“We continue to make significant progress in advancing our AML-focused pipeline, as demonstrated by the positive Phase 2 results evaluating our novel CDK9 inhibitor, SLS009, for the treatment of r/r AML,” said Angelos Stergiou, president and CEO of Sellas. “The Phase 2 trial met all primary endpoints, achieving a 44% response rate among patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes, which at the optimal dose level, nearly tripled the median overall survival compared to a historical benchmark. Based on the strength of these data, we conducted an end-of-Phase 2 meeting and the FDA recommended advancing SLS009 into the front-line setting for AML. We are now preparing an 80-patient trial that is focused on newly diagnosed and early refractory to venetoclax and azacitidine AML patients, with enrollment anticipated to begin by Q1 2026.”
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