SELLAS Life Sciences Announces R&D Day to Showcase Phase 3 AML Trial Results and CDK9 Inhibitor Program
核心洞察
SELLAS Life Sciences will host a virtual R&D Day on October 29, 2025, featuring key opinion leaders discussing acute myeloid leukemia treatment advances and unmet medical needs.
The company will present an overview of its ongoing Phase 3 REGAL trial of galinpepimut-S (GPS), with results expected by year-end for AML patients in complete second remission.
SELLAS will provide updates on SLS009, a highly selective CDK9 (搜索) inhibitor showing high response rates in AML patients with unfavorable prognostic factors, with a new frontline study planned for Q1 2026.
SELLAS Life Sciences Group announced it will host a virtual R&D Day on October 29, 2025, bringing together key opinion leaders and company management to discuss advances in acute myeloid leukemia (AML) therapeutics. The event will focus on the company's two lead programs targeting this challenging hematologic malignancy.
Phase 3 REGAL Trial Nears Completion
The centerpiece of the R&D Day will be an overview of the ongoing Phase 3 REGAL trial evaluating galinpepimut-S (GPS), with results expected by year-end. The trial specifically addresses unmet needs of AML patients in complete second remission (CR2), a critical patient population with limited treatment options.
GPS, licensed from Memorial Sloan Kettering Cancer Center, targets the WT1 (搜索) protein present across various tumor types. The therapeutic has potential as both a monotherapy and in combination with other treatments to address a broad spectrum of hematologic malignancies and solid tumor indications.
Dr. Omer Jamy, Assistant Professor of Medicine at the University of Alabama (搜索) and principal investigator of the REGAL study at one of the trial's highest enrolling sites, will participate in the event. Dr. Panagiotis Tsirigotis, Professor of Hematology at the National and Kapodistrian University of Athens, who has enrolled the highest number of patients in the REGAL study, will also contribute his expertise.
CDK9 Inhibitor Shows Promise in Challenging AML Cases
SELLAS will present updates on SLS009 (tambiciclib), described as potentially the first and best-in-class differentiated small molecule CDK9 (搜索) inhibitor. The compound demonstrates reduced toxicity and increased potency compared to other CDK9 inhibitors currently in development.
Recent Phase 2 data suggests SLS009 achieved high response rates in AML patients with unfavorable prognostic factors, including ASXL1 (搜索) mutation, which is commonly associated with poor prognosis in various myeloid diseases. The company plans to initiate a newly diagnosed and frontline AML study in the first quarter of 2026.
Dr. Philip Amrein, Assistant Professor of Medicine at Harvard Medical School and physician at Massachusetts General Hospital, who has conducted research with SLS009 and specializes in cyclin-dependent kinases, will provide expert commentary during the event.
Expert Panel Addresses Treatment Landscape
The virtual event will feature a distinguished panel of hematology-oncology experts discussing the evolving treatment landscape for AML. Dr. Sharif Khan, a hematologist at Bon Secours Health System who serves as an investigator in both the REGAL trial and SLS009 clinical program, will contribute insights from his clinical experience with both therapeutic approaches.
The program will include a live Q&A session following formal presentations, allowing participants to engage directly with the expert panel and company management on the latest developments in AML therapeutics.
SELLAS Life Sciences positions itself as a late-stage clinical biopharmaceutical company focused on developing novel therapeutics for a broad range of cancer indications, with particular emphasis on addressing unmet medical needs in hematologic malignancies.