The Company protects its technology through an aggressive strategy to cover its intellectual property. The Company’s intellectual property includes:
Enzolytics is the owner of the following issued U.S. Patents covering its technology relating to a peptide that has been demonstrated in clinical trials to provide anti-HIV-1 retroviral benefit in vivo.
U.S. Patent No. 7,479,538, issued January 20, 2009, entitled Irreversibly-Inactivated Pepsinogen Fragment and Pharmaceutical Compositions Comprising the Same for Detecting, Preventing and Treating HIV
U.S. Patent No. 8,066,982, issued November 29, 2011, entitled Irreversibly-Inactivated Pepsinogen Fragment and Pharmaceutical Compositions Comprising the Same for Detecting, Preventing, and Treating HIV.
These patents cover an Inactivated Pepsin Fragment (IPF) identified and characterized by the amino acid sequence GDEPLENYLDTEYF. This peptide has demonstrated a significant in vitro binding affinity for HIV-1 gp 120 and gp 41 and human CD4 cells. The peptide exhibits antiretroviral activity in vivo, particularly anti-HIV-1 activity. IPF appears to modulate helper T1 cells’ expression of elaborate cytokines INFy, IL-2, which selectively promote cell-mediated immune response and subsequently stimulate cytotoxic lymphocytes. These lymphocytes have a prominent role in the host’s immunologic response to HIV infection. Proteins encoded by these pathogens enter the endogenous pathway for antigen presentation and are expressed on the surface of the infected cell as a complex with class I MHC – proteins. IPF appears to present a novel mechanism to reduce the viral burden and stimulate innate immune responses to the virus for patients with significant antiretroviral resistance.
Proprietary Cell Line Producing Clone 3 anti-HIV monoclonal antibody
The Company’s Clone 3 cell line, which produces fully human monoclonal antibodies (mAbs) that specifically target and neutralize the HIV-1 virus, is proprietary to the Company.
Pending Patent Applications
The Company has the following pending patents covering its anti-HIV monoclonal antibody technology:
- Pending Patent covering the recombinant of the Clone 3 antibody. This form of the Clone 3 antibody is prepared using the known amino acid sequence of the antibody in conjunction with a high producing CHO cell line for generating recombinant form of the monoclonal antibodies that will ultimately be used in patient application.
- Pending Patent coverage of small molecules (mini-peptides) for commercial use derived from the structure of the Clone 3 antibody for interrupting and preventing binding between the HIV virus and the human CD4+ cell.
- Coverage is directed to blocking peptides that bind to and neutralize the HIV virus, and
- Competitive peptides that bind to the target CD4+ cells at the point of virus access into the human cell to prevent infection.
- Pending Patent covering the proprietary methodology for producing fully human neutralizing monoclonal antibodies against infectious diseases, including Rabies, influenza A, influenza B, Tetanus, Diphtheria, HIV-2, Anthrax, Smallpox, H1N1 influenza, Herpes Zoster, Varicella Zoster and Ebola.
- Pending Patent covering the proprietary methodology for produced anti-antigen monoclonal antibodies to produce vaccines to achieve a broad and durable humoral protective antibody response against the corresponding infectious agent.
Proprietary Methodology for Producing Fully Human Monoclonal Antibodies
The Company proprietary mAb methodologies & immunotherapeutic technologies platform will be used to create therapeutics for treatments of viral infectious diseases against:
- H1N1 Influenza
- Herpes Zoster
- Varicella Zoster
The Company antibody-based immunotherapeutic platform can be utilized for both human and all animal infectious-disease applications.
In addition to the anti-HIV monoclonal antibodies produced by the Company, the Company currently has also produced fully human monoclonal antibodies against:
- Influenza A
- Influenza B
The Significance of the Methodology for Producing Fully Human Therapeutic Monoclonal Antibodies
Biologics, specifically fully human neutralizing monoclonal antibodies directed against infectious disease, is considered the new frontier in biotechnology. In the past, the initial starting products were “humanized” rat and mouse mAbs being created for therapeutic use. “Humanized” immunoglobulins are the major immunotherapeutic that is prevalent today. What sets the Company’s antibody technology apart from that employed by other pharma? The Company’s technology permits the cloning of human or animal immune system cells. With the Company’s proprietary methodologies, stable parent hybridomas cell lines can be created that produce fully human antibodies.
Enzolytics specializes in the creation of human neutralizing monoclonal antibodies, not “humanized” mouse or rat counterparts, as are many mAb therapeutics in pharmaceutical use today. The Company’s technological methodologies have developed an effective, strong, and robust portfolio of biologics that have a pharmaceutical application with significant benefits to patients or animals in the global marketplace. From an identified and created parent hybridoma cell line, four distinct and effective products can be produced: (1) fully human neutralizing monoclonal antibody—directed against any pathogen based disease entity—through use in passive immunotherapy; (2) an effective humoral active vaccine that is safe and effective; (3) an oral mini‑antibody peptide-based medication with an efficacy that is equivalent to the immunologic capacity of the monoclonal antibody produced by parent hybridoma cell; and (4) an entry-fusion inhibitor that is immunologic in character and scope. The applications are broad, effective, and beneficial for immunotherapeutic use.
The methodologies and processes for creating immortalized cells that stably produce human monoclonal antibodies are Company proprietary trade secrets.
Anti-HIV Technology and Products
Using its proprietary technology, The Company has created a proprietary cell line that produces a fully human monoclonal antibody (known as Clone 3) that specifically targets and neutralizes the HIV virus (i.e., renders the virus incapable of reproduction). This capability to neutralize the virus means that Clone 3 may be used successfully to treat those infected with HIV and provide an ideal immunogen in the development of an active anti-HIV/AIDS vaccine that is both prophylactic and therapeutic.
Additional supplemental products may be produced as well, for example, vaginal creams for prevention of transmission of the virus. Additionally, Clone 3 has the potential to enormously reduce the incidence of mother-to-child transmission (MTCT) of the virus. Not only might it prevent in-utero viral transmission but, postnatally, effective treatment can be administered without fear of antiretroviral (ARV) toxicity or resistance.
Each of these distinct products flows from the Company’s technology. The first is the use of the antibody itself or a recombinant of the antibody. The second is the Clone 3 vaccine, the third is a mini-antibody or paratope of the Clone 3 antibody, and the fourth is a competitive binding entry-fusion inhibitor that prevents infectivity.
In addition to the Clone 3 monoclonal antibody against HIV, the Company has also created human monoclonal antibodies against other infectious diseases, including rabies, influenza A, influenza B, tetanus, and diphtheria. This immunotherapeutic technology platform can be readily applied to creating monoclonal antibodies against other pathogenic diseases, including the SARAS-CoV-2 (CoronaVirus), HIV-2, anthrax, smallpox, H1N1 influenza, herpes zoster, varicella zoster, Rh (+) auto=immune disease, and the Ebolavirus. The Company’s antibody-based Immunotherapeutics platform can be utilized across both human and animal infectious-disease applications. For example, the technology can be used to produce treatment for elephant and equine diseases that threaten these species.