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 Life Sciences Group announces the appointment of Andrew Elnatan as Vice President, Head of Regulatory Affairs, Chemistry, Manufacturing, and Controls (CMC) and Quality. With nearly 30 years of experience in regulatory affairs, particularly in oncology, Elnatan aims to strengthen SELLAS' leadership during critical development phases for its clinical programs galinpepimut-S (GPS) and GFH009. His prior success with drug approvals across various global bodies, including the FDA, positions him well to advance SELLAS' regulatory strategies and milestones.
SELLAS Life Sciences Group (NASDAQ: SLS) announced encouraging results from its dose-escalating Phase 1 trial of GFH009, a CDK9 inhibitor, showing a confirmed complete response (CR) in a patient with acute myeloid leukemia (AML). Notably, 97.6% of patients exhibited reduced CDK9 activity biomarkers. The trial, consisting of 57 heavily pretreated patients, reported no dose-limiting toxicities and improved neutrophil counts. These findings suggest GFH009's potential as a treatment for AML and lymphoma, marking a significant milestone in oncology therapeutics.
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.