Business
SELLAS Life Sciences Provides Business Update and Reports Second Quarter 2023 Financial Results
First Patients Dosed in Phase 2a Clinical Trial of SLS009 (formerly GFH009) in Acute Myeloid Leukemia with Topline Data Expected in 4Q 2023 Phase 3 REGAL
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"First Patients Dosed in Phase 2a Clinical Trial of SLS009 (formerly GFH009) in Acute Myeloid Leukemia with Topline Data Expected in 4Q 2023 Phase 3 REGAL Study of Galinpepimut-S in Patients with Acute Myeloid Leukemia on Track for Interim Analysis by Late 2023/Early 2024 REGAL Independent Data Monitoring Committee to Meet in 3Q 2023 NEW YORK, Aug. 10, 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 provided a business update and reported its financial results for the quarter ended June 30, 2023. “We are pleased with the solid progress across our clinical programs in the first half of the year. We expect to complete enrollment in our Phase 3 REGAL study of galinpepimut-S (GPS) in the second half of this year. In addition to our REGAL study, following a strong safety and efficacy profile for SLS009, our CDK9 inhibitor, as a monotherapy in acute myeloid leukemia (AML) in our Phase 1 study, we are particularly excited about the commencement of the Phase 2a study of SLS009 in combination with azacitidine and venetoclax in relapsed and refractory AML, for which we expect topline data in the fourth quarter of 2023,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “The focus of our clinical programs is to potentially deliver treatments to impact the lives of patients with AML, from tackling active disease to prolonging patients’ lives in the maintenance setting, and we look forward to our upcoming milestones across the AML treatment landscape.” Pipeline Update: Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic Phase 3 REGAL study in AML: The interim analysis of the ongoing REGAL global Phase 3 registrational clinical trial of GPS in patients with AML who have achieved complete remission following second-line salvage therapy (CR2 patients) is expected in late 2023 or early 2024. In April, the Independent Data Monitoring Committee (IDMC) recommended that REGAL continue as planned, following a routine, prespecified risk-benefit assessment of unblinded data from the study. The next routine IDMC meeting is scheduled for the third quarter of 2023. A trial in progress poster titled “A randomized...