Enzolytics, Inc. Announces Expansion of Production of Its Monoclonal Antibody Therapeutics and Marketing of IPF Immune(TM)

COLLEGE STATION, TX / ACCESSWIRE / November 16, 2022 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/).

Enzolytics, Inc. is a drug development company committed to the commercialization of its multiple proprietary therapeutics for the treatment of debilitating infectious diseases. The Company's proprietary technologies include therapeutics for treating HIV and monoclonal antibodies for infectious diseases including HIV, SARS-CoV-2, and numerous other viruses in both humans and animals, and the production of over-the-counter nutritional supplements.

Planned Expansion of the Company's Monoclonal Antibodies

Enzolytics is focused on the production of anti-HIV therapeutics and monoclonal antibodies to treat viruses that affect humans. At the same time, the Company is applying its technology to address viruses that affect animals. The Company's primary therapeutics in progress include the following.

ITV-1 anti-HIV Therapeutic

ITV-1 is an anti-HIV therapeutic produced under patents invented by the Company's CSO, Harry Zhabilov, U.S. Patent Nos. 8,066,982 and 7,479,538. These and all patents relating to all Company technologies and products are exclusively licensed to the Company. No other company or individual has an ownership right or license in any Company related patent. Patent Office records verify this fact.

The Company has announced the completion of the first phase of the animal toxicology studies on its ITV-1 anti-HIV therapeutic and continues to progress with the GLP Compliant Repeat Dose Toxicity Study. https://www.nasdaq.com/press-release/enzolytics-reports-successful-completion-of-an-mtd-tolerability-study-of-its-itv-1. Upon completion of final Toxicity Study by BTS Pharma under GLP conditions, the Company expects 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 34 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 are in Africa.

Prior successful Clinical Trials of the Company's ITV-1 treatment were completed earlier under the Bulgarian Drug Agency requirements. The Company moving forward to complete further clinical trials to fulfill the European Medicines Agency (EMA) requirements to launch the therapy in the EU followed by seeking FDA approval for use in North America. The Company is finalizing a comprehensive clinical development plan based on the prior clinical trials completed earlier, preparing a CMC non-clinical Gap analysis, and a necessary EU Regulatory Strategy.

Thereafter, CMC and GMP Requirements for EMA and FDA will be completed, followed by production of ITV-1 as per EMA and FDA requirements and a Fast-Tracked Clinical Trial to fulfill EMA and FDA requirements. ITV-1 has been successfully produced and has been earlier successfully clinically tested in human trials under the Bulgarian Drug Agency requirements.

In the prior clinical trials of ITV-1, the following beneficial results were established:

• ITV-1 inhibits the infection of CD4 T-cells by HIV.
• Use resulted in an increase in the patient's CD4/CD8 index.
• CD4 T-cell counts were raised to healthier levels, with a 68% increase in CD4+T-lymphocytes.
• HIV viral loads were reduced. Tests showed an 80.5% drop in viral loads.
• Use resulted in a decrease in the absolute number and the relative percent of CD8 lymphocytes.
• Use replaces or complements current anti-retroviral therapies.
• ITV-1 was less toxic than anti-retroviral and would be less costly.
• ITV-1 was unaffected by HIV mutations that can hamper anti-retroviral therapies (HAART).
• ITV-1 demonstrated a good effect on opportunistic infections.
• ITV-1 had good compatibility with other anti-retroviral drugs.
• There was good tolerance without any side effects.
• ITV-1 use boosted the immune system to fight HIV infections.

Monoclonal Antibodies against HIV and the CoronaVirus

Acquired Immunodeficiency Syndrome (AIDS) is considered to be one of the most serious and chronic diseases, caused by the human immunodeficiency virus (HIV). The prevalence of HIV is souring at a significant rate. According to the World Health Organization (WHO), an estimated 34 million individuals are currently living with the HIV virus. Due to increased awareness among people, there is now an increase in testing which has led to a surge in demand for HIV medications.

Today, there is no cure for HIV. The virus and its disease are treated by administering antiretroviral (ARV) drugs that do not cure and must be taken for life. The global HIV drug market size was $28.79 Billion in 2020. Even though sales rise was moderated during the height of the COVID pandemic, a steady growth of 5.7% in 2020 occurred. The market is expected to grow from $30.46 Billion in 2021 to $45.58 Billion in 2028. The rise in CAGR is attributable to this market's demand and growth, returning to pre-pandemic levels once the pandemic subsides. https://www.fortunebusinessinsights.com/industry-reports/hiv-aids-drugs-market-101115.

To address this need, the Company is focused on both the production of its ITV-1 therapeutic and producing multiple anti-HIV monoclonal antibodies using its proprietary methodology.

The Company's primary anti-HIV monoclonal antibody has been produced and successfully tested in vitro against multiple strains of the virus where it demonstrated 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 currently undergoing efficacy testing in Europe 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. 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 cell and the chemokine co-receptors CXCR4 and/or CCR5 (on gp41).

The Company's Clone 3 Antibody interrupts the binding of the virus transmembrane gp41 to the human CD4 cells via blocking of binding to the 2^nd 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 CD4 cell membrane.

The success of an anti-HIV monoclonal antibody would be significant. The objective is to have a therapy that would not require lifelong use as is the case for antiretrovirals, the only available therapeutic treatment for HIV treatment. The statistics for HIV are alarming.

• Of the 34 million individuals living with the HIV virus today, only 66% had access to antiretroviral treatment - leaving 34% with no treatment.
• 1.7 million people become newly infected with HIV each year.
• 1 million people die yearly from AIDS-related illnesses. 2,700 die each day - over 300 are children (almost twice the number who die from cancer).
• 32.7 million people have died from AIDS-related illnesses since the start of the pandemic.

Antiretroviral drugs have significant drawbacks.

• They do not cure a patient and must be taken for life.
• They are extremely expensive.
  • The cost of Biktarvy by Gilead is $90,000 per year.
  • The cost of Cabenuva by ViiV Healthcare is $48,000 per year.
  • The cost of Dolutegravir/tenofovir is $46,000 per year.
  • It is well recognized (even by the producers of these drugs - as is publicly revealed in advertisements for the drugs) that these antiretroviral drugs cause serious damage over time to the heart and the kidneys, decrease bone density and contribute to Vitamin D deficiency. These are only some of the potential negative side effects attributed to the therapies.
• HIV infections are most treatable during their earlier stages, and patients cannot take antiretrovirals during earlier stages since drug resistance often develops.
• Limited or no treatment options exist when viral load and CD4 cell counts are at their worst, i.e., AIDS.

Thus, the need for alternative treatment is critical. A successful treatment using multiple monoclonal antibodies offers the hope for a therapeutic cure at a fraction of the current treatment cost.

U.S. Product Launch Scheduled for IPF Immune™

The Company's nutritional supplement IPF Immune™ will be available in the U.S. market this month. The Company's IPF Immune™, produced under U.S. Patent No. 8,309,072, invented by the Company CSO, Harry Zhabilov, and exclusively licensed to the Company, will now be available to consumers in the U.S. "We have met with buyers from some of the most sought-after retailers in the country. We are working to add retail outlets to make it easy for consumers to find IPF Immune™," said Harry Zhabilov, CSO of Enzolytics. The Company has high expectations for this product, in view of the strength of the dietary supplement industry. The average American spends almost $100 per trip on vitamins and supplements. The U.S. vitamin and supplement industry currently totals $35.6 Billion in 2022 while the global sector is worth $151.9 billion. Older Americans from the Greatest Generation and Baby Boomers spend the most per purchase on dietary supplements, $129.58 and $111.59, respectively. Gen X totals $82.06 and Millennials are at $62.73.

"It is obvious that Americans take vitamins and supplements for health reasons," Mr. Zhabilov said. "Dietary supplement usage has been increasing for years, but the pandemic forced everyone to focus more on their health." During the health crisis, consumers started searching for vitamins and supplements that would support their immune systems. Enzolytics IPF Immune™ is a nutritional supplement that is taken orally. "In the coming months, we will be working hard promoting IPF Immune™ to consumers and retailers," Mr. Zhabilov said. "Retailers know consumer interest in dietary supplements has been increasing. Consumers want to take a proactive approach to their health, which is why they are turning to dietary supplements," he added. "Retailers are taking note of this trend."

The Company is also investigating the sale and distribution of IPF Immune™ in foreign countries. The Company is focused on sales in the U.S., Latin America, and Europe. The Latin American nutritional supplements market was valued at US $48.10 Billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 8.1% from 2022 to 2030. The increasing consumer awareness regarding personal health and well-being is one of the key drivers of the market, with 77 percent of U.S. adults taking dietary supplements. The Company's IPF Immune™ product is expected to command a meaningful market share as an effective nutritional supplement.

The Company is Now Deploying its Monoclonal Antibody Technology for the Treatment of Animal Viruses.

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 (AI), epitopes of these viruses and have 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.

Targeting the conserved sites discovered by Enzolytics allows the production of a therapeutic that will not be rendered ineffective due to mutation (variants) of the virus. Even a "variant form of the virus" will contain the immutable targeted sites. Targeting immutable sites avoids the ineffectiveness that is experienced when a therapeutics or vaccine targets a site that has mutated.

Enzolytics is combining its technology in a collaboration with Abveris, a division of Twist Bioscience Corporation, for the application of the Company's methodology to produce monoclonal antibodies against human and animal viruses. The collaboration makes possible the combination of the synergistic technologies of the two companies in producing monoclonal antibodies against numerous pathogenic viruses. https://www.nasdaq.com/press-release/enzolytics-inc.-announces-collaboration-with-abveris-to-discover-monoclonal.

This process of producing monoclonal antibodies for the treatment of FeLV and FIV is proceeding with the objective of producing antibodies for the treatment of Feline Leukemia Virus and Feline Immunodeficiency Virus, viruses that are one of 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 affect 3% of the cat population in the United States, resulting in over 4 million cats suffering from these viruses. This same problem exists around the world. Production of monoclonal antibodies targeting these viruses will be more direct and the time to treatment 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 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/]. The lab uses the Company's proprietary methodology for producing fully human monoclonal antibodies which target conserved, immutable sites on the viruses, thereby avoiding ineffectiveness due to virus mutation.

The methodology implemented by the Company to produce monoclonal antibodies is proprietary and the subject of pending international patent applications. In the initial process step, Artificial Intelligence (computer analysis - AI) is used to identify conserved, immutable epitopes on the target virus utilizing Enzolytics' proprietary AI platform. In the AI initial analysis process step, the sequences (structure) of virus isolates are analyzed. From that analysis, epitopes (target sites) are identified which are conserved across all isolates curated. The Company production process is then employed to produce monoclonal antibodies targeting these identified conserved sites.

As a part of this process, 3 Dimensional models of these conserved targets are generated, and the targets may be analyzed for linearity, accessibility by antibodies, and neutralizability by antibodies. Then Enzolytics produces multiple broadly neutralizing antibodies targeting these multiple conserved, immutable epitopes on the targeted virus.

Enzolytics' methodology for producing monoclonal antibodies is unique and innovative, unlike those employed by other biotech companies. In the case of a monoclonal antibody to treat an animal virus, the Company's antibodies are produced from animal "immune-B cells", obtained from convalescent animals who have recovered from the target virus. The Company's monoclonal antibodies are then developed directly where the original antibody affinity and specificity are maintained, and the chances of immunogenicity are minimized.

Enzolytics' Focus on Intellectual Property (I.P)

"As Enzolytics advances its science and clinical products, the Company continues to build a robust Intellectual Property portfolio", said Gaurav Chandra, MD, the Company COO. "The focus is on gaining competitive advantage through an aggressive patent strategy." This comprehensive program is described in detail in the Company's Press release of March 25, 2022, and on the Company New page of its website (https://enzolytics.com/company-news/).

Charles Cotropia, the Company CEO, said, "The international patent system is an optimum way for a small biotech company to lay claim, for a 20-year period dating back to an early priority date, to significant intellectual property even before or without bringing the therapeutic to market. The filing of a patent application serves as a constructive reduction to practice of the subject matter described in the application. In this way, we are taking every opportunity to cover the waterfront on all of the viruses we are fully analyzing."

The Company is the exclusive worldwide licensee of each of the patents and applications covering its technologies. Any assertions by others to the contrary are false claims. The company's patent portfolio ownership if verified in Patent Office records. These patents include:

1. Fully human anti-HIV monoclonal antibodies and vaccines covered by PCT Patent Application No. PCT/US2022/020682. The Company's pending PCT patent application cover the multiple highly conserved antigens and epitopes of the HIV virus that can be used in vaccines and to produce bindings proteins (e.g., monoclonal antibodies) for detecting, treating, preventing, or reducing the risk of HIV infection
2. Anti-Corona Virus monoclonal antibodies and vaccine covered by PCT Patent Application No. PCT/US2022/016926. The Company's pending PCT patent application claims the 19 highly conserved antigens and epitopes of SARS-CoV-2 that can be used in vaccines and to produce bindings proteins (e.g., monoclonal antibodies) for detecting, treating, preventing, or reducing the risk of SARS-CoV-2 infection. In these applications, the Company has claimed its discoveries including the use of these identified conserved epitopes for (1) use in any diagnostics to identify whether a person has HIV or the CoronaVirus, (2) producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus, and (3) producing a vaccine against HIV or the CoronaVirus.
3. Artificial intelligence platform for use in diagnosing COVID-19 and HIV covered by PCT Patent Applications. The Company's patent claims cover the use of any one identified epitope or any combination of any of the multiple identified epitopes in any of the following ways:

• For producing a therapeutic monoclonal antibody to treat HIV or the CoronaVirus.
• For producing a vaccine against HIV or the CoronaVirus.
• For producing related prophylactic/therapeutic methods relating to the epitopes/antigens.
• For use in any diagnostic test to identify whether a person has HIV or the CoronaVirus.

1. The Company will file patent applications on its discovery leading to the production of monoclonal antibodies against Feline Leukemia Virus (FeLV) and Feline Immunodeficiency Virus (FIV) and other animal viruses.
2. ITV-1 - a clinically tested anti-HIV therapy is covered by U.S. Patent Nos. 8,066,982 and 7,479,538. The final production process requires Company proprietary technology.
3. IPF Immune™ - a currently marketed immune supplement, is covered by U.S. Patent No. 8,309,072. The patent covers using an Irreversibly inactivated Pepsin fragment which has significant benefit as an immune supplement.

These issued patents cover the Company's ITV-1 anti-HIV therapeutic and IPF Immune™. Supplemental patent applications are planned to cover improvements of ITV-1 and IPF Immune.

The PCT patent applications covering the anti-HIV and anti-Coronavirus monoclonal antibodies and the AI platform have received an initial PCT Patent Office review. In the anti-HIV PCT application, PCT/US2022/020682, "Human Immunodeficiency Virus (HIV) Antigens and Epitopes and Proteins That Bind Thereto", the first PCT Patent Office search report found that inventions claimed were both novel and inventive and thus the Company is assured of the issuance in the final country prosecutions.

In the PCT/US2022/016926 application, "Coronavirus Antigens and Epitopes and Proteins That Bind Thereto", in the first examination, not all of the 39 claims were examined. Examined claims were found to be inventive though not novel. The prior art references cited in reaching the conclusion of lack of novelty clearly do not disclosure or suggest the claimed target epitopes and thus the Company is confident that in the numerous countries in which the application will be finally prosecuted (each country having its own standard as to patentability), patent coverage will be granted. It is a regular occurrence that claims may be initially objected to but later allowed after argument and submission of relevant evidence to the Patent Office. This is particularly the case where not all the filed claims were the subject of any review and where the cited references do not disclose the epitope sequences claimed as is the case in this application. The 39 separate patent claims submitted in this application are drafted to cover varying inventions (1) the discovered highly conserved antigens and epitopes (sites) on the virus, (2) antibodies that bind to the disclosed antigens and epitopes, (3) vaccines based on the antigens, (4) methods of treating, preventing, or reducing the risks of infection with the antigens or binding proteins, and (5) methods and kits for detecting or diagnosing infection by using the antigens or binding proteins.

The Company fully expects that the patent claims sought in these applications will be issued in the U.S. and the foreign countries in which they will be advanced. The Company intends to prosecute the applications in all major countries around the world. The life for any patent issued is 20 years from the effective priority date.

Charles Cotropia, the Company CEO, said: "The breadth of patent coverage that is sought and expected is extremely far-reaching based on the discovery of the critical target epitope sites necessary to most effectively neutralize these viruses. The Company has identified conserved epitopes using its AI platform on multiple viruses other than HIV and CoronaVirus, namely including HIV-2, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Small-Pox, Ebola Virus, Tetanus, Diphtheria, HTLV-1/2, Rabies, Herpes zoster, Varicella zoster, Anthrax, Mason-Pfizer monkey virus (MPMV) and Visna virus (VISNA). These findings will also be the subject of protection through international patents. Our patent portfolio will be extensive".

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 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.

Company Contact:

Enzolytics, Inc.
www.enzolytics.com
[email protected]

SOURCE: Enzolytics, Inc.