Enzolytics Announces Its New Technology For Entry Into The In-Vitro Diagnostics Market

COLLEGE STATION, TX / ACCESSWIRE / February 21, 2022 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/) announces its plans for entry into the diagnostics market. Enzolytics has filed a comprehensive U.S. and foreign Patent Cooperation Treaty (PCT) Patent Application covering its invention of a novel, innovative technology for improved diagnostics. The PCT Application covers the Company's identification of highly conserved antigens and epitopes of SARS-CoV-2 that can be used in vaccines and to produce bindings proteins (e.g., antibodies) for treating, preventing, or reducing the risks of infections caused by β-coronaviruses such as SARS-CoV-2. The patent also covers the discovery of using these identified antigens and epitopes as targets for detecting and diagnosing SARS-CoV-2 infection.

The Company's Artificial Intelligence platform has been used to build 3D Models of the conserved targets. The analysis of the SARS-CoV-2 spike protein revealed that all epitopes identified by the Company are linear on the spike proteins, accessible by antibodies, neutralizable, and unaffected by mutations.

The Company's finding provides the basis for addressing the challenge posed by the fast evolution of SARS-CoV-2 variants having mutations in their genomic and protein sequences, which have precluded the development of effective methods for accurately detecting infection. The effect of mutations on a test's performance may be influenced by several factors, including the sequence of the variant (including the number, identity, and location of mutations), the design of the test, and the prevalence of the variant in the population. For example, tests with single targets are more likely to fail to detect new variants. On the other hand, tests with multiple targets (e.g., a PCR test designed to detect more than one section of the SARS-CoV-2 genome or an antigen test intended to detect more than one region of the spike protein) can more accurately detect new variants. For example, a molecular test able to detect other variants is expected to fail to detect the SARS-CoV-2 Omicron variant (B.1.1.529) due to a nine-nucleotide deletion in the N-gene, spanning positions 28370-28362, while a two-target antigen test able to detect other variants is expected to fail to detect the Omicron variant due to deletions at amino acid positions 69-70 and mutations at nucleotide positions 23599.

Enzolytics is developing tests that diagnose SARS-CoV-2 based on the presence of the conserved sites that remain unaffected by mutations. Using its Artificial Intelligence technology, all the conserved sites identified by the Company have remained present in all of the variants of concern and variants of interest.

Enzolytics is currently working with diagnostic companies with track records for taking this technology and the tests produced under it through regulatory approval, leading to patient use.

The global in-vitro diagnostics market was valued at approximately U.S. $68.41 Billion in 2020. The market value is expected to increase to U.S. $91.25 Billion in revenue in 2026, with a CAGR of 4. 90% over the forecast period.

The COVID-19 pandemic turned attention to in-vitro diagnostics. As a result, there is an increasing demand for IVD kits and reagents for the rapid and accurate diagnosis of SARS-CoV-2 virus infection among the global population. The outbreak of COVID-19 is expected to positively impact the market studied, as in-vitro diagnostics involves the testing of various biological samples. This is expected to aid the diagnosis of infectious diseases, such as COVID-19. Therefore, testing remains a crucial step in controlling the COVID-19 pandemic. As a result, there is an increased push for faster, reliable, and accurate diagnosis of SARS-CoV-2. The Company's new technology addresses this need.

This new technology is supplemental and additive to the Company's multiple technology platforms, which include:

The Company's immune modulator IPF Immune™ coming to the U.S. market in March.

The Company's development of ITV-1 therapeutic for treating HIV.

The Company's production of anti- HIV Monoclonal Antibodies.

The Company's production of anti-SARS CoV-2 Monoclonal Antibodies.

The Company's planned production of Monoclonal Antibodies addressing animal viruses such as the Equine Infectious Anemia Virus, Feline Leukemia Virus, Feline Immunodeficiency Virus, Equine Herpesvirus (EHV), Koala Retrovirus (KoRV), and the Elephant Endotheliotropic Herpesvirus (EEHV).

The Company's Artificial Intelligence (A.I.) Platform including:

A.I. Analysis to identify immutable sites. 3D Modelling of the epitopes to establish linearity, neutralizing potential and accessibility to antibodies.

A.I. to assess the effects of nutrition, genetics, and microbiome on diseases to:

• Build prediction models for infectious diseases (preferably COVID), mental health disorders, and chronic medical diseases.
• Identify biomarkers for infectious diseases and chronic medical diseases.
• Identify novel targets and clear intervention strategies for infectious diseases and chronic medical diseases.

A.I. Platform for genomic surveillance, monitoring of viral epidemiology.

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), covered by U.S. Patent Nos. 8,066,982 and 7,479,538. Studies have shown it to be effective in treating HIV/AIDS. 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, covered in its pending U.S. Patent Application 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 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.

I.R. contact:
TEN Associates, LLC
Tom Nelson, CEO
(480) 326-8577

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

SOURCE: Enzolytics, Inc.