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SELLAS Life Sciences Group, Inc. develops novel cancer therapeutics as a late-stage clinical biopharmaceutical company. News about SLS centers on its acute myeloid leukemia programs, including galinpepimut-S (GPS), a WT1-directed peptide immunotherapy evaluated in the REGAL Phase 3 trial, and SLS009 (tambiciclib), a selective CDK9 inhibitor studied in AML settings.
Recurring updates include clinical and preclinical data presentations, trial progress, regulatory and corporate updates, financial results, cash-position disclosures, warrant exercises, and other capital-structure developments tied to funding its oncology pipeline.
SELLAS has completed enrollment for its Phase 2a trial of SLS009 in relapsed/refractory acute myeloid leukemia (r/r AML) ahead of schedule. The trial includes 30 patients who have not responded to venetoclax-based regimens.
Initial results show promising efficacy with an overall response rate (ORR) of 33% and 50% in the 60 mg QW and 30 mg BIW dosing cohorts, respectively. Median overall survival (OS) was 5.4 months at the 45 mg QW dose, significantly higher than the 2.5 months standard of care. Notably, patients with ASXL1 mutations in the 30 mg BIW cohort achieved a 100% ORR. The trial will now proceed with two additional cohorts focusing on patients with specific genetic mutations, with further updates expected in Q3 2024.
SELLAS Life Sciences (SLS) announced its Q1 2024 financial results, highlighting significant clinical and financial milestones. The Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 3 REGAL study without modifications and confirmed the completion of patient enrollment. Positive Phase 2 data for SLS009 in AML patients showed a 100% response rate in those with the ASXL1 mutation at a 30 mg BIW dose. Financially, R&D expenses decreased to $5.1 million, while G&A expenses rose slightly to $4.5 million. The net loss narrowed to $9.6 million, with cash reserves at $18.4 million.
SELLAS Life Sciences Group, Inc. announces positive Phase 2 preliminary data of SLS009 in relapsed/refractory acute myeloid leukemia (r/r AML), achieving a 100% response rate in patients with ASXL1 mutation at the optimal dose level. The company has filed IP protection related to the ASXL1 mutation, showing a highly significant market potential. SLS009 exhibits strong anti-leukemic activity with a favorable safety profile across all dose levels. Study enrollment is ongoing, with updates expected in Q3 2024.
SELLAS Life Sciences Group, Inc. announced a positive review by the Independent Data Monitoring Committee (IDMC) of the Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML). The IDMC recommended the trial continue without modifications based on efficacy and safety data, with the next assessment scheduled for June 2024. The trial aims to develop a novel therapy for AML patients who have achieved complete remission following second-line salvage therapy, with overall survival as the primary endpoint.
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