COLLEGE STATION, TX / ACCESSWIRE / July 28, 2022 / Enzolytics, Inc. (OTC PINK:ENZC) ("ENZC" or the "Company"). In the first Official Action on the Company's International Patent Application covering its discovery and exclusive claim to conserved antigens and epitopes of the HIV virus, the PCT International Search Report concluded that inventions claimed therein are novel and inventive and thus will expectedly be issued in final international patents.
The Company's International Patent application covers (1) the discovered highly conserved antigens and epitopes (sites) on the HIV virus, (2) antibodies that bind to the disclosed antigens and epitopes, (3) vaccines based on the antigens, (4) methods of treating, preventing, or reducing the risks of HIV infection with the antigens or binding proteins, and (5) methods and kits for detecting or diagnosing infection by HIV using the antigens or binding proteins.
The claimed virus sites were discovered by the Company through computer analysis (Artificial Intelligence (AI)), wherein tens of thousands of HIV isolates were curated to identify these critical, conserved, immutable epitopes on the virus. These sites are now claimed as patentable based on their novel specificity and the finding that they are conserved on the HIV virus. This is significant in that by producing antibodies that attack these conserved, immutable sites, the virus can be neutralized rather than be unaffected as a result of virus mutation that avoids the therapeutic.
The Company is producing fully human monoclonal antibodies against these claimed sites. These discoveries have now been confirmed by the International Patent Office to be novel and inventive, capable of being patented and claimed exclusively for a 20-year term in every member country under the Patent Cooperation Treat in which the Company pursues these claims.
The Company expects the same favorable results in the PCT Patent Office for its pending applications covering epitopes (binding sites) on the CoronaVirus (covering all variants), on the Monkeypox Virus, and on numerous animal viruses, namely Feline Leukemia Virus (FeLV), Feline Immunodeficiency Virus (FIV), Elephant Endotheliotropic Virus, Equine Infectious Anemia, and Koala Retrovirus. The Company fully expects the issuance of multiple international patents covering these discoveries.
The Company's PCT applications also cover the identification of highly conserved antigens and epitopes of these viruses that can be used in the production of treating antibodies, and the production of vaccines for treating, preventing, or reducing the risks of infections caused by these viruses.
The patents also cover the discovery of using these identified antigens and epitopes as targets for detecting and diagnosing viral infection. This is a significant development since these patents cover not only treatment and prevention but also targets for detection and diagnosis of infections for all viruses being pursued by Enzolytics.
In the Company's unique process, computer analysis (AI) was used to identify conserved, immutable epitopes on the target virus utilizing Enzolytics' proprietary AI platform invented by Dr. Gaurav Chandra, the Company COO. The sequences (structure) of over 87,500 HIV isolates were analyzed in the initial AI step for HIV, and for the Coronavirus, over 2 Million SARS-CoV-2 virus isolates were curated. In the case of HIV, eight (8) epitopes (target sites) were identified and claimed in the Company's PCT application. As a part of this process, 3 Dimensional models of these conserved targets were generated, and the targets were analyzed for linearity, accessibility by antibodies, and neutralizability by antibodies. From this, Enzolytics' scientists are producing multiple broadly neutralizing antibodies targeting these multiple conserved, immutable epitopes on the targeted virus. The monoclonal antibodies produced against these targets will expectedly be universal, durable, broadly neutralizing, and unaffected by virus mutation. In the case of SARS-CoV-2, nineteen (19) conserved sites were identified and are claimed in the Company's pending PCT applications.
The Company considers the forthcoming patent protection highly significant in view of the following facts:
- 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 87,000 HIV isolates and has identified 19 conserved sites (98 to 99% conserved) on the Coronavirus and 8 conserved sites on the HIV virus.
- The Company's patent claims cover these findings and from the most recent PCT International Patent Office Action, claims have been recognized as novel and Inventive and thus can be expected to issue in the U.S, and many foreign countries pursued. The Company claims 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.
Enzolytics' methodology for producing monoclonal antibodies is unique and innovative, unlike those employed by other biotech companies. The Company's antibodies are produced from human "immune-B cells," obtained from convalescent individuals (or animals in the case of veterinarian monoclonal antibodies) who have recovered from the target virus. The Company's monoclonal antibodies are not "humanized" but are fully human monoclonal antibodies where the original antibody affinity and specificity are maintained, and the chances of immunogenicity are minimized.
To accelerate and fully execute in the successful production of the multiple monoclonal antibodies the subject of the Company's intellectual property (specifically the numerous monoclonal antibodies (mAbs) targeting both human and animal viruses), the Company continuously engages with numerous entities to accomplish the successful goal of production, testing and delivery of successful therapeutics. Entities with whom the Company is working includes companies having:
- Expertise in providing specialized peptides having precise amino acid sequences corresponding to the precise target sites on both the Coronavirus and HIV viruses which are then used in the Company's Texas lab against which mAbs are being produced. This strategy accelerates the production of the mAbs for further development.
- Specialized cell soring technology that is complementary to the process used in the Company's lab to accelerate production of mAbs for advancing production.
- Expertise in hybridoma production techniques for production of mAbs using hybridoma methodologies that are complementary to the process used in the Company's lab.
- Animal trials centers, both in the U.S. and abroad, for preparation of animal trials.
- Promotional entities with specialized expertise in targeting large funding sources for the purpose of raising the substantial funds needed for the production of the recombinant mAbs necessary for future trials and for conducting animal trials.
As to each of these entities, and those with whom the Company currently works on an ongoing basis, the Company has entered into NDA's (Nondisclosure Agreements) necessary to preserve and protect the intellectual property being discussed and exchanged between the parties. These contractual restrictions are critical for the Company and its partners. Maintenance of strict confidentiality is absolutely essential to preserving intellectual property rights (patent rights) which are now being sought and which will be sought in the future. Premature disclose of technical information may and generally does bar the right to successfully seek patent protection at a later date. The Company is not able to share specific information regarding arrangements regarding these NDA's
Charles Cotropia, the company CEO, said, "We are very confident in our Artificial Intelligence empowered Intellectual Patent Portfolio. It has allowed us to claim exclusive rights on an international stage covering critical target sites on numerous human and animal viruses. This places our relatively small company on an equal level with the largest biotech companies in that we are the first to identify and patent critical sites on these many human and animal viruses. This same technology and strategy is being implemented by the Company continuously on new viruses, human or animal. We note that we have identified the conserved sites on the Monkeypox Virus even before the World Health Organization declared it a global health emergency last week.
An extensive patent portfolio will provide a return on investment through partnering or licensing technology covered by multiple international patents."
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.
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.
Company Contact:
Enzolytics, Inc.
Texas A&M Institute for Preclinical Studies
Enzolytics, Inc.
800 Raymond Stotzer Parkway
College Station, Texas 77843-4478
SOURCE: Enzolytics, Inc.