COLLEGE STATION, TX / ACCESSWIRE / April 19, 2021 / Enzolytics, Inc. (OTC Markets "ENZC" or the "Company").
We continue to make great strides in the application of our multiple platforms for production of therapeutics for treating infectious diseases. Our future success will follow as we meet our goals to bring these therapeutics to market with new developments made possible by our extensive platform for producing new and effective therapies.
We acknowledge our partners Genscript (https://www.genscript.com), STC Biologics (https://stcbiologics.com) and California National Primate Research Center (University of Southern California) for their continued support in our research and development efforts. We are also grateful for the overwhelming support from world-renowned scientists and continue to expand our team of advisors to build a strong company based on research and development.
We are encouraged by the positive feedback received from pharmaceutical companies who have acknowledged an interest in partnering upon achievement of defined milestones. The milestones we have set include the following:
Monoclonal Antibodies for Treatment of HIV Milestones
1st Milestone: Testing of anti-HIV Monoclonal Antibodies at University of Montana
Status: in process. Time to completion: 1 month
2nd Milestone: Broad-based neutralization testing of existing anti-HIV Monoclonal Antibodies at University of Strasbourg, France
Status; in process. Time to completion: 2 months
3rd Milestone: Animal Studies of anti-HIV Monoclonal Antibodies at California National Primate Research Center, University of Southern California
Time to completion: 6 months following in vitro testing in process.
4th Milestone: Using Artificial Intelligence, identification of additional conserved immutable target sites (epitopes) on the HIV-1 virus
Status: Completed
5th Milestone: Production of additional Monoclonal Antibodies targeting identified sites (epitopes) on the HIV virus
Status: in process. Time to completion: 5-6 months
COVID-19
We are proud of the significant advances we have made in the development of Monoclonal Antibodies for treating Covid-19. We have reported that the Monoclonal Antibodies being produced by the Company will target immutable, conserved sites on SARS-CoV-2 (Coronavirus) that exist on the variant strains of the virus from the UK, Brazil, and South African.
These findings are considered highly significant in that the Center for Disease Control ("CDC") has reported these "variants of concern" are ones "for which there is evidence of an increase in transmissibility, more severe disease (meaning increased hospitalizations or deaths), a significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures."
Our AI platform developed in collaboration with Denver Scientific has been one of our many successes. The patentable discoveries will be significant in our ongoing partnering dialogue with pharmaceutical companies interested in treatments for the Coronavirus and numerous other infectious diseases.
We intent to expedite our development of anti-Coronavirus Monoclonal Antibodies including an eventual fast-track clinical trial to progress to market.
SARS-CoV-2 (Coronavirus) Monoclonal Antibodies Milestones
1st Milestone: Using Artificial Intelligence, identification of conserved immutable target sites (epitopes) on the Coronavirus
Status: Completed
2nd Milestone: Production of Monoclonal Antibodies targeting identified sites (epitopes) on the SARS-CoV-2 virus
Status: In process. Time to completion: 3-4 months
3rd Milestone: Fast-Track Clinical Studies
Time to Completion: 6 months following production of Monoclonal Antibodies
ITV-1 anti-HIV Therapeutics
Clinical trials are planned for the Company's patented anti-HIV therapeutics ITV-1. Earlier this year, we announced the execution of Articles of Association to form International Medical Partners ("IMPL"), a Bulgarian Limited Liability Company of which the Company is 50% owner. The Company's partners in IMBL will fund the total cost of the Clinical trials under the European Medicine Agency (the "EMA") standards and the application cost for the EMA permit for the Company's ITV-1 patented therapeutics for treating HIV. Under the Mutual Recognition Agreement (the "MRA") between the EMA and the United States Federal Drug Administration (the "FDA"), the Company believes that issuance of the EMA permit for the ITV-1 compound could qualify ENZC's treatment for recognition by the FDA. IMBL has entered negotiations to engage a CRO to begin the clinical trials required under EMA standards.
We will have a definitive timeline for the expected date of initiation and completion of clinical trials in the coming weeks.
Production of Monoclonal Antibodies for HTLV-1/2
We are committed to developing "universal, durable and broadly neutralizing" Monoclonal Antibodies for many infectious diseases. We have an "intent to partner" agreement with a pharmaceutical company to create Monoclonal Antibodies against HTLV-1/2. We expect to complete the production by the end of 2021.
Monoclonal Antibodies for HTLV-1/2
1st Milestone: Using Artificial Intelligence, identification of conserved immutable target sites (epitopes) on the HTLV1/2 virus
Time to Completion: 2-3 months
2nd Milestone: Creation of anti-HTLV1/2 Monoclonal Antibodies
Time to completion: 6-8 months following identification of target epitopes
CEO Charles Cotropia said, "The strength of our company lies in our multiple technology platforms and the ability to produce fully human Monoclonal Antibodies against conserved and immutable targets on identified viruses. The viruses that may be addressed using our technology range from HIV to the Coronavirus to HTLV-1/2 to Ebola and many more. These numerous targeted viruses and bacteria are listed on our website [http://enzolytics.com/proprietary-therapeutics/]. We will continue to provide updates on our developments and progress toward completing the milestones we have set. We thank all our shareholders for their ongoing support of our Company and its technologies."
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.
IR 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 77843-4478
SOURCE: Enzolytics, Inc.
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