SELLAS Life Sciences Receives Positive Recommendation from Independent Data Monitoring Committee for Phase 3 AML REGAL Trial

The Independent Data Monitoring Committee (IDMC) has advised that the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) should proceed without any changes. This trial is conducted by SELLAS Life Sciences Group, Inc., a biopharmaceutical company dedicated to developing innovative cancer treatments. The IDMC's recommendation follows a thorough assessment of unblinded data, revealing no safety or futility concerns. The interim analysis of the trial is expected to take place by the fourth quarter of 2024.

Angelos Stergiou, MD, ScD hc, President and CEO of SELLAS, expressed optimism about the positive feedback and the IDMC's decision to continue the trial without modifications. He highlighted that the committee's review underscores the potential of GPS as a safe and effective treatment for AML patients. This is the first time the IDMC has provided a timeline for the interim analysis, which is based on their extensive evaluation of the REGAL trial data.

Panagiotis Tsirigotis, MD, a principal investigator and Professor of Medicine at the University of Athens, shared his enthusiasm about the upcoming interim analysis, which marks a significant milestone. He is particularly excited about the potential expansion of GPS into broader applications, including treatment for patients in their first remission and those post bone marrow transplant.

The REGAL trial is a Phase 3 open-label study designed to evaluate GPS in AML patients who have achieved complete remission after second-line salvage therapy (CR2 patients). The primary goal of the trial is to measure overall survival. The IDMC, comprising independent medical, scientific, and biostatistics experts, is responsible for reviewing and assessing patient safety and efficacy data, ensuring the study's quality, and maintaining its scientific and clinical integrity. The IDMC charter includes periodic reviews of safety, efficacy, and futility, along with interim and final analyses.

SELLAS Life Sciences Group, Inc. is a biopharmaceutical company in the advanced stages of clinical development. It focuses on creating novel therapeutics for various cancer types. One of its leading product candidates, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein found in many tumor types. GPS shows promise as both a standalone treatment and in combination with other therapies, potentially addressing a wide range of hematologic malignancies and solid tumors. Additionally, SELLAS is developing SLS009 (formerly GFH009), a small molecule and highly selective CDK9 inhibitor, licensed from GenFleet Therapeutics (Shanghai), Inc., for worldwide use outside of Greater China.