COLLEGE STATION, TX / ACCESSWIRE / December 1, 2022 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/).
World AIDS Day has been recognized on this day since 1988. It is an important day for the world to reflect on those who have been lost in the HIV pandemic and recommit to the challenge necessary to address this deadly disease.
But why has the world failed to conquer HIV?
Even though there are treatments for those with HIV - antiretroviral drugs (ARVs) -, the treatments do not cure and require lifelong use - which over a lifetime cause severe side effects including bone loss, heart disease, diabetes, lactic acidosis, kidney, liver, or pancreas damage, among others.
Additionally, ARV treatments are extremely expensive. New ARV drugs such as Biktarvy by Gilead can costs up to $75K per year. Cabenuva by VIIV Healthcare costs $48K a year. As a result, of the 38.4 Million people in the world who have HIV, only 69% have access to any available treatment, leaving 31% with no treatment. Of children in the world with HIV, only 50% have access to treatment, leaving 50% with no treatment.
During the pandemic, over 40 Million have died from the virus. In 2021, 860,000 died from HIV, over 2,000 each day. Each day in 2021, approximately 850 children became infected with HIV and approximately 301 children died from AIDS-related causes.
In 2021, 301 children died each day from HIV. More than the number of children who succumb to cancer.
Attempts to produce monoclonal antibodies to successfully treat HIV have not succeeded. The anti-HIV monoclonal antibodies VRC01 and VRC02, produced by the NIH in conjunction with Vaccine Research Center, failed - due to virus mutation - namely "virus escape". https://www.jci.org/articles/view/134395. Many other attempts have also not been successful in providing effective treatment at a reasonable cost.
On this World AIDS Day, Enzolytics wishes to call attention to the continued need for more effective, and affordable treatments for HIV, including successful treatments for the growing number of individuals living longer with HIV. Because almost ½ of those with HIV are now 50 or older and approximately 1 in 6 new diagnoses of HIV occur in this age group, people aging with HIV can face treatment-related challenges, such as drug interactions between HIV medicines and medicines used for other conditions. Because older individuals are more likely not to be diagnosed with HIV, a delayed diagnosis means treatment is also delayed, resulting in HIV potentially causing more damage to the immune system. Additionally, data suggest that untreated HIV is resulting in the development of SARS-CoV-2 variants. In this regard, the Company's technology remains focused on both HIV and SARS-CoV-2.
The Company's technologies focus on a definitive therapy for treating HIV compared to the current treatment using ARVs. Specifically, the Company is advancing two platforms, one being a clinically tested, patented, antiviral therapeutic, known as ITV-1, that has shown significant effectiveness in treating patients with HIV/AIDS. This therapeutic is complementary to the Company's development of fully human monoclonal antibodies that target and neutralize the virus. Experts in the field have consistently acknowledged that a cure for HIV will require the administration of "multiple, broadly neutralizing monoclonal antibodies." Just as multiple anti-CoronaVirus monoclonal antibodies are now widely recognized as effective in treating those with COVID-19, the same will be true for anti-HIV monoclonal antibodies. But to be successful, such antibodies must be "broadly neutralizing" - that is, they must target conserved, immutable sites not rendered ineffective by mutant strains of the HIV virus. This is exactly the focus of the Company's technology.
A.I. PLATFORM SUCCESS
To enhance its production of effective anti-HIV monoclonal antibodies, the Company has employed Artificial Intelligence (A.I.), using computer analysis to curate (analyze) the amino acid sequences of targeted viruses to identify the conserved, immutable, and neutralizable target sites (epitopes) on viruses. Once identified, the Company uses its proprietary technology to produce fully human monoclonal antibodies that target these identified immutable sites - thereby producing a therapeutic that does not fail due to virus mutations - known as virus escape. Additionally, these identified target sites may be used to develop more effective vaccines - a vaccine development methodology significantly different than mRNA vaccine production.
Using Artificial Intelligence, Enzolytics has identified immutable conserved epitopes for numerous viruses and is focused on producing monoclonal antibodies targeting these sites. The Company has fully analyzed over 87,000 HIV isolates using A.I. identifying 8 conserved epitopes and over 2 Million COVID-19 isolates to identify 19 conserved epitopes. The Company is in the process of producing antibodies targeting these conserved sites. These conserved epitope sites on the HIV and CoronaVirus are claimed in the Company's now pending PCT patent applications.
The far-reaching nature of the Company's A.I. analysis is seen by noting that in addition to curating isolates of HIV and COVID-19, the Company has fully analyzing each of the following viruses and identified the conserved epitopes on the viruses: HTLV-1, 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, Feline Immunodeficiency virus, Small Ruminant Lentivirus, and Koala retrovirus. The Company's future efforts are production of monoclonal antibodies targeting these virus sites. PCT Patent Applications will be filed covering these discoveries.
The Company's A.I. is significant for the following reasons:
- The A.I. platform incorporates genomic surveillance and monitoring of virus epidemiology. The Enzolytics AI team is working on a comprehensive Artificial Intelligence protocol to analyze existing viruses and any new virus immediately upon its emergence globally.
- Enzolytics also utilizes A.I. to assess the effects of Genetics, Nutrition, and the Human Microbiome on infectious diseases, mental health disorders, and chronic medical diseases. The purpose of this focus is to:
- Build prediction models for infectious diseases, mental health disorders, and chronic medical diseases.
- Identify biomarkers for infectious diseases, mental health disorders, and chronic medical diseases.
- Identify novel targets and clear intervention strategies for infectious diseases, mental health disorders, and chronic medical diseases.
This is part of Enzolytics' strategic effort to expand to the personalized medicine market and increase its Intellectual Property portfolio. The Company's Chief Operating Officer, Dr. Gaurav Chandra, has described the role of Artificial Intelligence in understanding the microbiome, leading to biomarkers, innovative diagnostic tools, and novel treatment strategies in diseases in an article "Demystifying the Human Microbiome using Artificial Intelligence" published in the Yuan (https://www.the-yuan.com/177/Demystifying-the-Human-Microbiome-Using-AI.html).
Addressing the HIV pandemic, the Company has two expectedly complementary therapeutics directed to the effective treatment of HIV. One therapeutic, ITV-1, a patented antiviral peptide that has been clinically tested, is a suspension of Inactivated Pepsin Fragment (IPF), a purified extract of porcine pepsin. This therapeutic has been shown to strengthen the immune system and has been tested in HIV patients in clinical trials with significant beneficial results. [https://enzolytics.com/proprietary-therapeutics/]. Currently, the Company is advancing this anti-HIV therapeutic for approval under the European Medicines Agency (EMA) for use in European Union countries.
The Company also is focused on deploying this tested therapeutic in African countries, where the HIV pandemic is severe. Upon completion of final Toxicity Studies of ITV-1, the Company plans to be able to make ITV-1 available in the countries in Africa, including Rwanda, the Democratic Republic of Congo, Angola, Kenya, and South Africa. The Company sees this as significant for individuals in Africa recognizing that out of the 38.4 Million HIV-positive people worldwide, 69% live in sub-Saharan Africa. There are roughly 23.8 Million infected persons in all of Africa. 40% of those infected with HIV in Africa do not have any access to any treatment for the virus. In addition, 91% of the world's HIV-positive children live in Africa.
The second therapeutic for treating HIV, the Company's anti-HIV monoclonal antibodies, are also in development. The Company's primary anti-HIV antibody has been produced from the parent antibody in the recombinant form (a form necessary for patient treatment) by Samsung Biologics. Samsung Biologics will provide end-to-end CDMO services from cell line development, clinical drug substance, and drug product manufacturing services to support IND filings for Anti-HIV Monoclonal Antibody Therapy for the treatment of HIV. The Company notes that this anti-HIV mAb targets an immutable site on the HIV virus that has existed unchanged over 30 years of analysis of the virus. This means that the target will not mutate rendering the antibody ineffective.
Addressing the COVID-19 pandemic, the Company is producing monoclonal antibodies targeting conserved sites on the SARS-CoV-2 virus identified using Artificial Intelligence. The conserved targeted conserved sites are found in all variants of concern - including the COVID-19 Omicron variant. Thus, the monoclonal antibodies being produced by the Company, due to the conserved nature of the targeted epitopes, are expected to be effective against current and future variants of the COVID-19 virus.
The Company is using multiple processes to accelerate the production of these monoclonal antibodies. As acknowledged by experts in the field, numerous monoclonal antibodies are needed for effective therapy. By using accelerated technology systems in collaboration with Abveris, a division of Twist Bioscience Corporation, desired antibodies may be produced in shorter time frames. Abveris applies advanced immunization methods combined with B cell screening and hybridoma-based antibody discovery technologies to provide comprehensive gene-to-antibody discovery services. In addition, the Company has a strong working relationship with Samsung Biologics, which provides end-to-end CDMO services from cell line development, clinical drug substance, and drug product manufacturing services to support IND filings for produced antibodies.
ENZOLYTICS IPF IMMUNE™ THERAPEUTIC
- The Company is now producing its "Enzolytics IPF Immune™," a liquid nutritional supplement that provides support for the body's immune system. The active components in the supplement have been registered with the FDA for use in the U.S. under NDI Reg. No. 1083. The Company's product is produced and sold pursuant to its license under U.S. Patent No. 8,309,072 (the '072 Patent). This '072 Patent, entitled "Irreversibly-Inactivated Pepsinogen Fragments for Modulating Immune Function," covers the use of Irreversibly Inactivated Pepsin Fragments (IPF). The primary IPF ingredient is a complex platform that provides support for the immune system. The U.S. vitamin and supplement industry currently totals $35.6 Billion in 2022 while the global sector is worth $151.9 Billion. The Company expects the product to be very well received by consumers.
CEO Charles Cotropia said, "In this past year, we have made great progress in advancing several platforms for providing multiple therapeutics for the treatment of many significant human conditions. While we are happy with our recent progress, we know we will be successful going forward given the wide range of our technologies and the multiple platforms we have developed. These platforms will make possible our production of therapeutics covering an extensive range of diseases for which therapies are desperately needed."
About Enzolytics, Inc.
Enzolytics, Inc. is a drug development company committed to commercializing 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. 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, SARS CoV-2, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology, covered in multiple PCT Patent Applications 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.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-44
SOURCE: Enzolytics, Inc.