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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 Group, Inc. (NASDAQ: SLS) announced that the Independent Data Monitoring Committee (IDMC) has recommended the continuation of the Phase 3 REGAL study for galinpepimut-S (GPS) in acute myeloid leukemia without modifications. The IDMC's assessment of unblinded data showed promising results, indicating patients live longer than expected. The primary endpoint focuses on overall survival. This recommendation underlines the integrity of the trial and the potential of GPS as a therapeutic option for AML patients.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) has announced that its CDK9 inhibitor, GFH009, will undergo evaluation in pediatric solid tumors and leukemia models, through the National Cancer Institute's PIVOT Program. This involves a two-phase research plan focusing on pharmacokinetics and efficacy testing. The program is backed by NCI grants and aims to enhance preclinical testing for pediatric cancer treatments. CEO Angelos Stergiou expressed optimism about GFH009's potential to demonstrate significant anti-tumor activity in these studies, paving the way for its clinical development in pediatric indications.
SELLAS Life Sciences Group (NASDAQ: SLS) announced promising preclinical results for GFH009, a CDK9 inhibitor, in treating small cell lung cancer (SCLC). In a study with NCI-H209 xenografts, GFH009 alone reduced tumor growth by 40.4%, while combining it with the PARP inhibitor olaparib led to a 72.3% decrease. These results bolster plans for GFH009 in an upcoming solid cancer trial. No significant safety concerns arose during the study, highlighting GFH009's potential as a novel treatment in personalized cancer therapy.
SELLAS Life Sciences Group announced its participation in the JMP Securities Hematology and Oncology Summit, a virtual investor conference set for December 6-7, 2022. The CEO, Angelos Stergiou, will host a fireside chat on December 7 at 3:20 p.m. ET. SELLAS is focused on developing innovative cancer therapies, including their lead product candidate, GPS, which targets the WT1 protein in various tumor types. The company is also working on GFH009, a selective CDK9 inhibitor.
SELLAS Life Sciences Group, Inc. (SLS) reported a cash position of $21.3 million as of September 30, 2022, along with its financial results for Q3 2022. The company is advancing its Phase 3 REGAL study of galinpepimut-S (GPS) for acute myeloid leukemia (AML) and exploring further developments in ovarian cancer treatments. Research and development (R&D) expenses were $4.3 million for Q3 2022, a slight decrease year-over-year. The net loss narrowed to $7.0 million for Q3 2022 compared to $7.1 million in Q3 2021, reflecting ongoing clinical advancements.
SELLAS Life Sciences Group (NASDAQ: SLS) has provided significant updates on its Phase 3 REGAL clinical trial for galinpepimut-S (GPS) in acute myeloid leukemia (AML) patients. The trial will now include 125 to 140 patients, and interim analyses will be based on 60 events, with final results anticipated by the end of 2024. Preliminary findings indicate a potential two-fold increase in median overall survival (OS). Furthermore, 3D Medicines will enroll around 20 patients, triggering milestone payments to SELLAS, potentially facilitating earlier market access in China.
SELLAS Life Sciences Group (NASDAQ: SLS) announced promising results from its Phase 1/2 clinical trial of galinpepimut-S (GPS) combined with Keytruda for advanced ovarian cancer. The median overall survival was 18.4 months, surpassing 13.8 months from similar studies using checkpoint inhibitors alone. Progression-free survival also improved to 12 weeks compared to 8 weeks previously. A notable finding was the enhanced efficacy seen in patients with detectable PD-L1 biomarkers, suggesting broader applicability for GPS in cancer treatment. Full trial data will be presented at a major medical conference in 1H 2023.
SELLAS Life Sciences Group (NASDAQ: SLS) announced its plans to present data on GFH009, a selective CDK9 inhibitor, at the ASH Annual Meeting from December 10-13, 2022, in New Orleans. The presentations will include GFH009’s mechanism of anti-proliferative activity in hematologic cancers and preliminary safety and efficacy from its first-in-human study. Key presentation details include:
- Title: In Vitro and In Vivo Studies Support GFH009
- Date: December 11, 2022
- Presenter: Dragan Cicic
SELLAS is dedicated to developing novel cancer therapies.
SELLAS Life Sciences Group (NASDAQ: SLS) will host a virtual investor event on November 14, 2022, at 8:30 a.m. ET, to discuss the Phase 3 REGAL clinical trial of galinpepimut-S (GPS) for acute myeloid leukemia. The event will feature company leadership including President and CEO Angelos Stergiou and expert M. Yair Levy from Baylor University Medical Center. GPS targets the WT1 protein, with potential applications in various cancer types. The company is also developing GFH009, a selective CDK9 inhibitor, licensed from GenFleet Therapeutics.
SELLAS Life Sciences Group (NASDAQ: SLS) has announced an update call regarding its Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) patients, scheduled for November 14, 2022. The call will feature company leadership and industry experts, including M. Yair Levy from the Baylor University Medical Center. Additionally, SELLAS is developing GFH009, a CDK9 inhibitor, licensed from GenFleet Therapeutics. This update could be pivotal for investors monitoring SLS' potential in the oncology market.
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