Enzolytics Inc (ENZC)

[DOGONE]

A few NUGGETS I see....bold


ITV-1 anti-HIV Therapeutic
August 22, 2022

The Company’s ITV-1 anti-HIV therapeutic is in production and the Company is proceeding with steps to advance it through approval under the European Medicines Act (EMA). Toxicology studies are ongoing and near completion in the Company’s partnering California lab. The results of these tests will be reported as they are completed. Simultaneously, the ITV-1 therapeutic is proceeding through the necessary multi-stage production process in the Company’s partnering lab in Europe. The current ongoing production of ITV-1 will be used in clinical trials conducted under the EMA guidelines. Early production of ITV-1 will be submitted to health care entities in Africa, where testing and use of the therapeutics are expected to be made possible before EMA approval.

To meet EMA requirements, the Company has engaged European medical specialists to guide the therapeutics through the EMA process. The Company's Board Advisor, Dr. Lachezar Ivanov, and the Company CSO Harry Zhabilov, in conjunction with medical field advisors in Europe, are managing this process for introducing ITV-1 to E.U. countries under the EMA.

The Company is also focused on providing its anti-HIV therapeutics to the African continent due to the tremendous need in African countries for effective and affordable treatment. The Company plans to make ITV-1 available in countries in Africa, including Rwanda, the Democratic Republic of Congo, Angola, Kenya, and South Africa and the Company is coordinating the introduction of ITV-1 for use in these countries as soon as possible. This is significant, recognizing that out of the 39 million HIV-positive people worldwide, 69% live in sub-Saharan Africa. There are roughly 23.8 million infected persons in all of Africa. In addition, 91% of the world's HIV-positive children live in Africa. More than 45% of the African population who have HIV do not have any access to the anti-retroviral treatment used in other countries to treat but not cure HIV.

The beneficial effects of ITV-1 are significant and will be complimentary to other treatments but at a lower cost and available to the over 45% of infected individuals in Africa who have no access to any treatment, including antiretrovirals which are used in other countries around the world for treating HIV patients.

Positive Therapeutic Effects of ITV-1
Prior European clinical trials have demonstrated the following beneficial effects of ITV-1.

ITV-1 inhibits the infection of CD4 T-cells by HIV.
It reduces HIV viral loads.
Replaces or complements current anti-retroviral therapies.
It is potentially less costly and much less toxic.
It may be effective as a periodic therapy instead of a daily one.
It is unaffected by HIV mutations that can hamper anti-retroviral therapies (HAART).
Tests have shown an 80.5% drop in viral loads.
It raises CD4 T-cell counts to healthier levels, with a 68% increase in CD4+T-lymphocytes.
Use achieved an increase in the CD4/CD8 index.
It demonstrated an excellent effect on opportunistic infections.
It had good compatibility with other anti-retroviral drugs.
There was good tolerance without any side effects.
Use resulted in a decrease in the absolute number and the relative percent of CD8 lymphocytes.
It boosts the immune system to fight HIV infections.
ITV-1 has benefits that anti-retrovirals do not and may be used in situations where anti-retrovirals are not appropriate.

Anti-retroviral therapies have serious side effects. In addition, they do not cure a patient.
HIV infections are most treatable during their earlier stages, and patients cannot take antiretrovirals during earlier stages since drug resistance often develops.
There are limited or few treatment options available when viral load and CD4 cell counts are at their worst, i.e., AIDS.
The Company’s IPF Immune ™ dietary supplement
Enzolytics IPF Immune™ will be available in numerous sales outlets throughout the U.S. Delays in producing sufficient quantiles for the market are being addressed. These delays have provided time for increasing production capability to meet demand. The company’s market research has indicated significant demand for IPF Immune™.

The nutritional supplement market is large and growing annually. The global dietary supplements market was valued at $151.9 Billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 8.9% from 2022 to 2030. Over the forecast period, increasing consumer awareness of personal health and wellbeing is expected to be a key driving factor for dietary supplements. In addition, increasing dependence on supplements to fulfill the nutrient requirements owing to their high convenience is expected to drive the market upwardly over the forecast period. The U.S. market for dietary supplements leads the North American market and matches the European market.

The Company is making plans for the sale of the IPF Immune™ product in numerous countries in Europe, Latin America, Australia, and Canada. These plans include engaging with promoters and distribution representatives in these countries. Just like in the U.S., each country's nutritional supplement market is large and growing rapidly. In addition, because the product is produced in Europe, providing the product to European markets will be easier and less expensive, providing a more significant profit margin to the Company.

Regarding marketing, the Company has engaged a marketing specialty firm that will use "computer analytics" to target individuals who are specifically searching for a nutrition supplement with the properties of IPF Immune™. Such focus will greatly increase sales of this new product while reducing advertising costs.

Production of Monoclonal Antibodies
Enzolytics' U.S. lab at the A&M Institute for Preclinical Studies is focused on producing fully human monoclonal antibodies targeting multiple infectious disease?s?, including SARS-CoV-2, HIV-1, Feline Leukemia virus and Feline Immunodeficiency virus. 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 - A.I.) is used to identify conserved, immutable epitopes on the target virus utilizing Enzolytics' proprietary A.I. platform invented by Dr. Gaurav Chandra the Company COO. In the A.I. initial analysis step, the sequences (structure) of over 2 million Coronavirus isolates have been analyzed. From that analysis, 19 epitopes (target sites) have been identified as immutable and conserved across all 2 million isolates. 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 are analyzed for linearity, accessibility by antibodies, and neutralizability by antibodies. Then Enzolytics’ scientists produce multiple broadly neutralizing antibodies targeting these multiple conserved, immutable epitopes on the targeted virus.

Enzolytics' methodology for producing monoclonal antibodies is innovative, unlike those employed by 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, and the chances of immunogenicity are minimized.

The team then produces broadly neutralizing antibodies using various techniques. The Company is partnering with a biotech company with specialized capabilities for accelerating process steps to speed production. This new strategy will allow the Company to reduce the time to completion significantly. In addition to the already produced anti-HIV monoclonal antibody Clone 3, the Company is focused on producing monoclonal antibodies for treating HIV-1, SARS-CoV-2, SARS-CoV-2, Feline Leukemia Virus (FeLV), and Feline Immunodeficiency Virus (FIV). However, the Company has identified the conserved and immutable epitope sites on 20 human and animal viruses, against which it plans to produce monoclonal antibodies for the treatment of those viruses.

This production process is highly technical and time-consuming. The process begins by creating the target epitopes identified using A.I. as sites fully conserved across millions of epitopes of the targeted virus. Then, the antibody creation process is conducted such that the produced antibodies are designed to neutralize by binding to these “Achilles heel” sites on the targeted virus.

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 confirming antibody activity, the Company's CDMO partner Samsung Biologics produces 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.

The plans are in place to proceed with animal studies to demonstrate the in-vivo efficacy of the monoclonal antibodies in partnership with European partners.

There is a significant role for mucosal immunity and secretory as well as circulating IgA antibodies in COVID-19. Therefore, Enzolytics focus on mucosal immunity for COVID-19. Enzolytics firmly believe that mucosal immunity can be exploited for beneficial diagnostic, therapeutic, or prophylactic purposes.

Enzolytics has created Class switched IgA1/2 Clone 3 Antibodies. This therapy will expectedly provide a protective immunological defense against an initial exposure to HIV virus at mucosal surfaces, such as occurs 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 anti-retroviral therapy helps 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 the most promising approach to preventing HIV transmission. Thus, the development of Class switched Clone 3 IgA1/IgA2 is highly significant.

Enzolytics is collaborating with companies to produce monoclonal antibodies for Feline Leukemia Virus (FeLV) and Feline Immunodeficiency Virus (FIV). Enzolytics has already identified a partner for the monoclonal antibodies targeting Feline Leukemia Virus (FeLV) and Feline Immunodeficiency Virus.

Enzolytics Patent Portfolio and Strategy
As of August 19, 2022, the Company has three (3) pending Patent Cooperation Treaty (PCT) Patent applications covering its fully human monoclonal antibodies targeting the CoronaVirus and HIV. Additional patent applications are being prepared to cover the numerous viruses against which the Company plans to produce monoclonal antibodies.

In the first PCT Patent Office Official Action on the Company’s International Patent Application covering its discovery and exclusive claim to conserved antigens and epitopes of the HIV virus, the PCT International Search Report concluded that inventions claimed therein are novel and inventive and thus will expectedly be issued in final international patents. The Company’s International Patent application covers (1) the discovered highly conserved antigens and epitopes (sites) on the HIV 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 HIV infection with the antigens or binding proteins, and (5) methods and kits for detecting or diagnosing infection by HIV using the antigens or binding proteins.

The Company discovered the claimed virus sites through computer analysis (Artificial Intelligence (A.I.)), wherein tens of thousands of HIV isolates were curated to identify these critical, conserved, immutable epitopes on the virus. These sites are now claimed as patentable based on their novel specificity and the finding that they are conserved on the HIV virus. This is significant in that by producing antibodies that attack these conserved, immutable sites, the virus can be neutralized rather than unaffected due to virus mutation that avoids the therapeutic.

The Company is producing fully human monoclonal antibodies against these claimed sites. The International Patent Office has now confirmed these discoveries to be novel and inventive, capable of being patented and claimed exclusively for a 20-year term in every member country under the Patent Cooperation Treat in which the Company pursues these claims.

Due to the novel nature of the Company’s discoveries, the Company fully expects the same favorable results in the PCT Patent Office for its pending applications covering epitopes (binding sites) on the CoronaVirus (covering all variants), on the Monkeypox Virus, and on numerous animal viruses, namely Feline Leukemia Virus (FeLV), Feline Immunodeficiency Virus (FIV), Elephant Endotheliotropic Virus, Equine Infectious Anemia, and Koala Retrovirus. The Company fully expects the issuance of multiple international patents covering these discoveries.

The Company's PCT applications also cover the identification of highly conserved antigens and epitopes of these viruses that can be used in the production of antibodies and the production of vaccines for treating, preventing, or reducing the risks of infections caused by these viruses.

The patents also cover the discovery of using these identified antigens and epitopes as targets for detecting and diagnosing viral infection. This is a significant development since these patents cover treatment and prevention and target detecting and diagnosing infections for all viruses pursued by Enzolytics.

In the Company's unique process, computer analysis (A.I.) was used to identify conserved, immutable epitopes on the target virus utilizing Enzolytics' proprietary A.I. platform invented by Dr. Gaurav Chandra, the Company COO. The sequences (structure) of over 87,500 HIV isolates were analyzed in the initial A.I. step for HIV, and for the Coronavirus, over 2 million SARS-CoV-2 virus isolates were curated. In the case of HIV, eight (8) epitopes (target sites) were identified and claimed in the Company's PCT application. As a part of this process, 3 Dimensional models of these conserved targets were generated, and the targets were analyzed for linearity, accessibility by antibodies, and neutralizability by antibodies. From this, Enzolytics' scientists are producing multiple broadly neutralizing antibodies targeting these multiple conserved, immutable epitopes on the targeted virus. As a result, the monoclonal antibodies produced against these targets will be universal, durable, broadly neutralizing, and unaffected by virus mutation. In the case of SARS-CoV-2, nineteen (19) conserved sites were identified and are claimed in the Company's pending PCT applications.

The Company considers the forthcoming patent protection highly significant in view of the following facts:

For a monoclonal antibody to be effective (that is, to be fully capable of neutralizing a virus), it must target an immutable site on the virus. Otherwise, a virus mutation will render the therapeutic ineffective.
The Company has analyzed over 2 million Coronavirus isolates and over 87,000 HIV isolates and has identified 19 conserved sites (98 to 99% conserved) on the Coronavirus and 8 conserved sites on the HIV virus.
The Company's patent claims cover these findings. From the most recent PCT International Patent Office Action, claims have been recognized as novel and Inventive. They thus can be expected to issue in the U.S. and many foreign countries pursued. The Company claims the use of anyone 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.
To accelerate and fully execute the successful production of the multiple monoclonal antibodies, the subject of the Company's intellectual property (specifically the numerous monoclonal antibodies (mAbs) targeting both human and animal viruses), the Company continuously engages with numerous entities to accelerate its progress toward production, testing, and delivery of successful therapeutics. Entities with whom the Company is working include other Biotech Companies having:

Technology and processes for accelerating the production of monoclonal antibodies that target critical virus sites identified by the Company using its A.I. platform. The Company has identified critical conserved target sites on 20 viruses, including human and animal viruses, and is engaging with biotech companies having expertise in accelerating the production of such antibodies.
Related, synergistic or complimentary therapeutics and business structure for the purpose of potential combination with other biotech entities.
Expertise in providing specialized peptides having precise amino acid sequences corresponding to the precise target sites on both the Coronavirus and HIV viruses which are then used in the Company’s Texas lab against which mAbs are being produced. This strategy accelerates the production of the mAbs for further development.
Specialized cell sorting technology that is complementary to the process used in the Company’s lab to accelerate production of mAbs for advancing production.
Expertise in hybridoma production techniques for producing mAbs using hybridoma methodologies complementary to the process used in the Company's lab.
Animal trials centers, both in the U.S. and abroad, for the preparation of animal trials.
Promotional entities with specialized expertise in targeting large funding sources for the purpose of raising the substantial funds needed for the production of the recombinant mAbs necessary for future trials and for conducting animal trials.
As to each of these entities and those with whom the Company currently works on an ongoing basis, the Company has entered into NDAs (Nondisclosure Agreements) necessary to preserve and protect the Company plans and intellectual property being discussed and exchanged between the parties. These contractual restrictions are critical for the Company and its partners. Maintenance of strict confidentiality is essential to preserving intellectual property rights (patent rights) which are now being sought and will be sought in the future. Premature disclosure of information can bar the right to seek patent protection at a later date. The Company is not able to share specific details regarding arrangements regarding these NDAs.

The term of these NDAs is not time limited. The term extends until the later of five (5) years from the Effective Date or "until such time as the proprietary information is publicly known and made generally available". This provision is necessary because under Patent Laws an issued patent may be invalidated where the patent is filed subsequent to public disclosure of the invention claimed. In view of this limitation, the Company makes no public disclosure of information subject to NDAs and inventions covered by them. Additionally, certain technical information shared with companies with whom the Company has entered into an NDA may not be included in a patent application, but rather the subject technical information is maintained as Company confidential ("secret") indefinitely. Also, in these Agreements, the parties generally agree not to reveal the names of the contracting parties for a specified period.

The Company is very confident in its Artificial Intelligence empowered Intellectual Property Portfolio. It has allowed the Company to claim exclusive rights on an international stage covering critical target sites on numerous human and animal viruses. This places the Company on an equal level with the largest biotech companies in that the Company is the first to identify and patent critical sites on many human and animal viruses. This same technology and strategy are being implemented by the Company on new viruses, human or animal. The Company identified the conserved sites on the Monkeypox Virus even before the World Health Organization declared it a global health emergency last week.

The Company believes that its extensive patent portfolio will provide a return on investment through partnering or licensing technology covered by multiple international patents.

Enzolytics Artificial Intelligence Platform
Enzolytics has a wholly owned Artificial Intelligence platform that:

1. Permits early drug discovery and development
2. Builds an Intellectual Property Portfolio
3. Provides for strategic entry into the personalized medicine market

The Artificial Intelligence platform is being built under the leadership of Dr. Gaurav Chandra., the Company’s COO. The Healthcare A.I. market is expected to be $34 Billion in 5 years. This platform makes possible:

1. Creation of an artificial intelligence platform for Genomic Surveillance and monitoring of virus epidemiology
2. Application of A.I. to analyze the amino acid sequences of the targeted viruses to identify conserved immutable and neutralizable sites on the targeted viruses.
3. A comprehensive A.I. protocol for the production of monoclonal antibodies, including implementing A.I. Analysis of existing viruses and any new virus immediately upon its emergence globally.
4. Collaboration with biotechnology companies and veterinary institutions in early drug discovery and development programs, increasing safety, efficacy, and probability of success.
5. An envisioned consortium to assess the effects of Genetics, Nutrition, and Human Microbiome on infectious diseases, mental health disorders, and chronic medical diseases.
6. Collaboration with technology companies to offer solutions with Global Pandemic Preparedness

Enzolytics A.I. platform is unique because it has been driving the Company’s discoveries and drug development. A.I. has helped Enzolytics move beyond big pharma's monoclonal antibody discovery and development. As a result, Enzolytics continues to forge ahead with the immediate strategy to identify novel biomarkers and therapeutic targets, design innovative diagnostic and prognostics tests, and expand the Company's Patent portfolio. Enzolytics' long-term plan is to be a serious contender in the personalized medicine market. Enzolytics continues to partner with technology, genetics, diagnostic and regulatory companies with that strategy in each of these areas:

1. Artificial Intelligence Platform for Genomic Surveillance and monitoring of virus epidemiology

2. Application of A.I. to analyze the amino acid sequences of the targeted viruses to identify conserved immutable and neutralizable sites on the targeted viruses. An extensive A.I. analysis of 2.8 million SARS-CoV-2 isolates confirmed the 19 immutable sites to be conserved in ALL Variants of Concern and Variants of Interest. The Company's Artificial Intelligence platform has been used to build 3D Models of all the 19 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. An extensive A.I. analysis of 87,500 HIV isolates and confirmed 8 immutable sites on the HIV virus. A.I. confirmed the KLIC amino acid binding site sequences targeted by the Company's primary anti-HIV monoclonal antibody is 100% conserved. The KLIC binding site on the HIV virus has remained unchanged for decades, as confirmed by the Company's analysis of the Los Alamos National Database of HIV sequences. This means that even mutations of the HIV virus will contain this neutralizable site, and virus escape will not occur in treatment with the Company's anti-HIV antibody.

3. A comprehensive A.I. protocol for producing monoclonal antibodies, including implementing A.I. analysis of existing viruses and any new virus immediately upon its emergence globally. Dr. Chandra discusses the significance of this protocol in an article published in The Yuan on December 20, 2021. https://www.the-yuan.com/191/AI-Provides-Key-to-Pandemic-Preparedness.html

4. Collaboration with biotechnology companies and veterinary institutions in early drug discovery and development programs, increasing safety, efficacy, and probability of success. A joint paper published by Enzolytics in conjunction with Intel Corporation provides more details regarding this collaboration. https://www.intel.com/content/www/us/en/healthcare-it/resources/enzolytics-whitepaper.html

5. Enzolytics A.I. Human Microbiome Consortium.

A.I. is a significant driver for advancing healthcare. Understanding the Human Microbiome will be pivotal to that transformation, to unlock the potential of the Human Microbiome by utilizing Artificial Intelligence.

Enzolytics is building on the consortium to utilize A.I. to assess the effects of nutrition, genetics, and the human microbiome on diseases. This is a part of the Company's long-term strategy to enter the personalized medicine market and build a strong I.P. portfolio.

1. Build prediction models for infectious diseases (preferably COVID), mental health disorders, and chronic medical diseases.

2. Identify biomarkers for infectious diseases and chronic medical diseases.

3. Identify novel targets and clear intervention strategies for infectious and chronic medical diseases.

A.I. Driven Diagnostics
Enzolytics is developing Artificial Intelligence for use in in-vitro diagnostic tests that diagnose viral diseases based on the presence of the conserved sites that remain unaffected by mutations. Enzolytics has identified conserved targets for many infectious diseases for humans and animals. The Company has identified conserved targets for Monkey Pox, SARS-CoV-2, HIV, rabies, influenza A, influenza B, HTLV1, Herpes, Smallpox, Ebola, Equine Infectious Anemia, Feline leukemia virus, Feline immunodeficiency virus, and Koala Retrovirus. The Company published information regarding these findings in its Press Release on February 21, 2022. https://www.accesswire.com/viewarticle.aspx?id=689605.

Documented studies show better clinical outcomes and delayed progression of diseases if patients have the antibodies to the conserved targets. Enzolytics is working on prognostic tests utilizing A.I. to predict the immune response before receiving viral therapy. This will allow physicians to understand if a patient will respond to a particular antiviral treatment. More information on this technology has been presented by Dr. Chandra, the Company's COO, published in The Yuan on April 4, 2022. https://www.the-yuan.com/269/AI-Driven-Diagnostics-Transform-Healthcare.html.

Enzolytics Advisory Board
Enzolytics continues to build a strong Advisory Board to support Enzolytics' leadership team in achieving the Company's goals and mission. In addition, the Company's Advisory Board is instrumental in fostering innovation and interfacing with potential biotech partners both in the U.S. and abroad.

Company Programs Funding
Given the large number of therapeutics being advanced by Enzolytics, the Company is focused on raising the necessary funds for the production and sale in the U.S. and abroad of IPF Immune™, final development of its anti-HIV ITV-1 therapeutic, accelerating the development of multiple monoclonal antibodies for human therapy, and production of animal monoclonal antibodies. The Company’s audit is being finalized,[/b] and the Company fully expects to be able to acquire the funding necessary to complete its multiple programs.