Sellas Life Sciences receives FDA ODD for SLS009

SELLAS Life Sciences announced that the U.S. Food and Drug Administration, FDA, has granted Orphan Drug Designation, ODD, for SLS009, the Company’s novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory Peripheral T-cell Lymphomas. “We are delighted to announce the FDA’s granting of ODD for SLS009, marking another significant milestone following the recent Fast Track Designation by the FDA for PTCL,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “In the recently completed dose-escalation portion of the Phase 1 trial in r/r hematological malignancies, SLS009 achieved clinical responses in PTCL including two patients reaching complete response. We are excited to see a favorable safety profile, strong initial efficacy signals, and evidence of anti-tumor activity across the Phase 1 study as well as the ongoing Phase 2 studies. With both designations in hand, we look forward to advancing the development of SLS009 and continuing to work closely with regulators with the goal of delivering this treatment to those who may benefit from it.