Enzolytics Inc (ENZC)

[falon]

Why with so many "other companies" introducing monoclonal antibodies is ENZC needed?


CEOCFO: What are you looking at regarding COVID?

Mr. Cotropia: We have produced an HIV monoclonal antibody that had been successfully tested in five international labs where it neutralized 95% of all strains against which it was tested. There are 6000 different strains of the HIV virus now known. We know that that our antibody is effective and we know the target site on the virus resulting in neutralization of the HIV virus. For an antibody to be effective it has to attack a neutralizable site on the virus that is always there, does not mutate from strain to strain. Knowing the binding site of our HIV monoclonal antibody, and then examining the CoronaVirus amino acid sequence, a correlation in the structures has been identified by our CSO, Dr. Joseph Cotropia, between the CoronaVirus and the HIV virus. With knowledge of these homologous viral structures, monoclonal antibodies will be created that target the corresponding “Achilles Heel” site on the CoronaVirus, an expected conserved immutable and neutralizable site on the virus. Additionally, using artificial intelligence, we will examine the numerous different strains of the virus to identify other conserved sites and produce additional monoclonal antibody targeting them. This is for the purpose of producing a “collection” or “cocktail” of antibodies for therapeutic use. We recognize that there are now known over 16,000 different variations or strains of the CoronaVirus, each slightly different due to mutation. A successful monoclonal antibody “cocktail” therapy must include multiple antibodies that specifically target several immutable sites and which results in neutralization.

Also, as all experts in the field of monoclonal antibodies agree, including Dr. Anthony Fauci, head of the NIAID/NIH, to have an effective therapy, we must have multiple monoclonal antibodies that target various sites on the virus - and in fact, even President Trump was given a cocktail of two. [color=purple][/color]Therefore, it is imperative to identify conserved neutralizing binding sites on the CoronaVirus, and create multiple monoclonal antibodies that target these critical neutralizable and immutable structures. It is like finding a needle in a haystack and retrieving the needle; you must identify the immutable sites on the virus and then create and characterize fully human monoclonal antibodies that target those sites. [/color]The process described here will be our focus and for the reason that success has already been achieved with regard to the production of broadly neutralizing antibodies directed against the HIV virus, we expect success will likewise be achieved in production of broadly neutralizing human monoclonal antibodies directed against the CoronaVirus.


What happened to Eli Lilly's Coronavirus monoclonal antibody?

FAILURE!!!

On Nov. 9, 2020, based on the totality of scientific evidence available at the time, the FDA issued an EUA to Eli Lilly and Co. authorizing the emergency use of bamlanivimab alone for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Importantly, although the FDA is now revoking this EUA, alternative monoclonal antibody therapies remain available under EUA, including REGEN-COV (casirivimab and imdevimab, administered together), and bamlanivimab and etesevimab, administered together, for the same uses as previously authorized for bamlanivimab alone. The FDA believes that these alternative monoclonal antibody therapies remain appropriate to treat patients with COVID-19 when used in accordance with the authorized labeling based on information available at this time.
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab

Then the HAMMER came down:

COMPLETE FAILURE!!!

The Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services are committed to ensuring timely and transparent communication regarding the COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.

Today, we are informing you that ASPR is immediately pausing all distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under EUA 094) on a national basis until further notice. In addition, FDA recommends that health care providers nationwide use alternative authorized monoclonal antibody therapies, as described below, and not use bamlanivimab and etesevimab administered together at this time.
https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab-etesevimab/Pages/bamlanivimab-etesevimab-distribution-pause.aspx

So what is Eli Lilly up to now?

Eli Lilly has begun clinical development of an anti-SARS-CoV-2 antibody designed to work against all currently known circulating variants of concern. The action comes weeks after the FDA revoked the single use emergency authorization of Lilly’s first COVID-19 antibody due to the rise of variants.

What about UNKNOWN or FUTURE variants?

Researchers have shown COVID-19 antibodies including Lilly’s bamlanivimab are less effective against variants of concern such as B.1.351 than the original SARS-CoV-2 virus when given as monotherapies. The research, coupled to the emergence of variants of concern as the dominant causes of COVID-19 in parts of the world, has led to reassessments of the use of antibodies as single agents.

AbCellera, which worked with Lilly on bamlanivimab, responded to variants by searching the blood of a patient who recovered from COVID-19 for an antibody that is effective against them. The result is LY-CoV1404, an antibody that binds to a conserved part of the receptor-binding domain.
https://www.fiercebiotech.com/biotech/lilly-takes-variant-busting-covid-19-antibody-into-clinic

What about the other Coronavirus monoclonal antibody from AstraZeneca?

FAILURE!!!

AstraZeneca said on Tuesday a late-stage trial failed to provide evidence that its Covid-19 antibody therapy protected people who had contact with an infected person from the disease, a small setback in its efforts to find alternatives to vaccines.

The study assessed whether the therapy, a cocktail of two types of antibodies, could prevent adults who had been exposed to the virus in the past eight days from developing Covid-19 symptoms.

The therapy, AZD7442, was 33% effective in reducing the risk of people developing symptoms compared with a placebo, but that result was not statistically significant — meaning it might have been due to chance and not the therapy.

The Phase III study, which has not been peer reviewed, included 1,121 participants in the United Kingdom and the United States. The vast majority, though not all, were free of the virus at the start of the trial.

AstraZeneca also said on Tuesday it was in talks with the U.S. government on “next steps” regarding a $205 million deal to supply up to 500,000 doses of AZD7442. Swiss manufacturer Lonza was contracted to produce AZD7442.
https://www.cnbc.com/2021/06/15/astra-antibody-cocktail-fails-to-prevent-covid-19-symptoms-in-trial.html

ENZC is going through the processes to produce monoclonal antibodies
that will be safe, effective against ALL variants known and UNKNOWN.

There is always a possibility that ENZC may be called upon to hurry things up of course with a BLANK CHECK.