Coeptis Therapeutics Announces Phase 1 Data on DVX201 for COVID-19 Treatment Has Been Accepted for Publication in Molecular Therapy Methods and Clinical Development

Study results demonstrate the safety and feasibility of adoptive immunotherapy using allogeneic off-the-shelf NK cells in hospitalized patients with COVID at high risk for progression of disease

DVX201, the first allogeneic NK cell therapy derived from pooled donor cord blood CD34+ cells, was administered to 9 patients with no dose limiting toxicities, cytokine release syndrome or infusion toxicities

WEXFORD, Pa., Nov. 7, 2024 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ:COEP) (the "Company" or "Coeptis"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, autoimmune, and infectious diseases, today announced that results from their Phase 1 study evaluating DVX201, an allogeneic natural killer (NK) cell therapy, for the treatment of patients hospitalized with COVID-19 has been accepted for publication in Molecular Therapy Methods and Clinical Development.

Results from the clinical trial demonstrated the safety and feasibility of DVX201 as a potential treatment for patients with active SARS-CoV-2 infections. The following key findings are highlighted in the accepted manuscript:

• First Demonstration of Safety: This is the first known study to demonstrate the safety of adoptive immunotherapy with allogeneic, off-the-shelf NK cells in patients with active COVID-19, especially those at high risk for disease progression.
• Innovative NK Cell Therapy: DVX201 is the first allogeneic NK cell adoptive immunotherapy used clinically that is derived from pooled donor cord blood CD34+ cells, offering a scalable, consistent, and cost-effective solution to barriers in the allogeneic cell therapy space.
• No Adverse Events: DVX201 infusions were safe and well-tolerated, with no treatment-related adverse events, including no cytokine release syndrome (CRS).
• Study Observations: Observations included rapid improvements in oxygenation, improved pulmonary radiographic findings, and hospital discharge within days of infusion.
• Future Potential for Viral Therapies: This study supports the potential of allogeneic NK cell therapy as a scalable, stockpile-ready antiviral treatment for future viral pandemics.

" Despite advances in treatment and prevention strategies for SARS-CoV-2, COVID-19 still results in substantial morbidity in certain patient populations underscoring the ongoing need for additional therapeutic options, particularly among immune compromised individuals," said Joshua Hill, MD, associate professor and physician at Fred Hutch Cancer Center and corresponding author of the study. "Although the study was not designed to assess efficacy, our findings demonstrate the safety and potential utility of NK cell therapy as a complementary therapeutic strategy for viral infections in high-risk patients."

"We are very excited by these results and look forward to sharing the full findings in Molecular Therapy Methods and Clinical Development," said Dave Mehalick, President and CEO of Coeptis Therapeutic. "These positive results, along with our recently announced expanded license agreement with Deverra, further strengthens Coeptis' role in the fight against infectious diseases."

To access the full publication in Molecular Therapy Methods and Clinical Development, please visit: https://www.cell.com/molecular-therapy-family/methods/fulltext/S2329-0501(24)00177-3

About Coeptis Therapeutics Holdings, Inc.

Coeptis Therapeutics Holdings, Inc., together with its subsidiaries including Coeptis Therapeutics, Inc. and Coeptis Pharmaceuticals, Inc., (collectively "Coeptis"), is a biopharmaceutical company developing innovative cell therapy platforms for cancer, autoimmune, and infectious diseases that have the potential to disrupt conventional treatment paradigms and improve patient outcomes. Coeptis' product portfolio and rights are highlighted by assets licensed from Deverra Therapeutics, including an allogeneic cellular immunotherapy platform and DVX201, a clinical-stage, unmodified natural killer cell therapy technology. Additionally, Coeptis is developing a universal, multi-antigen CAR T technology licensed from the University of Pittsburgh (SNAP-CAR), and the GEAR cell therapy and companion diagnostic platforms, which Coeptis is developing with VyGen-Bio and leading medical researchers at the Karolinska Institutet. Coeptis' business model is designed around maximizing the value of its current product portfolio and rights through in-license agreements, out-license agreements and co-development relationships, as well as entering into strategic partnerships to expand its product rights and offerings, specifically those targeting cancer and infectious diseases. The Company is headquartered in Wexford, PA. 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 risk that the integration of the Deverra licensed assets will disrupt current plans and operations of the Company; (3) the inability to recognize the anticipated benefits of the newly-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; (4) 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; (5) costs related to integrating the newly-licensed Deverra assets and pursuing the contemplated asset development paths; (6) changes in applicable laws or regulations; (7) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; and (8) 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.

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