In my opinion I think you may be correct about there being more than one NDA.
OTC DISCLOSURE & NEWS SERVICE
Enzolytics Highlights Its Comprehensive PCT Patent Applications Covering Discovered Conserved Target Epitopes on the SARS-CoV-2 and HIV Viruses
Press Release | 03/25/2022
COLLEGE STATION, TX / ACCESSWIRE / March 25, 2022 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/.)
In submissions under the Patent Cooperation Treaty (PCT), Enzolytics, Inc. has pending international patent applications covering the use of any of its discovered numerous conserved Coronavirus epitopes or conserved HIV epitopes in the production of monoclonal antibodies, the production of vaccines or use in diagnostic tests for detecting the viruses in patients.
The applications are pending as Patent Cooperation Treaty (PCT) applications which allow the Company to prosecute the applications both in the U.S. and in all PCT member countries. The applications identify and claim the conserved, immutable sites on the SARS-CoV-2 virus and HIV virus that have been identified by the Company through its Artificial Intelligence (AI) technology. These applications, and their significance, are based on the following findings by the Company.
By using computer analysis (AI), the Company has analyzed over 2 Million different isolates of the Coronavirus. From that analysis, the Company identified 19 conserved, immutable sites (epitopes) on the virus. The 19 conserved sequences identified on the isolates analyzed have been identified on the basis that they are 98.71% to 99.29% conserved over the entirety of the over 2 Million CoronaVirus isolates which have been analyzed by the Company using AI.
Additionally, the Company has analyzed over 100,000 HIV isolates using AI and has identified 9 conserved sites, some with over 98% conserved sequences.
In its PCT Patent Applications, the Company has claimed its discoveries including the use of these identified conserved epitopes for (1) producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus, (2) producing a vaccine against HIV or the CoronaVirus, or (3) for use in any diagnostics to identify whether a person has HIV or the CoronaVirus.
The Company considers these filings significant because:
For a monoclonal antibody to be effective (that is to be fully capable of neutralizing a virus), it must target an immutable site on the virus. Otherwise, a virus mutation will render the therapeutic ineffective.
The Company has analyzed over 2 Million Coronavirus isolates and over 100,000 HIV isolates and have identified 19 conserved sites (98 to 99% conserved) on the Coronavirus and 9 conserved sites on the HIV virus.
The Company's patent claims cover these findings in a number of ways, claiming the use of any one identified epitope or any combination of any of the multiple identified epitopes in any of the following ways:
For producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus.
For producing a vaccine against HIV or the CoronaVirus.
For producing related prophylactic/therapeutic methods relating to the epitopes/antigens.
For use in any diagnostic test to identify whether a person has HIV or the CoronaVirus.
The Company fully expects that the patent claims sought in these applications will be issued in the U.S. and the foreign countries in which they are filed. And the Company intends to prosecute the applications in all major countries around the world. The life for any patent issued is 20 years from the effective priority date. In the case of the Company's applications, the priority dates are early in the pandemic time frame, as the Company was alert to the need for and significance of making the discoveries found. Use of any of the 19 Coronavirus epitopes or any of the 9 HIV epitopes in the production of a therapeutic, vaccine or diagnostic will be covered by the issued patents.
Charles Cotropia, the Company CEO, said: "The breadth of patent coverage that is sought and expected is extremely far-reaching based on the discovery of the critical target epitope sites necessary to effectively neutralize these viruses. The Company has also identified conserved epitopes using its AI platform on multiple other viruses, including HIV-2, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Small-Pox, Ebola Virus, Tetanus, Diphtheria, HTLV-1/2, Rabies, Herpes zoster, Varicella zoster, Anthrax, Mason-Pfizer monkey virus (MPMV) and Visna virus (VISNA). These findings will also be protected by patent coverage."
"The Company is also now focused on therapeutics for veterinarian treatment, namely the production of treatments for the Horse Equine Infectious Virus, Chicken Anemia Virus, Cat Feline Leukemia Virus, Feline Immunodeficiency Virus, Koala Retrovirus (KoRV), and Elephant Endotheliotropic Herpesvirus (EEHV). Patent coverage will be obtained on discovered conserved epitopes for these animal viruses, and specifically on the use of any of the discovered epitopes/antigens in producing therapies, any vaccines or related prophylactic/therapeutic method relating to the identified epitope/antigens and on diagnostics."
Numerous mutants have arisen during the CoronaVirus pandemic and monoclonal antibodies produced by pharma have failed as a result of the mutation of the virus. As recently as early this year, anti-COVID-19 monoclonal antibodies produced by Regeneron and Eli Lilly were found ineffective against the Omicron variant and their use was discontinued.
Charles Cotropia said, "It can be concluded that Eli Lilly's ‘bamlanivimab' monoclonal, that has been pulled from the market, did not target one of the conserved 19 epitopes covered in our discovery of conserved sites and covered in our patent application."
"Similarly, in 2014 through 2016, the NIH funded the development of anti-HIV monoclonal antibodies VRC01 and VRC02 but these antibodies failed due to what the NIH called "virus escape". ‘Virus escape' is a euphemism for the fact that antibodies targeted a mutable site on the virus. Enzolytics' focus is on producing monoclonal antibodies that target immutable sites to avoid ‘virus escape'."
Targeting the conserved sites discovered by Enzolytics allows the production of a therapeutic that will not be rendered ineffective due to mutation (variants) of the virus. In other words, even a "variant form of the virus" will contain the immutable targeted sites. Targeting immutable sites avoids the ineffectiveness that is experienced when a therapeutics or vaccine targets a site that has mutated.
This capability is highly significant in that experts agree that even though effective vaccines have been developed and deployed, it is expected the CoronaVirus will be with us going into the future, with a resurgence year to year. Thus, therapeutics to treat the virus will be necessary for the future. And the same applies for all other viruses.
Charles Cotropia said, "We are confident in our discoveries. The patent system is an optimum way for a small biotech company to lay claim, for a 20-year period dating back to an early priority date, to such significant intellectual property even before or without bringing the therapeutic to market. The filing of a patent application serves as constructive reduction to practice of the subject matter described in the application. In this way, we are taking every opportunity to cover the waterfront on all of the viruses we are fully analyzing. This is a step that big pharma has not taken but one we have."
About Enzolytics, Inc.
Enzolytics, Inc. is a drug development company committed to commercializing its proprietary proteins and monoclonal antibodies to treat debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), covered by U.S. Patent Nos. 8,066,982 and 7,479,538. Studies have shown it to be effective in treating HIV/AIDS. ITV-1 has also been shown to modulate the immune system.
The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. In addition, its proprietary methodology, covered in its pending U.S. Patent Application for producing fully human monoclonal antibodies, is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the CoronaVirus (SARS-CoV-2) and HTLV-1.
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. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. 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 its therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics 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. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and 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. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.
I.R. contact:
TEN Associates, LLC
Tom Nelson, CEO
(480) 326-8577
Company Contact:
Enzolytics, Inc.
2000 North Central Expressway
Plano, Texas 75074
Texas A&M Institute for Preclinical Studies
Enzolytics, Inc.
800 Raymond Stotzer Parkway
College Station, Texas 77843-4478
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