SELLAS Life Sciences Group (NASDAQ: SLS) announced enrollment of the first patient in its Phase 2 trial evaluating SLS009 for newly diagnosed acute myeloid leukemia patients.

The randomized trial will enroll approximately 80 patients across two cohorts in the United States and Europe. The first cohort includes newly diagnosed patients unlikely to benefit from standard venetoclax/azacitidine therapy based on molecular profiling. The second cohort comprises patients who demonstrate confirmed lack of response after two treatment cycles of venetoclax/azacitidine.

SLS009, also known as tambiciclib, is a CDK9 inhibitor that targets patients with high unmet medical needs. The company plans to utilize predictive biomarker and AI-assisted precision medicine models in the study.

"The strength of our Phase 2 data in r/r AML, particularly in high-risk molecular subtypes, together with the FDA's guidance, provided a strong foundation for moving into earlier lines of therapy," said Angelos Stergiou, the company's chief executive officer.

The trial follows previous Phase 2 results in relapsed/refractory AML and FDA guidance recommending advancement into newly diagnosed AML patients. In the completed Phase 2 trial, SLS009 combined with venetoclax/azacitidine achieved a 33% overall response rate across all evaluable patients and 40% at the recommended 30mg dose level.

The company expects topline data from the new trial in the fourth quarter of 2026. The study is registered under clinical trial identifier NCT04588922.

SELLAS develops cancer therapeutics and has two main product candidates: GPS, which targets the WT1 protein, and SLS009 for various cancer indications.