Welcome to our dedicated page for Sellas Life Sciences Group news (Ticker: SLS), a resource for investors and traders seeking the latest updates and insights on Sellas Life Sciences Group stock.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company focused on developing novel therapies for cancer, with a strong emphasis on acute myeloid leukemia (AML) and other hematologic malignancies. This news page aggregates company announcements, clinical updates, financial disclosures, and collaboration news related to SLS.
Readers can follow developments around SELLAS’ lead product candidate galinpepimut-S (GPS), a WT1-targeted peptide immunotherapy licensed from Memorial Sloan Kettering Cancer Center, which is being evaluated in the pivotal Phase 3 REGAL trial as a potential maintenance therapy in AML after second complete remission. News items include updates on the REGAL trial’s progress, Independent Data Monitoring Committee recommendations, and commentary from investigators and key opinion leaders.
The SLS news feed also covers SLS009 (tambiciclib), SELLAS’ highly selective CDK9 inhibitor. Articles highlight Phase 2 clinical data in relapsed or refractory AML with myelodysplastic syndrome-related changes (AML-MR) after prior venetoclax-based treatment, including reported response rates, survival outcomes, and safety findings for SLS009 in combination with azacitidine and venetoclax. Preclinical results in T-cell prolymphocytic leukemia (T-PLL) and mechanistic studies in AML cell lines are also featured in conference-related releases.
In addition to clinical and scientific news, this page includes corporate updates such as participation in investor conferences, warrant exercise transactions, and quarterly financial results as reported in press releases referenced by Form 8-K filings. Investors and followers of SLS can use this page to review the sequence of material events, from R&D days and conference presentations to financing activities and operational updates, in one organized stream of company-specific news.
SELLAS Life Sciences Group (NASDAQ: SLS) has launched a Pre-Approval Access Program for its lead immunotherapy asset, Galinpepimut-S (GPS), targeting patients with Acute Myeloid Leukemia (AML). This initiative responds to demand from physicians under the 21st Century Cures Act. GPS, which targets the WT1 protein, is currently in pivotal Phase 3 trials and has shown promise as a monotherapy and in combination with PD1 inhibitors. SELLAS aims to improve outcomes for AML patients seeking novel therapeutic options.
SELLAS Life Sciences Group (NASDAQ: SLS) has initiated the fifth dose level cohort of its clinical trial for GFH009, a selective CDK9 inhibitor, focusing on acute myeloid leukemia (AML). The first four dose levels reported no dose-limiting toxicities, with significant anti-leukemic effects noted at 9mg and 15mg doses. Approximately 35% of newly diagnosed AML patients are resistant to current treatments. SELLAS plans to advance to a Phase 2 trial, leveraging GFH009's potential to enhance the effectiveness of venetoclax and azacitidine in treating AML.
SELLAS Life Sciences Group has received approval from China's NMPA for an IND application to begin the first clinical trial of 3D189 (GPS) in China, scheduled for mid-2022. This milestone triggers a $1 million payment to SELLAS, which it expects in Q2 2022. The potential total milestone payments from the licensing agreement with 3D Medicines could reach $191.5 million, excluding future royalties. GPS targets the WT1 protein in various cancers, offering hope for improved patient outcomes.
SELLAS Life Sciences Group (NASDAQ: SLS) announced significant advancements in Q1 2022, including the in-licensing of GFH009, a selective CDK9 inhibitor from GenFleet Therapeutics, which aims to enhance their cancer therapy pipeline. The company closed a public offering raising $25 million for its development projects, including the GPS treatment for acute myeloid leukemia and other cancers. Key organizational changes include the appointment of Robert Francomano as Chief Commercial Officer. Enrollment in the Phase 1/2 GPS study with KEYTRUDA is completed, and an IND for GPS in China is approved.
SELLAS Life Sciences Group (NASDAQ: SLS) announced a public offering of 4,629,630 shares of its common stock and accompanying warrants at a price of $5.40 per share. The offering is expected to generate gross proceeds of $25 million before deducting costs. The securities will be sold by the company and the offering is set to close on April 5, 2022, subject to customary conditions. SVB Leerink and Cantor are the joint book-running managers for this offering. The securities are part of a shelf registration statement previously filed with the SEC.
SELLAS Life Sciences Group (Nasdaq: SLS) has initiated an underwritten public offering of its common stock and associated warrants, with all securities sold by the company. SVB Leerink and Cantor are the joint book-running managers for this offering, which is subject to market conditions. The offering will be conducted under a previously filed shelf registration statement. SELLAS is focused on developing novel cancer therapies, notably GPS and GFH009, potentially addressing various malignancies. The completion details depend on market and closing condition satisfaction.
SELLAS Life Sciences Group has entered a license agreement with GenFleet Therapeutics for worldwide rights to develop GFH009, a selective CDK9 inhibitor, outside Greater China. GFH009 is currently in Phase 1 trials in the U.S. and China, showing promising early results and lower toxicity compared to older versions. SELLAS plans to initiate multiple Phase 2 trials in 2023 for hematological malignancies and pediatric soft tissue sarcomas. The financial terms include an initial $10 million payment and potential milestone payments totaling up to $140 million.
SELLAS Life Sciences Group has appointed Robert Francomano as Chief Commercial Officer, effective immediately. With over 25 years of experience in the biopharmaceutical sector, Francomano previously led Stemline Therapeutics through its transition to full commercialization. His expertise is expected to significantly contribute to SELLAS’s pipeline, particularly with its lead candidate, galinpepimut-S (GPS), which targets various tumor types. CEO Angelos Stergiou expressed confidence in Francomano’s capabilities, hoping to advance the company's mission in cancer therapies.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced on February 28, 2022, that the United States District Court for the District of New Jersey approved a $1.6 million settlement related to litigation involving its predecessor, Galena Biopharma. The settlement, fully covered by insurance, resolves all legacy legal claims. CEO Angelos M. Stergiou expressed satisfaction with the modest settlement, emphasizing the company's focus on developing innovative cancer immunotherapies. SELLAS's lead candidate, galinpepimut-S, targets the WT1 protein in various tumors.
SELLAS Life Sciences Group (NASDAQ: SLS) has completed enrollment in a Phase 1/2 clinical trial for its lead asset, galinpepimut-S (GPS), in combination with Merck’s KEYTRUDA® for advanced ovarian cancer. The trial aims to assess safety and efficacy in 17 patients, with interim data expected by mid-2022 and final results by the end of 2022. This milestone reflects SELLAS's commitment to improving treatment options for difficult-to-treat patients, despite challenges posed by COVID-19.