Coeptis Therapeutics Secures Worldwide Development and Commercialization Rights to Next-Generation GEAR™ Cell Therapy Platform Strengthening its High-Impact Precision Immuno-Oncology Pipeline

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Biotechnology: Biological Products (No Diagnostic Substances)
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COEP forms GEAR Therapeutics, as a majority-owned subsidiary, to advance GEAR-modified natural killer (NK) cells into first-in-human studies for broad range of cancers and other therapeutic modalities.

WEXFORD, Pa., March 11, 2025 (GLOBE NEWSWIRE) -- COEPTIS, Inc. (NASDAQ:COEP) ("the Company" or "Coeptis"), a pioneering technology firm at the forefront of innovative biotechnology solutions today announced it has successfully licensed exclusive worldwide development and commercialization rights to the GEAR™ (Gene Edited Antibody Resistant) Cell Therapy Platform, representing a first-in-class approach to modifying potent cancer-targeting immune cells to optimize the likelihood of deep remission in patients with hematologic malignancies and other cancers. Coeptis had previously held limited co-development rights to GEAR. As part of this exclusive GEAR license agreement with VyGen-Bio, Inc., Coeptis has formed a new majority-owned subsidiary, GEAR Therapeutics, Inc., with the mission to advance GEAR-based cell therapy towards human proof-of-concept studies to initially evaluate GEAR-modified natural killer cells (GEAR-NK) for the treatment of a broad range of cancers and other therapeutic modalities.

How Is GEAR-NK Expected to Enhance Current Blood Cancer Treatments?

Gene-Edited Antibody Resistant NK cells (GEAR-NK) are being developed as novel cancer strategy to allow for modified NK cells to be co-administered with targeted monoclonal antibodies ("mAbs"), which in the absence of the GEAR-NK would otherwise be neutralized/eradicated by mAb therapy due to a common receptor shared by both malignant cells and NK cells. GEAR-NK represents a combination cancer therapy with the potential for significantly improved outcomes for patients. The GEAR platform also holds the potential to modify hematopoietic stems cells (HSCs) in combination with mAbs to improve bone marrow transplant outcomes in the treatment of a broad range of hematological malignancies.

According to COEP Scientific Advisory Board member, Evren Alici, M.D., Ph.D., "GEAR-based immunotherapy represents a differentiated approach to potentially optimize and enhance current antibody-based cancer therapy, such as CD38 mAbs for the treatment of multiple myeloma. By leveraging specific sites, we aim to enable GEAR-modified immune cells, NK cells in this instance, to be co-administered in combination with antibodies in a manner that largely avoids undesired ‘on target/off tumor effects' on a plethora of combination or retargeting therapies. The encouraging pre-clinical proof-of-concept data lead us to believe a GEAR-NK strategy holds the potential to advantageously eliminate or reduce the risk of NK cell fratricide while improving clinical benefit." Dr. Alici serves as head of the cell & gene therapy group at Sweden's renowned Karolinska Institutet.

Dave Mehalick, CEO of COEPTIS, expressed excitement, saying, "This expanded ownership of the GEAR technology is a major achievement for COEPTIS. The market potential of GEAR is extensive and is driven by therapeutic need. GEAR, integrated into our allogeneic cellular immunotherapy platform, has the potential to provide a beneficial, cost-effective therapeutic option available to all patients in need."

About VyGen-Bio, Inc.

With operations in Florida, USA and Stockholm, Sweden, VyGen-Bio is a majority-owned subsidiary of Vycellix, Inc (www.Vycellix.com). The Company's platforms were discovered by research scientists based at the Cell & Gene Therapy Group at Karolinska Institutet (KI), Sweden. Additionally, VyGen-Bio is a member-partner in "NextGenNK", the international Competence Center for the development of next-generation NK cell-based cancer immunotherapies based at KI and funded by Sweden's innovations agency, Vinnova. KI is globally recognized for its Nobel Assembly, which awards the Nobel Prize in Physiology or Medicine. Website: www.VyGen-Bio.com

About COEPTIS, Inc.

COEPTIS, Inc., together with its subsidiaries Coeptis Pharmaceuticals, Inc., GEAR Therapeutics, Inc., SNAP Biosciences, Inc., and Coeptis Technologies (collectively "Coeptis"), is a biopharmaceutical and technology company. The biopharmaceutical divisions focus on developing innovative cell therapy platforms for cancer, autoimmune, and infectious diseases. Coeptis aims to advance treatment paradigms and improve patient outcomes through its cutting-edge research and development efforts.

The Company's therapeutic portfolio is underscored by assets licensed from Deverra Therapeutics, which include an allogeneic cellular immunotherapy platform and DVX201, a clinical-stage, unmodified natural killer cell therapy technology. COEPTIS is also developing a universal, multi-antigen CAR technology licensed from the University of Pittsburgh (SNAP-CAR), alongside GEAR cell therapy and companion diagnostic platforms in collaboration with VyGen-Bio and distinguished medical researchers at the Karolinska Institute.

Building on its core competencies, COEPTIS has recently established a Technology Division, which focuses on enhancing operational capabilities through advanced technologies. This division features AI-powered marketing software and robotic process automation tools acquired from NexGenAI Solutions Group, designed to optimize business processes and improve overall efficiency.

Headquartered in Wexford, PA, COEPTIS is dedicated to advancing its mission within the regulatory framework set forth by the FDA, ensuring that all activities align with the highest standards of compliance and patient care. For more information on COEPTIS, visit https://coeptistx.com

Cautionary Note Regarding Forward-Looking Statements

This press release and statements of our management made in connection therewith contain or may contain "forward-looking statements" (as defined in 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 include statements concerning our plans, objectives, goals, strategies, future events or performance, and underlying assumptions, and other statements that are other than statements of historical facts. When we use words such as "may," "will," "intend," "should," "believe," "expect," "anticipate," "project," "estimate" or similar expressions that do not relate solely to historical matters, we are making forward-looking statements. Forward-looking statements are not a guarantee of future performance and involve significant risks and uncertainties that may cause the actual results to differ materially and perhaps substantially from our expectations discussed in the forward-looking statements. Factors that may cause such differences include but are not limited to: (1) the inability to maintain the listing of the Company's securities on the Nasdaq Capital Market; (2) the inability to recognize the anticipated benefits of the Deverra licensed assets, which may be affected by, among other things, competition, the ability of the Company to grow and manage growth economically and hire and retain key employees; (3) the risks that the Company's products in development or the newly-licensed assets fail clinical trials or are not approved by the U.S. Food and Drug Administration or other applicable regulatory authorities; (4) costs related to ongoing asset development including the Deverra licensed assets and pursuing the contemplated asset development paths; (5) changes in applicable laws or regulations; (6) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; and (7) the impact of the global COVID-19 pandemic on any of the foregoing risks and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission (the "SEC"). The foregoing list of factors is not exclusive. All forward-looking statements are subject to significant uncertainties and risks including, but not limited, to those risks contained or to be contained in reports and other filings filed by the Company with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings made or to be made with the SEC, which are available for review at www.sec.gov. We undertake no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof unless required by applicable laws, regulations, or rules.

Contacts

IR@coeptistx.com



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