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SELLAS Life Sciences Announces Enrollment of First Patient in Newly Diagnosed First-Line AML Trial of SLS009
- Study to Enroll 80 Patients Unlikely to Benefit from Venetoclax/Azacitide (Aza/Ven) Therapy in the US and Europe -- SELLAS’ Predictive Biomarker and AI
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"- Study to Enroll 80 Patients Unlikely to Benefit from Venetoclax/Azacitide (Aza/Ven) Therapy in the US and Europe -- SELLAS’ Predictive Biomarker and AI Assisted Precision Medicine Models to be Utilized -- Topline Data Expected in Q4 2026 – NEW YORK, March 12, 2026 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced the first patient has been enrolled in its randomized Phase 2 trial evaluating SLS009 (tambiciclib), a highly selective CDK9 inhibitor in newly diagnosed, first-line acute myeloid leukemia (AML) patients. The newly initiated NCT04588922 is designed to enroll approximately 80 patients and includes two AML cohorts with high unmet need and greatest potential benefit: Predictive biomarker cohort: Newly diagnosed patients unlikely to benefit from standard aza/ven therapy based on molecular profilingEarly resistance cohort: Patients who initiate treatment with aza/ven but demonstrate a confirmed lack of any response after two treatment cycles “Enrolling the first patient in this first-line AML Phase 2 study represents an important milestone in the advancement of our SLS009 program and reflects our precision medicine strategy to address challenging subgroups of AML patients through our extensive transcriptomics, genomics, and proteomics models we have established,” said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. “The strength of our Phase 2 data in r/r AML, particularly in high-risk molecular subtypes, together with the FDA's guidance, provided a strong foundation for moving into earlier lines of therapy. By targeting molecularly defined subgroups and those demonstrating early non-response, we aim to address a critical need in frontline AML and position SLS009 for potential registrational development.” This milestone follows the Company’s previously reported positive Phase 2 results in relapsed/refractory (r/r) AML and the FDA’s guidance recommending advancement into a study that includes newly diagnosed AML patients eligible for venectoclax and azacitidine (aza/ven) therapy. In the completed Phase 2 trial in r/r AML, SLS009 in combination with aza/ven met all endpoints, exceeding the pre-specifi...