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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.
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.
SELLAS Life Sciences Group reported progress in its clinical programs and financials for 2022. Their Phase 3 REGAL AML study is on track for interim analysis in late 2023/early 2024, with milestone payments from 3D Medicines expected to total $13 million in H1 2023. The company raised $20 million in February, enhancing its cash position to $37.1 million. Negative trends include a net loss of $41.3 million, a sharp increase from 2021's loss of $20.7 million, and a significant drop in licensing revenue from $7.6 million to $1 million. Research and development expenses rose to $20.3 million, partly due to higher clinical trial costs.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced the publication of Phase 1 trial results combining galinpepimut-S (GPS) with nivolumab in treating relapsed WT1-expressing ovarian cancer. The study, published in Cancers, revealed that 70% of patients achieved one-year progression-free survival, significantly higher than historic rates of 55%. Notably, 91% of patients exhibited WT1-specific T-cell responses, indicating robust immunologic activity. The results suggest GPS may provide substantial clinical benefits and delay disease relapse compared to salvage chemotherapy alone.
SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) announced a public offering of 7,220,217 shares of common stock at $2.77 per share, including warrants with the same exercise price. The offering, expected to raise $20 million prior to expenses, is anticipated to close on February 28, 2023. Cantor Fitzgerald & Co. is the sole book-running manager. All securities are being sold by SELLAS under a previously declared effective shelf registration. The company focuses on developing novel cancer therapies, with lead candidate GPS targeting various tumors.
SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) announced an underwritten public offering of shares and warrants to purchase its common stock. All securities in this offering will be sold by the company, with Cantor Fitzgerald & Co. acting as the sole book-running manager. The offering is subject to market conditions, and its terms are yet to be finalized. This initiative is in accordance with a previously filed shelf registration statement with the SEC. SELLAS focuses on developing novel cancer therapies, including its lead candidate, GPS, targeting the WT1 protein found in various tumors, and a CDK9 inhibitor, GFH009.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is set to host a virtual event on January 31, 2023, at 8:30 a.m. EST, focusing on the treatment landscape for acute myeloid leukemia (AML) and its lead therapy, galinpepimut-S (GPS). The event will feature hematology oncology expert Omer Jamy, MD, who leads the Phase 3 REGAL study at the University of Alabama. GPS targets tumors overexpressing the WT1 antigen and is currently in a Phase 3 trial for AML patients in complete remission post second-line therapy. A live Q&A session will follow the presentation, providing insights into SELLAS's innovative cancer therapies.
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.