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BioClonetics LOI Sparks Enzolytics Inc (OTCMKTS: ENZC)

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Enzolytics Inc (OTCMKTS: ENZC) is making a powerful move up the charts on a massive surge of volume after the Company announced the execution of a non-binding LOI to merge with BioClonetics Immunotherapeutics, Inc. 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. 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).

This is huge news for Enzolytics who’s flagship compound ITV-1 is a suspension of Inactivated Pepsin Fragment (IPF), which studies have shown is effective in the treatment of HIV. The Company is at the right place at the right time; according to a report by marketsandresearch the global HIV drugs market is expected to grow from $27 billion in 2019 to about $30.5 billion in 2020 due to an increase in demand for such drugs for the treatment of COVID-19 patients.  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. 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.

Enzolytics Inc (OTCMKTS: ENZC) operating out of Monrovia, California, is a drug development company committed to the commercialization of its proprietary proteins for the treatment of debilitating infectious diseases such as HIV and Hepatitis C. The Company is committed to creating drugs for the better health of mankind. It’s flagship compound ITV-1 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 not shown to be subject to viral resistant and is cost effective. Enzolytics has a License Agreement for US Patent 7479538. The claim is for Irreversibly-inactivated Pepsinogen Fragments for Modulating Immune Function. The Company successfully completed Phase III clinical trials for ITV-1 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.

Enzolytics currently holds a 49% Interest in Immunotech Laboratories BG-Europe. Immunotech BG-Europe has a license for the development and commercialization of Enzolytics Patented ITV-1 Technology. Immunotech BG-Europe, under the branded ImmunH , utilizing the technology has successfully completed Phase III clinical trials at the Specialized Hospital for Active Treatment of Infectious and Parasite Disease in Sofia, Bulgaria, specific for the treatment of HIV/AIDS.

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ENZCAccording to the September 16 press release 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. 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.

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.

As part of the proposed merger 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.

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.”

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Currently running northbound in a hurry ENZC is an exciting story developing in small caps; the Company just announced a non-binding LOI to merge with BioClonetics Immunotherapeutics, Inc. a biotech company in the final stage of development of a parent monoclonal antibody 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. This is huge news for Enzolytics who’s flagship compound ITV-1 is a suspension of Inactivated Pepsin Fragment (IPF), which studies have shown is effective in the treatment of HIV. 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. 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. We will be updating on ENZC when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with ENZC.

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Disclosure: we hold no position in ENZC either long or short and we have not been compensated for this article.

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