SELLAS Life Sciences Group announced the delivery of an oral presentation of data for the cohort of patients with acute myeloid leukemia from the Phase 1 dose-escalation study of SLS009 by Dr. Tapan Kadia, Professor at MD Anderson Cancer Center and the study’s primary investigator, at the 2024 European School of Haematology Acute Leukaemias Conference: How to Diagnose and Treat Acute Leukaemias, taking place March 1-3, 2024, in Stockholm, Sweden. All key study objectives regarding pharmacokinetic, pharmacodynamic, safety, and clinical activity were met. Presented findings included: No dose-limiting toxicities or significant off-target adverse events at any dose level. Maximum tolerated dose was not reached due to a favorable safety profile. Dose-proportional anti-leukemic activity across all dose levels and administration regimens studied, including bone marrow blast reduction of greater than 50% in patients with high burdens of leukemic bone marrow blasts indicating a broad therapeutic index and meaningful cell killing activity. Durable CR was observed in one patient who had previously failed aza/ven therapy, after three months of treatment, lasting eight months and one-year survival at the most recent assessment. Strong inhibitory activity against key biomarkers with a dose-proportional response and universal decrease of MYC and MCL-1 in evaluable patients. Proportional and well-controlled pharmacokinetics at all dose levels and at different dosing regimens. The recommended phase two dose for AML was established at 60 mg. Favorable safety profile observed with a notable absence of higher-grade extramedullary toxicities which have been frequently observed with other CDK9 inhibitors in development.
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