SELLAS Unveils Breakthrough Preclinical Data Highlighting Efficacy of SLS009 in TP53 Mutated AML at the 2025 AACR Conference

Core Insights - SLS009 (tambiciclib) shows potential in overcoming resistance to the azacitidine-venetoclax regimen in TP53 mutated Acute Myeloid Leukemia (AML) cells, with promising preclinical efficacy data presented at the AACR conference [1][2][3] Company Overview - SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications, with SLS009 being a key candidate [7] Preclinical Findings - SLS009, a selective CDK9 inhibitor, can induce apoptosis in TP53 mutated AML cells by targeting proteins like MCL-1 and survivin, achieving up to 97% reduction in leukemia cell populations when combined with azacitidine-venetoclax, and up to 80% as a monotherapy [2][3] - Immunoblot analysis indicates near-complete removal of targeted proteins within 8 hours of SLS009 exposure [2] Clinical Trial Progress - SLS009 is currently in Phase 2 clinical trials for relapsed or refractory AML, showing a median overall survival (mOS) of 8.8 months for all patients and 8.9 months for AML myelodysplasia-related changes (MRC) patients, significantly exceeding the historical benchmark of 2.5 months [3][6] - Response rates among patients with specific mutations include 67% for ASXL1, 60% for RUNX1, and 33% for TP53 [3] Expert Commentary - Experts highlight the significance of SLS009 in addressing the unmet needs of TP53 mutated AML, which has poor outcomes even with existing therapies [4]