PLANO, TX / ACCESSWIRE / November 13, 2020 / Enzolytics Inc. (OTC PINK:ENZC) or the "Company" today shared the following update provided by ENZC's Merger target BioClonetics Immunotherapeutics, Inc. ("BCLS" or "BioClonetics"), resulting from the application of proceeds from the initial funding received on October 26, 2020. The full text of the update is presented below.
November 13, 2020
Dear Investors and Supporters,
We are making great progress on our plans to further develop additional anti-HIV monoclonal antibodies and to now begin the production of fully human monoclonal antibodies targeting the CoronaVirus. On December 1, we are expanding our lab to the campus of Texas A&M University at its Institute for Preclinical Studies. This expansion will allow us to complete production of monoclonal antibodies against both the HIV virus and the CoronaVirus and collaborate with the biopharma experts on the campus. Although we have NIH grant applications pending for the production of anti-HIV and anti-CoronaVirus monoclonal antibodies, we have secured funding that allows us to proceed without delay.
We welcome the recent news from Eli Lilly regarding its production of monoclonal antibodies for treatment of COVID-19 patients. We note that experts agree that for a monoclonal antibody therapy to be effective, a "combination" (or "cocktail") of such antibodies used in combination will likely be needed. Dr. Anthony Fauci, head of NIAID/NIH, has repeatedly clarified (as recently in his keynote address at the AIDS International Conference) that a success in treatment of such viruses can be expected to be found in the use of multiple broadly neutralizing HIV antibodies - meaning several antibodies that neutralize a broad spectrum of a virus in its numerous mutation forms.
Thus, we recognize that while other pharma companies may produce effective antibodies, there will necessarily be a need for additional monoclonal antibodies to be used in tantum with those initially discovered. Also, and unfortunately, the mutation of viruses, both the HIV and the CoronaVirus, will necessitate the production of numerous effective antibodies as the virus mutates around the therapeutics initially discovered.
Here is why we are confident in our technology.
It will be imperative that produced antibodies target a conserved and immutable site on the virus - otherwise the antibody (over time) will be rendered ineffective due to mutation - known as "virus escape". Our anti-HIV monoclonal antibody targets an immutable virus site on the HIV virus - one that is constant within virtually all 6000 now known different HIV isolates (strains) of the virus. The CoronaVirus has structure correlative to that of the HIV virus. Because our primary anti-HIV monoclonal antibody has been proven to neutralize numerous different strains of the HIV virus in tests in 5 international labs, and knowing the binding site on the HIV virus to which our antibody binds resulting in neutralization, this knowledge provides insight necessary to identifying corresponding structure (amino acid sequences) on the CoronaVirus that should be targeted to effectively neutralize the CoronaVirus. Moreover, we have proprietary methodology needed to produce anti-CoronaVirus monoclonal antibodies targeting such known - to us - sites.
Thus, while the Eli Lilly monoclonal antibody will hopefully have lasting effect, if it is targeting a mutable site on the virus, the virus may "escape" around it. And indeed, a close look at the results of the Eli Lilly initial tests of its antibody show that the antibody reduced the effect of the virus in some but not all of the patients receiving the antibody.
Thus, even these initial Eli Lilly trials demonstrate that additional monoclonal antibodies can be expected to be needed to fully treat COVID-19 patients.
The procedure for producing monoclonal antibodies is also significant and our procedure differs from those used by other pharma companies. In some cases, 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 model starts with human "immune-B cells", 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 - namely from human "immune-B cells" from humans who have survived successfully from a "natural" CoronaVirus infection. From these, we then produce antibodies that target conserved immutable sites on the virus - to avoid "virus escape".
Additionally, our antibodies 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 are actively moving forward in our production and testing of such antibodies.
Charles S. Cotropia
BioClonetics Immunotherapeutics, Inc.
The recent appointment of Dr. Ronald Moss to the medical advisory board is another step toward achieving a successful combination of the management and technology teams and business strategies of the two entities. The second tranche of the initial funding is scheduled for receipt early next week and those funds will be used to further our clinical and administrative progress. Final documentation of the combination agreement is currently being reviewed with closing anticipated to be 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.