Enzolytics, Inc. Announces U.S. Distribution of IPF Immune(TM) and Progress in each of its Therapeutic Platforms

COLLEGE STATION, TX / ACCESSWIRE / December 13, 2022 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/).

Enzolytics’ focus is on the production and distribution of the Company’s therapeutics and advancing its research and development programs. The Company sees the coming year as a transformative period in which it plans to advance its three synergistic therapeutic platforms generating multiple clinical products for human and veterinary use.

The Company’s IPF Immune™ therapeutic, a dietary supplement that supports the body’s self-defense system, is now available in the U.S. (www.onelavi.com) and will be widely available through national retailers and their internet platforms and websites. To meet demand, additional production of IPF Immune is ongoing.

The Company is also advancing production of its ITV-1 anti-HIV therapeutic moving forward toward its use in Africa and EMA approval for use in Europe. In addition, the Company is advancing its AI platform technology and production of monoclonal antibodies against multiple infectious diseases for both humans and animals. The Company plans to move forward with its technology for diagnostics, therapeutics, and vaccines, with each new discovery to be covered by PCT International Patent protection.

Enzolytics’ Dallas, Texas Laboratory

From the Dallas laboratory, the Company is coordinating the development and production of two of the Company’s primary therapeutics, IPF Immune™ and ITV-1. Both therapeutics are produced under U.S. Patents exclusively licensed to the Company, U.S. Patent Nos. 8,066,982, 7,479,538, and 8,309,072, invented by Harry Zhabilov, the Company CSO.

The Company’s IPF Immune™ therapeutic is now available through www.onelavi.com and will be available in the U.S. through national retailers and their internet platforms and websites. To meet demand, additional production of IPF Immune is ongoing. The Company plans to introduce the product in foreign markets.

Enzolytics IPF Immune™ is a nutritional dietary supplement that provides support to the body’s natural immune system. The product supports normal immune function beneficial to maintaining good health. The product is natural and tested for safety. Enzolytics IPF Immune™ is registered under NDI No. 1083 as well as covered by U.S. Patent No. 8,309,072.

This product enters the market as annual sales of American Dietary Supplements in North American reach $50.11 Billion. Dietary Supplement sales are forecast to increase to $77.10 Billion in 2028. Enzolytics has engaged Nutritional Products International (NPI) (https://nutricompany.com/) to access this 50-Billion-dollar market.

The Company’s ITV-1 therapeutic is a therapy for treating individuals with HIV. It has been produced and earlier clinically tested in human trials under the Bulgarian Drug Agency requirements. The following positive therapeutic effects of ITV-1 have been demonstrated in prior European clinical trials.

• Inhibits the infection of CD4 T-cells by HIV.
• Produced an 80.5% drop in viral loads.
• Replaces or complements current antiretroviral therapies.
• Is less costly and less toxic.
• May be effective as a periodic therapy instead of a daily one.
• Is unaffected by HIV mutations that can hamper antiretroviral therapies (HAART).
• Raises CD4 T-cell counts to healthier levels, a 68% increase in CD4+T-lymphocytes.
• Use achieved an increase in the CD4/CD8 index.
• Demonstrated an excellent effect on opportunistic infections.
• Had good compatibility with other antiretroviral 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.
• Boosts the immune system to fight HIV infections.

ITV-1 Ongoing Development

The Company has completed 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 the second-phase toxicology studies, the Company expects to be able to make the ITV-1 therapeutic available in countries in African countries, where the HIV pandemic is severe, namely 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 38.4 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 live in Africa.

The Company is progressing toward approval of ITV-1 under the EMA requirements to launch the therapy in the E.U., followed by seeking FDA approval for use in North America.

Enzolytics’ Lab at the Texas A&M University Institute for Preclinical Studies

Enzolytics’ Texas lab is focused on producing fully human monoclonal antibodies targeting multiple infectious diseases, 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 methodology implemented by the Company to produce monoclonal antibodies is proprietary and the subject of pending Patent Cooperation Treaty (PCT) 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. 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 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.

For HIV, the Company used A.I. to analyze 87,000 HIV isolates to identify 8 conserved epitopes sites against which monoclonal antibodies are being produced. As a part of the production process, 3 Dimensional models of these conserved targets are generated, and the targets are analyzed for linearity, accessibility by antibodies, and neutralizability by antibodies.

The prosecution of the PCT international patent applications filed on these discoveries is progressing through the patent process under the PCT rules. Additional PCT applications are being prepared as additional findings are made regarding the subject therapeutics. In the production of the monoclonal antibodies, Enzolytics, Inc. is working in collaboration with Abveris to produce fully human monoclonal antibodies against multiple viruses using the Company’s proprietary methodology. The collaboration makes possible the combination of the synergistic technologies of the two companies to rapidly produce monoclonal antibodies against numerous pathogenic viruses. https://www.nasdaq.com/press-release/enzolytics-inc.-announces-collaboration-with-abveris-to-discover-monoclonal. In this way, the Company is producing multiple broadly neutralizing antibodies targeting these multiple conserved, immutable epitopes on the targeted virus, in a shortened development time.

Enzolytics’ methodology for producing monoclonal antibodies is unique and innovative, unlike 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.

The methodology starts with human “immune cells” obtained from convalescent individuals who have recovered from the virus. From these human B cells, the Company then produces antibodies that target conserved immutable sites (neutralizable epitopes) on the virus’ surface envelope proteins that will be ever-present, rendering the virus neutralizable even through mutation, thus voiding “virus escape”. These antibodies also retain the original natural antibody’s affinity and specificity and have a very low risk of immunogenicity when used as a therapeutic.

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 the final confirmation of antibody activity, the Company’s CDMO partner Samsung Biologics will produce 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.

Enzolytics is developing Class switched IgA1/2 Clone 3 Antibodies. This therapy will expectedly provide a protective immunological defense against an initial exposure to HIV at mucosal surfaces, such as 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 antiretroviral therapy is intended to 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 a most promising approach to preventing HIV transmission. Thus, the development of Class switched Clone 3 IgA1/IgA2 is highly significant. In addition to the anti-HIV monoclonal antibody already produced and tested, Enzolytics is producing monoclonal antibodies targeting the additional seven conserved targets identified by the A.I. platform.

The Company COO Dr. Gaurav Chandra noted, “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, epitopes of these viruses and has 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.

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/]. Using the Company’s proprietary methodology for producing fully human monoclonal antibodies which target conserved, immutable sites on the viruses, multiple monoclonal antibodies are being produced.”

Producing antibodies for the treatment of Feline Leukemia Virus and Feline Immunodeficiency Virus is significant because these viruses are 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 a significant percentage of the cat population in the United States and around the world. Production of monoclonal antibodies targeting these viruses will be more direct and the time to market 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.

IPF Immune, ITV-1 and HIV Monoclonal Antibodies Potential

Each of the Company’s therapeutic products offers significant potential. Charles Cotropia, the Company CEO, said, “Our IPF Immune product will be beneficial to those who take it and because production is efficient, value will be easily realized both to consumers and the Company. For the first time, 80 percent of American adults are taking dietary supplements, before the pandemic, that number was in the 70s. The U.S. vitamin and supplement industry currently totals $35.6 Billion in 2022 while the global sector is worth $151.9 Bllion.”

Mr. Cotropia went on to say, “We are developing therapeutics to treat HIV, considered one of the most serious and chronic diseases. The prevalence of HIV is souring at a significant rate. The World Health Organization (WHO) reports that 34 million individuals are living with HIV. Due to increased awareness, there is now an increase in testing, leading to a surge in demand for HIV medications.

Today, there is no cure for HIV. Instead, 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.

Even though there are treatments for those with HIV - antiretroviral drugs (ARVs) -, the treatments do not cure and require lifelong use - which over a lifetime cause severe side effects including bone loss, heart disease, diabetes, lactic acidosis, kidney, liver, or pancreas damage, among others.”

Additionally, ARV treatments are extremely expensive. New ARV drugs such as Biktarvy by Gilead can cost up to $75K per year. Cabenuva by VIIV Healthcare costs $48K a year. As a result, of the 38.4 Million people in the world who have HIV, only 69% have access to any available treatment, leaving 31% with no treatment. Of children in the world with HIV, only 50% have access to treatment, leaving 50% with no treatment.

To address this dire situation, the Company is focused on producing its ITV-1 therapeutic and multiple anti-HIV monoclonal antibodies using its proprietary methodology 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 (Clone 3) has been produced and successfully tested in vitro against multiple virus strains, showing 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 undergoing efficacy testing 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.

The Company CSO Dr. Joseph Cotropia said, “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 cells, namely: (1) binding to CD4 receptor initially (on gp120), and (2) binding to the chemokine co-receptors CXCR4 and/or CCR5 (on gp41). The Clone 3 Antibody interrupts the binding of the virus transmembrane gp41 to the human CD4 cells via blocking of binding to the 2^nd 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 human CD4 cell membrane.”

In view of the test results completed on the Company’s Clone 3 Monoclonal Antibody and ITV-1 activity, plans are in place to assess combination therapy using these 2 therapeutics to treat HIV.

The Companies A.I. analysis, coupled with the ability to produce targeted monoclonal antibodies, allows the Company to produce effective antibodies against multiple human and animal viruses. With this focus, A.I. analysis has been completed on each of the following viruses in preparation for the production of anti-monoclonal antibodies for use in the 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, Respiratory Syncytial Virus, Equine Infectious Anemia Virus, Feline Leukemia Virus, Feline Immunodeficiency Virus, Elephant Endotheliotropic Virus.

Enzolytics Artificial Intelligence Platform

Enzolytics has a wholly owned Artificial Intelligence platform that drives:

1. Early Drug Discovery and Development
2. Builds a valuable Intellectual Property Portfolio
3. Allows for strategic entry into the personalized medicine market

The Healthcare A.I. market is expected to be $34 Billion 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 to identify novel biomarkers and therapeutic targets, design innovative diagnostic and prognostic 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 confirmed eight immutable sites on the HIV. A.I. confirmed the KLIC amino acid binding site sequences targeted by the Company’s primary anti-HIV monoclonal Antibody are 100% conserved. The KLIC binding site on HIV 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 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, the Company COO, discussed 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

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 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, Monkey Pox, Ebola, Respiratory Syncytial Virus, Equine Infectious Anemia, Feline leukemia virus, Feline immunodeficiency virus, and Koala Retrovirus. The Company has published more information 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, and 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

The Company plans to expand its Intellectual Property portfolio. This expansion of coverage will be an extension of the current patents and pending patent applications, including the following:

1. ITV-1 - an anti-HIV therapy covered by U.S. Patent Nos. 8,066,982 and 7,479,538.
2. IPF Immune™ - a currently marketed immune booster covered by U.S. Patent No. 8,309,072.
3. PCT Patent Application No. PCT/US2022/043598 covering specifically claimed fully human anti-HIV antibodies and vaccines.
4. Anti-Corona Virus monoclonal antibodies and vaccine covered by PCT Patent Application No. PCT/US2022/016926. 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/US2022/016926 and PCT/US2022/043598. (The Company’s patent claims cover 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.

CEO Charles Cotropia said, “During the past year, we have made great progress in advancing several platforms for providing multiple therapeutics for the treatment of many significant human conditions. We expect to be successful going forward given the wide range of our technologies and the multiple platforms we have developed. We expect these platforms to make possible our production of therapeutics covering an extensive range of diseases for which therapies are desperately needed.”

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.

Company Contact:
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-44

www.enzolytics.com

SOURCE: Enzolytics, Inc.

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