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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.
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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced the acceptance of an abstract for a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for June 2-6, 2023, in Chicago. The poster will detail a study on the efficacy and safety of galinpepimut-S (GPS) maintenance therapy for patients with acute myeloid leukemia (AML) who have achieved complete remission after second-line therapy. The study, led by Dr. Omer Jamy, Principal Investigator, will be presented on June 5, 2023. Additionally, SELLAS is advancing its cancer therapies, notably GPS, targeting the WT1 protein across various malignancies, and GFH009, a CDK9 inhibitor licensed from GenFleet Therapeutics.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) has announced promising results from its Phase 1 trial of GFH009, a selective CDK9 inhibitor for patients with acute myeloid leukemia (AML). The trial achieved safety and efficacy objectives, with no dose-limiting toxicities reported. Key findings include a complete response at an intermediate dosage and a significant reduction in leukemic cell blasts. SELLAS is set to initiate a Phase 2a clinical trial in 2Q 2023, combining GFH009 with venetoclax and azacitidine for AML patients who have relapsed. Topline data from this trial is expected in Q4 2023. The favorable pharmacokinetic profile supports the potential for once-weekly dosing, indicating a significant advancement in addressing AML treatment challenges.
SELLAS Life Sciences Group (NASDAQ: SLS) reported a positive review from the Independent Data Monitoring Committee (IDMC) of its ongoing Phase 3 REGAL clinical trial for galinpepimut-S (GPS) targeting acute myeloid leukemia (AML). The IDMC assessed unblinded data and recommended the trial's continuation without modifications, also endorsing the addition of clinical sites in China. This milestone is critical as SELLAS aims for interim analysis by late 2023 or early 2024. The REGAL trial evaluates overall survival in AML patients who achieved complete remission after second-line salvage therapy. Galinpepimut-S is designed to target the WT1 protein found in various tumors, and is being developed as both monotherapy and in combination with other therapies.