagnosed with HIV, a delayed diagnosis means treatment is also delayed, resulting in HIV potentially causing more damage to the immune system.

    Enzolytics is proud to be on the leading edge of developing more effective and strategic therapeutics to successfully treat HIV. The Company’s focus is on treatments that do not cause the significant negative side effects caused by antiretroviral (ARV) therapies – currently the only therapy available to treat HIV. The negative side effects caused by ARV treatment are well documented and include kidney problems, kidney failure, liver damage (hepatotoxicity), heart disease, osteoporosis, diabetes, or insulin resistance, an increase in fat levels in the blood (hyperlipidemia), and changes in how the body uses and stores fat (lipodystrophy). [https://www.healthline.com/health/hiv-aids/antiretroviral-drugs-side-effects-adherence#other-side-effects].

    As HIV patients live longer, these side effects become all the more problematic. Moreover, antiretroviral treatment is only accessible to 74% of the over 37 million people infected worldwide – leaving 26% of infected HIV patients with no treatment. And while this day is a focus on the older HIV patients, the world must not lose sight of the fact that of the 37 million individuals living with HIV, over 1.8 Million are children and of those, 47% have no access to any treatment whatsoever. And 320 children and adolescents die every day from HIV. [https://www.unaids.org/en/keywords/children].

    The Company’s focus is on a superior therapy for treating HIV as compared to the current treatment using ARVs. Specifically, the Company is producing fully human monoclonal antibodies that neutralize the virus. Experts in the field have consistently acknowledged that a cure for HIV will require the administration of “multiple broadly neutralizing monoclonal antibodies”. Just as multiple anti-CoronaVirus monoclonal antibodies are now widely recognized as successful in treating those with COVID-19, the same will be true for anti-HIV monoclonal antibodies. But to be successful, such antibodies must be “broadly neutralizing” – namely not subject to mutant strains of the HIV virus. Such monoclonal antibodies are precisely what Enzolytics is producing.

    Enzolytics, Inc. is a drug development company with two separate but complementary therapy platforms for treating HIV. The Company is in the final development of the recombinant of one of its antibodies, identified as “Clone 3”, which has been shown in in vitro studies conducted in 5 international laboratories to fully neutralized over 95% of all strains and viral subtypes of HIV-1 against which it was tested. The basis for its broad-spectrum efficacy is the fact that Clone 3 mAb targets an immutable epitope on the HIV virus. The targeted epitope has remained present in 98% (either directly or by way of conserved substitutions) of all 87,336 HIV isolates analyzed by the Company’s use of Artificial Intelligence (A.I.). The failure of other mAbs, such as the NIH/Vaccine Research Group VRC01, resulted from the targeting of mutable epitopes on the HIV virus [Bar KJ, et al. Effect of HIV Antibody VRC01 on Viral Rebound after Treatment Interruption. N Engl J Med. 2016;375(21):2037-50. PMCID|5292134].

    To expand on the Company’s proprietary technology for producing fully human monoclonal antibodies, the Company has applied Artificial Intelligence (A.I.) to identify additional conserved, immutable target sites on the HIV virus. Using this process, an additional seven (7) conserved sites (with up to 98% conservativeness) on HIV have been identified. This analysis also confirmed that the site against which the Company’s already produced anti-HIV monoclonal antibody (Clone 3) targets one of these identified conserved sites on the HIV virus, which site is 98% conserved overall 87,336 HIV isolates analyzed by the Company use of A.I.

    The Company is producing multiple antibodies targeting each of these 7 epitope sites.

    Because the Company's monoclonal antibodies are produced to target epitopes on the virus that do not change, virus mutations will not negate the neutralizing effect of the monoclonal antibody therapy. Significant testing has demonstrated the basis for this expectation. Specifically, in in vitro tests conducted in five independent laboratories, Clone 3 was tested against 43 clinical HIV isolates (strains) of the virus. In those tests, Clone 3 successfully neutralized 41 of the 43 HIV isolates against which it was tested (100% effective against over 95% of the HIV strain against which it was tested). The Company’s Clone 3 antibody is the only fully human monoclonal antibody found to neutralize the Clade C isolate found in Africa, China, and India. Clone 3 also neutralizes the Clade B isolate that is predominate in North America and Europe.

    These results, demonstrating in vitro neutralization effect against geographically distinct clinical HIV (primary) isolates, were achieved in testing in the following 5 independent laboratories:

    1.   University of California, San Francisco, CA, USA
    2.   University of South Florida, Tampa, FL, USA
    3.   Polymun Scientific, GmbH, Vienna, AUSTRIA
    4.   Duke University, Durham, NC, USA (
    5.   Dana Farber Cancer Institute (DFCI), Harvard Medical School, Boston, MA, USA,

    In these tests, Clone 3 neutralized [at IC90] 41 of 43 (>95%) of the clinical HIV-1 group M, N, and O isolates. Clone 3 neutralized 3 of 3 group O HIV isolates tested at 10 µg/ml in PBMC-based assay. In another study of Clone 3 tested against one group N primary HIV-1 isolate, results indicated that the IC90 for Clone 3 versus the HIV primary isolate YBF30 was 3.72 µg/ml. Further, Clone 3 has also been demonstrated to effectively neutralize 4 of 4 virulent pediatric South African clade C isolates [ZA349, ZA562, ZA600, ZA737]; and at 10 µg/ml, neutralize [IC99] a pediatric Zambian clade C HIV-1157, as well as the simian immunodeficiency virus, construct SHIV-1157ip. Therefore, of the 43 HIV isolates against which Clone 3 has been tested, it neutralized 41 (over 95%).

    These Company monoclonal antibodies have been amino acid sequenced using denovo mass spectrometry and polymerase chain reaction (PCR) methodologies. Using these identifying sequences, the Company’s partnering CRO labs are applying recombinant protein technology in FDA-approved CHO cell lines to create pharmaceutical-grade material for use in final PBMC in vitro validation testing, followed by animal and clinical trials.

    Multiple antibodies targeting the identified 7 conserved immutable sites on the HIV virus are being created and this same procedure is followed to produce multiple monoclonal antibodies. This will permit the administration of a “cocktail” therapy which will be significantly more effective than administrating just one monoclonal antibody.

    Additionally, the Company’s separate but complimentary anti-HIV therapeutic, a patented antiviral peptide designated ITV-1, is being advanced to clinical trials. In earlier completed clinical studies at the National Center of Infectious and Parasitic Diseases in Bulgaria, this therapeutic demonstrated effectiveness in the treatment of HIV patients in various stages of the disease. In these clinical trials, the therapeutic showed significant efficacy. In 68% of those individuals tested, there was an increase in CD4+ T lymphocytes. This increase was accompanied by an increase in the CD4/CD8 index and CD4% in over 50% of those tested. The increase in these parameters demonstrated statistical significance compared to the control group. The absolute number and the relative percent of CD8+ T lymphocytes decreased. And the viral load in 80.5% of those tested was below the threshold of detection.

    This ITV-1 anti-HIV treatment is now being advanced through the certification stage in Europe under the European Medicines Agency to thereafter be made available for patient therapy.

    It is expected that there will be a synergistic effect achieved by combining the Company’s two distinctive therapies, its monoclonal antibodies and its ITV-1 therapeutic. The Company will be reporting the progress made on these therapeutics as it is achieved.

    Company Contact:
    Research Center
    Enzolytics, Inc.
    Texas A&M University
    Institute for Preclinical Studies
    College Station, TX 77843

    Enzolytics Progress Update

    COLLEGE STATION, TX August 25, 2021 / With over 1,000 U.S. deaths per day (and rising) and 150,000 new daily infections of COVID-19, monoclonal antibodies are now being recognized as a significant therapeutic for addressing the CoronaVirus pandemic. Enzolytics has always recognized this fact and is aggressively producing targeted anti-CoronaVirus monoclonal antibodies for the treatment of the virus. This progress report provides an update on both the production of the Company’s anti-CoronaVirus monoclonal antibodies and the production and clinical trials of the Company’s ITV-1 anti-HIV therapeutics.

    Monoclonal Antibodies Are Now Being Fully Recognized as a Significant Therapeutic for Addressing the CoronaVirus Pandemic.

    The Company is in active production of anti-CoronaVirus fully human monoclonal antibodies in its Texas lab. The monoclonal antibodies being produced target multiple specific epitopes on the virus. To be effective, monoclonal antibodies produced against viruses must target immutable, conserved epitopes (sequences) on the virus or the antibodies will be ineffective due to virus mutation. This has occurred with regard to anti-CoronaVirus monoclonal antibodies recently produced by Eli Lilly and AstraZeneca, antibodies now withdrawn from the market. [https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab]; [https://www.reuters.com/business/healthcare-pharmaceuticals/astrazeneca-says-its-antibody-treatment-failed-in-preventing-covid-19-exposed-2021-06-15/].

    The monoclonal antibodies being produced by Enzolytics against the CoronaVirus target 19 conserved immutable sites on the virus, sites which the Company has now confirmed are conserved sites not only on the initial virus strains but also existing in the Delta and Lambda variants, as well as in the Alpha, Beta and Gamma variants.

    The Company’s process for producing monoclonal antibodies against infectious diseases begins with conducting an Artificial Intelligence (A.I.) analysis of the epitope sequences to identify conserved sites with a conservativeness of up to 99%. In the case of the CoronaVirus, the Company initially analyzed 50,512 CoronaVirus isolates and has now analyzed over 1 million isolates resulting in the identification of 19 conserved, immutable sites. These 19 conserved sites were confirmed as 98.71% to 99.29% conserved over the entirety of all 1 million CoronaVirus isolates analyzed. From further analysis of the Delta variant, Lambda variant, Alpha, Beta, and Gamma variants, the Company has confirmed that the 19 sites against which it is producing monoclonal antibodies exist in these variants.

    With this information, the Company is producing fully human monoclonal antibodies targeting these sites. Early in 2021, the Company filed patent applications claiming these 19 conserved CoronaVirus epitope sites and its methodology for the production of such antibodies.

    Following the production of the multiple monoclonal antibodies in its Texas lab, the monoclonals will be processed at CRO/CDMO labs contracted by the Company where the sequencing of the antibodies will be determined using denovo mass spectrometry. Peptide sequences will also be determined using polymerase chain reaction (PCR) methodology. Once the sequencing of the antibodies is determined, the antibodies will be produced using recombinant protein technology in FDA-approved Cho cell lines to create pharmaceutical-grade material for animal and clinical trials.

    These follow-on steps, after monoclonal antibodies are produced in the Company lab, will be conducted in specialized CRO/CDMO labs under the Company’s guidance and pursuant to contracts. The Company has multiple therapeutics which it is developing. For each, the Company engages and interfaces with CROs and CDMOs to conduct follow-on process steps necessary to produce clinical-grade therapeutics for trials.

    From the essential information created by the Company, namely the specific amino acid sequences necessary to produce the final therapeutics, the Company engages CRO/CDMO entities to produce the clinical-grade anti-SARS-CoV-2, anti-HIV, anti-HTLV-1, and many other therapeutic monoclonal antibodies which the Company is producing. Moreover, for each of these viruses, multiple monoclonal antibodies (targeting precise conserved sites on the viruses) will be produced for use in combination therapy.

    There are many highly qualified international CRO/CDMO companies engaged by Enzolytics. All are experts in their fields and fully capable of conducting the follow-on steps necessary to advance Enzolytics’ initial monoclonal antibodies to the production of pharmaceutical-grade material for animal and clinical trials. In the engagement of CROs/CDMOs as a part of the production of the Company’s targeted therapeutics, the application of the follow-on processes they provide comes into play subsequent to the production of monoclonal antibodies produced by Enzolytics and under the Company’s complete control.

    ITV-1 anti-HIV Therapeutics Development Progress.

    With regard to the Company’s additional therapeutics under development to treat HIV, agreements have been reached with Danhson [https://danhson.bg/en/] and Clinic Design [https://clinicdesign.eu/] and progress is proceeding to advance the Company’s anti-HIV therapeutic ITV-1 to production and clinical trials. These steps are prefatory to approval by the European Medicines Agency (EMA), leading to patient use authorization.

    Production of the therapeutic is being accomplished at Danhson pharmaceutical company facilities, to be followed by clinical trials conducted by Clinic Design. Production of the therapeutics is expected to be completed in the next few months followed by clinical trials to be conducted immediately thereafter. The protocol of the trials will be guided by Pharmalex [https://www.pharmalex.com/], an EU regulatory consulting company.

    Monoclonal Antibodies Are Now Being Recognized as a Significant Therapeutic for Treating COVID-19.

    A new wave of recognition is now emerging in the healthcare and political arenas regarding the significance of monoclonal antibodies. The U.S. government has spent $2.65 Billion on the Regeneron monoclonal antibodies and on August 20, 2021, the UK approved the Regeneron/Roche antibodies cocktail for COVID-19. There is now widespread recognition of the potential effectiveness and role that monoclonal antibodies can play in current and future pandemics.

    The Enzolytics process differs from the process used by Regeneron.  Regeneron antibodies are produced by the company's VelocImmune® mice, which have been genetically modified to have a human immune system. Enzolytics’ process does not use mice with a genetically modified human immune system. The Enzolytics’ proprietary methodology for creating hybridomas produces a specific monoclonal antibody secreted by human immune B cells—obtained from convalescent donor patients—followed by isolating a single cell that produces a monoclonal antibody that targets an identified conserved epitope on the virus.

    A primary distinction of the Enzolytics process for creating fully human monoclonals is the starting point is from human “immune-B cells” from humans who have survived successfully from a "natural" CoronaVirus infection. These antibodies will retain the original natural antibody affinity and specificity and have a lower risk of immunogenicity when used as a therapeutic. They are expected to provide broad-spectrum coverage against viral variants with increased potency, stability as a single-domain molecule, and, in the recombinant form, will have accessibility to the virus epitopes (binding sites) not accessible with a whole antibody.

    On August 21, 2021, Florida Governor Ron DeSantis announced that the State of Florida opened a new monoclonal antibody therapy treatment site in Broward County. “We are working to raise awareness about monoclonal antibodies because they save lives and reduce severe illness and risk of hospitalization,” said Governor DeSantis. “Today, I am proud to further expand access to treatment with the opening of a monoclonal antibody treatment site in Broward County. We will continue to open more sites to support Floridians’ ability to receive this treatment which has been proven to be safe and effective.”

    In his statement, Governor DeSantis acknowledged that monoclonal antibodies are proven as successful therapies in other illnesses and do not carry the suspect confusion that surrounds the mRNA technology used to produce the current anti-CoronaVirus vaccines. Indeed, monoclonal antibodies are not new to medicine. They were invented in 1976 by Georges Köhler and César Milstein who were awarded the Nobel Prize for their discovery. They are currently successfully produced and administered in treating autoimmune diseases, cancer tumors, Ebola, Respiratory syncytial virus (RSV), and others. Use to date has been limited but is expanding as their unique effectiveness and safety are being recognized.

    Monoclonal antibodies are being recognized as prime therapeutics on many levels. This week, Erin McCreary, director of stewardship innovation at the University of Pittsburgh Medical Center, which has treated 3,427 patients with the drugs since December 9, 2020, stated, “We have a long way to go on how do we reach the general public where they are. It is absolutely the standard of care for Covid-19,” she said. “It is my hope that clinics know that.”

    [https://www.washingtonpost.com/health/covid-monoclonal-abbott/2021/08/19/a39a0b5e-0029-11ec-a664-4f6de3e17ff0_story.html].

    Enzolytics has recognized this fact for decades having produced anti-HIV monoclonal antibodies.

    The process of producing monoclonal antibodies follows nature’s role in the body in attempting to ward off infection where the body naturally produces antibodies to counteract viruses. Unfortunately, while the body, through its B cells, recognizes viruses, it produces polyclonal antibodies in response—not all of which are neutralizing. In its process, the Company isolates a single B cell and clones it so that it produces monoclonal antibodies to a specific part of the virus. To be successful and avoid virus escape due to mutation, an immutable target must be identified and the antibody produced must singularly attack that site. This is accomplished by the Company through initially screening over 57,000 CoronaVirus isolates followed by screening over 1 million and identifying the conserved sites which are then targeted.

    In his comments this week, even Governor DeSanctis noted that monoclonal antibodies are a therapy that simulates what the body does to protect us from viruses and bacteria. They are not manipulated therapies like the mRNA vaccine that causes many to question the safety of vaccines produced by the mRNA methodology.

    In a podcast in August 2020 [https://www.youtube.com/watch?v=VdRXTcI7rs8], Dr. Anthony S. Fauci, head of the NIAID/NIH, reported that the U.S. government had commissioned and prepaid millions for doses of anti-CoronaVirus monoclonal antibodies that would be available in October of 2020. Successful monoclonal antibodies did not surface in the Fall of 2020 as reported in that podcast. This demonstrates the critical importance of producing monoclonal antibodies that target a precise and immutable site on the virus.

    More recently, in Dr. Fauci’s presentation on August 3, 2021, at the Center for Strategic and International Studies about the ongoing development of coronavirus treatments (Reuters), he commented that “monoclonal antibodies turned out to be an early success but they have had their vulnerability particularly when you deal with the variants we have had to face.” One interpretation of Dr. Fauci’s statement is the early monoclonal antibodies produced by the NIH, and apparently, those from Eli Lilly and AstraZeneca failed because of virus mutation, the emergence of “variants”. Enzolytics has recognized all along that mAbs must target “immutable”, “conserved” sites. With Artificial Intelligence and the screening of over 1 million CoronaVirus isolates and identifying 19 that are conserved across all those analyzed at a level of up to 99%, the Company has identified those sites that do not mutate and is now producing monoclonal antibodies targeting those sites.

    This history highlights the fact that the process is one that is complex and must be precisely executed. If the produced antibody attacks a part of the virus that mutates, as the NIH did in the production of anti-HIV monoclonal antibodies VRC01 and VRC02, they fail. [https://www.jci.org/articles/view/134395]. The Emergency Use Authorization (EAU) for Eli Lilly’s and AstraZeneca’s anti-CoronaVirus monoclonal antibodies were earlier revoked due to lack of effectiveness.

    Enzolytics is producing 19 fully human monoclonal antibodies each targeting a conserved immutable site on the CoronaVirus. These monoclonal antibodies are being created and tested and expectedly will be administered as a successful therapy against the virus. While experts now agree that one monoclonal antibody is good, they likewise agree that multiple antibodies are better. Moreover, monoclonal antibodies may be produced against multiple viruses and the Company has on its agenda production of such antibodies against a long list of viruses, including H10N3, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Ebola, Small-Pox, Tetanus, Diphtheria, Rabies, Herpes zoster, Varicella zoster, Anthrax, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, and Koala retrovirus. The Company looks forward to demonstrating success with each of these monoclonal antibodies in the future.

    Forward Looking Statements

    This progress update may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of our company, are generally identified by the use of words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “seek,” “strive,” “try,” or future or conditional verbs such as “could,” “may,” “should,” “will,” “would,” or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Some of the factors that could cause our actual results to differ from our expectations or beliefs include, without limitation, the risks discussed from time to time in our filings with the Securities and Exchange Commission or OTC Markets. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Certain forward-looking statements may involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.

    While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of the Company to establish the efficacy of monoclonal antibodies, ITV-1, or its other therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States and abroad, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.

    Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.

     

    ENZOLYTICS REPORTS ITS PROGRESS TOWARD COMPLETION OF CLINICAL TRIALS FOR ITS ITV-1 ANTI-HIV THERAPEUTIC AND SECURING USE AUTHORIZATION UNDER THE EUROPEAN MEDICINES AGENCY

    COLLEGE STATION, TX July 28, 2021 / Enzolytics, Inc. has completed arrangements and agreements with Danhson (https://danhson.bg/en/) and Clinic Design (https://clinicdesign.eu/) to advance its anti-HIV therapeutic ITV-1 to production and clinical trials. These steps are prefatory to approval by the European Medicines Agency (EMA), leading to patient use authorization.

    Production of the therapeutic will be accomplished at Danhson pharmaceutical company facilities, to be followed by clinical trials conducted by Clinic Design. Production of the therapeutics is expected to be completed in the next few months followed by clinical trials to be conducted immediately thereafter. The protocol of the trials will be guided by Pharmalex (https://www.pharmalex.com/), an EU regulatory consulting company.

    Earlier in the year, the Company announced the formation of International Medical Partners (“IMPL”), a Bulgarian Limited Liability Company, of which the Company is 50% owner. Pursuant to that formation, the Company will fund the initial production of the ITV-1 therapeutic and the Company’s partners in IMPL will fund the cost of the clinical trials and cost of EMA permitting.

    IMPL will be the exclusive distributor of the ITV-1 therapeutic in the European Medicines Agency member countries (namely all 27 European Union member states and Iceland, Liechtenstein and Norway) as well as the countries of Russia, Georgia, Ukraine, Moldova, Belarus, Armenia, Azerbaijan, Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan, Tajikistan, Estonia, Latvia and Lithuania. IMPL may distribute the ITV-1 therapeutic outside of its exclusive territory where an exclusive license does not otherwise exist.

    All documentation for registration of IMPL has been filed with the Registry Office in Sofia. The initial funding of IMPL, by Enzolytics and its partners, has been provided by the partners.

    The Company’s two-year audit is proceeding in accordance with GAAP requirements and will be completed and filed as soon as completed. The audit is proceeding as planned without any unanswered issues.

    Harry Zhabilov, CSO of Enzolytics, stated, “We are excited about the progress we have made with the assistance of our IMPL partners. Contracting with Danhson, Clinic Design and PharmaLex is integral to the success of the EMA permitting process. As this is the second time our ITV-1 therapeutic has progressed through clinical trials and the first trials were successful, we are fully confident that we will succeed in the permitting process. With the reciprocal treaty between the EMA and FDA, we believe that the EMA approval with lead to further advancement of our ITV-1 as a successful therapy.”

    Company Contact

    Enzolytics, Inc.
    2000 North Central Expressway
    Plano, TX 75074
    and
    Research Center
    Enzolytics, Inc.
    Texas A&M University
    Institute for Preclinical Studies
    College Station, TX 77843

    ENZOLYTICS ANNOUNCES ITS PROGRESS TOWARD COMPLETION OF CLINICAL TRIALS FOR ITS ANTI-HIV ITV-1 THERAPEUTIC AND PLANS FOR ITS DISTRIBUTION THROUGHOUT EUROPE

    COLLEGE STATION, TX / ACCESSWIRE / June 14, 2021 / Enzolytics, Inc. (OTC PINK: ENZC) (https://enzolytics.com/) has concluded definitive plans to advance its previously tested ITV-1 anti-HIV therapeutics to clinical trials and distribution throughout Europe. Completion of these steps will establish its anti-HIV therapy as a significant revenue source for the Company, a meaningful milestone for both human health and Company profitability.

    The Company’s ITV-1 anti-HIV therapeutic earlier progressed toward certification under the Bulgarian Drug Agency (BDA), but that process was interrupted before completion. However, in that process, significant positive clinical trial results in patients were documented. These positive results give the Company complete confidence that the now planned clinical trials under the European Medicines Agency (EMA) will likewise be successful.

    The steps now in place to accomplish the Company’s goal of bringing its anti-HIV ITV-1 therapeutic to patients are:

    • The Company has formed International Medical Partners Ltd. (IMPL) in partnership with European partners.
    • IMPL is owned equally by the Company and its partners and has the license to distribute the ITV-1 therapeutic in the 27 European countries covered by the European Medicines Agency plus Russia, Georgia, Ukraine, Moldova, Belarus, Armenia, Azerbaijan, Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan, Tajikistan, Estonia, Latvia, and Lithuania.
    • The Company has engaged the Contract Manufacturing Organization (CMO) Danhson Ltd. to produce the initial quantity of ITV-1 used in preparing the required Best Methods Report for future production and clinical trials documentation.
    • The Company has engaged the Contract Research Organization (CRO) Clinic Design Ltd. to prepare the protocol for human clinical trials that will lead to the licensing of the Company’s ITV-1 therapeutic under the European Medicines Agency (EMA).
    • The production at Danhson Ltd. will produce initial production quantities of the therapeutic to be used for completion of preclinical testing and then initiating clinical trials with Clinic Design Ltd.
    • IMBL is contracting with PharmaLex, a leading EU regulatory consulting company, to manage document review of product compliance according to EMA requirements.
    • The clinical trials will be funded fully by the Company’s European partners in IMPL. None of the clinical trial costs will be borne by the Company.

    The Company’s two-year audit is proceeding in accordance with GAAP requirements and will be completed and filed as soon as possible. No unanswered issues have arisen.

    Harry Zhabilov, CSO of ENZC, stated, “We are excited about the progress we have made with the assistance of our partners at IMPL. Engaging Danhson Ltd., Clinic Design Ltd., and PharmaLex is an integral step toward our success in the EMA permitting process. As this is the second time ITV-1 has gone through clinical trials and the first trials were successful, our confidence is at an all-time high regarding permitting, and with the reciprocal treaty between the EMA and FDA, we believe that the “redo” on clinical trials will be a blessing in disguise in the long run.”

    CEO Charles Cotropia said, “The Company’s objective is to provide new, better, and safer therapeutics to treat HIV. Currently, treatment is solely through the lifelong use of antiretrovirals (ARVs) which are expensive and have long-lasting, serious negative effects on the body. The costs for such ARVs are high - from $27,540 per year for Dovato by ViiV/Glaxo SmithKline to $42,635 per year for Biktarvy by Gilead and a lifetime costs of up to $350,000 – and even then, only 54% of those infected by HIV have access to such treatments – leaving 46% with no treatment. New and improved therapies that are less expensive and more effective are desperately needed. Providing these better therapies is our Company’s objective.”

    About Enzolytics, Inc.

    Enzolytics, Inc. is a drug development company committed to the commercialization of its proprietary proteins and monoclonal antibodies for the treatment of debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), which studies have shown is effective in treating HIV/AIDS. IPF is the active component of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has also been shown to modulate the immune system.

    The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology for producing fully human monoclonal antibodies is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the Coronavirus (SARS-CoV-2) and HTLV-1.

    I.R. contact

    TEN Associates, LLC
    Tom Nelson, CEO
    (480) 326-8577
    Investor Relations Contact

    Company Contact

    Enzolytics, Inc.
    2000 North Central Expressway
    Plano, TX 75074
    And
    Research Center
    Enzolytics, Inc.
    Texas A&M University
    Institute for Preclinical Studies
    College Station, TX 77843-44

    SOURCE: Enzolytics, Inc.

    ENZOLYTICS ANNOUNCES A COMPREHENSIVE THERAPEUTIC PROTOCOL FOR THE PRODUCTION OF MONOCLONAL ANTIBODIES TO ADDRESS ONGOING AND FUTURE PANDEMICS

    COLLEGE STATION, TX / ACCESSWIRE / June 7, 2021 / Enzolytics, Inc. (OTC PINK: ENZC) (https://enzolytics.com/) has announced a coherent protocol that it intends to execute to meet the Company’s objective of producing a therapeutic cure for HIV as well as a planned protocol to address existing and future pandemics. This protocol has been defined as a result of the Company’s collaboration with Intel Corporation in the field of applying computer analysis (Artificial Intelligence – A.I.) to accelerate health care discoveries and development.

    The Company’s collaboration with Intel is discussed in a recently published White Paper (https://www.intel.com/content/www/us/en/healthcare-it/resources/enzolytics-whitepaper.html) and in an internet streamed presentation (https://www.youtube.com/watch?v=8peEJdTRoe8) featuring Intel representatives Clifton Roberts and Nikhil Deshpande with Enzolytics' COO, Dr. Gaurav Chandra. Enzolytics’ collaborative partnership with Intel focuses on achieving groundbreaking drug discovery and development pathways. This collaboration includes exploring the interaction of monoclonal antibodies with viruses in 3-dimensional matrices. This opens new innovative pathways for drug discovery and development.

    The Company is actively exploring biotech partnerships, and in the same way, the Company is working with Intel Corporation to advance and provide effective therapies and cures for existing and new viral illnesses. In combination with the Company’s patented and clinically tested anti-HIV peptide ITV-1, the Company proposes a collaboration to fully implement the following protocol for developing and deploying therapeutics to address existing and future pandemics.

    The Company’s defined protocol includes:

    • Application of computer analysis (Artificial Intelligence – A.I.) to curate (analyze) the amino acid sequences of targeted viruses to identify the conserved, immutable, and neutralizable target sites (epitopes) on targeted viruses. Enzolytics has accomplished this goal for HIV, the Coronavirus, HTLV-1 and is in the process of doing the same for H10N3, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Ebola, Small-Pox, Tetanus, Diphtheria, Rabies, Herpes zoster, Varicella zoster, Anthrax, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, and Koala retrovirus.
      • The protocol includes the implementation of A.I. analysis of existing viruses (or mutants thereof) and on any new virus immediately upon its emergence anywhere in the world.
      • The A.I. analysis identifies the conserved, immutable, and neutralizable target sites on the subject virus. It provides for the production of multiple monoclonal antibodies, each targeting an immutable epitope for the administration of combination therapy.
    • Creation of cell lines to produce fully human monoclonal antibodies targeting each identified conserved virus site (epitope). In this step, multiple broadly neutralizing antibodies are produced targeting multiple conserved, immutable epitopes on the targeted virus.
      • The Company’s methodology for producing monoclonal antibodies is unique.
      • Antibodies are produced from human "immune-B cells," obtained from convalescent individuals who have recovered from the target virus.
      • The antibodies are not "humanized" rat and mouse monoclonal antibodies where the original antibody affinity and specificity are not maintained, and the chances of immunogenicity are increased.
      • The antibodies are not transgenic mouse models (a human immune system that has been “grafted” within a mouse model) having been "vaccinated" with specific and selected purified proteins.
      • Given the production method, a "Black Box Warning" (a warning of potential adverse reactions) would not be expected to be applicable to the Company’s produced antibodies.
    • Administering multiple monoclonal antibodies in the early stages of infection as treatment or cure of the targeted virus.

    This protocol is now being executed and may be applied to any virus using the Company’s existing technology. The first step of using A.I. to identify conserved, immutable target sites has been completed by Enzolytics for HIV, the Coronavirus (SARS-CoV-2), and the HTLV-1 virus. With regard to the HIV virus, the Company has screened more than 87,336 HIV isolates, the largest known repository of HIV isolates known. From this extensive A.I. analysis, seven (7) conserved sites (with up to 98% conservativeness) on HIV were identified. This analysis also confirmed that the site against which the Company’s already produced anti-HIV monoclonal antibodies (called Clone 3) targets one conserved site on the HIV virus, which site is 98% conserved (either directly or by way of conservative amino acid substitutions) overall 87,336 HIV isolates curated (analyzed) by the Company using Artificial Intelligence.

    Likewise, the Company has completed the same type of analysis for the Coronavirus and HTLV-1. Using A.I., the Company screened more than 50,512 Coronavirus isolates currently known and has identified conserved, immutable sites which are neutralizable. Through the analysis, nineteen (19) conserved sequences have been identified on the Coronavirus on the basis that they are 98.71% to 99.29% conserved over the entirety of the 50,512 Coronavirus isolates analyzed. From these findings of 19 conserved, neutralizable sites (epitopes) on the Coronavirus, the Company is producing multiple (a cocktail of) targeted anti-SARS-CoV-2 monoclonal antibodies.

    Experts acknowledge the necessity of treating with multiple monoclonal antibodies. More importantly, the target sites must be conserved, immutable sites to avoid “virus escape” for the therapeutics to be effective. Producing antibodies against each conserved targeted site on the virus permits the creation and administration of a "cocktail" of antibodies, each of which will have an effect without regard to the mutation of the virus. Using the Company’s proprietary methodology for producing fully human monoclonal antibodies, the Company is producing antibodies targeting these virus sites in its lab at Texas A&M University in the University's Institute for Preclinical Studies.

    Patents have been filed on these discoveries claiming the inventive findings. These patents claim the discovered epitope/antigens, with proposed vaccine claims, antibody claims, and related prophylactic/therapeutic method claims relating to these identified epitope/antigens.

    The Company is also curating (analyzing) the amino acid sequences of other significant viruses, covered by patents claiming the identified antigens/epitopes and associated therapeutics. Using A.I. analysis, the Company is now identifying, and it will claim the conserved epitopes/antigens on the infectious diseases caused by Ebola, Influenza A and B, H1N1 influenza, H10N3, Respiratory syncytial virus (RSV), Small-Pox, Tetanus, Diphtheria, Rabies, Herpes zoster, Varicella zoster, Anthrax, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, and Koala retrovirus.

    The Company expects to accelerate its development of these highly significant therapeutics and test its monoclonal antibodies in combination with its patented and clinically tested anti-HIV peptide ITV-1. Such tests are expected to validate the expected synergistic effect of combining the two anti-HIV therapeutics. The Company is actively seeking and dialoguing with pharma companies active in developing therapeutics for treating infectious diseases.

    About Enzolytics, Inc.

    Enzolytics, Inc. is a drug development company committed to the commercialization of its proprietary proteins and monoclonal antibodies for the treatment of debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), which studies have shown is effective in treating HIV/AIDS.  IPF is the active component of ITV-1 and is a purified extract of porcine pepsin.  ITV-1 has also been shown to modulate the immune system.

    The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology for producing fully human monoclonal antibodies is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the Coronavirus (SARS-CoV-2) and HTLV-1.

    Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.

    While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of ITV-1 or its therapeutic monoclonal antibodies in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.

    Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.

    I.R. contact

    TEN Associates, LLC
    Tom Nelson, CEO
    (480) 326-8577
    Investor Relations Contact

    Company Contact

    Enzolytics, Inc.
    2000 North Central Expressway
    Plano, TX 75074
    And
    Research Center
    Enzolytics, Inc.
    Texas A&M University
    Institute for Preclinical Studies
    College Station, TX 77843-44

    SOURCE: Enzolytics, Inc.

    ENZOLYTICS INC. AND INTEL CORPORATION CO-AUTHOR WHITE PAPER ON USE OF ARTIFICIAL INTELLIGENCE FOR SOCIAL GOOD

    COLLEGE STATION, TX / ACCESSWIRE / May 17, 2021 / In a significant white paper, Enzolytics Inc. (OTC PINK: ENZC) (https://enzolytics.com/) and Intel Corporation (https://www.intel.com) have published a thought leadership collaboration. The white paper titled "Optimizing Empathetic A.I. to Cure Deadly Diseases" [https://www.intel.com/content/www/us/en/healthcare-it/resources/enzolytics-whitepaper.html] highlights Intel's Artificial Intelligence Analytic tools and Enzolytics' innovative approach and groundbreaking contributions to create universal, durable, and broadly effective treatment targeting all virus variants.

    This collaborative effort approaches the future of medicine, a future wherein the process of healthcare evolves from reactive to anticipatory, as exemplified by P4 Medicine, a term coined by Biologist Leroy Hood:

    • Predictive - Our genetic makeup can predict the diseases we are at risk for.
    • Preventative - Medicine that refocuses care on the future rather than the present.
    • Personalized - Every human is genetically different and unique. This kind of approach will give autonomy to individuals as they transition from health to disease.
    • Participatory - This pillar is a crucial aspect that involves (i) convincing physicians of the potential of adopting newer technology, (ii) educating patients about the opportunities, challenges, and responsibilities of adopting the technology, and (iii) revolutionizing the entire medical community's mindset.

    The White Paper underscores Intel's recognition of the premise of P4 Medicine and embraces Artificial Intelligence to deliver on the promise. Intel has made incredible advances in Artificial Intelligence's applications to Empathetic A.I., outsourcing healthcare tasks and decisions to rational machines, freeing up time for healthcare professionals to engage in empathetic care, and cultivating trusting relationships with their patients.

    While Empathetic A.I. is promising, scientific and healthcare-related studies generate large amounts of invaluable data. Intel is empathetic to this challenge and has responded by building a graph analytics processor that can process streaming graphs thousands of times faster and at much lower power than current processing technology. Graph representation of data enables a schema of independent analytics that scales with the data size and data types. Knowledge Graphs - a significant class of graphical representations of data - are expected to play a substantial role in several spaces: investment insights, fraud prevention, cybersecurity, government analytics, enterprise A.I. analytics, social media insights, drug discovery & repurposing, and predictions of virus mutations.

    A breakthrough of traversing issues with scalability, Intel's Programmable Integrated Unified Memory Architecture (PIUMA) offers solutions. Both PIUMA and graph analytics will add velocity to drug discoveries, repurposing of existing drugs, and predictions of virus mutations. Dr. Gaurav Chandra, Chief Operating Officer of Enzolytics, talking about Intel's A.I. Analytic tools, says, "There is excellent potential for Intel's Innovative Artificial Intelligence Analytics to pioneer the way for a paradigm shift in healthcare. We are confident that Intel's PIUMA and Graph Analytics will advance drug discoveries and prognosticate virus mutations. "

    Intel commends the discovery of Dr. Joseph Cotropia, CSO of Enzolytics, and Dr. Gaurav Chandra. Dr. Cotropia discovered a genetic amino acid sequence designated KLIC in the outer envelope of HIV. Discovering this sequence is like finding a "needle in a haystack" and retrieving the needle. This immutable site has been identified, and the antibody that targets this site was created. This antibody (Clone 3) can lock onto the KLIC epitope. Once bound by the antibody, the virus cannot infect a human cell and cannot ultimately reproduce.

    Patented by Dr. Cotropia, this HIV monoclonal antibody has been successfully tested in five international labs. In those tests, Clone 3 antibody neutralized [at an IC90] 95% of all HIV primary isolate strains (41/43) - across all clades and groups - against which it was tested. For an antibody to be effective, it has to attack a neutralizable site on the virus that is always present and does not mutate. Knowing the binding site for the monoclonal Clone 3 antibody on the HIV-1 virus and then examining the Coronavirus amino acid sequence, a correlation in the structures has been identified by Drs. Cotropia and Chandra. Having identified the correlative sequence on the Coronavirus, Enzolytics is now producing monoclonal antibodies targeting that site.

    Specific antibodies that broadly neutralize are necessary to provide effective therapy and prevention of disease. Producing multiple neutralizing monoclonal antibodies for use in passive immunotherapy is now possible by using AI to identify multiple conserved sites, followed by applying Enzolytics' proprietary method of producing neutralizing monoclonal antibodies targeting those sites. Thus, Enzolytics' primary focus is now on identifying conserved, immutable sites on viruses and then creating monoclonal antibodies that bind to such conserved sites resulting in the neutralization of even mutant strains of viruses. Dr. Chandra recognized A.I.'s potential and, based on knowledge of these homologous viral structures, targeting the corresponding "Achilles Heel" site on a virus, an expected conserved immutable and neutralizable site was identified.

    Consequently, Dr. Chandra worked with Denver Scientific's genetics molecular biology data science team to screen more than 50,512 Coronavirus and 87,336 HIV isolates, the largest known repository of HIV and Covid- 19 isolates in the world. From this very complex and extensive A.I. analysis, conserved sites immutable on HIV and Covid-19 were identified. Through this search, the earlier identified correlative structure to the neutralizable site on HIV was confirmed as also conserved and expectedly neutralizable. Additionally, another seven conserved sequences have also been identified using A.I. technology, while in another breakthrough, 19 conserved sequences over the entirety of the 50,512 Coronavirus isolates analyzed have been identified. These immutable sites on the SARS-CoV-2 virus have also been confirmed as existing (100%) in the U.S. SARS-CoV-2 virus variants that have surfaced in United Kingdom, Brazil, and South Africa.

    As a trifecta, Intel technology, P4 Medicine, and the efforts of Enzolytics require effective public policy - policies that will fuel this trifecta as a promising thought leadership experiment - a necessary journey of experimentation as humanity bravely marches towards cures for society's most deadly diseases and a more Empathetic A.I. Cultivating a technology-neutral public policy and a regulatory government-investment environment are paramount to this end.  The consensus is for five primary policy drivers to cultivate trust, empathy, and velocity that will assist in realizing the potential described in the White Paper. The five policy drivers are to:
    1.perpetuate public-private partnerships
    2.foster secure federated machine learning
    3.implement standards and frameworks to address structured and unstructured data challenges
    4.ethically liberate datasets for evolving regulatory environments
    5.minimize bias to optimize empathetic A.I.

    The conclusion described in the White Paper is that Enzolytics Inc's use of Artificial Intelligence underscores a novel approach in assessing millions of virus sequences to identify the conserved segments essential for virus survival. Through effective public and private sector symbiosis and the fostering of a technology-neutral regulatory environment, the genuine power of A.I., coupled with advanced techniques in proprietary technologies illustrated in the Enzolytics immunotherapeutics, will no doubt create universal, durable, and broadly effective treatment targeting all virus variants.

    Charles Cotropia, the CEO, said: "We are honored and privileged to work with the preeminent international corporation Intel in a collaborative manner focused on the optimum way to advance healthcare using science and technology together. Combining science with technology will guarantee success."

    I.R. contact

    TEN Associates, LLC
    Tom Nelson, CEO
    (480) 326-8577Investor Relations Contact

    Company Contact
    Enzolytics, Inc.
    2000 North Central Expressway
    Plano, TX 75074

    And
    Research Center
    Enzolytics, Inc.
    Texas A&M University
    Institute for Preclinical Studies
    College Station, TX 77843-44

    SOURCE: Enzolytics, Inc.

    ENZOLYTICS, INC. ANNOUNCES THE GRANT OF A DISTRIBUTORSHIP LICENSE FOR THE RIGHT TO DISTRIBUTE ITS ANTI-HIV-1 THERAPEUTIC ITV-1 AND A STOCK AGREEMENT VALUED IN TOTAL AT $7 MILLION US DOLLARS

    College Station, TX, May 12, 2021/PRNewswire/ Enzolytics, Inc. (OTC Markets “ENZC” or the “Company”) today announced it had granted a distributorship license to a European pharma entity (the Licensing Entity) for the right to distribute the Company’s anti-HIV-1 therapeutic ITV-1 in the countries of India, Pakistan, UAE, Indonesia, Philippines, Nigeria, Benin and Togo, Kenya, Tanzania, Rwanda, Libya, Uganda, North Sudan, Egypt, Morocco, and Tunisia (the Licensed Territory). The Licensing Entity is the owner of a pharmaceutical plant in Eastern Europe. Pursuant to the Agreement, Enzolytics will receive $1 Million USD and 50% ownership in the Licensing Entity valued at $8 Million. The License is granted with a commitment by the Licensee to sell and distribute the ITV-1 therapeutic in the Licensed Territory.

    In addition, the Licensing Entity will invest $2 Million USD in the Company in exchange for Company Preferred Series E stock bring to the Company $3 Million in cash plus a 50% ownership in the Licensing Entity. This agreement will result in establishing a committed partner for the sale and distribution of the Company’s ITV-1 therapeutic in the Licensed Territory as well as 50% ownership in Licensee and its profit derived from sales in the Licensed Territory.

    Charles Cotropia, the CEO, stated, “This is yet another milestone in our Company’s progress toward producing revenue from our technology and the therapeutics produced from it. We gratefully acknowledge Harry Zhabilov’s years of commitment to the Company that is making possible the partnerships and agreements now being finalized. As a result of his efforts, we have another European transaction which we expect to consummate and report in the coming week. Just as important as the investments being made into the Company are the partners and licensees being engaged – all individuals who have strategic contacts within the countries in which they will be distributing our therapeutics. These strategic contacts and their familiarity with geographic areas being served is as significant as any aspect of the arrangements we are completing.”

    “For many years, we have been developing and strengthening the relationships that are now leading to our current significant partnerships. With the advances, the Company is making toward preparation for and completion of clinical trials in Europe, which will lead to approval from the EMA, we are meeting our goal of bringing our technology to those in need”, said Harry Zhabilov, CSO.

    About Enzolytics, Inc.

    Enzolytics, Inc. is a drug development company committed to the commercialization of its proprietary proteins for the treatment of debilitating infectious diseases.
    Enzolytics' flagship compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), which studies have shown is effective in the treatment of HIV/AIDS. IPF is the active component of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has also been shown to modulate the immune system.

    About BioClonetics Immunotherapeutics, Inc.

    BioClonetics Immunotherapeutics, Inc., a wholly-owned subsidiary of Enzolytics, is a Dallas and College Station, Texas biotech company with proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology for producing fully human monoclonal antibodies is currently employed to produce monoclonal antibody therapeutics for other infectious diseases, including the Coronavirus (SARS-CoV-2).

    Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the US Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.

    While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of ITV-1 in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of ITV-1 in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.

    Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release, and the Company expressly disclaims any intention or obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements.

    IR contact

    TEN Associates, LLC

    Tom Nelson, CEO

    (480) 326-8577

    Investor Relations Contact

    Company Contact

    Enzolytics, Inc.
    2000 North Central Expressway
    Plano, TX 75074
    and
    Research Center
    Enzolytics, Inc.
    Texas A&M University
    Institute for Preclinical Studies
    College Station, TX 77843-44

    SOURCE: Enzolytics, Inc.

    PRESENTATION OF TECHNOLOGY ON THE EMERGING GROWTH CONFERENCE

    Enzolytics was recently invited to present at The Emerging Growth Conference (https://emerginggrowth.com/conference/), where we discussed our technology. Those presentations may be viewed here on YouTube: https://youtu.be/LD9qeDdiRvY.

    ENZOLYTICS REPORTS PROGRESS ON ITS MULTIPLE THERAPEUTICS PLATFORMS AND INITIATIVES

    News Release April 19, 2021
    We continue to make great strides in applying our multiple platforms for the production of therapeutics for treating infectious diseases. Our future success will follow as we meet our goals to bring these therapeutics to market with new developments made possible by our extensive platform for producing new and effective therapies.
    We acknowledge our partners Genscript (https://www.genscript.com), STC Biologics (https://stcbiologics.com), and California National Primate Research Center (University of Southern California) for their continued support in our research and development efforts. We are also grateful for the overwhelming support from world-renowned scientists and continue to expand our team of advisors to build a strong company based on research and development.
    We are encouraged by the positive feedback received from pharmaceutical companies who have acknowledged an interest in partnering upon the achievement of defined milestones. The milestones we have set include the following:

    Monoclonal Antibodies for Treatment of HIV Milestones

    1st Milestone: Testing of anti-HIV Monoclonal Antibodies at University of Montana

    Status: in process. Time to completion: 1 month

    2nd Milestone: Broad-based neutralization testing of existing anti-HIV Monoclonal Antibodies at University of Strasbourg, France

    Status; in process. Time to completion: 2 months

    3rd Milestone: Animal Studies of anti-HIV Monoclonal Antibodies at California National Primate Research Center, University of Southern California

    Time to completion: 6 months following in vitro testing in process.

    4th Milestone: Using Artificial Intelligence, identification of conserved immutable target sites (epitopes) on the HIV-1 virus

    Status: Completed

    5th Milestone: Production of additional Monoclonal Antibodies targeting identified sites (epitopes) on the HIV

    Status: in process. Time to completion: 5-6 months

    COVID-19

    We are proud of the significant advances we have made in the development of Monoclonal Antibodies for treating Covid-19. We have reported that the Monoclonal Antibodies being produced by the Company will target immutable, conserved sites on SARS-CoV-2 (Coronavirus) that exist on the variant strains of the virus from the UK, Brazil, and South African.

    These findings are considered highly significant in that the Center for Disease Control ("CDC") has reported these "variants of concern" are ones "for which there is evidence of an increase in transmissibility, more severe disease (meaning increased hospitalizations or deaths), a significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures."

    Our AI platform developed in collaboration with Denver Scientific has been one of our many successes. The patentable discoveries will be significant in our ongoing partnering dialogue with pharmaceutical companies interested in treatments for the Coronavirus and numerous other infectious diseases.

    We are intent to expedite our development of anti-Coronavirus Monoclonal Antibodies, including an eventual fast-track clinical trial to progress to market.

    SARS-CoV-2 (Coronavirus) Monoclonal Antibodies Milestones

    1st Milestone: Using Artificial Intelligence, identification of conserved, immutable target sites (epitopes) on the Coronavirus

    Status: Completed

    2nd Milestone: Production of Monoclonal Antibodies targeting identified sites (epitopes) on the SARS-CoV-2 virus

    Status: In process. Time to completion: 3-4 months

    3rd Milestone: Fast-Track Clinical Studies

    Time to Completion: 6 months following the production of Monoclonal Antibodies

    ITV-1 anti-HIV Therapeutics

    Clinical trials are planned for the Company’s patented anti-HIV therapeutics ITV-1. Earlier this year, we announced the execution of Articles of Association to form International Medical Partners ("IMPL"), a Bulgarian Limited Liability Company of which the Company is 50% owner. The Company's partners in IMBL will fund the total cost of the Clinical trials under the European Medicine Agency (the "EMA") standards, and the application cost for the EMA permit for the Company's ITV-1 patented therapeutics for treating HIV. Under the Mutual Recognition Agreement (the "MRA") between the EMA and the United States Federal Drug Administration (the "FDA"), the Company believes that issuance of the EMA permit for the ITV-1 compound could qualify ENZC's treatment for recognition by the FDA. IMBL has entered negotiations to engage a CRO to begin the clinical trials required under EMA standards.

    We will have a definitive timeline for the expected date of initiation and completion of clinical trials of ITV-1 in the coming weeks.

    Production of Monoclonal Antibodies for HTLV-1/2

    We are committed to developing universal, durable, and broadly neutralizing Monoclonal Antibodies for many infectious diseases. We have entered into an "intent to partner" agreement with a pharmaceutical company to create Monoclonal Antibodies against HTLV-1/2. We expect to complete the production by the end of 2021.

    Monoclonal Antibodies for HTLV-1/2 Milestones

    1st Milestone: Using Artificial Intelligence, identification of conserved immutable target sites (epitopes) on the HTLV1/2 virus

    Status: in process. Time to Completion: 2-3 months

    2nd Milestone: Creation of anti-HTLV1/2 Monoclonal Antibodies

    Time to completion: 6-8 months following identification of target epitopes

    CEO Charles Cotropia said, “The strength of our Company lies in our multiple technology platforms and the ability to produce fully human Monoclonal Antibodies against conserved and immutable targets on identified viruses. The viruses that may be addressed using our technology range from HIV to the Coronavirus to HTLV-1/2 to Ebola and many more. These numerous targeted viruses and bacteria are listed on our website [https://enzolytics.com/proprietary-therapeutics/]. We will continue to provide updates on our developments and progress toward completing the milestones we have set. We thank all our shareholders for their ongoing support of our Company and its technologies.”

    CORONAVIRUS TARGETED EPITOPES CLAIMED IN ENZOLYTICS’ PENDING PATENT APPLICATIONS ARE VERIFIED AS FULLY CONSERVED IN THE UK, BRAZIL, AND SOUTH AFRICAN VARIANTS OF THE CORONAVIRUS (SARS-COV-2).

    College Station, TX, April 5, 2021/PRNewswire/ Enzolytics, Inc. (OTC Markets "ENZC" or the "Company").

    In a significant development, recent findings have revealed that the monoclonal antibodies being produced by the Company against targeted sites on the Coronavirus are directed against epitopes that exist conservatively on each of the variant strains of the virus from the UK, Brazil, and South African.

    These findings are considered by the Company as highly significant in that the Center for Disease Control (the "CDC") recently reported this Coronavirus as "variants of concern," defining them as ones "for which there is evidence of an increase in transmissibility, more severe disease (meaning increased hospitalizations or deaths), a significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures."
    These Coronavirus variants are largely responsible for the recent increase in COVID-19 cases across the U.S., with the UK variant (B.1.1.7) accounting for 26 percent of all infections in the U.S. This variant, which is between 50 and 70 percent more transmissible, is the predominant strain in at least five regions of the country, according to Rochelle Walensky, MD, CDC director. Mutations in viruses are common, but most are insignificant and do not cause any change in the viruses’ ability to transmit or cause serious infection. But some mutations, like the ones in the UK or South Africa variant lineages, make the virus more infectious and, in some cases, even deadlier.

    Significantly, Federal officials have halted the distribution of Eli Lilly's bamlanivimab monoclonal antibody treatment in three states (California, Arizona, and Nevada) due to concerns about a homegrown COVID-19 variant that renders it ineffective. There are reports of the "double mutant" COVID-19 variant discovered in India and the United States. "Such [double] mutations confer immune escape and increased infectivity."

    The Company’s targeted approach is to produce fully human monoclonal antibodies against the identified conserved epitopes on the Coronavirus. Using computer analysis (Artificial Intelligence [AI]), the Company has identified 19 conserved sequences identified on the Coronavirus on the basis that they are 98.71% to 99.29% conserved over the entirety of the 50,512 Coronavirus isolates analyzed. Significantly, these conserved sequences have been identified in the UK, Brazil, and South African variants.

    This discovery is significant in Enzolytics’ continued commitment to producing therapeutics for the treatment of COVID-19. Specifically, Enzolytics creates human heterohybridoma cell lines using convalescent human patients' peripheral "immune" human B cells to create fully human monoclonal antibodies directed individually against the identified conserved sites on the virus S1 protein and S2 (transmembrane) protein on the Coronavirus. These monoclonal antibodies will expectedly have a universal effect (on all known variants) and durable. As the virus mutates, the targeted site will still exist in the virus, subjecting it to neutralization. Such therapeutics would have universal (worldwide application), be durable (have successful long-term benefit), and thereby prevent failure of successful vaccines and/or provide effective treatment, which are both points of failures that have occurred as a result of “mutational virus escape.”

    This capability is highly significant in that experts, such as Dr. Paul Offit, MD, Director of the Vaccine Education Center at Children's Hospital in Philadelphia, have stated that even though successful vaccines have been developed and deployed, we can expect the Coronavirus to be with us going into the future, with a resurgence year to year. Thus, therapeutics to treat the virus will be necessary for the future. Additionally, the Company’s monoclonal antibodies may be used in conjunction with other pharma antibodies, such as Eli Lily’s bamlanivimab monoclonal antibody in combination therapy.

    The Company’s pending patents claim the identified target sites and include patent claims to the CDR sequences of the produced antibodies. Such patent claim structure will expectedly provide the Company the exclusive rights to therapeutics based on these findings for 20 years from the date of filing. International patent coverage is also being sought.
    CEO Charles Cotropia said, “The discoveries made by our AI team, and implemented by our research team, are extremely significant. The creation of monoclonal antibodies that target the Achilles’ heels of the Coronavirus, which will be present even in mutated strains worldwide, means that a therapeutic may be produced that will affect the world for the expected continuous lifecycle of the Coronavirus. These findings have their origin in the critical analysis performed by our AI team, which has used sophisticated computer analysis and years of AI experience to curate the amino acid sequences (which are in the tens of thousands) of each of the over 50,000 Coronavirus isolates now known. Our AI team has identified the “golden needles” in an enormous haystack of data from this analysis. This is a remarkable achievement.

    Recently, we have become aware of commentators on our technology who, rather than fairly and validly analyzing our technology and our findings, instead propound, for what we perceive as some self-serving reasons, erroneous and irrelevant assertions to mislead those interested in knowing the fundamental truth about our discoveries. For example, one “red flag” raised by one commentator has been to criticize our AI team - not based on the technology and substance of its findings - but by focusing on the date of incorporation of the partner. The date an entity is incorporated is irrelevant when those on the research team have decades of experience with the knowledge, skill, and capability to analyze the amino acid sequences (containing thousands in number) of each of over 50,000 different Coronavirus isolates. From this sophisticated analysis and resulting findings, the Achilles’ heels of the Coronavirus are revealed, namely, those epitopes that must be and that can be targeted by monoclonal antibodies to treat the virus not only today effectively but into the future. We question the motive behind these grossly misdirected comments, made for what we perceived as self-serving reasons, and not to provide an honest, fair, and truthful dialogue about a most serious medical crisis. While we perceive such irrelevant and misleading comments as intending to divert attention from the problem at hand and the solutions that are possible, we stand resolved to focus on the science and applying our capabilities to achieve success for all who will confront this virus – a virus that has and will do societal damage around the world, not only today but in the future”.

    About Enzolytics, Inc.
    Enzolytics, Inc. is a drug development company committed to commercializing its proprietary proteins for the treatment of debilitating infectious diseases.
    Enzolytics' flagship compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), which studies have shown is effective in the treatment of HIV/AIDS. IPF is the active drug substance of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has been shown to modulate the immune system.
    About BioClonetics Immunotherapeutics, Inc.

    BioClonetics Immunotherapeutics, Inc., a wholly-owned subsidiary of Enzolytics, is a Dallas and College Station, Texas biotech company with proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology for producing fully human monoclonal antibodies may be used to produce therapeutics treatments for many infectious diseases, including the Coronavirus.
    Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the US Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.

    While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of ITV-1 in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of ITV-1 in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.
    Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.

    IR Contact:

    Enzolytics, Inc.
    2000 North Central Expressway
    Plano, TX 75074
    and
    Research Center

    Enzolytics, Inc.

    Texas A&M University
    Institute for Preclinical Studies
    College Station, TX 77843-4478
    SOURCE: Enzolytics, Inc.

    Enzolytics Technologies Targeting HIV and the CoronaVirus

    This interview of the Company’s CEO, Charles Cotropia, was conducted by and published in CEOCFO Magazine.

    CEOCFO: Mr. Cotropia, what is the concept behind Enzolytics, Inc?

    Mr. Cotropia:

    Enzolytics, Inc. is a drug development company with two separate but complementary therapy platforms for treating infectious diseases, including treatment for HIV. One technology, invented by Harry Zhabilov, the CSO of the Company, includes a patented antiviral peptide that has been tested in clinical studies at the National Center of Infectious and Parasitic Diseases in Bulgaria. In these trials, this therapeutic, known as ITV-1, demonstrated effectiveness in the treatment of HIV patients in various stages of the disease. In trials conducted in 31 patients, the therapeutic showed efficacy; specifically, in 68% of those individuals tested, there was an increase in CD4 + T lymphocytes. This increase was accompanied by an increase in the CD4/CD8 index and CD4% in over 50% of those tested. The increase in these parameters demonstrated statistical significance compared to the control group. The absolute number and the relative percent of CD8 + T lymphocytes decreased. And the viral load in 80.5% of those tested was below the threshold of detection.

    This Enzolytics anti-HIV treatment is now being advanced through the certification stage to thereafter be made available for patient therapy.

    The Company is now combining this technology with recently acquired technology, created by BioClonetics Immunotherapeutics, for creating fully human anti-monoclonal antibodies for treating HIV. Using this technology, the Company has produced a fully human anti-monoclonal antibody that has been tested in 5 international labs where it neutralized over 95% of all strains of the HIV virus against which it was tested. Additional neutralizing antibodies are being produced.

    The therapies of Enzolytics’ two technologies, that produced by Enzolytics and that created by BioClonetics, are expected to be synergistic. Additionally, because the HIV virus and the CoronaVirus have correlative structures and with our knowledge of how our monoclonal antibodies neutralize HIV, we are now developing monoclonal antibodies for treating the CoronaVirus.

    CEOCFO: Isn’t HIV pretty well taken care of now?

    Mr. Cotropia:

    That is the view, particularly in the U.S., but it is a misconception. There are over 36 million people in the world infected with HIV. There are more than 2 million new infections every year, and over one million people die from the virus annually. Ten percent of the HIV deaths are children – amounting to over 300 child deaths per day. The number of children who die from HIV is greater than those that die from cancer.

    The reason there is the belief that HIV is no longer a problem is that there is now, and has been for years, a treatment but no cure. The treatment is through administering antiretrovirals, a treatment that must be taken daily and for life. There is no effective anti-HIV monoclonal antibody on the market for treating HIV, and that is the focus of the therapies developed by Enzolytics. In recent months, the entire world has now come to know “monoclonal antibodies.” This is what was used in a treatment provided to President Trump for the CoronaVirus and is now being developed by several companies. In contrast, the current (and for decades) treatment for HIV has been antiretrovirals, which do not cure HIV patients but rather just keep the virus at bay. Monoclonal antibody therapy offers the promise of total viral neutralization and, as a result, an effective cure in place of the present antiretroviral therapy, which requires lifelong treatments.

    There are several downsides to the use of antiretrovirals. Because antiretroviral drugs are chemotherapy and not a humoral immunobiological therapeutic such as monoclonal antibodies, long-term side effects of the chemotherapy can result – including kidney problems, involving kidney failure, liver damage (hepatotoxicity), heart disease, osteoporosis, heart disease, diabetes, or insulin resistance, an increase in fat levels in the blood (hyperlipidemia), and changes in how the body uses and stores fat (lipodystrophy).

    Moreover, the antiretroviral treatment is only accessible to 40% of the over 36 million people infected in the world – leaving 60% of the 36 million infected HIV patients with no treatment.

    Thus, these issues can be resolved by the implementation of a better HIV treatment, using immunotherapy with the administration of our technologies, including broadly neutralizing monoclonal antibodies.

    CEOCFO: I think to a lot of people, it seems the crisis is over.

    Mr. Cotropia:

    Your observation is exactly right! The perception is that the HIV crisis is over, but it is a misconception. The extent of the world crisis can be appreciated by the facts I just mentioned; namely, there are over 36 million people in the world infected, and only 40% of those have access to the antiretroviral therapy now used to treat HIV. There are over two million new infections per year, and more than one million people die from the virus annually.

    The current antiretroviral therapy is not a cure, and as mentioned earlier, the side effects of lifelong use are significant. Also, the yearly average costs of treatment on antiretrovirals are $14,000 to $20,000 per year, and the average lifetime cost is calculated as $379,000. The cost of an anti-HIV therapy we are proposing would be a fraction of this cost since the treatment would be for a limited time and would not require life-long use.

    Just as monoclonal antibodies were made available to successfully treat President Trump when he contracted the CoronaVirus, monoclonal antibodies can be made available to treat HIV patients, and we believe we are on the verge of providing and validating specific therapies in order to safely and successfully treat HIV.

    CEOCFO: From your recent press release, you have a proprietary methodology for producing fully human OGG1 monoclonal antibodies. How is your approach different?

    Mr. Cotropia:

    There are a number of different ways of producing monoclonal antibodies. The procedure is significant, and our procedure differs from those used by other pharma companies.

    In some cases, other pharma companies produce “humanized” rat and mouse monoclonal antibodies where the original antibody affinity and specificity are not maintained, and the chances of immunogenicity are increased. Our methodology also differs significantly from other pharma approaches using the transgenic mouse model, which is a human immune system that has been “grafted” within a mouse model having been "vaccinated" with specific and selected purified virus proteins.

    In contrast, our method starts with human "immune-B cells," obtained from convalescent individuals who have recovered from the target virus. The primary distinction of our process for creating fully human monoclonals is the starting point – namely, from human “immune-B cells” obtained from humans who have survived successfully from a "natural" infection. From these human “immune-B cells,” we then produce antibodies that target conserved immutable sites (neutralizable epitopes) on the virus’ surface envelope proteins – which will thereby avoid “virus escape,” which has been frequently demonstrated to occur as a consequence of mutations in the HIV virus surface structure.

    Additionally, our antibodies retain the original natural antibody affinity and specificity and have a lower risk of immunogenicity when used as a therapeutic. They will provide broad-spectrum coverage against viral variants with increased potency, stability as a single-domain molecule, in what is called the camelid structure form, and, in the recombinant form, will have greater accessibility to the virus binding sites not accessible with a whole antibody. We believe that our method is one that produces an antibody that will be more effective with less risk of adverse reaction.

    There is an infinite number of distinct anti-HIV and anti-CoronaVirus monoclonal antibodies that can exist – some disease neutralizing, some perhaps of no benefit, and some perhaps disease enhancing. Thus, specific antibodies that neutralize are necessary to provide effective therapy. Enzolytics’ method of producing effective monoclonal antibodies focuses on identifying immutable binding sites on the virus and then creating monoclonal antibodies that bind to such sites and neutralize the virus. In this way, the virus cannot mutate around the therapy. For example, the antibodies administered to President Trump to treat him for the CoronaVirus may target a site on the virus that will mutate. Thus, the same antibodies may not be effective for you or me later if the CoronaVirus has mutated, changed structure at this binding site. Our anti-HIV monoclonal antibody binds to a site on the HIV virus that is conserved in 98% of the more than 6000 strains of the HIV-1 viruses now known, sequenced, and archived in the Los Alamos National Laboratory HIV Database. The same will have to be achieved for successful anti-CoronaVirus monoclonal antibodies.

    CEOCFO: What are you looking at regarding COVID?

    Mr. Cotropia:

    We have produced an HIV monoclonal antibody that had been successfully tested in five international labs where it neutralized 95% of all strains against which it was tested. There are 6000 different strains of the HIV virus now known. We know that our antibody is effective, and we know the target site on the virus resulting in neutralization of the HIV virus. For an antibody to be effective, it has to attack a neutralizable site on the virus that is always there, does not mutate from strain to strain. Knowing the binding site of our HIV monoclonal antibody and then examining the CoronaVirus amino acid sequence, a correlation in the structures has been identified by our CSO, Dr. Joseph Cotropia, between the CoronaVirus and the HIV virus. With knowledge of these homologous viral structures, monoclonal antibodies will be created that target the corresponding “Achilles Heel” site on the CoronaVirus, an expected conserved immutable and neutralizable site on the virus. Additionally, using artificial intelligence, we will examine the numerous different strains of the virus to identify other conserved sites and produce additional monoclonal antibodies targeting them. This is for the purpose of producing a “collection” or “cocktail” of antibodies for therapeutic use. We recognize that there are now known over 16,000 different variations or strains of the CoronaVirus, each slightly different due to mutation. A successful monoclonal antibody “cocktail” therapy must include multiple antibodies that specifically target several immutable sites and which results in neutralization.

    For example, we all now know that President Trump received a combination of two Regeneron antibodies. Eli Lilly has also produced an anti-CoronaVirus antibody. However, what we do not know is whether those antibodies will be successful as the virus mutates. As I mentioned, there are now known 16,000 different variants to the CoronaVirus, and immutable sites must be targeted in order to be effective in the long run.

    Also, as all experts in the field of monoclonal antibodies agree, including Dr. Anthony Fauci, head of the NIAID/NIH, to have an effective therapy, we must have multiple monoclonal antibodies that target various sites on the virus - and in fact, even President Trump was given a cocktail of two. Therefore, it is imperative to identify conserved neutralizing binding sites on the CoronaVirus and create multiple monoclonal antibodies that target these critical neutralizable and immutable structures. It is like finding a needle in a haystack and retrieving the needle; you must identify the immutable sites on the virus and then create and characterize fully human monoclonal antibodies that target those sites. The process described here will be our focus, and for a reason, that success has already been achieved with regard to the production of broadly neutralizing antibodies directed against the HIV virus, we expect success will likewise be achieved in the production of broadly neutralizing human monoclonal antibodies directed against the CoronaVirus.

    CEOCFO: I realize your brother is the medical person behind the Company, but what led you to take on this role. You have been a practicing attorney for many years. Why this challenge now?

    Mr. Cotropia:

    Obviously, it is very rewarding to hope that we will produce something that will be so meaningful to so many people. Our initial focus has been on HIV, a still devastating disease that is very much still with us and certainly more so in other counties. That is because, in the U.S., the focus is on HIV; because most U.S. citizens who contract HIV can afford $20,000 a year, through insurance or otherwise, and be treated. Unfortunately, many of those who have taken antiretroviral for thirty years or less have to suffer side effects caused by the current therapy, so there are a great reward and a great challenge in the hope that we can produce something that is better. We see a better therapy and a therapy that can be produced inexpensively for all, and particularly for the 60% and the 36 million people who have no access to currently available antiretroviral therapy. In many countries, like the U.S., this situation no longer makes the headlines in the news. For us, we recognize the need for better therapy.

    Now, we turn to the CoronaVirus, and that is something that is on the front page of the U.S. and world news. We definitely have taken note of that. How do you address it? The antibodies that are being produced by other pharma companies may very well have initial beneficial effects. However, a solution requires more than one antibody to be effective. If their antibody targets a site that mutates, and that is what has happened to every other monoclonal antibody produced by the NIH and big pharma in their attempts to treat HIV, it is ultimately not going to be effective. The virus will mutate around it. Therefore, what worked, perhaps, for President Trump, will not necessarily work for you or me in the future. Consequently, as the virus mutates over and over again—in order to be therapeutically successful—you have to target a site that is immutable.

    We also note that even those who have been fully vaccinated against the Coronavirus have now contracted the virus. This means that going forward; there will be a continuing need for therapeutics that will treat those that contract the virus. Additionally, experts, such as Dr. Paul Offit, MD, Director of the Vaccine Education Center at Children's Hospital in Philadelphia, have stated that even though successful vaccines have been developed and deployed, we can expect the CoronaVirus to be with continuously into the future, with a resurgence year to year. Thus, therapeutics to treat the virus will be necessary for the future.

    We do know that our identified initial target on the CoronaVirus is significantly different from the targets of the antibodies produced by Regeneron and Eli Lily. Thus, with a combination of our proposed broadly neutralizing anti-CoronaVirus antibodies, the administration of a “cocktail” of several antibodies could be expected to produce a more significant neutralizing effect.

    If you look back to the history of HIV, the NIH, with Vaccine Research Center, and all the other companies that the NIH has supported, they all attempted for forty years to produce an effective anti-HIV monoclonal antibody and the ones that they produced, VRC01 and VRC02, to name just a few, failed in years-long testing because of what is called “virus escape.” Virus escape is a euphemism for the fact that the virus mutated around what they spent decades trying to produce. Hence, there is a challenge to develop a successful therapy. To answer your question more directly, it is the challenge, and more than that, it is the hope of having a successful therapeutic that drives us. Also, at Enzolytics, we also have a therapeutic which will, we expect, be synergistic with our monoclonal antibodies. It is a peptide that binds to the virus and provides a clinically tested therapeutic effect, which will be examined in combination with our monoclonal antibodies. Again, this combination hopefully will be synergistic and provide a therapeutic that will be highly effective.

    CEOCFO: What is your funding position? Development and eventually commercialization are very expensive.

    Mr. Cotropia:

    Yes, that is a very relevant question. We will be securing long-term financing for advancing our technology. We have begun the process of producing variants of our existing anti-HIV monoclonal antibodies and identifying the target site on the CoronaVirus for producing multiple antibodies against that virus. We have extended our lab capabilities on the Texas A&M University campus at its Institute for Pre-clinical Studies, where we will be producing both additional monoclonal antibodies against HIV and the against the CoronaVirus. For HIV, we will be combining the anti-HIV neutralizing antibodies with the anti-HIV peptide—which is also immunomodulating—that has been previously clinically tested by Enzolytics to have a beneficial effect in HIV patients. The funding we arrange will take us through that development which will include animal trials to be followed by human clinical trials of these therapeutics.

    Success in these steps will bring the necessary funding for success. Demonstrating positive results will translate into the necessary funding due to the dire need for these therapies. As I mentioned, there is not going to be one bullet that fends off either the HIV virus or the CoronaVirus. It will be necessary to have more than one. We welcome Eli Lilly and Regeneron in their initial antibody production, and that success is all to be rewarded and celebrated. However, as we have seen in the past with HIV, it is going to be very difficult to completely control the CoronaVirus and all of its mutated forms. Success will require multiple therapeutics, and we know that monoclonal antibodies will certainly be in the picture and in the front line of successful treatments.

    Another important aspect of our technology is that identification of a neutralizable binding site on the virus can lead to the creation of a vaccine – one that would be of a different format from the current mRNA vaccines now being produced. Specifically, the vaccine would be based on the known broadly neutralizing antibody and the highly conserved binding site to produce an active immunization that would not comprise nor incorporate an immunization process using nucleic acid constructs. In this process, an active protective immunization would use the neutralizable binding site on the virus as a subunit peptide vaccine. The use of peptide sub-unit immunogens in active immunization obviates the concerns for weak humoral immune response, theoretical risks of insertional mutagenesis, and provocation of an autoimmune response; in other words, concerns associated with immune response outcomes that are related to DNA and mRNA vaccination.

    Therefore, different vaccines may be produced in very different ways, some of which hopefully will be very effective and very safe as to their long-term effect on the human body. A safe vaccine can be expected based on a subunit peptide vaccine formulation using the neutralizable bind site on the virus in its development.

    CEOCFO: There are so many new ideas, especially around COVID. Why does Enzolytics’s approach stand out?

    Mr. Cotropia:

    We have a patented anti-HIV peptide, ITV-1, that has been tested in clinical studies. It is now being advanced through the next certification stage in preparation for patient application.

    As a complementary treatment for HIV, we have created monoclonal antibodies for treating HIV. These antibodies can accurately be identified as being “fully human,” broadly neutralizing monoclonal antibodies in that the starting point is from human “immune-B cells,” providing the basis for the production of the antibodies. Antibodies created in this way retain the original natural antibody affinity and specificity and have a lower risk of immunogenicity when used as a therapeutic. They will provide broad-spectrum coverage against viral variants with increased potency and stability as a single-domain camelid molecule. Our technology then further stands out in that we are able to identify conserved, immutable sites on the targeted virus, and we have the ability to specifically create monoclonal antibodies that target these identified sites. The whole process is, in our view, a perfect approach to producing therapeutics that are safe and effective and that address and overcome the effect of virus mutation - all the while being able to be produced inexpensively, so they may be provided throughout the world.

    Enzolytics, Inc. Announces Program for Creation of Multiple Monoclonal Antibodies for Veterinary application Utilizing Hybridoma and Phage Display Technology

    COLLEGE STATION, TX / ACCESSWIRE / November 8, 2021 / Enzolytics, Inc. (OTC PINK: ENZC) (https://enzolytics.com/) has announced a coherent protocol that it is executing to meet the Company's objective of producing monoclonal antibodies for a veterinary application utilizing Hybridoma and Phage Display Technologies.

    The Company’s defined protocol includes:

    • Application of computer analysis (Artificial Intelligence – A.I.) to curate (analyze) the amino acid sequences of targeted viruses to identify the conserved, immutable, and neutralizable target sites (epitopes) on targeted viruses. Enzolytics has accomplished this goal for HIV, the Coronavirus, HTLV-1, as well as for H10N3, Influenza A, and B, H1N1 influenza, Respiratory syncytial virus (RSV), Ebola, Small-Pox, Tetanus, Diphtheria, Rabies, Herpes zoster, Varicella zoster, Anthrax, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, Feline Immunodeficiency virus, Small Ruminant Lentivirus, and Koala retrovirus.
      • The new protocol includes implementing A.I. analysis of existing viruses (or mutants thereof) and on any new virus immediately upon its emergence anywhere in the world.
      • The A.I. analysis identifies the conserved, immutable, and neutralizable target sites on the subject virus. It provides for the production of multiple monoclonal antibodies, each targeting an immutable epitope for administering combination therapy.
    • Creation of cell lines to produce monoclonal antibodies targeting each identified conserved virus site (epitope). In this step, multiple broadly neutralizing antibodies are being produced targeting multiple conserved, immutable epitopes on the targeted virus.
      • The Company utilizes both the Hybridoma Technology and the Phage Display for producing Monoclonal Antibodies for veterinary use.

    Enzolytics utilizes Hybridoma Technology by creating hybrid cell lines called "hybridomas" by combining a specific antibody-producing lymphocyte B cell with a myeloma cell that can grow in tissue culture. Hybridoma produces antibodies that have single specificity to the conserved epitopes identified by Artificial Intelligence.

    Enzolytics is also utilizing Phage Display technology for the production of Monoclonal Antibodies. Phage Display technology offers a significant advantage: it provides a means to identify target-binding proteins from a library of millions of different proteins without the need to screen each molecule individually. Phage display vaccines are made by expressing multiple copies of an antigen on the surface of immunogenic phage particles, thereby eliciting a powerful and effective immune response.

    According to the Chief Operating Officer, Dr. Gaurav Chandra, "We are utilizing Phage Display techniques for the production of our Monoclonal Antibodies since the Phages are very suitable for vaccine design due to higher stability under severe environmental conditions. Additionally, they are less expensive, have potent adjuvant capacities, and offer an expedited process for vaccine development. Phage Vaccines have efficient immunostimulatory effects and present a high safety profile. As a result, Enzolytics is focusing on Phage-based Vaccines for various infectious diseases. Our Phage Display techniques can be used to create novel molecules that can lead to breakthroughs in technology and medicine."

    The monoclonal antibodies for veterinary use at Enzolytics are being created in three phases.

    Phase 1
    Feline Immunodeficiency virus
    Feline Leukemia virus
    Equine Infectious Anemia virus
    Small Ruminant Lentivirus
    SARS-CoV-2 for Wild Animals

    Phase 2
    Koala retrovirus
    Elephant Endotheliotropic Herpesvirus
    Camel Pox
    Avian Flu
    Swine flu
    Falcon Herpesvirus

    Phase 3
    Striped dolphin morbillivirus
    Phocine distemper virus

    The Company is actively exploring proposals for collaborations and partnerships with U.S. and foreign veterinary companies for their monoclonal antibodies for veterinary use.