COLLEGE STATION, TX / ACCESSWIRE / 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 46% 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 analyzing 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 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).
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 marshalling 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 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.
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.
ENZOYTICS IPF IMMUNE THERAPUTIC
The Company is beginning production for sale in the U.S. 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 Company has initiated production, and sales will begin in the North American market in the coming year. In addition, the Company has entered into a long-term contract with a National Distributor for sales, marketing, and distribution of the product nationwide and throughout North America.
The active components in the supplement have been registered with the FDA for use in the U.S. under NDI Reg. No. 1083. The Company's product is produced and sold 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 various diseases.
CEO Charles Cotropia said, "As we complete the first year of the merger of technologies within Enzolytics, we have made great progress and now have multiple platforms for providing multiple therapeutics for the treatment of many significant human diseases. While we are happy with our recent progress, we know we will be successful going forward given the wide range of our technologies and the multiple platforms we have developed. These platforms will make possible our production of therapeutics covering an extensive range of diseases for which therapies are desperately needed."
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.
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SOURCE: Enzolytics, Inc.