Enzolytics Inc (ENZC)

[falon]

When will the full story of Enzolytics, Regeneron and probably other unnamed suitors come to light.

Regeneron previous antibody had limitations due to the way it attacked the virus:

REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron's proprietary VelocImmune® and VelociSuite® technologies. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Cell and Science.

About Regeneron's VelocImmune Technology

Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and
Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved fully human monoclonal antibodies currently available. This includes REGEN-COV (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).

https://investor.regeneron.com/news-releases/news-release-details/regeneron-announces-new-us-government-agreement-purchase

Regeneron’s lastest antibody is different as it binds outside the RBD and NTD regions:

Differentiated vs. prior antibody approaches:

• Binding site outside of immunodominant, highly variable RBD and NTD regions, lowering risk of losing activity against future variants

• Targeted epitope highly conserved, with over 99.9% conservation since beginning of the pandemic

• Demonstrated high neutralization potency against all known SARS-CoV-2 variants and lineages to date

https://investor.regeneron.com/static-files/5f682777-4984-400b-bacb-3041044bb4b6


Somehow in a short period of time when the FDA shut down their previous antibody, Regeneron introduces a new and improved antibody that is totally different from their previous antibodies and uses a different procedure from the one they spent decades creating VelocImmune and related VelociSuite technologies.


Regeneron, which early on in the pandemic developed a monoclonal antibody cocktail to address a treatment paradigm for COVID, is pivoting to what CEO Len Schleifer called “the jackpot antibody.”

In response to the original antibodies losing their efficacy, the company has developed a new one. The drug, dubbed REGN-14287, “has demonstrated potency against all known SARS variants and lineages to date,” reported Regeneron chief scientific officer George Yancopoulos, adding that the biotech expects the drug to enter clinical development later this year.

https://www.mmm-online.com/home/channel/jpm23-week-storm-prep-top-of-mind-for-biopharma-ceos/

What changed their focus?

Why the sudden change in direction?

Are other companies involved?

Could Enzolytics be involved?

Monoclonal Antibodies Are Now Being Recognized as a Significant Therapeutic for Treating COVID-19.

A new wave of recognition is now emerging in the healthcare and political arenas regarding the significance of monoclonal antibodies. The U.S. government has spent $2.65 Billion on the Regeneron monoclonal antibodies and on August 20, 2021, the UK approved the Regeneron/Roche antibodies cocktail for COVID-19. There is now widespread recognition of the potential effectiveness and role that monoclonal antibodies can play in current and future pandemics.

The Enzolytics process differs from the process used by Regeneron. Regeneron antibodies are produced by the company's VelocImmune® mice, which have been genetically modified to have a human immune system. Enzolytics’ process does not use mice with a genetically modified human immune system. The Enzolytics’ proprietary methodology for creating hybridomas produces a specific monoclonal antibody secreted by human immune B cells—obtained from convalescent donor patients—followed by isolating a single cell that produces a monoclonal antibody that targets an identified conserved epitope on the virus.


A primary distinction of the Enzolytics 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. These antibodies will retain the original natural antibody affinity and specificity and have a lower risk of immunogenicity when used as a therapeutic. They are expected to 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.
https://enzolytics.com/company-news/

There are currently no monoclonal antibody treatments authorized for use in the United States. Because the virus that causes COVID-19 continues to change, previously available monoclonal antibody treatments do not protect against the currently circulating variants and subvariants.Dec 7, 2022

https://www.lung.org/lung-health-diseases/lung-disease-lookup/covid-19/treatment-recovery/monoclonal-antibodies