• DVX201, a first-ever allogeneic, cord-blood derived, natural killer (NK) cell therapy, has been administered to 16 patients with no dose limiting toxicities, cytokine release syndrome or infusion toxicities to date at all dose levels

WEXFORD, Pa., Sept. 14, 2023 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, today provided a safety and patient dosing update from two Phase 1 clinical trials investigating DVX201 for the treatment of relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and patients hospitalized with COVID-19 infection. DVX201 is a novel allogeneic, unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ hematopoietic stem and progenitor cells (HSPC) cells.

Interim data from both trials involving 16 patients and 23 infusions of DVX201 indicate that the NK cell therapy is well-tolerated with no dose limiting toxicities (DLTs), cytokine release syndrome (CRS) or infusion toxicities observed thus far through the highest dose level. The Phase 1 clinical trial investigating DVX201 in patients with hospitalized COVID-19 infection (NCT04900454) has completed the three dosing cohorts (3+3 design), enrolling a total of nine patients each receiving a single infusion. DVX201 was tolerated at all dosing levels. 

The Phase 1 trial investigating DVX201 in relapsed/refractory AML or high-risk MDS (NCT04901416) has safely dosed a total of seven subjects each receiving two infusions (14 total). The trial is expected to enroll three to five additional patients who will be infused at the highest dosing level. Coeptis expects to report topline safety and efficacy data from the full patient population in the first quarter of 2024.

"The excellent safety results to date for DVX201 across two trials with distinct patient populations, including 16 patients and 23 infusions, is extremely encouraging and represents a major step for this first in-human use of an allogeneic NK cell therapy derived from pooled donor CD34+ HSPCs," said Colleen Delaney, MD, Chief Scientific and Medical Officer. "DVX201, a pooled donor product, represents a truly novel manufacturing platform, and these preliminary safety results give us confidence as we continue enrolling the highest dose cohort, which should total seven subjects for 14 infusions for the remaining portion of the Phase 1 trial in relapsed/refractory AML and high risk MDS. We anticipate receiving top line data for this trial in 1Q24."

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 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. 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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