On December 21, 2023 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, reported 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) (Press release, Sellas Life Sciences, DEC 21, 2023, View Source [SID1234638754]).
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"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 efficacy. Complete or partial responses were observed in patients with acute myeloid leukemia as well as lymphoma, including four PTCL patients (36.4%) who achieved clinical responses with one patient with complete metabolic response who is continuing treatment for over 62 weeks, and another patient with complete response by CT scan who is continuing treatment for over 24 weeks. The current standard of care for r/r PTCL, belinostat, an HDAC inhibitor, 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. The patients who achieved complete response in the SLS009 study were previously treated with regimens containing an HDAC inhibitor.
The FDA’s Office of Orphan Products Development grants ODD status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. ODD provides benefits to drug developers designed to support the development of drugs and biologics for small patient populations with unmet medical needs. These benefits include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.