SELLAS Life Sciences Group (SLS) R&D Day 2025 summary

Pipeline overview and program updates

• Two late-stage clinical assets, GPS (WT1-targeted immunotherapy) and SLS009 (CDK9 inhibitor), address significant unmet needs in AML and other cancers, both with first- or best-in-class potential.

• GPS is in a global phase III REGAL trial for AML maintenance, with enrollment completed and the 80th event (primary endpoint) expected soon.

• SLS009 has shown strong activity in relapsed/refractory AML and is advancing to frontline settings, targeting high-risk and Venetoclax-refractory patients.

• Biomarker-driven strategies and AI models are being used to optimize patient selection for SLS009.

• Expansion into post-transplant maintenance and solid tumor indications is under consideration for GPS and SLS009.

Clinical trial data and development milestones

• GPS has demonstrated prolonged survival in both first and second remission AML patients, with median survival exceeding historical controls (over 60 months in CR1, 21 months in CR2).

• SLS009 phase II data show response rates of 44–57% in high-risk AML subgroups, including those with TP53 mutations, and survival far exceeding standard therapies.

• The REGAL trial's primary endpoint is overall survival (hazard ratio), with longer-than-expected survival delaying the final analysis, suggesting positive trends.

• Upcoming milestones include REGAL final analysis and initial frontline SLS009 data in 2026.

R&D strategy and innovation priorities

• Focus on rigorous, high-quality science, leveraging transcriptomic, genomic, and proteomic analyses to guide development.

• AI-driven patient stratification and biomarker validation are central to SLS009's clinical strategy.

• Emphasis on expanding GPS into post-transplant maintenance and SLS009 into earlier lines of therapy.