This version includes the Safe Harbor statement that was missing from the previous version of this release.
COLLEGE STATION, TX / ACCESSWIRE / April 25, 2022 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/).
Enzolytics continues to make significant progress in its multiple therapeutic platforms and outlines here the technical aspects of the implementation of those programs and the Company's plans for the future.
Enzolytics Texas Laboratory
Texas A&M University Institute for Preclinical Studies
Enzolytics' primary U.S. lab is focused on the production of fully human monoclonal antibodies targeting multiple infectious diseases, including SARS-CoV-2 and HIV-1. 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 lab is located on the campus of Texas A&M University in the University's Texas Institute for Preclinical Studies [https://tips.tamu.edu/] and is led by the Company's Chief Science Officer, Dr. Joseph Cotropia. Dr. Cotropia is assisted by multiple scientists with significant experience in the technology relating to production of monoclonal antibodies.
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 process step, the sequences (structure) of over 2 million Coronavirus isolates have been analyzed. From that analysis, 19 epitopes (target sites) have been identified as being immutable and conserved across all 2 million 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 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 unique and 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" antibodies but rather 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 three techniques: 1) Hybridomas, 2) Fluorescent Antibody Cell Sorting (FACS) technology, and 3) Phage Display technique. Currently, the laboratory is focused on the production of monoclonal antibodies for treatment of HIV-1, SARS-CoV-2, Feline Leukemia Virus (FeLV), and Feline Immunodeficiency Virus (FIV).
This production process is highly technical, laborious and time consuming. The process begins by creating the target epitopes that have been identified using A.I. as sites that are fully conserved across millions of epitopes of the targeted virus. Then, the antibody creation process begins with millions of cells from the donor's peripheral blood and follows a process where over a period of many months, the million cells are processed to identify a single cell line that produces a single monoclonal antibody that binds to the single targeted epitope that is a conserved site on the subject virus.
Once produced, the monoclonal antibodies are then tested for binding activity and neutralizing activity. These characteristics are confirmed, by the Company's partnering laboratories, Genscript Labs and the University of Strasbourg, France, respectively. After the final confirmation of antibody activity, the Company's CDMO partner Samsung Biologics produces 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.
Upon completion of these steps, animal and then clinical trials will be conducted.
Enzolytics Laboratory
Dallas, Texas
Enzolytics's Dallas laboratory is managed by Harry Zhabilov, the Company's CSO. From the Dallas laboratory, Mr. Zhabilov coordinates the development and the production of two of the Company's primary therapeutics, ITV-1 and IPF Immune. Both therapeutics are produced under patents invented by Mr. Zhabilov, U.S. Patent Nos. 8,066,982, 7,479,538, and 8,309,072.
ITV-1 is a therapeutic for treating individuals with HIV. It has been successfully produced and has been earlier successfully clinically tested in human trials under the Bulgarian Drug Agency requirements. The Company has also completed the production of IPF Immune™, a product shown to function effectively as an immune booster.
Both ITV-1 and IPF are currently in production in accordance the precise methodology and specifications developed by Mr. Zhabilov. IPF Immune™ will now be available on the U.S. market. The Company IPF Immune™ dedicated website is expected to premiere this or next week. And the Company expects the product to be available in both large and small retail outlets as well as accessible from the dedicated IPF Immune™ website.
With regard to the anti-HIV therapeutic ITV-1, the Company expects to be able to deploy the therapeutic initially in countries in Africa, followed by completion of EMA certification for use and distribution of the product for therapeutic use throughout Europe.
The Company is also planning to launch IFP Immune™ in Europe and Canada. The Company has distributorship contacts in Europe and sees tremendous added potential from sales outside the U.S.
Positive Therapeutic Effects of ITV-1
The following beneficial effects of ITV-1 have been demonstrated in clinical trials in Europe.
ITV-1 has benefits that antiretrovirals do not and may be used in situations where antiretrovirals are not appropriate.
ITV-1 Production for Sale
Upon completion of scheduled toxicology studies, the ITV-1 therapeutic will be made available in the countries in Africa, including Rwanda, the Democratic Republic of Congo, Angola, Kenya and South Africa. Dr. Chandra is coordinating the introduction of ITV-1 for individuals in Africa. This is significant, 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. In addition, 91% of the world's HIV-positive children live in Africa.
Prior successful Clinical Trials were completed earlier under the Bulgarian Drug Agency requirements. The Company plans to complete further clinical trials to fulfill EMA requirements to launch the therapy in the EU followed by seeking FDA approval for use in North America.
The Company has engaged Scendea (https://www.biospace.com/article/enzolytics-reports-its-engagement-of-scendea-usa-inc-a-leading-international-product-development-and-regulatory-consulting-group-to-guide-the-progress-toward-clinical-trials-and-market-approval-for-its-itv-1-anti-hiv-therapeutic/) to assist in introducing ITV-1 to EU countries through the EMA and to North America through FDA.Scendea (https://www.scendea.com) is a leading product development and regulatory consulting group serving the pharmaceutical and biotechnology industry. Scendea's service will focus on reducing time-to-market and minimizing development costs. Scendea's team offers strategic and operational support in quality/CMC, non-clinical/toxicology, clinical/medical, and regulatory, guiding the Company's ITV-1 therapy efficiently to market approval.
In the approval process, Scendea's critical role 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 FDA and EMA will be completed under the direction of Eurofin, followed by production of ITV-1 as per EMA and FDA requirements and Fast-Tracked Clinical Trial to fulfill EMA and FDA requirements
IPF Immune™ Production and Sale in the U.S. and Europe
The Company's IPF Immune therapeutic is now entering the U.S. market.

IPF Immune™ is a science-backed immune modulator that helps strengthen the body's defenses against viruses or other pathogens. The product works as an immune booster that increases the ability of the immune system to fight infections by stimulating antiviral activity and helping to increase cell defense. The product supports the body's immune system thereby enhancing recovery and reducing the recovery period after an illness. The introduction of this product onto the U.S. market is described in detail in the Newswire release of January 5, 2022, and in the Company Press Release of April 11, 2022. https://www.yahoo.com/now/enzolytics-ipf-immune-tm-introduced-110000242.html.
The Company is also planning to launch IFP Immune™ in Europe and Canada. The Company has distributorship contacts in Europe and sees tremendous added potential from foreign sales.
This product enters the market as sales of American Dietary Supplements in North American reach $50.11 Billion. These sales are forecast to increase to $77.10 Billion in 2028. Enzolytics has engaged Nutritional Products International (NPI) https://nutricompany.com/ to access this 50-billion-dollar market. NPI has over 100 years of combined experience in the distribution and retail markets. Their experts have worked in and had success stories with virtually every major retail channel in the United States. Details of the Company's progress were also reported in the January 6, 2022 article on NewsWire https://www.einnews.com/pr_news/560014946/enzolytics-ipf-immune-helps-fight-infections and in the Company's Press Release of March 23, 2022.
Enzolytics IPF Immune™ will meet consumer needs due to its significant benefits:
IPF Immune™ may be used alone or in conjunction with other therapies.
ITV-1 and HIV Monoclonal Antibodies Sales Potential
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 an 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 antiretroviral drugs market was $30.46 Billion in 2021 and is expected to rise to $45.58 billion in 2028, at a CAGR of 5.9% in the forecast period, 2021-2028.
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 dire situation, the Company is focused on both the production of its ITV-1 therapeutic and producing multiple anti-HIV monoclonal antibodies using its proprietary methodology as described above in this report. The Company's ITV-1 has been successfully tested in clinical trials and the Company is initiating production.
The Company's primary anti-HIV monoclonal antibody has been produced and successfully tested in vitro against multiple strains of the virus where it shows 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.
The Companies A.I. analysis, coupled with the ability to produce targeted monoclonal antibodies, allows the Company to produce effective antibodies against multiple viruses, both human and animal. With this focus, A.I. analysis has been completed on each of the following viruses in preparation for production of anti-monoclonal antibodies for use in treatment of these human and animal viruses: HIV-2, SARS-CoV-2, H1N1 Influenza, HTLV1 & HTLV2, Influenza A and B, Herpes Simplex I & II, Anthrax, Smallpox, Equine Infectious Anemia Virus, Feline Leukemia Virus, Feline Immunodeficiency Virus, Elephant Endotheliotropic Virus.
The statistics for HIV are alarming.
Antiretroviral drugs have significant drawbacks.
The reason these ARV drugs do not cure is because they do not act on the virus in the same way that our ITV-1 therapeutics or our a monoclonal antibody can. In the case of using monoclonal antibodies, our technology is to produce monoclonal antibodies that target immutable, conserved epitopes on the virus so that a therapeutic cure may be achieved.
The same is true with regard to the CoronaVirus. Because the virus mutates and will continue to mutate, to defeat it, it is imperative to produce therapeutics (in our case monoclonal antibodies) that target conserved, an immutable epitope on the virus (that is always present even in a mutant of the virus).
To achieve such a therapy is not simple. The NIH in conjunction with Vaccine Research Center tried for years to produce a successful anti-HIV monoclonal antibody and failed. In clinical trials, their VRC01 and VRC02 monoclonal antibodies were found to fail due to "virus escape", a euphuism for the fact that the antibody targeted a site that mutated and rendered the therapy ineffective.
Due to the enormity of the HIV pandemic, it is understandable that a successful therapeutic that would replace the exorbitant cost of antiretrovirals, and would be affordable for the 34% of the 34 Million infected HIV individuals who have no access to treatment, would have enormous potential.
An independent national consulting firm has calculated projected Earnings (Profit) from a successful HIV Monoclonal Antibody therapy. This analysis examined the expected potential profits from 2 perspectives: (1) considering sales only to North America and Western Europe and (2) considering sales to the major markets including North America, Western and Central Europe, Eastern Europe and Central Asia, South and Southeast Asia and Latin America.
An appropriate market for the Company's therapy includes the regions referred to as the "Major Markets," including North America, Western and Central Europe, Eastern Europe and Central Asia, South and Southeast Asia, and Latin America; wherein there are 10.6 million HIV positive individuals. Assuming a penetration rate of 1% rising to a maximum of 15% over five years, profit from making treatment available to these 10.6 million HIV-positive individuals in the 7 major world markets would be $105 Billion in the first 11 years. http://bioclonetics.com/profit-potential.html.
An HIV vaccine against HIV has a much broader application and would produce significantly larger profits.
It should be noted that the above-referenced financial analysis focused only on what was termed the Major Markets and did not include expected sales in countries in Africa. However, providing anti-HIV therapeutics to Africa is a prime focus of the Company for a number of reasons. The Company's therapeutics may be produced economically and supplied at a cost that would be optimum for the African continent. The African situation as to the HIV pandemic is a significant humanitarian issue and at the same time a significant opportunity for the Company to play a key role in addressing this humanitarian crisis.
The Company plans to provide its ITV-1 therapeutic to countries on the African continent and this is expected to be achieved prior to full EMA approval for use in Europe.
Enzolytics Artificial Intelligence Platform
Enzolytics has a wholly owned Artificial Intelligence platform that drives:
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 USD in 5 years. 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:
A.I. is a significant driver for advancing healthcare, and 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.
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 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. More information has been published by the Company in its Press Release of 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
Intellectual Property (I.P). Portfolio
As Enzolytics advances its multiple scientific endeavors and clinical products, the Company continues to build a robust Intellectual Property portfolio. 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/). The highlights of the Company's intellectual property are listed:
Enzolytics Advisory Board
Enzolytics continues to build a strong Advisory Board to support Enzolytics' leadership team in achieving the Company's goals and mission. The Company's Advisory Board is instrumental in fostering innovation and interfacing with potential biotech partners both in the U.S. and abroad.
Enzolytics recently brought on board Dr. Suraj Kumar Saggar as an Advisory Board Member. https://www.biospace.com/article/releases/enzolytics-inc-announces-new-advisory-board-member/. Dr. Saggar brings to the Company his vast experience as a physician and healthcare research professional with an established track record of exceptional performance in healthcare operations, clinical trials, and regulatory compliance. He is a dynamic leader, physician, and healthcare research professional, and his vast experience and expertise, based on his background as an accomplished infectious disease specialist spanning two decades, will be a great asset to the Company. He complements the Company's team of experienced scientists and advisors and adds a unique set of skills and background, given his accomplished career in infectious diseases.
Enzolytics has also added Dr. Lachezar Bogomilov Ivanov to its Advisory Board. (https://www.parliament.bg/en/MP/1016 ). Dr. Ivanov acquired degrees in internal medicine from the ESPU-Sofia (European Society for Paediatric Urology) and the Medical Academy in Sofia. He holds a Master's degree in health management. He has worked as a physician at the Razgrad Municipal Hospital in the field of obstetrics and gynecology. He has served at the Military Medical Academy in Sofia as a physician with a specialty in anesthesiology, intensive care and pulmonology. Dr. Ivanov has also served as a member of the Bulgarian National Assembly and as a member of Parliament. He has training in the fields of health services administration, marketing and promotion. He has served in positions coordinating initiations between the United States and Bulgaria relating to health care issues.
Dr. Ivanov brings significant academic and medical practice experience, and an understanding of the clinical practices in Bulgaria, and will guide the Clinical Trials for the Company's ITV-1 therapeutic in accordance with EMA requirements.
Safe Harbor Statement: This release may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of our company, are generally identified by use of words "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Some of the factors that could cause our actual results to differ from our expectations or beliefs include, without limitation, the risks discussed from time to time in our filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, we undertake no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made.
I.R. contact:
TEN Associates, LLC
Tom Nelson, CEO
(480) 326-8577
Company Contact:
Enzolytics, Inc.
2000 North Central Expressway
Plano, Texas 75074
Texas A&M Institute for Preclinical Studies
Enzolytics, Inc.
800 Raymond Stotzer Parkway
College Station, Texas 77843
SOURCE: Enzolytics, Inc.