Enzolytics Inc (OTCMKTS: ENZC) is holding strong at support levels in the high $0.05’s as the overall markets have seen significant declines. ENZC was among the biggest runners of 2021 skyrocketing from well under a penny to highs of highs of 0.958 per share after it completed the historic merger between BioClonetics. The stock has an enormous investors following and shareholder base that will buy heavily on any breakout north. ENZC has been making big moves in monoclonal antibodies, a market currently worth $144 billion globally. One of the Company’s labs at the Texas A&M University Institute for Preclinical Studies lab is focused on the production of fully human monoclonal antibodies targeting multiple infectious diseases, including SARS-CoV-2 and HIV-1. Enzolytics is also making moves in the booming Healthcare A.I. market expected to be 34 billion USD in 5 years. The Companies A.I. analysis, coupled with the ability to produce targeted monoclonal antibodies, allows Enzolytics to produce effective antibodies against multiple viruses, both human and animal. 

The new biotech is getting noticed as its platform technology ITV-1 has shown strong antiviral properties against HIV. ITV-1 inhibits the infection of CD4 T-cells by HIV, reduces HIV viral loads and replaces or complements current anti-retroviral therapies. It is much less toxic then then any competitor therapeutic and is unaffected by HIV mutations that can hamper anti-retroviral therapies (HAART). Tests have shown an 80.5% drop in viral loads in HIV and it raises CD4 T-cell counts to healthier levels, a 68% increase in CD4+T-lymphocytes and is associated with an increase in the CD4/CD8 index. 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. ENZC engaged Scendea to assist in introducing ITV-1 to EU countries through the EMA and to North America through FDA. 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

Enzolytics Inc (OTCMKTS: ENZC) is a drug development company committed to the commercialization of its proprietary proteins for the treatment of debilitating infectious diseases. The Company is committed to creating drugs for the better health of mankind. ENZC’s flagship compound ITV-1 is a suspension of Inactivated Pepsin Fragment (IPF), which studies have shown is effective in the treatment of HIV. IPF is the active drug substance of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has been shown to modulate the immune system. IPF is a platform technology that can be used to facilitate a broad range of applications. It is free from major neurological, gastrointestinal and hematological side effects seen in the anti-retrovirals in use today. IPF has not shown to be subject to viral resistance and is cost effective. Incorporated under the laws of Delaware, ENZC currently has 2,830,435,953 shares outstanding out of 3,000,000,000 authorized, of the OS 483,789,585 are restricted. The Company has $3.1 million in assets vs. $7 million in liabilities. 

ENZC continues to build its Intellectual Property portfolio. ITV-1 is covered by U.S. Patent Nos. 8,066,982 and 7,479,538. IPF Immune™ is covered by U.S. Patent No. 8,309,072. Fully human anti-HIV monoclonal antibodies and vaccines are covered by PCT Patent Application No. PCT/US/018672. Anti-Corona Virus monoclonal antibodies and vaccine covered by PCT Patent Application No. PCT/US/014916. The Company’s AI platform is covered by PCT Patent Application Nos. PCT/US/020682 and PCT/US/014936. 

Microcapdaily has been reporting on the ENZC BioColnetics merger since the beginning stating in our article (BioClonetics LOI Sparks Enzolytics Inc (OTCMKTS: ENZC)) in September 2020, when ENZC was $0.003: “Enzolytics Inc (OTCMKTS: ENZC) is making a powerful move up the charts on a massive surge of volume after the Company announced the execution of a non-binding LOI to merge with BioClonetics Immunotherapeutics, Inc. a biotech company located in Dallas Texas. BioClonetics is in the final stage of development of a parent monoclonal antibody (“mAbs”) (designated as Clone 3), which is non-toxic and has shown in initial in vitro testing to be effective against more than 95% of all strains and viral subtypes of HIV-1 against which it has been tested. Final testing of BioClonetics’ anti-HIV recombinant mAbs in PBMC neutralization assays are being conducted to be followed by animal trials at the California National Primate Research Center, UCDavis (Davis, CA). 

Enzolytics has quickly attracted a power house team behind it which speaks of big things to come here. They recently appointed Ronald Moss, M.D., to the Medical Advisory Board. Mr. Moss has been an executive with numerous biotech’s over the past 25 years. He has extensive clinical and regulatory management expertise in guiding programs through Phase I, II, and III clinical trials, including IND and NDA experience. The Company is led by patent attorney, Charles S. Cotropia who has litigated hundreds of cases over the years in the areas of patents, trademarks, trade dress, unfair competition and copyrights. His brother, Dr. Joseph Cotropia leads the Company’s research at the Texas A&M University Institute for Preclinical Studies. The Company’s COO Dr. Chandra is a dynamic leader with proven ability to build high performance teams and organizations who has spent years in academic/clinical research and has experience with clinical trials and medical devices. He consults for and speaks to companies, governments, and hospitals around the world.  Enzolytics Chief Science Officer, Mr. Henry Zhabilov has managed several clinical trials utilizing therapeutic proteins. He is the inventor of several U.S. patents related to the immunotherapy of HIV and cancer and an immune enhancer based on the company’s IPF platform. Also, more recently, ENZC added Dr. Suraj Kumar Saggar and Dr. Lachezar Bogomilov Ivanov to its Advisory Board.  

Enzolytics’ primary U.S. lab at the Texas A&M University Institute for Preclinical Studies is led by Dr. Joseph Cotropia who is assisted by multiple scientists. The lab is focused on the production of fully human monoclonal antibodies targeting multiple infectious diseases, including SARS-CoV-2 and HIV-1. In the initial process step, AI is used to identify conserved, immutable epitopes on the target virus utilizing Enzolytics’ proprietary A.I. platform sequencing over 2 million Coronavirus isolates have been analyzed. Using 3 Dimensional models of these conserved targets, Enzolytics’ scientists produce multiple broadly neutralizing antibodies. The antibodies are produced from human “immune-B cells”, obtained from convalescent individuals who have recovered from the target virus. The team then produces broadly neutralizing antibodies using three techniques: 1) Hybridomas, 2) Fluorescent Antibody Cell Sorting (FACS) technology, and 3) Phage Display technique. 

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 that are processed to identify a single cell line that produces a single monoclonal antibody. 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. 

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. 

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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 is also planning to launch IFP Immune™ in Europe and Canada and already has distributorship contacts in Europe. ENZC plans to first deploy the therapeutic initially in countries in Africa including Rwanda, the Democratic Republic of Congo, Angola, Kenya and South Africa. Currently there are roughly 23.8 million HIV infected persons in Africa 

ITV-1 inhibits the infection of CD4 T-cells by HIV, reduces HIV viral loads and replaces or complements current anti-retroviral therapies. It is much less toxic then then any competitor therapeutic and is unaffected by HIV mutations that can hamper anti-retroviral therapies (HAART). Tests have shown an 80.5% drop in viral loads in HIV and it raises CD4 T-cell counts to healthier levels, a 68% increase in CD4+T-lymphocytes and is associated with an increase in the CD4/CD8 index. ITV-1 has shown good compatibility with other anti-retroviral drugs, with no side effects. 

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. 

ENZC engaged Scendea to assist in introducing ITV-1 to EU countries through the EMA and to North America through FDA. Scendea is a leading product development and regulatory consulting group serving the pharmaceutical and biotechnology industry. 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 

Enzolytics’s  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. 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. 

The Artificial Intelligence platform is being built under the leadership of Dr. Gaurav Chandra. 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. 

AIDS is considered to be one of the most serious and chronic diseases, caused by the human immunodeficiency virus (HIV). According to (WHO), an estimated 34 million individuals are currently living with the HIV virus. 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. 

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ENZC is holding strong at support levels in the high $0.05’s as the overall markets have seen significant declines. ENZC is a major league runner and powerhouse stock and was among the biggest runners of 2021 skyrocketing from well under a penny to highs of highs of 0.958 per share after it completed the historic merger between BioClonetics. ENZC is an exciting story developing in small caps; ENZC platform technology ITV-1 has shown strong antiviral properties against HIV, and could be a disruptor in this enormous multi-billion-dollar market. ENZC has also been making big moves in monoclonal antibodies, a market currently worth $144 billion globally as well as in Healthcare A.I. another booming market. ENZC is one biotech that investors are watching carefully, trading just over 52-week lows of $0.0531 the stock has runner in its blood with a gap to fill to $0.958 and could go parabolic at any time. We will be updating on ENZC when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with ENZC.

Disclosure: we hold no position in ENZC either long or short and we have not been compensated for this article.