PLANO, TX / ACCESSWIRE / September 16, 2020 / Enzolytics, Inc. (OTC PINK:ENZC or the “Company”) today announced the execution of a non-binding letter of intent (the “LOI”) to merge with BioClonetics Immunotherapeutics, Inc. (“BCLS” or “BioClonetics”) a biotech company located in Dallas Texas.
BioClonetics is in the final stage of development of a parent monoclonal antibody (“mAbs”) (designated as Clone 3), which is non-toxic and has shown in initial in vitro testing to be effective against more than 95% of all strains and viral subtypes of HIV-1 against which it has been tested. [http://www.bioclonetics.com/validation.html]. Final testing of BioClonetics’ anti-HIV recombinant mAbs in PBMC neutralization assays are being conducted to be followed by animal trials at the California National Primate Research Center, UCDavis (Davis, CA).
The BioClonetics Clone 3 recombinant mAbs will be combined with the Enzolytics’ flagship compound ITV-1 which is a suspension of Inactivated Pepsin Fragment (IPF), which studies have shown is effective in the treatment of HIV. 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. IPF is a platform technology that can be used to facilitate a broad range of applications. It is free from major neurological, gastrointestinal and hematological side effects seen in the anti-retrovirals in use today. IPF has been shown to not be subject to viral resistance and is cost effective.
The Companies plan to conduct binding studies combining the therapeutics produced by both companies to evaluate the beneficial effects and increased binding capability of the BioClonetics Clone 3 antibodies to multiple HIV isolates.
Thereafter, PBMC based in-vitro neutralization studies will be conducted with the Enzolytics ITV-1 peptide in combination with the BioClonetics Clone 3 antibodies. Based on the results, the best combination with be tested in primate studies at the California National Primate Research Center University of California, Davis, California.
With its technology for producing fully human monoclonal antibodies against numerous infectious diseases viruses, including those targeting the HIV-1 virus [http://www.bioclonetics.com/effectiveness.html] and recognizing a significant correlative structure between the HIV virus and the SARS-CoV-2 (COVID-19) virus, BioClonetics has been invited by the National Science Foundation (NSF) to submit an application for funding for development of anti-SARS-Cov-2 monoclonal antibodies using its proprietary technology. Such application to the NSF and a corresponding application to the NIH are now pending.
ENZC is in the process of compiling the information to bring current its OTC filings. The company has several additional initiatives which it will work towards the remainder of 2020 and into 2021. The company has begun the process of identifying a clinical research organization for the preparation of pre-IND protocols for submission to the FDA.
The Company is also looking to expand its medical advisory board with individuals that have direct experience taking medical products through the regulatory process and bringing them to market. The Company’s intent is to take the ITV-1 treatment, which has already successfully completed Phase III clinical trials at the Specialized Hospital for Active Treatment of Infectious and Parasite Diseases in Sofia, Bulgaria, through the permitting process and begin the process of gaining regulatory approval with the FDA in the United States.
The proposed merger anticipated in the non-binding LOI will result in Charles Cotropia being appointed as CEO of the merged entity and Harry Zhabilov and Joseph Cotropia, MD, being appointed as co-CSO. Gaurav Chandra, MD, will serve as COO of the merged entity. Additional details will be disclosed as the transaction progresses.
“The combination of our two companies’ proprietary technologies and products is a once in a lifetime opportunity that should benefit both of our organizations letting us achieve more together than we could apart”, stated Harry Zhabilov, CEO of ENZC.
Charles Cotropia, CEO of BioClonetics added, “Our proprietary methodology may also be applied to produce monoclonal antibodies against other infectious diseases and the invitation by the National Science Foundation (NSF) to apply for funding to further BioClonetics efforts to develop an anti-SARS-Cov-2 monoclonal antibodies using our proprietary technology is an exciting development for BioClonetics. We have previously produced monoclonal antibodies against HIV, rabies, influenza A, influenza B, tetanus and diphtheria. We look forward to discovering how ENZC’s ITV-1 treatment can be used with our monoclonal antibody platform to synergistically improve our such antibodies for treating HIV.”
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. Immunotech is committed to creating drugs for the better health of mankind.
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. is a Dallas 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 produce fully human monoclonal antibodies may be use to produce therapeutics treatments for name 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. (f/k/a Eco Petroleum Solutions, Inc. / Immunotech Laboratories, Inc.) from time to time in its periodic reports filed with the SEC. IPF 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 IPF in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of IPF 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.
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SOURCE: Enzolytics, Inc.
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