SELLAS Life Sciences Group is gearing up for a potentially transformative year in 2025, with significant milestones anticipated for its pipeline of novel cancer therapies. The company's focus remains on advancing its clinical-stage portfolio, particularly in hematologic malignancies, with key data readouts and regulatory feedback expected in the coming months.
REGAL Phase 3 Interim Analysis
The Independent Data Monitoring Committee (IDMC) is slated to conduct an interim analysis of the Phase 3 REGAL study in January 2025. This global registrational trial is evaluating Galinpepimut-S (GPS), a Wilms Tumor-1 (WT1) targeting immunotherapeutic, in patients with acute myeloid leukemia (AML) who have achieved complete remission following second-line salvage therapy (CR2). The IDMC's recommendation will determine whether the trial should be stopped early for efficacy, stopped for futility, or continued without modification. If the trial continues, the next and final analysis will occur upon reaching a total of 80 events, as predefined in the study protocol.
SLS009 Phase 2 Data and Regulatory Path
SELLAS anticipates full topline data from its Phase 2 trial of SLS009, a highly selective CDK9 inhibitor, in the first half of 2025. This trial focuses on AML patients resistant to venetoclax combination therapies. The company also expects regulatory feedback from the FDA regarding the development path for SLS009 in relapsed/refractory AML. Positive data from the Phase 2 trial reported in Q4 2024 showed a median overall survival (mOS) exceeding 7.7 months, a significant improvement compared to the historical mOS of approximately 2.5 months in this setting. In expansion cohorts of patients with AML-myelodysplasia-related changes (AML-MRC), the overall response rate (ORR) was 56% in 9 evaluable patients, surpassing the pre-specified target response rate of 33%.
Regulatory Recognition and Pediatric Programs
In 2024, SELLAS achieved significant regulatory milestones, with GPS receiving FDA Rare Pediatric Disease Designation for pediatric AML and SLS009 receiving the same designation for pediatric AML and pediatric acute lymphoblastic leukemia (ALL). SLS009 also received FDA Fast Track Designation for AML and EMA orphan drug designation for AML and peripheral T-cell lymphoma (PTCL). These designations highlight the unmet medical needs in these patient populations and reinforce the confidence of regulatory authorities in SELLAS's innovative approach. The company is also actively developing SLS009 pediatric programs in hematological and potentially other malignancies and has applied for non-dilutive grant funding to expand SLS009 development into the frontline setting in AML.
