Enzolytics Inc (ENZC)

[falon]

IPF Immune is in the marketplace

ITV-1 therapeutic is treating patients in Africa

Anti-HIV Monoclonal Antibody Therapy may be very close to an IND filing based on past ENZC press releases:

(Newsfile Corp. - May 16, 2022) https://www.newsfilecorp.com/release/124101/Enzolytics-Inc.-Discusses-the-Significance-and-Revenue-Potential-of-Its-Therapeutic-Platforms-with-The-Stock-Day-Podcast:

HIV THERAPEUTICS
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.

COLLEGE STATION, TX / ACCESSWIRE / December 1, 2022 https://www.theglobeandmail.com/investing/markets/stocks/ENZC/pressreleases/12132162/enzolytics-recognizes-world-aids-day-and-highlights-the-companys-focus-on-producing-effective-therapies-for-treating-hiv/

HIV THERAPEUTICS
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.

COLLEGE STATION, TX / ACCESSWIRE / December 13, 2022 https://www.theglobeandmail.com/investing/markets/stocks/ENZC/pressreleases/12457227/enzolytics-inc-announces-us-distribution-of-ipf-immunetm-and-progress-in-each-of-its-therapeutic-platforms/

Enzolytics' methodology for producing monoclonal antibodies is unique and innovative, unlike other biotech companies. The Company's antibodies are produced from human "immune-B cells" obtained from convalescent individuals who have recovered from the target virus. The Company's monoclonal antibodies are not "humanized" but are fully human monoclonal antibodies where the original antibody affinity and specificity are maintained.

The methodology starts with human "immune cells" obtained from convalescent individuals who have recovered from the virus. From these human B cells, the Company then produces antibodies that target conserved immutable sites (neutralizable epitopes) on the virus' surface envelope proteins that will be ever-present, rendering the virus neutralizable even through mutation, thus voiding "virus escape". These antibodies also retain the original natural antibody's affinity and specificity and have a very low risk of immunogenicity when used as a therapeutic.

Once produced, the monoclonal antibodies are tested for binding and neutralizing activity. These characteristics are confirmed by the Company's partnering laboratories, Genscript Labs and the University of Strasbourg, France. After the final confirmation of antibody activity, the Company's CDMO partner Samsung Biologics will produce the recombinant antibodies in their proprietary, FDA-approved stable CHO cell line suitable for Clinical Application. https://www.bloomberg.com/press-releases/2021-10-07/enzolytics-inc-and-samsung-biologics-announce-development-and-manufacturing-agreement-for-anti-hiv-and-anti-sars-cov-2.

Enzolytics is developing Class switched IgA1/2 Clone 3 Antibodies. This therapy will expectedly provide a protective immunological defense against an initial exposure to HIV at mucosal surfaces, such as in the passage of the virus from mother to child through maternal breastfeeding. HIV mucosal infection plays a critical role in virus transmission and AIDS pathogenesis, affecting mucosal surfaces of the gastrointestinal tract early on by depleting CD4+ T helper cells independently of the virus transmission route. Although current antiretroviral therapy is intended to control HIV infection in most patients, it cannot eradicate the virus from the human host. Therefore, the development and use of HIV microbicides (i.e., topical pre-exposure prophylaxis) have become a most promising approach to preventing HIV transmission. Thus, the development of Class switched Clone 3 IgA1/IgA2 is highly significant. In addition to the anti-HIV monoclonal antibody already produced and tested, Enzolytics is producing monoclonal antibodies targeting the additional seven conserved targets identified by the A.I. platform.

The Company COO Dr. Gaurav Chandra noted, "While the Company's focus is on producing monoclonal antibodies for treating human viruses, the Company is now applying its technology in the production of monoclonal antibodies against animal viruses, including Feline Leukemia Virus (FeLV) and Feline Immunodeficiency Virus (FIV). The Company has analyzed, using Artificial Intelligence, epitopes of these viruses and has identified conserved sites against which targeting monoclonal antibodies are being developed. The Company has also analyzed epitopes of the Equine Infectious Anemia Virus, Koala Retrovirus, Elephant Endotheliotropic Herpes Virus (EEHV), Avian Flu Swine Flu, and others. This analysis has revealed the conserved immutable sites on these viruses against which monoclonal antibody production is planned.

The production of these monoclonal antibodies begins in the Company's lab located at the Texas A&M University Institute for Preclinical Studies [https://tips.tamu.edu/]. Using the Company's proprietary methodology for producing fully human monoclonal antibodies which target conserved, immutable sites on the viruses, multiple monoclonal antibodies are being produced."

Producing antibodies for the treatment of Feline Leukemia Virus and Feline Immunodeficiency Virus is significant because these viruses are the most common infectious diseases in cats. There are more than 150 million cats in the U.S. and over 25% of households in America own cats. These Feline viruses a significant percentage of the cat population in the United States and around the world. Production of monoclonal antibodies targeting these viruses will be more direct and the time to market will be significantly less than is the case required for monoclonal antibodies developed for the treatment of individuals. The Company has initiated discussions with animal health providers who express an interest in this technology and its end product.

The Company's primary anti-HIV monoclonal antibody (Clone 3) has been produced and successfully tested in vitro against multiple virus strains, showing complete efficacy. The recombinant form of the parent antibody (necessary for patient therapy) has been successfully produced for the Company by Samsung Biologics. This recombinant Antibody is undergoing efficacy testing and has shown significant activity even against drug-resistant HIV strains. Studies have confirmed the dual tropic activity of the HIV monoclonal antibody - Clone 3.

The Company CSO Dr. Joseph Cotropia said, "For HIV to be infectious, there is a requirement of specific binding between the virus envelope protein and the human CD4 cell at two receptor sites on the CD4 cells, namely: (1) binding to CD4 receptor initially (on gp120), and (2) binding to the chemokine co-receptors CXCR4 and/or CCR5 (on gp41). The Clone 3 Antibody interrupts the binding of the virus transmembrane gp41 to the human CD4 cells via blocking of binding to the 2nd co-receptor-to both the CCR5 and the CXCR4 receptors-on the CD4 cell surface. Because Clone 3 is dual-tropic, it consequently prevents HIV infection by abrogating the essential infectivity process which requires the fusion between the viral membrane and the human CD4 cell membrane."

In view of the test results completed on the Company's Clone 3 Monoclonal Antibody and ITV-1 activity, plans are in place to assess combination therapy using these 2 therapeutics to treat HIV.

COLLEGE STATION, TX / ACCESSWIRE / February 8, 2023 https://www.theglobeandmail.com/investing/markets/stocks/ENZC/pressreleases/14009682/enzolytics-announces-preliminary-results-of-glp-toxicology-study-for-its-anti-hiv-therapeutic-itv-1-and-production-of-itv-1-for-initiation-of-registration-in-africa/

The Company COO, Dr. Gaurav Chandra, said, "The Company has made significant progress on its multiple therapeutic platforms. These platforms include the Company's ongoing development of multiple Monoclonal Antibodies for the treatment of various infectious diseases, an AI platform that makes possible rapid production of effective multiple Monoclonal Antibodies, including those targeting both human and animal viruses, and an effective nutritional supplement, IPF Immune™, that is currently on the market. With several therapeutic platforms providing significant value to the Company and its shareholders, we are confident in our future. The Company's strengths are its multiple technologies that will individually provide effective therapies and treatments for patients and consumers."

COLLEGE STATION, TX / ACCESSWIRE / April 17, 2023 /https://www.theglobeandmail.com/investing/markets/stocks/ENZC/pressreleases/16033356/enzolytics-inc-announces-execution-of-non-binding-term-sheet-with-the-special-purpose-acquisition-company-sagaliam-acquisition-corp-and-updates-the-progress-on-the-african-project/

The CEO of BGEN, Dr. Gaurav Chandra, emphasized the progress being made by the Company using its Artificial Intelligence (AI) platform. "We continue to utilize our disruptive AI platform to identify conserved immutable epitopes on viruses and then produce species-specific monoclonal antibodies targeting those sites. We are advancing in production of multiple monoclonal antibodies against HIV, SARS-CoV-2, and the Feline Leukemia virus. Our AI platform drives the Company's drug discovery and development and executes our strategy to produce multiple therapeutics protected by International Patents. We take pride in strengthening our IP portfolio and protecting the anti-virus therapeutics, their production method, use in diagnostics and prognostics. Our application of Artificial Intelligence to drug formulation and creation is a move ahead of big pharma's monoclonal antibody discovery and development. We recognize that large pharmaceutical companies are now focused more than ever on the significant advantage provided by AI in creating highly successful therapeutics. We continue to engage with large pharma and discuss potential partnerships involving our AI platform."

Enzolytics CEO Charles Cotropia stated, "Enzolytics is focused on accelerating the growth of our clinical products, technology platforms and multiple programs now in progress. This agreement with Sagaliam will allow us to accelerate progress in each of these areas."

COLLEGE STATION, TX / ACCESSWIRE / April 27, 2023 / https://www.theglobeandmail.com/investing/markets/stocks/ENZC/pressreleases/16359745/enzolytics-inc-continues-progress-with-business-combination-biogenysis-announces-team-and-plans-for-success/

Dr. Joseph Cotropia will assume the Chief Scientific Officer position of Biogenysis. Dr. Cotropia said, "I am encouraged to see a roadmap and strategies in place to fulfill my life's work. We were few when we started, and it is encouraging to now have many professionals and partnering companies that believe in our science and therapies. Our AI platform and the collaboration we have with Samsung Biologics will accelerate our progress. Since the steps from early discovery to IND studies are identical, we can move ahead rapidly with production of multiple Monoclonal Antibodies."

Dr. Suraj Saggar will be an Advisory Board Member of Biogenysis. Dr. Saggar said, "There is tremendous progress in developing our Monoclonal Antibodies for multiple infectious diseases. Besides IgG Monoclonal Antibodies, the IgA Monoclonal Antibodies for COVID-19 have disruptive potential. In addition, we recognize the role of IgA antibodies in the immune function of mucous membranes and are working on harnessing their potential for powerful, efficient Immunotherapeutics. These can be offered as an intranasal spray which can be easily applied to achieve long-term protection."

Charles Cotropia, CEO of Enzolytics, stated, "At Biogenysis, we have a pipeline of Monoclonal Antibodies. In addition, we are creating a strong IP portfolio for multiple infectious diseases covering diagnostics, therapeutics, and vaccines for these viruses. Strategically, we are focused on meeting milestones and licensing each of these assets. The SPAC agreement allows us to move forward with multiple Monoclonal Antibodies simultaneously, bringing significant value to our shareholders."