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, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CLN-049, a novel, investigational FLT3xCD3 T cell engager, for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML).

"FDA Orphan Drug Designation for CLN-049 emphasizes both the urgent need for new therapies for people living with relapsed or refractory acute myeloid leukemia – including patients with TP53-mutated AML who currently face a particularly poor prognosis – and the potential of this FLT3-directed T cell engager to expand treatment options across the broadest population of AML patients," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "Coupled with promising results from our ongoing Phase 1 program, this designation by the FDA reinforces a shared goal to rapidly advance novel therapies for patients living with AML."

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