COLLEGE STATION, TX / ACCESSWIRE / March 22, 2021 / Enzolytics, Inc. (OTC PINK:ENZC or the "Company") today announced it has filed NIH grant applications seeking funding for its production of monoclonal antibodies targeting the identified conversed epitope sites on both the HIV-1 and the SARS-CoV-2 viruses. Using its recent discovery of conserved sites on both viruses, the Company has filed updated NIH grant applications for funding for the production of monoclonal antibodies against these conserved sites on both viruses.
In the case of the HIV viruses, 8 conserved sites on the HIV-1 virus, some with over 98% conserved sequences, have been identified using Artificial Intelligence to analysis over 87,336 HIV isolates now known. In the case of the Coronavirus, 11 conserved sites have been identified, with conserved sequences of from 97.68% to 99.28%. Patent applications have been filed covering both discoveries.
The identification of these conserved sites on both viruses was accomplished using artificial intelligence techniques analyzing the 87,336 HIV isolates and 50,512 isolates on the Coronavirus.
Using these new discoveries, the Company has bolstered its applications to the NIH seeking funding based on these additional discoveries. By renewing its applications with these significant additional discoveries, the prospect of grant funding is increased.
These revised applications incorporate the focus on the capability to produce multiple (a "cocktail" of) monoclonal antibodies for therapeutic treatment. While the Company sees value in pursuing NIH grant funding, the progress of the Company is not in any way affected or delayed by awaiting the review of such applications. Preparing such applications allows the Company to marshal its technology in a detailed confidential technical presentation that can be used in discussing our technology with potential biotech partners.
The December 31, 2021 year end OTC report for the Company is expected to be filed before the March 31, 2021 deadline. The Audits of the year ends December 31,2021 and 2020, that the PCAOB auditors were engaged to perform on January 31, 2020, along with the OTCQB application will be filed upon completion of the audits. No additional shares of the Company's common stock have been issued since October 15, 2020.
Additionally, the Company has entered negotiations with Pro Wave Ad Product ("PWA"), a Bulgarian Company, to supply the raw material for PWA's Contract in India for the production of a spray modulating the immune system under U.S. Patent No. 8,309,072 owned by Zhabilov Trust. This contract is valued at more than $50 million to PWA. This is the only approved use of this technology as a nutraceutical. The FDA issued a nutraceutical number to Harry Zhabilov on October 12, 2018. The first delivery under this agreement with PWA is expected to be in late spring 2021. The value to the Company is yet to be determined.
The spray product is a nutraceutical application, separate from the ITV-1 treatment that successfully completed Phase 3 clinical trials on August 7, 2014, with the Final Report being issued in November of 2016 by Assoc. Prof. Ivaylo Elenkov, MD, Chief researcher at the Specialized Hospital for Active Treatment of Infectious and Parasite Diseases. This report and the associated clinical trials were conducted under Bulgarian Drug Administration (BDA) guidelines. With Bulgaria joining the EMA in April of 2019, the BDA can no longer issue permits for mass use for the HIV/AIDS virus. Under the Company's new business arrangement with International Medical Partners, Ltd. (IMBL), new clinical trials are being planned and scheduled with Clinical Design, a Clinical Research Organization (CRO) in Bulgaria. The Company is finalizing negotiations with a Contract Manufacturer, also located in Bulgaria, for the production of the ITV-1 Immunotherapy treatment. The new clinical trials for the Patented and licensed ITV-1 treatment under the EMA guidelines will be submitted upon completion. When the EMA permit for mass use is issued, the Company plans to pursue Federal Drug Administration (FDA) approval under the Mutual Recognition Agreement between the FDA and EMA.
As a result of the necessity to perform Clinical trials under the EMA guidelines, the agreements with IMMB BG, which were in default, have been cancelled and superseded by the new agreements with IMBL and PAW.
Harry Zhabilov, CSO, stated, "With our new partners at IMBL, the CRO and the CMO, all located in Bulgaria, and all experienced in the EMA Permitting process, the next steps in bringing our Immunotherapy Treatment for HIV/AIDS and hepatitis C viruses to a point of approval by the EMA is on the right path. The contract being negotiated with PAW is expected to produce meaningful revenue generated from our technology."
Charles Cotropia, CEO, added, "Since the combination of BioClonetics and Enzolytics in December of 2020, only 3 and a half short months ago, we have continued to accelerate efforts to commercialize the old, new and yet to be identified therapeutics under the ENZC banner".
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.
IR Contact:
Enzolytics, Inc.
2000 North Central Expressway
Plano, TX 75074
Phone: (972) 292-9414 Fax: (972) 292-9414
and
Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-4478
SOURCE: Enzolytics, Inc.