Production of Monoclonal Antibodies Targeting These Sites Is in Process in the Company's Texas Lab
COLLEGE STATION, TX / ACCESSWIRE / February 22, 2021 / Enzolytics, Inc. (OTC Markets "ENZC" or the "Company") today announced it has identified eleven 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's genetics and molecular biology data science team has now screened more than 50,512 Coronavirus isolates currently known and has 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 98.71% to 99.29% conserved over the entirety of the 50,512 Coronavirus isolates analyzed.
The Company has filed a comprehensive patent application covering these discoveries. This initial application has been filed in the U.S. and will be extended to claim international patent coverage through the International Patent Cooperation Treaty (PCT) to which 153 countries subscribe. The patent coverage sought includes patent claims on the discovered epitope/antigens, vaccine claims, antibody claims, and related prophylactic/therapeutic method claims relating to the epitope/antigens.
Under U.S. and foreign patent laws, filing of a patent application constitutes reduction to practice of the claimed invention. Rights of priority to claimed inventions date from the date of filing of the U.S. application. This priority date will be accorded to the inventions claimed in supplemental U.S. and all foreign corresponding applications filed through the PCT. A PCT filing provides the basis for seeking coverage in any or all of the 153 member countries. The term of protection provided by such patent or patents will be 20 years from the effective filing date. The Company follows a rigorous and comprehensive patent strategy as patent protection is considered a strategic and significant asset of the Company.
Before completing the Artificial Intelligence analysis of the 50,512 SARS-CoV-2 isolates to identify conserved epitopes, the Company's scientists predicted a specific target epitope that is correlative in structure to the site on the HIV virus to which the Company has produced a monoclonal antibody that has been shown to neutralize the HIV virus. The prediction was that this site would be conserved as is the correlative site on the HIV virus. The AI analysis of the 50,512 SARS-CoV-2 isolates identified this predicted site on the virus as 99% conserved across all 50,512 isolates. This primary site on the SARS-CoV-2 virus has also been confirmed as existing (100%) in the U.S. SARS-CoV-2 virus and the virus variants which have surfaced in United Kingdom, Brazil and South Africa, which are now in the U.S. This epitope on the SARS-Cov-2 virus is included in the first being targeted by the Company in its production of epitope specific monoclonal antibodies.
The Company has always emphasized the need for therapeutics that target conserved and expectedly immutable virus sites - whether the therapeutics is a monoclonal antibody or a preventative vaccine. There is agreement among experts that multiple neutralizing antibodies is critical to effective control of viruses such as the Coronavirus. Recognizing this necessity, if a site is 99% conserved (exits in all 99% of the 50,512 Coronavirus isolates curated), then it can be expected that the next 50,512 variations will also contain the conserved sites. Targeting these conserved sites allows the production of a therapeutic that will not become ineffective due to mutation of the virus. In other words, even a "variant form of the virus" will expectedly contain the immutable targeted sites. Targeting those immutable sites avoids the ineffectiveness that is experienced when a therapeutics or vaccine targets a site that has mutated.
Variant have arisen in viruses other that the Coronavirus. Prior government funding in 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".
In addition to patenting Company's findings of conserved sites on the SARS-CoV-2 (Coronavirus), the Company is also filing patent applications covering the conserved sites on the HIV virus. Filings will be made in the U.S. Patent Office and then extended for international coverage through the PCT covering 153 countries.
As the Company has previously reported, it is also curating (analyzing) the amino acid sequences of other major viruses and will file patent applications claiming the identified antigens/epitopes and associated therapeutics. Using AI analysis, the Company is now identifying and will claim the conserved epitopes/antigens on the infectious diseases caused by 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), Visna virus (VISNA) and mouse mammary tumor virus (MMTV). 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.
In addition to the AI analysis, the Company is applying its proprietary methodology for producing fully human monoclonal antibodies targeting these identified epitope sites on the various viruses curated. 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.
Legislation was introduced this week in the U.S. House of Representatives by Rep. Tammy Baldwin seeking funding of $7.5 Billion for analysis to "better identify, survey and understand these (Coronavirus) variants, and better protect all Americans from this public health crisis." This proposal is to merely "monitor" and "identify" the changes in the amino acid sequences of the Coronavirus. The Company considers its progress to be a step beyond this proposed effort. The intent of the proposed legislation is to increase the current database of sequences for the Coronavirus from the current level to a larger number. However, the Company has already curated (analyzed) over 50,000 isolates known and has identified 11 epitopes within these isolates as over 98% conserved. These conserved sites will expectedly be present in any number of additionally identified isolates found by a government program costing $7.5 Billion. The Company plans to explore the possibility of participating in any such program should Representative Baldwin's legislation be passed.
As reported, the Company has completed its initial analysis of the 87,336 HIV isolates which have been curated (analyzed) by the Company using Artificial Intelligence (AI) and have identified 8 conserved sites, some with over 98% conservativeness. 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. Testing of the recombinant form of this antibody (the parent antibody being designated as Clone 3) against multiple HIV isolates is underway at the University of Strasbourg in France. Patent protection is pending on the Clone 3 "recombinant" antibody. Further patent protection on the additional sequences is also being sought.
The Company has clarified the lack of significance of the prior expired Company patents covering the Company's "parent" Clone 3 anti-HIV antibody. The expired Company patents were issued on the "parent" Clone 3 antibody. As is the case with virtually all parent antibodies, the parent antibody is a "slow producer" - which means it could not produce sufficient antibody therapeutics to treat the 36 million individuals infected with HIV. Thus, a recombinant form of the antibody had to be created employing a fast-producing CHO cell line. This has been accomplished by the Company and patent applications are pending claiming the recombinant form of the antibody, the form that will be used in patient therapy. The term of issued patents will be 20 years from filings, such filings having been made in 2020.
The Company notes the recent reports of Coronavirus vaccines not being as effective against newly discovered variant 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.
With each day of progression of the Coronavirus pandemic, the dire need for multiple active therapeutics becomes more evident. Recent studies are revealing that the immunity provided by having contracted the virus declines, and may even be lost, in association with a decrease in systemic IgA antibody levels, in as little as 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.
Charles Cotropia, CEO of the Company stated "with each round of new discoveries the value to mankind of our proprietary methodology for producing fully human monoclonal antibodies for treating infectious diseases, including potentially the Coronavirus, drives us to continue to our work."
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.
2000 North Central Expressway
Plano, TX 75074
Phone: (972) 292-9414 Fax: (972) 292-9414
Texas A&M University
Institute for Preclinical Studies
College Station, TX
SOURCE: Enzolytics, Inc.