Enzolytics Announces A Comprehensive Therapeutic Protocol For Production Of Monoclonal Antibodies To Address Ongoing And Future Pandemics

COLLEGE STATION, TX / ACCESSWIRE / June 7, 2021 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/) has announced a coherent protocol that it intends to execute to meet the Company's objective of producing a therapeutic cure for HIV as well as a planned protocol to address existing and future pandemics. This protocol has been defined as a result of the Company's collaboration with Intel Corporation in the field of applying computer analysis (Artificial Intelligence - A.I.) to accelerate health care discoveries and development.

The Company's collaboration with Intel is discussed in a recently published White Paper (https://www.intel.com/content/www/us/en/healthcare-it/resources/enzolytics-whitepaper.html) and in an internet streamed presentation (https://www.youtube.com/watch?v=8peEJdTRoe8)

featuring Intel representatives Clifton Roberts and Nikhil Deshpande with Enzolytics' COO, Dr. Gaurav Chandra. Enzolytics' collaborative partnership with Intel focusing on achieving groundbreaking drug discovery and development pathways. This collaboration includes exploring the interaction of monoclonal antibodies with viruses in 3-dimensional matrices. This opens new innovative pathways for drug discovery and development.

The Company is actively exploring biotech partnerships, in the same way the Company is working with Intel Corporation, to advance and provide effective therapies and cures for existing and new viral illnesses. In combination with the Company's patented and clinically tested anti-HIV peptide ITV-1, the Company proposes a collaboration to fully implement the following protocol for developing and deploying therapeutics to address existing and future pandemics.

The Company's defined protocol includes:

• Application of computer analysis (Artificial Intelligence - A.I.) to curate (analyze) the amino acid sequences of targeted viruses to identify the conserved, immutable, and neutralizable target sites (epitopes) on targeted viruses. Enzolytics has accomplished this goal for HIV, the Coronavirus, HTLV-1 and is in the process of doing the same for H10N3, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Ebola, Small-Pox, Tetanus, Diphtheria, Rabies, Herpes zoster, Varicella zoster, Anthrax, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, and Koala retrovirus.
  • The protocol includes implementation of A.I. analysis of existing viruses (or mutants thereof) and on any new virus immediately upon its emergence anywhere in the world.
• The A.I. analysis identifies the conserved, immutable, and neutralizable target sites on the subject virus. It provides for the production of multiple monoclonal antibodies, each targeting an immutable epitope for the administration of combination therapy.
• Creation of cell lines to produce fully human monoclonal antibodies targeting each identified conserved virus site (epitope). In this step, multiple broadly neutralization antibodies are produced targeting multiple conserved, immutable epitopes on the targeted virus.
  • The Company's methodology for producing monoclonal antibodies is unique.
  • Antibodies are produced from human 'immune-B cells,' obtained from convalescent individuals who have recovered from the target virus.
  • The antibodies are not 'humanized' rat and mouse monoclonal antibodies where the original antibody affinity and specificity are not maintained, and the chances of immunogenicity are increased.
  • The antibodies are not transgenic mouse model (a human immune system which has been "grafted" within a mouse model) having been 'vaccinated' with specific and selected purified proteins.
  • Given the production method, a 'Black Box Warning' (a warning of potential adverse reactions) would not be expected to be applicable to the Company's produced antibodies.
• Administering multiple monoclonal antibodies in the early stages of infection as treatment or cure of the targeted virus.

This protocol is now being executed and may be applied to any virus using the Company's existing technology. The first step of using A.I. to identify conserved, immutable target sites has been completed by Enzolytics for HIV, the Coronavirus (SARS-CoV-2), and the HTLV-1 virus. With regard to the HIV virus, the Company has screened more than 87,336 HIV isolates, the largest known repository of HIV isolates known. From this extensive A.I. analysis, seven conserved sites (with up to 98% conservativeness) on HIV were identified. This analysis also confirmed that the site against which the Company's already produced anti-HIV monoclonal antibodies (called Clone 3) targets one conserved site on the HIV virus, which site is 98% conserved (either directly or by way of conservative amino acid substitutions) overall 87,336 HIV isolates curated (analyzed) by the Company using Artificial Intelligence.

Likewise, the Company has completed the same type of analysis for the Coronavirus and HTLV-1. Using A.I., the Company screened more than 50,512 Coronavirus isolates currently known and has identified conserved, immutable sites which are neutralizable. Through the analysis, 19 conserved sequences have been identified on the Coronavirus on the basis that they are 98.71% to 99.29% conserved over the entirety of the 50,512 Coronavirus isolates analyzed. From these findings of 19 conserved, neutralizable sites (epitopes) on the Coronavirus, the Company is producing multiple (a cocktail of) targeted anti-SARS-CoV-2 monoclonal antibodies.

Experts acknowledge the necessity of treating with multiple monoclonal antibodies. More importantly, the target sites must be conserved, immutable sites to avoid "virus escape" for the therapeutics to be effective. By producing antibodies against each conserved targeted site on the virus permits the administration of a 'cocktail' of antibodies, each of which will have effect without regard to mutation of the virus. Using the Company's proprietary methodology for producing fully human monoclonal antibodies, the Company is producing antibodies targeting these virus sites in its lab at Texas A&M University in the University's Institute for Preclinical Studies.

Patents have been filed on these discoveries claiming the inventive findings. The Patents claim the discovered epitope/antigens, with proposed vaccine claims, antibody claims, and related prophylactic/therapeutic method claims relating to these identified epitope/antigens.

The Company is also curating (analyzing) the amino acid sequences of other significant viruses, covered by patents claiming the identified antigens/epitopes and associated therapeutics. Using A.I. analysis, the Company is now identifying, and it will claim the conserved epitopes/antigens on the infectious diseases caused by Ebola, Influenza A and B, H1N1 influenza, H10N3, Respiratory syncytial virus (RSV), Small-Pox, Tetanus, Diphtheria, Rabies, Herpes zoster, Varicella zoster, Anthrax, Elephant endotheliotropic herpesviruses, Feline Leukemia Virus, Equine Infectious Anemia Virus, and Koala retrovirus.

The Company expects to accelerate its development of these highly significant therapeutics and test its monoclonal antibodies in combination with its patented and clinically tested anti-HIV peptide ITV-1. Such tests are expected to validate the expected synergistic effect of combining the two anti-HIV therapeutics. The Company is actively seeking and dialoguing with pharma companies active in developing therapeutics for treating infectious diseases.

About Enzolytics, Inc.

Enzolytics, Inc. is a drug development company committed to the commercialization of its proprietary proteins and monoclonal antibodies for the treatment of 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), which studies have shown is effective in treating HIV/AIDS. IPF is the active component of ITV-1 and is a purified extract of porcine pepsin. 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. Its proprietary methodology 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 ITV-1 or its therapeutic monoclonal antibodies 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 and 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
Investor Relations Contact

Company Contact
Enzolytics, Inc.
2000 North Central Expressway
Plano, TX 75074

And

Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-44

SOURCE: Enzolytics, Inc.