FDA lifts partial clinical hold on Curis leukemia study; RP2D set at 300 mg BID

CURIS INC

FDA removed partial clinical hold on TakeAim Leukemia Phase 1/2 study of emavusertib (CA-4948).
Recommended Phase 2 dose (RP2D) for monotherapy established at 300 mg BID in AML/MDS patients.
At 300 mg BID, 2 of 3 FLT3-mutant AML patients achieved CR; 2 of 3 spliceosome-mutant achieved CR/CRh.
Company plans to enroll targeted AML patients and initiate front-line combination study with azacitidine/venetoclax.
Expects updated monotherapy data, registrational study design, and initial combo data in 2024.

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