ENZC Technology
ITV-1
Enzolytics is a Texas based biotechnology company with both patented anti-HIV therapeutics and a proprietary methodology for producing fully human IgG1 monoclonal antibodies for treating infectious diseases with non-toxic passive immunotherapy. The Company has clinically tested its anti-HIV therapeutics known as ITV-1. ITV-1 is a suspension of Inactivated Pepsin Fragment (IPF), a purified extract of porcine pepsin. ITV-1 has been shown to strengthen the immune system and may be used to facilitate a broad range of applications. ITV-1 has been tested in HIV patients in a clinical trial conducted under the strict guidelines of the European Union where it demonstrated beneficial outcomes. Additionally, the Company has created a proprietary cell line that produces fully human monoclonal antibodies that target and neutralize the HIV virus.
The Company has also pioneered a proprietary method for creating human cell lines that produce fully human monoclonal antibodies directed against many infectious diseases. One antibody (designated as CLONE 3) has been demonstrated in tests in 5 international labs to fully neutralize over 95% of all strains and viral subtypes of HIV-1 against which it has been tested.
ITV-1 has been through Phase I, II and III clinical Trials however due to ENZC being informed that the inclusion of the BDA in the EMA restricted the permitting of our Treatment by the BDA and the permitting will now be done by the EMA for all the European Union. As a result, some, if not all of the Phase III clinical trials may need to be completed under the EMA standards.
Clone 3
Clone 3 is what’s known as a monoclonal antibody—a laboratory-made molecule produced by repeated replication of a single parent cell.
Monoclonal antibodies mimic the ones your body naturally produces as part of your immune system's response to germs, viruses and other invaders. Because monoclonal antibodies come from a single cell source, they’re engineered to target a specific part of a virus. The Clone 3 monoclonal antibodies that we’re developing target a specific site on HIV and as a result neutralizes the virus.
These HIV therapeutics may be used as an immunotherapeutic treatment for individuals with HIV/AIDS. They may also be developed for use as a prophylactic and therapeutic vaccine to prevent uninfected populations from contracting the HIV virus. Treatment using the fully human anti-HIV antibody will be far superior to current ARV therapy for several significant reasons: (1) the therapy will be effective and non-toxic, (2) will not require lifetime treatment and (3) will be far less expensive.
Thus, for the patient, immunotherapy will be remarkably different — it will be safer, provide a much-needed immunotherapeutic cure rather than requiring lifelong treatment and costs substantially less than current antiretroviral therapy.
The Company also has created human cell lines that produce human antibodies against other infectious diseases, including rabies, influenza, tetanus and diphtheria. As a part of its mission, the Company is testing these antibodies to prepare them for use as therapies against these diseases.
Final testing of the Company’s anti-HIV mAb in PBMC neutralization assays is currently being completed, to be followed by animal trials at the California National Primate Research Center, UC Davis (Davis, CA).
The anti-HIV therapies of Enzolytics’ two technologies, that produced by Enzolytics and created at BioClonetics, are expected to be synergistic in treating HIV. Tests to establish such synergy are scheduled.
Anti-CoronaVirus Monoclonal Antibodies
The Company’s proprietary methodology may also be applied to produce monoclonal antibodies against other infectious diseases. This includes production of monoclonal antibodies against the SARS-CoV-2 virus (CoronaVirus), as well as other infectious diseases including HIV-2, anthrax, smallpox, H1N1 influenza, herpes zoster, varicella zoster, Rh (+) auto-immune disease and the Ebolavirus. A Company program is underway to produce monoclonal antibodies against the SARS-CoV-2 virus (CoronaVirus). Such production will be achieved using the proprietary methodology used to previously produce monoclonal antibodies (mAbs) against HIV, rabies, influenza A, influenza B, tetanus and diphtheria.
Having produced neutralizing antibodies against the HIV-1 virus and recognizing a significant correlative structure between the HIV virus and the SARS-CoV-2 virus, the Company is developing anti-SARS-Cov-2 (CoronaVirus) monoclonal antibodies using its proprietary technology. These antibodies are expected to provide a therapeutic for patients infected with COVID-19. Identification of these neutralizable epitopes also will permit the production of a phage display anti-SARS-CoV-2 (CoronaVirus) vaccine.
Production of these monoclonal antibodies is being conducted in the Company’s lab at the Texas A&M University Institute for Preclinical Studies in College Station, Texas.
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