Enzolytics Announces the Signing of a Letter of Intent with Creative Biolabs, Inc. for Licensing and Commercialization of anti-HTLV-1 Monoclonal Antibodies

COLLEGE STATION, TX / ACCESSWIRE / July 20, 2021 / Enzolytics, Inc. (OTC PINK:ENZC) ("Enzolytics" and the 'Company') announces the signing of a Letter of Intent (LOI) with Creative Biolabs ("Creative") (https://www.creative-biolabs.com) to complete the joint production and commercialization of HTLV-1 monoclonal antibodies by combining the technologies of the companies. There are no effective vaccines against HTLV-1 and no antiviral drugs available for treating infections caused by the virus.

The technologies of Enzolytics and Creative will be combined to achieve the objective of production and commercialization of HTLV-1 monoclonal antibodies in the following way.

Through the application of Enzolytics' proprietary Artificial Intelligence (AI) methodology, the Company has identified conserved immutable target sites on the HTLV-1 virus. The Company will produce targeted anti-HTLV-1 monoclonal antibodies (mAbs) in its lab at Texas A&M University's Institute for Preclinical Studies using the Company's proprietary technology for producing fully human monoclonal antibodies.

Pursuant to the LOI, Creative will:

  1. test the efficacy and neutralizing capability of the anti-HTLV-1 mAbs produced by Enzolytics,
  2. mass-produce the mAbs for purposes of marketing and distribution, and
  3. promote and market the HTLV-1 mAbs for uses agreed to by the Parties.

Enzolytics recognizes Creative as a significant partner in this effort as Creative is a life-science company that produces and supplies biotech products and services for early drug discovery and development, including various phage display libraries such as pre-made libraries, phage display services, antibody sequencing and antibody humanization.

Under the LOI, Creative would bear the cost of production and sale of the anti-HTLV-1 mAbs manufactured. From such sales, Creative would share with Enzolytics a percentage of net profit from sales of the anti-HTLV-1 mAbs made through Creative's channels of distribution. In the event Enzolytics chooses to commercialize the HTLV-1 mAbs, Enzolytics would share with Creative a percentage of the net profit or return generated from such sales.

Adult T-cell leukemia (ATL) and HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/TSP) are several diseases associated with HTLV-1. More than 20 million people worldwide are infected with the virus. Up to 10% will develop the debilitating and sometimes deadly disease. HTLV-1 causes adult T-cell leukemia/lymphoma (ATL), HTLV-associated myelopathy (HAM), spastic paraparesis, and other rare illnesses. Signs and symptoms of HTLV-1 infection include motor and sensory changes in the extremities, inflammation in the spinal cord, a spastic gait in combination with weakness of the lower limbs, cognitive impairment, bladder dysfunction and bladder cancer. HTLV-1 is similar to the human immunodeficiency virus (HIV), is transmitted through sexual contact, from mother to child via breastfeeding and through exposure to contaminated blood.

HTLV-1 requires cell-to-cell contact for efficient transmission. The virus utilizes Envelope (Env) glycoprotein-mediated cell binding and entry. Using Enzolytics' proprietary AI methodology, multiple conserved sites have been identified in the outer envelope of the HTLV-1 virus. Enzolytics continues to harness the power of artificial intelligence, in conjunction with the Company's proprietary fully human monoclonal antibody methodology, to create universal, durable, broadly neutralizing monoclonal antibodies against multiple viruses, now to include monoclonal antibodies against HTLV-1.

Charles Cotropia, CEO of Enzolytics, said: 'We now have a comprehensive platform for producing multiple targeted monoclonal antibodies against numerous infectious diseases. This platform includes our ability to identify multiple conserved and immutable sites on viruses to produce fully human monoclonal antibodies targeting those sites. This approach opens the door to new and durable therapies that can be used to treat innumerable human infectious diseases. We are now discussing licensing, commercialization, and distribution of these monoclonal antibodies with various pharmaceutical partners to expedite the development. We have completed the process of identifying conserved sites for HIV, the Coronavirus (SARS-CoV-2), HTLV-1, Influenza-A and Influenza-B. In addition, we have an ongoing AI analysis to identify conserved, immutable sites for HINI Influenza, HINI, H10N3, Herpes zoster, Varicella zoster, Herpes HSV 1/2, Koala Retrovirus, Feline Leukemia virus, Elephant Endotheliotropic Herpesvirus, and Feline Immunodeficiency virus.'

About Enzolytics, Inc.

Enzolytics, Inc. is a drug development company committed to commercializing its multiple proprietary therapeutics to treat debilitating infectious diseases. The Company's patented ITV-1 therapeutic suspension of Inactivated Pepsin Fraction (IPF), which studies have shown effectively treats HIV/AIDS. IPF is the active component of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has also been shown to modulate the immune system.

Additionally, the Company has proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. In addition, its proprietary methodology for producing fully human monoclonal antibodies is currently employed to produce monoclonal antibody therapeutics to treat other infectious diseases, including the Coronavirus (SARS-CoV-2).

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 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 the Company to establish the efficacy of ITV-1 or its other 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 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. 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.

I.R. contact

TEN Associates, LLC
Tom Nelson, CEO
(480) 326-8577
Investor Relations Contact

Company Contact

Enzolytics, Inc.
2000 North Central Expressway
Plano, TX 75074

and

Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-44

SOURCE: Enzolytics, Inc.



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