513(g) request will help initiate dialogue with FDA and guide regulatory pathway
WEXFORD, Pa., Aug. 1, 2023 /PRNewswire/ — Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) (“Coeptis” or “the Company”), a biopharmaceutical company developing innovative cell therapy platforms for cancer, announced that it has submitted a 513(g) request to the U.S. Food and Drug Administration (FDA) for an in vitro companion diagnostic test designed to be used with anti-CD38 monoclonal antibody therapies. The 513(g) request serves to introduce Coeptis’ diagnostic technology to the FDA and to request guidance in determining the appropriate classification and regulatory pathway.
The companion diagnostic test is intended to guide clinicians’ decisions in difficult to treat oncology indications. Treatments for complicated oncology indications that target CD38 can have significant impact on the immune system including increased risk for infectious complications, autoimmune disorders, and secondary malignancies, so in vitro companion diagnostics could be a valuable tool in guiding treatment decisions.
“With this 513(g) submission, we now look forward to initiating a dialogue with the FDA to advance the regulatory development of our CD38 diagnostics technology, which we believe has potential to significantly improve the treatment of severe and complicated oncology indications,” said Dave Mehalick, President and CEO of Coeptis Therapeutics. “For patients living with these very severe and difficult to treat conditions, this companion diagnostic could potentially relieve substantial burdens and cost of treatments to those individuals who likely won’t respond to treatment. Importantly, predicting treatment could provide clinicians with the opportunity to choose a different, possibly more effective treatment plan, rather than losing time with an ineffective therapy as the disease progresses.”
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 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 Global Market; (2) the risk that, if the Deverra transaction closes it will disrupt current plans and operations of the Company; (3) the inability to recognize the anticipated benefits of the proposed transaction, 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 targeted Deverra 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 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.
SOURCE Coeptis Therapeutics
Source PR Newswire