Enzolytics, Inc. Completes Merger with BioClonetics Immunotherapeutics, Inc.

Rhea-AI Summary

Enzolytics, Inc. (ENZC) has successfully merged with BioClonetics Immunotherapeutics on December 1, 2020, coinciding with World AIDS Day. This strategic merger enhances Enzolytics' capabilities in developing therapies for HIV and the Coronavirus. The patented antiviral peptide, ITV-1, has shown promising results in clinical trials, with 68% of HIV patients experiencing improved immune parameters. Additionally, Enzolytics is advancing fully human monoclonal antibodies, which have neutralized over 95% of HIV strains in tests. Future studies are planned in France and Italy to further validate these therapies.

Positive

• Successful merger with BioClonetics enhances therapy development for HIV and Coronavirus.
• ITV-1 demonstrated efficacy in clinical trials with 68% of patients showing improved immune response.
• Fully human monoclonal antibodies from BioClonetics neutralized over 95% of HIV strains in testing.
• Plans to conduct further testing at reputable international laboratories for validation.

Negative

• The antiviral therapy ITV-1 is not yet FDA approved.
• There are inherent risks in the commercialization process and clinical validation.

PLANO, TX / ACCESSWIRE / December 1, 2020 / Enzolytics, Inc. (OTC Markets "ENZC" or the "Company") announced the execution of the definitive business combination agreement successfully merging the biotech companies Enzolytics, Inc. and BioClonetics Immunotherapeutics, Inc. on World AIDS Day.

Through a merger of biotech companies, Enzolytics now advances two separate but complementary therapy platforms for treating infectious diseases, targeting HIV and the CoronaVirus. One technology, invented by Harry Zhabilov, the CSO of the Company, is a patented antiviral peptide that has been tested in clinical studies at the National Center of Infectious and Parasitic Diseases in Bulgaria. In these trials, the therapeutic, known as ITV-1, demonstrated effectiveness in the treatment of HIV patients in various stages of the disease. In trials conducted in 31 patients, the therapeutic showed efficacy, with 68% of those individuals tested experiencing an increase in CD4 + T lymphocytes. This increase was accompanied by an increase in the CD4/CD8 index and CD4% in over 50% of those tested. The increase in these parameters demonstrated statistical significance compared to the control group. The absolute number and the relative percent of CD8 + T lymphocytes were also decreased. And the viral load in 80.5% of those tested was below the threshold of detection. This Enzolytics anti-HIV treatment is now being advanced through the certification stage to thereafter be made available for patient therapy.

The Company is now combining this technology with recently acquired technology for creating fully human anti-monoclonal antibodies for treating HIV. From this technology created by BioClonetics, the Company has a fully human anti-monoclonal antibody that has been tested in 5 international labs where it neutralized over 95% of all strains of the HIV virus against which it was tested. Multiple recombinant forms of this parent antibody are now being produced, and additional neutralizing antibodies are being created to provide combined monoclonal antibody therapies for patients with HIV.

The Company has recently confirmed plans to test its monoclonal antibodies at the University of Strasbourg, France, under the direction of Dr. Christiane Moog, Ph.D., Research Director at INSERM, University of Strasbourg, a leading specialist in conducting the preferred PBMC based in vitro neutralization assays protocol for anti-HIV monoclonal antibodies. Additional testing of the Company's antibodies is also being planned at San Raffaele Scientific Institute, Milan, Italy, under the direction of a further expert in the field, Dr. Gabriella Scarlatti, M.D., Ph.D., Head of Viral Evolution and Transmission Unit at San Raffaele Scientific Institute.

The therapies of Enzolytics' two technologies, that produced by Enzolytics and that created by BioClonetics will be tested in combination and are expected to be synergistic.

Additionally, the Company has identified correlative structure between the HIV virus and the CoronaVirus and, with its capability to produce targeted monoclonal antibodies, is moving forward to produce monoclonal antibodies targeting the CoronaVirus. The Company is extending its lab capabilities on the Texas A&M University campus at the Institute for Pre-clinical Studies, where it will be producing both addition monoclonal antibodies against HIV and the against the CoronaVirus.

The Company's addition of Dr. Ronald Moss, MD, to its Medical Advisory Board has provided experienced guidance for its strategies and in its planned testing and validation of its therapeutics in animal and clinical trials.

Harry Zhabilov, CSO of Enzolytics, stated, "The technologies of the combined entities will afford the Company the opportunity to unlock the potential of our HIV-AIDS treatments at a time when the seriousness of the disease is still a major concern given that the current form of treatment for HIV patients is anti-retroviral treatment and where such treatment is only accessible to 40% of the 36 million peoples in the world infected by HIV - leaving 60% of the 36 million infected HIV patients with no treatment."

"The current antiretroviral therapy for HIV/AIDS is not a cure, and the side effects from lifelong use are significant. Also, the yearly average cost of treatment on anti-retroviral is $14,000 to $20,000 per year, and the average lifetime cost is calculated as $379,000. The cost of an anti-HIV therapy we propose would be a fraction of these costs as the treatment would be for a limited time and not require life-long use. Just as monoclonal antibodies were available to President Trump when he contracted the Coronavirus, monoclonal antibodies can be made available to treat HIV patients, and we believe we are on the verge of providing such a therapy", stated Charles Cotropia, CEO of Enzolytics.

About Enzolytics, Inc;

Enzolytics, Inc. is a drug development company committed to the commercialization of its proprietary proteins for the treatment of debilitating infectious diseases. Enzolytics is committed to creating drugs for the better health of mankind. Enzolytics is a 49% shareholder of IMMB BG.

Enzolytics' flagship compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), which studies have shown is effective in the treatment of HIV/AIDS. 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.

About BioClonetics Immunotherapeutics, Inc.

BioClonetics Immunotherapeutics, Inc. is a Dallas, Texas biotech company with proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology for produce fully human monoclonal antibodies may be used to produce therapeutics treatments for name infectious diseases, including the Coronavirus.

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. (f/k/a Eco Petroleum Solutions, Inc. / Immunotech Laboratories, Inc.) from time to time in its periodic reports filed with the SEC. IPF is not approved by the US Food and Drug Administration or by 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 IPF in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of IPF 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 and involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and could 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, and the Company expressly disclaims any intention or obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements.

IR Contact:

Enzolytics, Inc.
2000 North Expressway
Plano, TX 75074
Phone: (972) 292-9414
Fax: (972) 292-9414

SOURCE: Enzolytics, Inc.

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FAQ

What is the significance of Enzolytics' merger with BioClonetics on December 1, 2020?

The merger combines their technologies to advance therapies for HIV and Coronavirus.

How effective is Enzolytics' ITV-1 treatment for HIV?

ITV-1 clinical trials showed 68% of participants experienced improved immune parameters.

What are the future testing plans for Enzolytics' monoclonal antibodies?

Testing is planned at the University of Strasbourg, France, and San Raffaele Institute in Italy.

What challenges does Enzolytics face following its merger?

Challenges include gaining FDA approval and the risks associated with clinical development.

What is the expected impact of the merger on Enzolytics' stock symbol ENZC?

The merger is expected to enhance business value and growth potential, impacting stock performance positively.