Cullinan Therapeutics, Inc. (CGEM) announced that the U.S. FDA has granted Fast Track Designation to CLN-049, a novel, investigational FLT3xCD3 bispecific T cell engager, for the treatment of R/R acute myeloid leukemia (AML).
AML is the most common form of acute leukemia in adults, characterized by rapid growth of abnormal white blood cells that crowd out healthy cells. Each year in the U.S., about 22,000 people are diagnosed and roughly half as many die from the disease.
Globally, AML affects 144,000 patients annually, with 130,000 deaths. For patients with R/R AML, five-year survival is less than 10%, and there are currently no approved immunotherapies.
CLN-049 is designed to bind both mutated and non-mutated FLT3, enabling broad applicability across AML patients. In a Phase 1 study, CLN-049 demonstrated promising efficacy and favorable safety, including complete responses in heavily pre-treated patients.
The therapy is evaluated in two ongoing Phase 1 trials: one is R/R AML or myelodysplastic syndrome (MDS) (NCT05143996) and another in AML patients with Measurable Residual Disease (MRD) (EUCT 2023-506572-27-00)
Chief Medical Officer Dr. Jeffrey Jones stated that Fast Track designation underscores both the urgent need AML and highlights the promise of CLN-049. He noted that early results reinforce the potential of FLT3-directed T cell engager in a population where effective treatments are limited.
Data from the Phase 1 trial will be presented at the 67th American Society of Hematology (ASH) Annual Meeting on December 8, 2025.The FDA's Fast Track Program is intended to expedite development and review of therapies for serious conditions with unmet medical need. Designated programs may also qualify for Accelerated Approval and Priority Review if criteria are met.
CGEM is currently trading in the pre-market at $11.70, up 2.92%. Over the past 12 months the stock has traded between $5.68 to $13.78.
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