SELLAS Announces Key Business Objectives for 2025

Business Update and Milestones - SELLAS Life Sciences expects 2025 to be a pivotal year with several transformative clinical milestones, including full topline Phase 2 data for SLS009 in AML and FDA regulatory feedback in 1H 2025 [2] - The interim analysis of the Phase 3 REGAL study for GPS in AML is expected in January 2025, with the IDMC providing recommendations on whether to stop the trial early for efficacy, futility, or continue without modification [2][3] - The Phase 3 REGAL study reached the pre-specified threshold of 60 events (deaths), initiating the interim analysis [7] SLS009 Development and Achievements - SLS009, a highly selective CDK9 inhibitor, demonstrated a 56% ORR in AML-MRC patients with ASXL1 mutation and other cytogenic changes, exceeding the pre-specified target response rate of 33% [11] - The median overall survival (mOS) for SLS009 in r/r AML has not been reached but exceeds 7.7 months, significantly higher than the historical mOS of 2.5 months [11] - SLS009 showed a 50% response rate in combination with azacitidine and venetoclax at the optimal dose level of 30 mg twice a week, with higher clinical activity in AML-MRC patients, particularly those with ASXL1 mutations [11] - The WHO approved "tambiciclib" as the recommended International Nonproprietary Name (INN) for SLS009 [11] Regulatory Designations - GPS received FDA Rare Pediatric Disease Designation (RPDD) for pediatric AML [9] - SLS009 received RPDD for pediatric AML and pediatric ALL, FDA Fast Track Designation for AML, and EMA orphan drug designation for AML and peripheral T-cell lymphoma [9] Clinical Trial Progress - Enrollment for the Phase 2a trial of SLS009 in r/r AML was completed ahead of schedule, with 30 patients enrolled across 5 US centers [11] - Two new Phase 2 cohorts for SLS009 in AML-MRC with ASXL1 mutations and other cytogenic changes were opened, including enrollment for certain pediatric patients [11] Preclinical and Research Developments - Preclinical data indicated ASXL1 mutations as predictors of response to SLS009 in solid cancers [11] - Research published in Oncotarget revealed the mechanisms of action behind the anti-proliferative effects of SLS009 in hematologic malignancies [11] - The National Cancer Institute (NCI) Pediatric Preclinical in Vivo Testing (PIVOT) Program continues to evaluate SLS009 in pediatric tumors [11] Corporate and Financial Updates - SELLAS applied for non-dilutive grant funding to expand SLS009 development into the frontline setting in AML [5] - The company is developing SLS009 pediatric programs for hematological and potentially other malignancies [5] - SELLAS hosted a corporate update webinar on January 8, 2025, to discuss its 2025 business outlook [5][10]