Sellas Life Sciences announces FDA grants ODD for SLS009 to treat AML

SELLAS Life Sciences Group announced that the U.S. Food and Drug Administration or FDA has granted Orphan Drug Designation ODD for SLS009, a novel and highly selective CDK9 inhibitor, for the treatment of acute myeloid leukemia AML. “We are honored to receive the ODD from the FDA. This designation underscores the potential of SLS009 to address a significant unmet medical need for patients with AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “SLS009 is a novel and highly selective CDK9 inhibitor that has already shown a favorable safety profile, strong initial efficacy signals, and evidence of anti-tumor activity. With the support of this ODD, we look forward to accelerating SLS009 clinical development and bringing new hope to those suffering from this devastating disease.”