On August 1, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported 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 (Press release, Coeptis Therapeutics, AUG 1, 2023, View Source [SID1234633609]). 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.
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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."