ENZC Big News 11/13/2020 https://finance.yahoo.com/news/enzolytics-inc-shares-current-bioclonetics-140000939.html
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.