Enzolytics provides guidance on engagement of manufacturer and OTC Markets Membership
PLANO, TX / ACCESSWIRE / October 19, 2020 / Enzolytics, Inc. (OTC PINK:ENZC)( "ENZC" or the "Company") today shared the update provided by ENZC's Merger target BioClonetics Immunotherapeutics, Inc. ("BCLS" or "BioClonetics"), to its Investors, Shareholders and Supporters. The full content of the update is presented below.
"October 19, 2020
Dear Investors and Supporters,
In these trying times caused by the Coronavirus pandemic, we sincerely hope all of you are doing well. We all look to a brighter future. We have been continuously engaged as a part of the effort to address this health crisis and we appreciate all of your support making our ongoing efforts possible.
We have conferred for some time with Enzolytics, Inc., (OTC PK: ENZC) a public company with a therapeutic that has been successfully tested in patients with HIV and have now entered into an agreement with Enzolytics to combine our technologies to more comprehensively address the HIV pandemic.
This combination of our technologies is underway but will take some time due to the intricacies of the process. We do not have a date for completion of this process but will keep our investors informed as the process progresses.
All of our steps are taken with two objectives in mind. First our focus is on creating successful therapeutics against infectious diseases, including HIV and now our focus on the Coronavirus. Secondly, our efforts are also intended to increase the value of our technology and the value of our company - which directly translates into value for our investors. Please know that these are our two guiding objectives with every effort we make.
Enzolytics is a drug development company focusing on the commercialization of its proprietary proteins for the treatment of infectious diseases, including HIV. 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.
Our plans are to test in combination the Enzolytics ITV-1 peptide in conjunction with our anti-HIV monoclonal antibodies. There is reason to believe that there will be synergistic effect achieved with this combination therapy.
As we have reported earlier, we have applications pending with the National Institute of Health (NIH) and the National Science Foundation (NSF) for further development of our anti-HIV monoclonal antibodies and our proposed production of anti-SARS-CoV-2 (Coronavirus) antibodies. These applications are being reviewed now. Without regard to the success or lack of success of these applications, our combination of technologies with Enzolytics will provide funding for our direct progress with the precise proposals now submitted to the NIH and NSF. As outlined in detail in these applications, we will use our proprietary methodology to produce additional monoclonal antibodies against HIV that specifically target conserved, immutable sites on the virus. Recall that others, including the NIH in conjunction with Vaccine Research Center attempted for years to produce monoclonal antibodies against HIV and failed because of "virus escape" - a euphonism for the fact that their antibodies targeted a site that mutates allowing the virus to "escape" over time.
The critical nature of targeting immutable sites on the Coronavirus will be the same. I note the recent news that Eli Lilly has paused its anti-Coronavirus monoclonal antibody trials. We are not privy to the underlying reasons for such pause, but this could be due to failure to target immutable sites on the virus or on the methodology for producing the monoclonal antibodies. When we recently asked Eli Lilly for the identity of the binding sites for its anti-Coronavirus monoclonal antibodies, they were unable to share that information with us. The fact is that multiple neutralizing antibodies will be necessary to control the Coronavirus, just as is the case with HIV. Our program is to produce multiple antibodies each targeting conserved, immutable sites on the virus.
As to the way we will identify the more effective epitopes (binding sites) on the Coronavirus to target, we recognize that the structure of the Coronavirus is correlative to that of the HIV virus. Because our anti-HIV monoclonal antibodies have been proven to neutralize the HIV virus in 5 international lab testing programs, and because we know the binding site on the HIV virus to which our antibodies bind resulting in neutralization, this knowledge provides insight necessary to identifying the structure (the amino acid sequence) on the Coronavirus we expect is at least one "Achilles Heel" of the Coronavirus. From this knowledge, a monoclonal antibody can be produced against this site that is expectedly virus neutralizing.
Additionally, we will use AI (artificial intelligence) to analyze the 16,000 known sequences of different SARS-Cov-2 viruses that have now been catalogued in the Los Alamos National Laboratory, with multiple different strains identified. By using computer analysis, several conserved (expectedly immutable and neutralizable) sites on the virus can be identified and additional monoclonal antibodies produced against these- to be used in a monoclonal antibody "cocktail". We all have now heard of the "monoclonal antibody cocktail" administered to President Donald Trump. This is exactly what we propose - note that there are numerous different anti-SARS-Cov-2 monoclonal antibodies that can exist - some disease neutralizing and some perhaps of no benefit and some perhaps disease enhancing. Recall that the NIH and big pharma tried for 35 years to produce neutralizing antibodies against HIV and failed - notable evidence being the millions spent of the monoclonal antibodies VRC01 and VRC02 - produced by Vaccine Research Center in conjunction the NIH - both failed in trials because of "virus escape" - meaning they "targeted a site on the virus that mutates and thus the virus escapes the therapeutic effect". The key is to produce monoclonal antibodies that target a conserved, immutable site on the virus such that the virus cannot mutate around the antibody therapeutic.
There are other pharma labs that are attempting to produce anti-Coronavirus monoclonal antibodies. We welcome such efforts as more than one antibody can be expected to needed be provided a successful therapy. And as the virus mutates, additional anti-monoclonal antibodies will be needed.
We do however note the procedure used by other pharma companies for producing these antibodies differs significantly from ours. Other pharma companies produce "humanized" rat and mouse monoclonal antibodies where the original antibody affinity and specificity are not maintained and the chances of immunogenicity are increased. Our methodology also differs significantly from other pharma approaches using the transgenic mouse model [a human immune system which has been "grafted" within a mouse model] having been "vaccinated" with specific and selected purified Coronavirus proteins.
In contrast, our procedure model starts with human "immune-B cells" that have been obtained from convalescent individuals who have recovered from the Coronavirus. The primary distinction of our process for creating fully human monoclonals is the starting point is from human "immune-B cells" from humans who have survived successfully from a "natural" Coronavirus infection. Our antibodies will retain the original natural antibody affinity and specificity, and have lower risk of immunogenicity when used as a therapeutic. They will provide broad-spectrum coverage against viral variants with increased potency, stability as a single-domain molecule, and, in the recombinant form, will have accessibility to the virus epitopes (binding sites) not accessible with a whole antibody.
We will keep you up to date on our progress. We extend our sincere appreciation for your support.
BioClonetics Immunotherapeutics, Inc."
The proposed merger anticipated in the recently announced 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. Charles Cotropia was appointed to the ENZC Board of Directors on October 1, 2020. Simultaneously, Harry Zhabilov was appointed to the BCLS board on October 1, 2020.
Enzolytics anticipates a response on the application recently made at OTC Markets in the coming week and will begin bringing their filings current, immediately upon membership. In addition, management of ENZC is scheduling a meeting with a GMP manufacturer before the end of the month.
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 is a 49% shareholder of IMMB BG.
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 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. (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.