Enzolytics Inc (ENZC)

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ENZC has so much going on that it is hard to grasp. They have in their arsenal the future of medical care in the way of therapeutic platforms first for HIV and Coronavirus and then for 14+ more viruses.

The future of health

How innovation will blur traditional health care boundaries

The life sciences and health care industry is on the brink of large-scale disruption. In a future of health that’s defined by radically interoperable data, open yet secure platforms, and consumer-driven care, what role will you play?

In our vision of the future of health, we view radically interoperable data, artificial intelligence (AI), and open, secure platforms as central to the promise of more consumer-focused, prevention-oriented care. AI will enable major scientific breakthroughs, accelerating the creation of new therapies and vaccines to fight diseases. AI-enabled digital therapeutics and personalized recommendations will empower consumers to prevent health issues from developing. AI-generated insights will influence diagnosis and treatment choices, leading to safer and more effective treatments. Additionally, intelligent manufacturing and supply chain solutions will ensure the right treatments and interventions are delivered at the exact moment needed by the patient. https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/future-of-health.html?id=us:2ps:3gl:fohc4:awa:lshc:121420:ad3:kwd-472491030708:the%20%2Bfuture%20of%20%2Bmedicine&gclid=CjwKCAiAsaOBBhA4EiwAo0_AnCsF0fPTERNdE4xTI2mbc961uiNTuuR1QoDHglNSC8VOJwNsgqwMIBoC5SoQAvD_BwE


Monoclonal Antibody Techniques
Monoclonal antibodies (mAbs) are monovalent antibodies which bind to the same epitope and are produced from a single B-lymphocyte clone. Monoclonal antibodies are important tools used in biomedical research, in diagnosis of diseases, and in treatment of such diseases as infections and cancer.

What is the value of monoclonal antibody technology?
Monoclonal antibody technology allows us to produce identical antibody molecules in large scale or industrial yields. It should be noted that the emergence of monoclonal antibody technology makes it possible for a variety of applicationsof monoclonal antibodies.

Single B cell antibody technologies
This approach to produce monoclonal antibodies from single human B cells is based on the analysis of the immunoglobulin gene repertoire and reactivity at the single-cell level by the application of reverse transcription-polymerase chain reaction (RT-PCR) and expression vector cloning.
By recognition of selected cell surface markers, individual mouse or human B cells are isolated (e.g., by fluorescence-activated cell sorting), and genes coding for VL and VH fragments are separately amplified by RT-PCR and combined by PCR. For the final production of human mAbs in vitro, H and L chain gene transcripts from each cell are amplified by RT-PCR before cloning and expression in a mammalian system. This method has the virtue of being able to produce many specific human mAbs in a short period. View more about "Single B cell antibody technologies".
https://www.sinobiological.com/resource/antibody-technical/monoclonal-antibody-technology

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.
https://www.otcmarkets.com/stock/ENZC/news/Enzolytics-Inc-Shares-Current-BioClonetics-Immunotherapeutics-Inc-Update?id=280113


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.

PLANO, TX / ACCESSWIRE / December 14, 2020 / Enzolytics, Inc. (OTC:ENZC, Company", )) has engaged SAMM SOLUTIONS, INC. (DBA BTS Research), through a Master Service Agreement ("MSA"), to conduct a toxicity study on the Company's Flagship compound ITV-1. The Company has previously tested the compound in successful Clinical Trials in Bulgaria, but FDA regulations require separate Toxicity tests before an Investigational New Drug process may begin in the United States. https://marketwirenews.com/news-releases/enzolytics-inc-engages-bts-research-to-conduct-toxic-6758170663840334.html

The toxicity test is a non-issue as we already know the expected results from the Annual Report and other documented data:

ITV, produced by Enzolytics, Inc. is a brand-new specific protein for the treatment of HIV and other viral infections. For the first time a naturally occurring strong binding with gp41 HIV-1 envelope protein “in vitro” was demonstrated.
Current market sales indicate that the majority of products show annual sales of 100 plus million, with a significant number ranging from 300 million up to 1 billion dollars in annual sales. Many of the major drug companies, have entered into partnership agreements with newcomers, or with companies in different stages of development in the research pipeline, combining current ARVs with new drug families that impact the HIV/AIDS virus through different mechanisms of action. Partnerships of this nature are a direct result of the major seven Pharmas who control a market with a potential of reaching over $ 15 billion in year 2018, prevent their control and stake in the market share from sliding, due to numerous issues, among which it is important to note, compliance to the drug regimen, adverse reactions to their chemotherapeutic agents impacting the human organs, cost, and eventual viral resistance.
In summation our product’s differentiation is based on:
1- Minimal and minor side effects
2- Zero toxicity issues
3- Tremendous cost savings
4- Short and limited treatment cycle
5- Easier Compliance adherence
6- Zero risk of viral resistance and mutation

The only reason the toxicity study is being done is the FDA requires it. Once it is completed ENZC can submit an Investigational New Drug (IND) application.

The IND application must contain information in three broad areas: Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).

I expect no press release on the toxicity study however I expect a release when the IND application is submitted.

Also I don’t expect a press release on the website because once it is up and running there is no reason to tell us as we will already know.

https://twitter.com/SportsCardsTVMe/status/1361002549608931328
https://twitter.com/drgauravchandra/status/1361006189249757187?s=19


COLLEGE STATION, TX / ACCESSWIRE / February 1, 2021 / Enzolytics, Inc. (OTC PINK:ENZC)(the "Company") today announced it has identified seven additional conserved, expectedly immutable sites on the HIV virus against which it plans to produce targeted anti-HIV monoclonal antibodies. The Company's primary anti-HIV monoclonal antibody targets one conserved site on the HIV virus, which site is 98% conserved (either directly or by way of conservative amino acid substitutions) over all 87,336 HIV isolates which have now been curated (analyzed) by the Company using Artificial Intelligence (AI). Additional conserved target sites (some with 98% conserved sequences) have now been identified against which fully human anti-HIV monoclonal antibodies will be produced in its lab on the campus of Texas A&M University in the University's Institute for Preclinical Studies. The significance of producing multiple monoclonal antibodies targeting multiple conserved sites is recognized by experts as a critical approach to effective therapy. This allows the administration of a "cocktail" of antibodies, all targeting conserved and expectedly immutable sites.
The Company is also applying Artificial Intelligence [AI] to scan the hundreds of thousands of isolates that exist in 14 other prevalent viruses, ranging from influenza to Rabies to Ebola. Using the Company's proprietary technique for producing fully human monoclonal antibodies directed against these infectious diseases, the Company will produce multiple neutralizing monoclonal antibodies against these viruses. The significance of this approach is well recognized by experts in virology due to the ability of all viruses to mutate and render ineffective initially developed therapeutics.
Production of the Company's primary anti-HIV monoclonal antibodies is underway at Genscript Labs. Testing of these newly produced monoclonal antibodies is scheduled for early 2021 at the University of Strasbourg in Strasbourg France. Thereafter, Macaque trials are planned at the California National Primate Research Center, Univ. of California, Davis, CA.
Additional information on the progress and Company facilities will be part of the new Company website expected to be rolled out in the coming days.

Quote:
CEO Charles Cotropia stated, "The Company is making significant progress on both of its therapeutic platforms: first, on the identification of prime target sites on both the CoronaVirus and the HIV virus and the creation of neutralizing antibodies directed against these sites, and second, on advancing its ITV-1 peptide therapeutic for patient application in the EU."


Quote:
CSO Harry Zhabilov stated, "With the Bulgarian Drug Administration joining the European Medicine Agency and being recognized under the Mutual Recognition Agreement with the FDA, once we have successfully finished the permitting process the Company will be able to pursue FDA approval for ITV-1. We are currently investigating the required steps but feel confident that this is a viable option for the ITV-1 patented therapy."

https://marketwirenews.com/news-releases/enzolytics-announces-the-discovery-of-seven-newly-id-7491922242125190.html

ENZC have accomplished many milestones to get their products to the marketplace. We come a long way in a short period of time however much more work is necessary and unforeseen circumstances to overcome such as the situation in Bulgaria. Getting our first product to the marketplace is a priority as it is needed and will be done as soon as possible. Whether that is weeks or months away is not only up to the company but also any requirements set forth by regulatory agencies as we have seen with the toxicity test. ENZC is fortunate to be at the The Texas A&M Institute for Preclinical Studies (TIPS)

Quote:
TIPS provides translational researchers with unique access to expertise in all major medical and scientific disciplines including surgery, biomedical engineering, advanced imaging, pathology, radiography, interventional cardiology, neurology, animal behavior, chemistry and engineering. This direct association with the College of Veterinary Medicine and Biomedical Sciences gives researchers the ability to pursue knowledge in a top research university, where cutting-edge technology and scientists at the head of their field can be accessed.

ENZC priority for obvious reasons is the monoclonal antibodies for HIV and CoronaVirus.

FDA is considering all possibilities by any means that can shut Covid-19 down or keep it in check. ENZC technology can certainly help in this process. It is only a matter of time when we find out just how involved we are either leading the charge or part of a collaboration with another company.
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-important-work-support-medical-product-development-address

For therapeutics, particularly virus-targeting monoclonal antibodies, we are considering approaches to help expedite drug development in this key area, including discussing appropriate regulatory flexibilities. We are aware that some of the neutralizing monoclonal antibodies that have been authorized or are under development are less effective against some of the COVID-19 variants that have emerged, and we are working with drug developers to accelerate the evaluation of new antibodies that could be effective against mutations. Relying on our growing experience with this class of drugs, our teams are discussing approaches to the generation and evaluation of pre-clinical, clinical and chemistry, manufacturing and controls data.


They are already working on 14 more prevalent viruses that they will eventually produce monoclonal antibodies to combat them.

The work ENZC is accomplishing is neither easy or quick however with the previous research and trials that have already taken place along with the laboratory at TIPS will certainly help in the process. There may be long stretches without press releases as the company works through the necessary processes to get their products to the marketplace. Patience is key and as long as Charles and team members take care of business everything else will fall into place as we have seen thus far.

Charles will release news when he has something to share.
Always have and Always will!

Remember two things.

First and foremost CHARLES is in Charge

Second and very important from the Press Release dated October 19, 2020:
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.


The link below has all ENZC Press Releases:
https://marketwirenews.com/stock/enzc/news/