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.
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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced the acceptance of an abstract for a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for June 2-6, 2023, in Chicago. The poster will detail a study on the efficacy and safety of galinpepimut-S (GPS) maintenance therapy for patients with acute myeloid leukemia (AML) who have achieved complete remission after second-line therapy. The study, led by Dr. Omer Jamy, Principal Investigator, will be presented on June 5, 2023. Additionally, SELLAS is advancing its cancer therapies, notably GPS, targeting the WT1 protein across various malignancies, and GFH009, a CDK9 inhibitor licensed from GenFleet Therapeutics.
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.