SELLAS to begin Phase 2a AML trial of CDK9 inhibitor GFH009; Phase 1 showed complete response in monotherapy

SELLAS Life Sciences Group, Inc.

Phase 2a single-arm trial to enroll up to 20 R/R AML patients previously failed venetoclax/azacitidine; primary endpoints: composite CR rate, duration of response, safety.
Trial expected to open June 2023 with top-line data by end of 2023; GFH009 dosed at 45 or 60 mg weekly in combination with standard aza/ven.
Phase 1 produced the first known complete response (MRD-negative, >6 months) from a CDK9 inhibitor monotherapy in R/R AML; no DLTs observed.
GFH009 targets MCL1 transcription, synergizing with BCL2 inhibitor venetoclax; triple combo may overcome venetoclax resistance by hitting both anti-apoptotic pathways.
GPS Phase 3 REGAL AML IDMC meeting set for Q3 2023; interim analysis expected by year-end 2023 or early 2024.

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