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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company dedicated to the development of novel therapeutics aimed at addressing a broad range of cancer indications. The company's core mission is to practice the medicine of tomorrow, today, by integrating innovative approaches that significantly impact the global healthcare landscape.
SELLAS' leading product candidate is galinpepimut-S (GPS), a peptide immunotherapy targeting the Wilms Tumor 1 (WT1) antigen. Licensed from Memorial Sloan Kettering Cancer Center, GPS is designed to treat various hematologic malignancies and solid tumors. Notably, GPS is currently undergoing a Phase 3 REGAL clinical trial for acute myeloid leukemia (AML), with promising safety and efficacy data observed so far.
Another pivotal asset in SELLAS' pipeline is SLS009 (formerly GFH009), a highly selective cyclin-dependent kinase 9 (CDK9) inhibitor. Licensed from GenFleet Therapeutics (Shanghai), Inc., SLS009 is being explored for its potential to treat relapsed/refractory acute myeloid leukemia (r/r AML) and other cancer types. Recent Phase 2a trial results show that SLS009 exhibits strong anti-leukemic activity, with favorable safety profiles and significant response rates, particularly in patients with identified biomarkers such as the ASXL1 mutation.
SELLAS is committed to advancing these therapeutics through rigorous clinical trials and strategic partnerships. The company collaborates with renowned scientists, healthcare professionals, and pharmaceutical executives to bring cutting-edge treatments to market. Recent collaborations include a clinical trial agreement with BeiGene Switzerland GmbH to study the combination of GFH009 and BRUKINSA® (zanubrutinib) in treating diffuse large B cell lymphoma (DLBCL).
Financially, SELLAS has shown resilience and growth, as evidenced by a successful $20 million registered direct offering in March 2024, bolstering their cash reserves for ongoing R&D activities. The company continues to report sound financial health, marked by a focused approach on strategic developments and clinical milestones.
For more information on SELLAS Life Sciences Group, Inc. and its innovative therapies, visit their official website at www.sellaslifesciences.com.
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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