Production of monoclonal antibodies targeting these sites is in process. U.S. patent protection has been filed claiming these sites.
COLLEGE STATION,TX / ACCESSWIRE / March 8, 2021 / Enzolytics, Inc. (OTC PINK:ENZC) (the "Company") today announced it has filed for patent protection on the identified 8 conserved sites on the HIV-1 virus, some with over 98% conserved sequences. These applications will be extended to international filings under the Patent Cooperation Treaty (PCT) allowing the Company to seek patent coverage in 153 countries.
The identification of these conserved sites on the HIV-1 virus was accomplished using artificial intellects techniques analyzing the 87,336 HIV isolates now known. Significantly, the Company's primary anti-HIV monoclonal antibody previously produced and tested by the Company was verified as conserved across all 87,336 isolates analyzed. Additional testing of the recombinant form of the antibody (the parent antibody being designated as Clone 3) against multiple HIV isolates is underway at the University of Strasbourg in France.
Experts agree that the most effective treatments for HIV and the Coronavirus will likely require the administering of multiple (a cocktail of) of monoclonal antibodies. Effective monoclonal antibodies will be those that target conserved and expectedly immutable virus sites - whether the therapeutics is a monoclonal antibody or a preventive vaccine. Targeting these conserved sites 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 expectedly 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 (changed).
Prior government funding for producing anti-HIV monoclonal antibodies have failed due to what the industry calls "virus escape". The anti-HIV monoclonal antibodies VRC01 and VRC02, produced by Vaccine Research Center in conjunction with the NIH, were tested for years and then abandoned due to "virus escape". The Company's focus is on producing monoclonal antibodies that target immutable sites to avoid "virus escape".
The Company notes the recent reports of CoronaVirus vaccines not being as effective against newly discovered mutants of the virus. The Company intends to use its knowledge of the conserved sites on both the Coronavirus and HIV in the production of vaccines that are expected to be less susceptible, or not susceptible at all, to virus mutation.
The patent coverage being sought includes patent claims on the discovered epitope/antigens, vaccine claims, antibody claims, and related prophylactic/therapeutic method claims relating to the epitope/antigens. Significantly, under U.S. and foreign patent laws, filing of a patent application constitutes reduction to practice of the invention. Moreover, rights of the priority to claimed inventions date from the date of filing of a U.S. application. This priority date will be accorded to the Company for supplemental foreign corresponding applications filed through the Patent Cooperation Treaty (PCT) to which 153 countries subscribe. The term of protection provided by a patent is 20 years from the effective filing date. The Company follows a comprehensive patent strategy as patent protection provides a significant benefit to the Company in the world of biopharma entities.
As reported earlier, the Company also has filed for patent protection on the identified 11 conserved, expectedly immutable sites (epitopes) on the Coronavirus against which it is producing targeted anti-SARS-CoV-2 monoclonal antibodies. Using computer analysis (Artificial Intelligence [AI]), the Company has screened more than 50,512 Coronavirus isolates currently known and identified conserved sites which expectedly are immutable. The 11 conserved sequences identified on the virus isolates curated have been identified on the basis that they are 97.68% to 99.29% conserved over the entirety of 50,512 Coronavirus isolates now sequenced which have been analyzed.
The Company is actively progressing to produce monoclonal antibodies against many other viruses. The proprietary methodically used by the Company will be employed to produce monoclonal antibodies against numerous other virus and using "AI", the Company is curating the know sequences of the following viruses and intends to both seek patent coverage and produce monoclonal antibodies targeting conserved sequences These viruses include:
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). Patent applications will be filed claiming the inventive findings. Patent claims will cover the discovered epitope/antigens, with proposed vaccine claims, antibody claims, and related prophylactic/therapeutic method claims relating to these identified epitope/antigens.
With each day of progression of the CoronaVirus pandemic, the dire need for multiple active therapeutics becomes more evident. Recent studies are showing that the neutralizing activity provided by having contracted the virus declines, and may even be lost, in association with a decrease in systemic IgA antibody levels, from two months after disease onset. Thus, even after one has had the virus, they may become reinfected. This short-lasting humoral protection is further evidence of the need for ongoing therapeutics which would include monoclonal antibodies and periodic boosts of SARS-CoV-2 vaccinations.
CEO Charles Cotropia stated: "While we recognize that the production of the therapeutics, we are creating takes time, we have immediately taken the necessary steps to protect our discoveries using U.S. and foreign patents. As a small biotech, this puts us on the same stage as big pharma. We also convey to our supporters our intent to progress as quickly as possible but recognize that accomplishing our goals will take time and effort - but progress and success we be achieved."
About Enzolytics, Inc.
Enzolytics, Inc. is a drug development company committed to the commercialization of its proprietary proteins for the treatment of debilitating infectious diseases.
Enzolytics' flagship compound ITV-1 (Immune Therapeutic Vaccine-1) is a suspension of Inactivated Pepsin Fraction (IPF), which studies have shown is effective in the treatment of HIV/AIDS. IPF is the active drug substance of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has been shown to modulate the immune system.
About BioClonetics Immunotherapeutics, Inc.
BioClonetics Immunotherapeutics, Inc., a wholly owned subsidiary of Enzolytics, is a Dallas and College Station, Texas biotech company with proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology for producing fully human monoclonal antibodies may be used to produce therapeutics treatments for many infectious diseases including the Coronavirus.
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 US 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 ITV-1 in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of ITV-1 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 and involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and could 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, and the Company expressly disclaims any intention or obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements.
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SOURCE: Enzolytics, Inc.
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