Cullinan Therapeutics Receives FDA Fast Track For CLN-049 To Treat Relapsed Or Refractory AML; Phase 1 Data To Be Presented At 67th ASH Annual Meeting

Cullinan Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on advancing first- or best-in-class therapies for 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 or refractory acute myeloid leukemia (AML). The company will present data from the ongoing Phase 1 clinical trial of CLN-049 during an oral session at the 67th American Society of Hematology (ASH) Annual Meeting on December 8.

Jeffrey Jones, MD, MBA, Chief Medical Officer of Cullinan Therapeutics, said that receiving Fast Track status highlights both the serious unmet need in relapsed/refractory AML and the strong early potential of CLN-049. He noted that initial findings from the Phase 1 study have shown encouraging activity, including complete responses, which support the development of this FLT3-directed T cell engager for patients with few available treatment options. Dr. Jones added that the designation provides important momentum, enabling closer collaboration with the FDA as the company works to advance CLN-049 as quickly as possible for patients in need.