ENZC Next CRACK Runner!
Enzolytics, Inc. Announces Execution of Letter of Intent with BioClonetics Immunotherapeutics, Inc. (With Additional Update on 2020 Initiatives)
9:01 am ET September 16, 2020 (Accesswire) Print
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."