COLLEGE STATION, TX / ACCESSWIRE / April 5, 2021 / Enzolytics, Inc. (OTC PINK:ENZC) (or the "Company").
In a significant development, recent findings have revealed that the monoclonal antibodies being produced by the Company against targeted sites on the Coronavirus are directed against epitopes that exist conservatively on each of the variant strains of the virus from the UK, Brazil and South African.
These findings are considered by the Company as highly significant in that the Center for Disease Control (the "CDC") recently reported these Coronavirus as "variants of concern," defining them as 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."
These Coronavirus variants are largely responsible for the recent increase in COVID-19 cases across the U.S., with the UK variant (B.1.1.7) accounting for 26 percent of all infections in the U.S. This variant, which is between 50 and 70 percent more transmissible, is the predominant strain in at least five regions of the country, according to Rochelle Walensky, MD, CDC director. Mutations in viruses are common but most are insignificant and do not cause any change in the viruses' ability to transmit or cause serious infection. But some mutations, like the ones in the UK or South Africa variant lineages, make the virus more infectious and in some cases even deadlier.
Significantly, Federal officials have halted the distribution of Eli Lilly's bamlanivimab monoclonal antibody treatment in three states (California, Arizona, and Nevada) due to concerns about a homegrown COVID-19 variant that renders it ineffective. There are reports of "double mutant" COVID-19 variant first discovered in India and in the United States."Such [double] mutations confer immune escape and increased infectivity".
The Company's targeted approach is to produce fully human monoclonal antibodies against the identified conserved epitopes on the Coronavirus. Using computer analysis (Artificial Intelligence [AI]), the Company has identified 19 conserved sequences 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. Significantly, these conserved sequences have been identified in the UK, Brazil and South African variants.
This discovery is significant in Enzolytics' continued commitment to producing therapeutics for the treatment of COVID-19. Specifically, Enzolytics is creating human heterohybridoma cell lines using convalescent human patients' peripheral "immune" human B cells to create fully human monoclonal antibodies directed individually against the identified conserved sites on the virus and against both S1 protein and S2 (transmembrane) protein on the Coronavirus. These monoclonal antibodies will expectedly have universal effect (on all known variants) and will be durable in that as the virus mutates, the targeted site will still exist in the virus subjecting it to neutralization. Such therapeutics would have universal (world-wide application), be durable (have long term successful benefit) and thereby prevent failure of successful vaccines and/or provide effective treatment, which are both points of failures that have occurred as a result of "mutational virus escape".
This capability is highly significant in that experts, such as Dr. Paul Offit, MD, Director of the Vaccine Education Center at Children's' Hospital in Philadelphia, have stated that even though successful vaccines have been developed and deployed, we can expect the Coronavirus to be with us going into the future, with a resurgence year to year. Thus, therapeutics to treat the virus will be necessary into the future. Additionally, the Company's monoclonal antibodies may be used in conjunction with other pharma antibodies, such as Eli Lily's bamlanivimab monoclonal antibody in combination therapy.
The Company's pending patents claim the identified target sites and include patent claims to the CDR sequences of the produced antibodies. Such patent claim structure will expectedly provide the Company the exclusive rights to therapeutics based on these findings for a 20 years period from the date of filing. International patent coverage is also being sought.
CEO Charles Cotropia said, "The discoveries made by our AI team, and implemented by our research team, are extremely significant. The creation of monoclonal antibodies that target the Achilles' heels of the Coronavirus, which will be present even in mutated strains worldwide, means that a therapeutic may be produced that will have affect throughout the world and for the expected continuous lifecycle of the Coronavirus. These findings have their origin in the critical analysis performed by our AI team, which has used sophisticated computer analysis and years of AI experience to curate the amino acid sequences (which are in the tens of thousands) of each of the over 50,000 Coronavirus isolates now known. From this analysis, our AI team has identified the "golden needles" in an enormous haystack of data. This is a remarkable achievement.
Recently, we have become aware of commentators on our technology who, rather than fairly and validly analyzing our technology and our findings, instead propound, for what we perceive as some self-serving reasons, erroneous and irrelevant assertions to mislead those interested in knowing the fundamental truth about our discoveries. For example, one "red flag" raised by one commentator has been to criticize our AI team - not on the basis of the technology and substance of its findings - but by focusing on the date of incorporation of the partner. Obviously, the date an entity is incorporated is irrelevant when those on the research team have decades of experience with the knowledge, skill and capability to analyze the amino acid sequences (containing thousands in number) of each of over 50,000 different Coronavirus isolates. It is from this sophisticated analysis and resulting findings that the Achilles' heels of the Coronavirus are revealed, namely those epitopes that must be and that can be targeted by monoclonal antibodies to effectively treat the virus not only today but into the future. We question the motive behind these grossly misdirected comments, made for what we perceived as self-serving reasons and not to provide an honest, fair and truthful dialogue about a most serious medical crisis. While we perceive such irrelevant and misleading comments as intending to divert attention from the problem at hand and the solutions that are possible, we stand resolved to focus on the science and applying our capabilities to achieve success for all who will confront this virus - a virus that has and will do societal damage around the world, not only today but in the future".
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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