SELLAS Presents SLS009 Phase 1 AML Data at 2024 ESH Conference

SELLAS Life Sciences Group, a biopharmaceutical firm specializing in cancer treatment innovation, has reported significant findings from their Phase 1 clinical trial of SLS009, a CDK9 inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML). The study met its primary objectives, including pharmacokinetic and pharmacodynamic assessments, safety, and clinical efficacy. Notably, a patient treated with SLS009 achieved a complete remission (CR) that lasted for eight months, with a one-year survival mark at the latest follow-up. This marks the first instance of CR being achieved through CDK9 inhibition monotherapy in such AML patients. The median survival for patients who relapse post-treatment with azacitidine and venetoclax is typically around 2.5 months, making this outcome particularly noteworthy.

The Phase 1 data, which demonstrated a favorable safety profile with no dose-limiting toxicities or significant adverse events, will be presented at the 2024 European School of Haematology Acute Leukaemias (ESH) Conference by Dr. Tapan Kadia, a leading investigator in the field. SELLAS anticipates releasing Phase 2a data for r/r AML patients in March and during the second quarter of 2024.

The treatment showed dose-proportional anti-leukemic activity, with over 50% reduction in bone marrow blasts in patients with high leukemic burdens, indicating a broad therapeutic range and effective cell kill. Additionally, a durable CR was observed in a patient who had previously not responded to standard aza/ven therapy. The study also highlighted strong inhibitory effects on key biomarkers, with a universal decrease in MYC and MCL-1 levels in patients evaluated.

The recommended Phase 2 dose for AML was set at 60 mg, based on the study's findings. SELLAS' Chief Development Officer, Dragan Cicic, MD, emphasized the potential of SLS009 due to its high selectivity, low off-target toxicity, and confirmed efficacy on relevant biomarkers and clinical outcomes in hematologic malignancies. He also mentioned the potential synergy of SLS009 with standard venetoclax and hypomethylating agent regimens, which could pave new ways in treating AML.

The ongoing Phase 2a trial aims to evaluate the safety and efficacy of SLS009 in combination with aza/ven for AML patients who have become refractory to standard treatments. The trial involves dosing patients with two levels of SLS009, 45 mg once weekly and 60 mg either weekly or divided into two doses.

SELLAS is also developing galinpepimut-S (GPS), a product candidate targeting the WT1 protein found in various tumor types, with potential applications in both monotherapy and combination treatments for a wide range of cancers.

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