Sellas Life Sciences receives Fast Track designation for SLS009

SELLAS Life Sciences Group announced that the U.S. Food and Drug Administration has granted Fast Track Designation to SLS009, its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory Peripheral T-cell Lymphomas. The Fast Track designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need. SLS009 demonstrated favorable safety/tolerability and promising clinical efficacy in the recently completed dose-escalation portion of the Phase 1 trial in r/r hematological malignancies. Complete or partial responses were observed in acute myeloid leukemia and lymphoma patients among which four out of eleven patients with PTCL achieved clinical responses including one in continuous treatment for over 56 weeks. The current standard of care for PTCL, belinostat, approved for r/r PTCL, showed in its pivotal Phase 2 study a 25.8% response rate in a similar patient population to that in the SLS009 Phase 1 clinical trial. An open-label, single-arm Phase 1b/2 trial of SLS009 to evaluate safety and efficacy in r/r PTCL, at the recommended phase 2 dose of 100 mg once per week, is ongoing in China and, based on the results, may serve as a registrational study. This initial PTCL study, which will enroll up to 95 patients, is fully funded by GenFleet Therapeutics. The Company is also actively pursuing potential Breakthrough Therapy designation from the FDA for SLS009 for the treatment of r/r PTCL and has a scheduled meeting in the fourth quarter of 2023 to discuss with the FDA.