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IMPACT-AML has entered into an agreement with SELLAS Life Sciences Group, a late-stage clinical biopharmaceutical company focused on developing novel therapies for a broad range of cancer indications. Under the agreement, the IMPACT-AML network will conduct a clinical study evaluating SLS009, a highly selective CDK9 inhibitor, enabling access to multiple European clinical sites and patients.

IMPACT-AML is a pan-European project that builds an inclusive clinical network, the STREAM platform, connecting patients, clinicians and researchers to test novel AML therapies and improve patient outcomes. It is part of the EU Mission on Cancer programme and represents a high-level scientific collaboration. The project is led by a consortium of major European research and clinical institutions, including IRCCS Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori” (IRST), the University of Bologna, IIS La Fe (Health Research Institute Hospital La Fe), several European AML collaborative groups, and supranational organisations under the umbrella of the European LeukemiaNet (ELN), as well as multiple university hospitals across Europe. By leveraging IMPACT-AML’s existing infrastructure and expertise, SELLAS expects to expand European patient access to SLS009 in a cost-efficient manner while supporting broader participation across the clinical programme.

“This is a highly meaningful milestone for SELLAS and for the SLS009 programme,” said Angelos Stergiou, M.D., Sc.D., President and Chief Executive Officer of SELLAS. “Gaining access to the IMPACT-AML framework represents strong external validation of SLS009 and reflects growing recognition of its potential to address critical unmet needs in AML. Importantly, this collaboration allows us to expand our clinical programme into Europe efficiently by leveraging an established infrastructure, improving capital efficiency while supporting broader and faster patient enrolment as we advance into frontline AML”.

The collaboration is expected to support continued execution of the SLS009 clinical programme as SELLAS advances into frontline AML. The European study is planned to enrol approximately 40 patients to evaluate SLS009 in combination with azacitidine and venetoclax (AZA/VEN) in patients with newly diagnosed AML with high-risk features. Enrolment in the first part of the trial for newly diagnosed patients is expected to begin at US sites in Q1 2026, followed by initiation at European sites in Q2 2026, subject to regulatory approval and site readiness.

“IMPACT-AML is committed to accelerating access to promising new therapeutic approaches for patients with AML who face limited treatment options,” said IMPACT-AML Scientific Coordinator Dr Giovanni Martinelli. “We are pleased to collaborate with SELLAS and support the evaluation of SLS009 within our European network, in line with our mission to facilitate efficient, high-quality clinical research in AML.”