SELLAS Life Sciences Announces Enrollment of First Patient in Newly Diagnosed First-Line AML Trial of SLS009

Core Insights - SELLAS Life Sciences Group has initiated a Phase 2 trial for SLS009 (tambiciclib), a CDK9 inhibitor, targeting newly diagnosed acute myeloid leukemia (AML) patients [1][2] - The trial aims to enroll approximately 80 patients, focusing on two cohorts with high unmet medical needs [2] - Topline data from the trial is expected in Q4 2026 [1] Group 1: Trial Details - The trial, designated NCT04588922, includes a predictive biomarker cohort and an early resistance cohort [4] - The predictive biomarker cohort targets newly diagnosed patients unlikely to benefit from standard venetoclax/azacitidine therapy based on molecular profiling [4] - The early resistance cohort includes patients who show no response after two cycles of aza/ven treatment [4] Group 2: Previous Results and Efficacy - In a completed Phase 2 trial for relapsed/refractory (r/r) AML, SLS009 combined with aza/ven met all endpoints, achieving an overall response rate (ORR) of 33% across all evaluable patients [3][5] - The ORR was 40% for the recommended 30mg BIW dose level, with specific subgroups showing even higher response rates: 44% in AML patients with myelodysplasia-related changes and 50% in ASXL1-mutated AML patients [5] - Median overall survival (mOS) for patients treated with the 30mg BIW dose was reported at 8.8 months, significantly higher than the 2.4 months with the best available therapy [5] Group 3: Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [3] - The company's lead product candidate, GPS, targets the WT1 protein and has potential applications in both hematologic malignancies and solid tumors [3] - SLS009 is positioned as a potentially first and best-in-class CDK9 inhibitor, aiming to offer reduced toxicity and increased potency compared to existing options [3]