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Company begins process of identifying conserved/immutable target sites on SARS-CoV-2 (the CoronaVirus) and other developments
COLLEGE STATION, TX / ACCESSWIRE / February 1, 2021 / Enzolytics, Inc. (OTC PINK:ENZC)(the "Company") today announced it has identified seven additional conserved, expectedly immutable sites on the HIV virus against which it plans to produce targeted anti-HIV monoclonal antibodies. The Company's primary anti-HIV monoclonal antibody targets one conserved site on the HIV virus, which site is 98% conserved (either directly or by way of conservative amino acid substitutions) over all 87,336 HIV isolates which have now been curated (analyzed) by the Company using Artificial Intelligence (AI). Additional conserved target sites (some with 98% conserved sequences) have now been identified against which fully human anti-HIV monoclonal antibodies will be produced in its lab on the campus of Texas A&M University in the University's Institute for Preclinical Studies. The significance of producing multiple monoclonal antibodies targeting multiple conserved sites is recognized by experts as a critical approach to effective therapy. This allows the administration of a "cocktail" of antibodies, all targeting conserved and expectedly immutable sites.
Additionally, the Company's Genetics and Molecular Biology data science team is now screening (using computer analysis/Artificial Intelligence [AI]) more than 275,000 CoronaVirus isolates now known, to also identify conserved sites which expectedly are immutable. From this information, anti-SARS-CoV-2 (CoronaVirus) monoclonal antibodies will be produced. The significance of producing monoclonal antibodies against conserved target sites on targeted viruses is made evident by the mutant strains of the CoronaVirus currently surfacing in the U.S, South Africa, Brazil, United Kingdom and around the world. The same virus mutation exists with HIV, as well as other well-known viruses. As a virus mutates, a therapeutic becomes ineffective when it neutralizes by attacking a site that changes. By targeting an immutable site, a therapeutic is not affected by the mutation. This is well understood by the necessity to produce a new flu vaccine with each flu season, namely because the flu virus mutates. Producing therapeutics that target a conserved site on viruses makes possible the production of a therapeutic that is not rendered ineffective by virus mutation, and therefore can be applied successfully both universally around the world and durably over time.
The Company is also applying Artificial Intelligence [AI] to scan the hundreds of thousands of isolates that exist in 14 other prevalent viruses, ranging from influenza to Rabies to Ebola. Using the Company's proprietary technique for producing fully human monoclonal antibodies directed against these infectious diseases, the Company will produce multiple neutralizing monoclonal antibodies against these viruses. The significance of this approach is well recognized by experts in virology due to the ability of all viruses to mutate and render ineffective initially developed therapeutics.
Production of the Company's primary anti-HIV monoclonal antibodies is underway at Genscript Labs. Testing of these newly produced monoclonal antibodies is scheduled for early 2021 at the University of Strasbourg in Strasbourg France. Thereafter, Macaque trials are planned at the California National Primate Research Center, Univ. of California, Davis, CA.
Additional information on the progress and Company facilities will be part of the new Company website expected to be rolled out in the coming days.
In addition, the Company offers this update on its progress toward FDA approval of ENZC's licensed ITV-1 Immunotherapy treatment previously tested in human trials in Bulgaria. On April 29, 2019, Bulgaria, as a member of the European Medicines Agency (EMA), was recognized under the Mutual Recognition Agreement (MRA) between the FDA and European Union for medicinal products for human use subject to limitations. This allows drug inspectors to rely upon information from drug inspections conducted within countries recognized under the Treaty. The limitations stated on the U.S. Food & Drug Administration Website, listed as current as of 5/08/2020, read as follows:
"The capability determinations apply to routine surveillance inspections. In the future the following product and inspection types may be included in the coverage of the agreement, pending further consideration:
Vaccines for human use
Plasma derived pharmaceuticals
Investigational products (clinical trial material)
Excluded from the MRA scope are: Advanced Therapy Medicinal Products (ATMPs), human blood, human plasma, human tissues and organs and veterinary immunologicals."
To establish the effect of this new directive on the Company, Company representatives visited Sofia, Bulgaria last month and met with the Executive Director of Bulgarian Drug Administration (BDA) to determine how this treaty affects the use of the Company's ITV-1 immunotherapy treatment which was successful in clinical trials completed in 2016. This meeting was followed by a meeting with a Clinical Research Organization, Clinic Design, in Sofia. The Company believes, and is currently reviewing the applicable information, that with the BDA recognition under the MRA and its membership in the European Medicines Agency (EMA), its Immunotherapy treatment should qualify for recognition by the FDA once the Clinical Trial process and Validation order have been completed. The Company has been 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 clinical trials may need to be completed under the EMA standards. The company is evaluating the necessary steps and cost for the FDA submission under the Mutual Recognition Agreement between the FDA and EMA.
Based on this information, the Company took the following actions. On January 28th, a notice of default and termination was registered with the courts in Sofia of the Sub License Agreement issued to IMMB BG. The company has entered into negotiations with a supportive group in Bulgaria to form a new entity and enter a funding agreement to cover any new cost of clinical trials under EMA standards and permitting by the EMA. Strategically, the Company believes that the actions will be cost effective resulting in a significant advancement of the Company's therapeutic portfolio.
As stated in the year end update, proposals were recently requested from several PCAOB accounting firms to provide quotes for Audits of the Company's current and prior year Financial Statements in order to become fully reporting. The Company has engaged MaloneBailey, LLC of Houston, Texas as its PCAOB accounting firm and has begun the audit process. It is still the Company's plan to complete the two-year audit as quickly as possible but will file the December 31, 2021 Annual Report Financial Statements pursuant to the OTC Markets Pink Basic Disclosure Guidelines immediately upon completion to allow time to complete the two-year audits and remain current with our filings.
CEO Charles Cotropia stated, "The Company is making significant progress on both of its therapeutic platforms: first, on the identification of prime target sites on both the CoronaVirus and the HIV virus and the creation of neutralizing antibodies directed against these sites, and second, on advancing its ITV-1 peptide therapeutic for patient application in the EU."
CSO Harry Zhabilov stated, "With the Bulgarian Drug Administration joining the European Medicine Agency and being recognized under the Mutual Recognition Agreement with the FDA, once we have successfully finished the permitting process the Company will be able to pursue FDA approval for ITV-1. We are currently investigating the required steps but feel confident that this is a viable option for the ITV-1 patented therapy."
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 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 and 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, 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.
2000 North Central Expressway
Plano, TX 75074
Phone: (972)292-9414 Fax: (972)292-9414
Texas A&M University
Institute for Preclinical Studies
College Station, TX
SOURCE: Enzolytics, Inc.
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