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SELLAS Receives FDA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas
- SLS009 Demonstrated Promising Efficacy in Phase 1 Study with 36.4% Clinical Response (ORR) in r/r Peripheral T-cell Lymphomas (PTCL); ORR in r/r PTCL
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"- SLS009 Demonstrated Promising Efficacy in Phase 1 Study with 36.4% Clinical Response (ORR) in r/r Peripheral T-cell Lymphomas (PTCL); ORR in r/r PTCL Patients with Standard of Care is 25.8% - - One Patient with Complete Metabolic Response Continuing Treatment for over 62 weeks and another patient with Complete Response by CT Continuing Treatment for over 24 weeks - - Phase 1b/2 Study in PTCL Ongoing with top line data expected in 1H 2024 - NEW YORK, Dec. 21, 2023 (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 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 (r/r) Peripheral T-cell Lymphomas (PTCL). “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.” As it relates to PTCL, SLS009 is currently being evaluated in a Phase 1b/2 trial in patients with r/r PTCL. The open-label, single-arm study will enroll up to 95 patients to evaluate safety and efficacy and, based on the results, may serve as a registrational study. This initial PTCL study is fully funded by GenFleet Therapeutics, Inc. and is being conducted in China. In the recently completed dose-escalation portion of the Phase 1 trial in r/r hematological malignancies, SLS009 demonstrated a favorable safety profile and promising clinical efficac...