Promising efficacy and favorable safety data from the Phase 1 study in heavily pre-treated patients show potential of CLN-049 to address a broad population of AML patients

 Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CLN-049 for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML). Data from the Phase 1 clinical trial of CLN-049 will be presented at the upcoming 67^th American Society of Hematology (ASH) Annual Meeting and Exposition in an oral presentation on December 8.

“Fast Track designation underscores both the urgent need for new options in relapsed and refractory acute myeloid leukemia and the promise of CLN-049,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “Initial results from our Phase 1 study have shown meaningful efficacy, including complete responses, reinforcing the broad potential of this FLT3-directed T cell engager in a population where effective treatment options are currently limited and fragmented. This regulatory milestone provides important momentum for development, and we look forward to collaborating closely with the FDA to rapidly advance CLN-049 for patients who desperately need more effective therapies.”