Core Insights - SELLAS Life Sciences Group, Inc. announced high efficacy of SLS009, a selective CDK9 inhibitor, in solid cancers with ASXL1 mutations, showing a response rate of 67% compared to 0% in non-mutated cancers [1][5] - ASXL1 mutations were identified as a predictive biomarker for SLS009 efficacy in colorectal cancer (CRC MSI-H) and non-small cell lung cancer (NSCLC) [1][2] - The company has filed for provisional patent protection for the use of ASXL1 mutations as a predictive diagnostic tool for selecting cancer patients likely to benefit from SLS009 [5] Summary by Sections Efficacy of SLS009 - In preclinical studies, SLS009 demonstrated high efficacy (IC50 < 100 nM) in 67% of ASXL1 mutated solid cancer cell lines, while no efficacy was observed in non-ASXL1 mutated lines [4][5] - In CRC MSI-H, 57% of ASXL1 mutated cell lines showed high efficacy, while none of the non-mutated lines responded [4] - In NSCLC, 100% of ASXL1 mutated cell lines exhibited high efficacy, with no response in non-mutated lines [4] ASXL1 Mutations in Solid Cancers - ASXL1 mutations were found in 58% of CRC MSI-H patient-derived cell lines and 33% of NSCLC cell lines, exceeding predicted frequencies [4] - Overall, ASXL1 mutations were recorded in 9 out of 18 studied solid cancer cell lines [4] Clinical Development and Future Prospects - The findings support the development of targeted therapies for solid tumors based on ASXL1 mutation status [5] - The company aims to leverage existing clinical data demonstrating SLS009's efficacy in acute myeloid leukemia (AML) to strengthen its position in solid cancers [5][6]

– Pre-specified Events to Trigger Interim Analysis of Phase 3 REGAL Study in Patients with Acute Myeloid Leukemia (AML) Remains on Track for Q4 2024 – – Data from the Phase 2a Trial of SLS009 in Relapsed/Refractory AML After Venetoclax Failure to be Presented at the Upcoming American Society of Hematology (ASH) Annual Meeting in December – – GPS Granted FDA Rare Pediatric Disease Designation (RPDD) for the Treatment of Pediatric AML – NEW YORK, Nov. 13, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, I ...

NEW YORK, Oct. 10, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that Dr. Angelos Stergiou, President and Chief Executive Officer of SELLAS, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on Tuesday, October 15, 2024 at 9:00 am EDT. Maxim Healthcare Virtual Summit Details: ...

-Dosing of the SLS-002 cohort is expected to commence in 4Q2024 NEW YORK, Sept. 24, 2024 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinicalstage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced the signing of a Material Transfer Agreement (MTA) with the U.S. Army Medical Materiel Development Activity (USAMMDA) to supply SLS-002 (intranasal racemic ketamine) for the U.S. Department of Defense ...

Galena Biopharma, Inc. (SLS) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years. The ...

- Announced Independent Data Monitoring Committee's (IDMC) Recommendation to Continue the Phase 3 REGAL Study in Patients with Acute Myeloid Leukemia (AML) Without Modifications: Interim Analysis Anticipated by Q4 2024 - - Reported Positive Preliminary Data from the Phase 2a Trial of SLS009 in r/r AML Demonstrating to Date Overall Response Rate (ORR) of 33%, 50%, and 100% in 60 mg QW, 30 mg BIW and 30mg BIW with ASXL1 Mutation Cohorts Respectively - - SLS009 Granted EMA Orphan Drug Designations and U.S. FDA ...

NEW YORK, Aug. 06, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL). "We are pleased t ...

NEW YORK, Aug. 06, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL). "We are pleased t ...

NEW YORK, July 31, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ:SLS) ("SELLAS'' or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that it has entered into a securities purchase agreement with a single institutional investor for the purchase and sale of 15,849,056 shares of common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggr ...

- Opened Enrollment for Pediatric AML Patients in Ongoing Phase 2 Clinical Trial - Rare Pediatric Disease (RPD) Designation is granted by the FDA for serious or life-threatening diseases that affect fewer than 200,000 people in the United States and in which the serious or life-threatening manifestations primarily affect individuals less than 18 years of age. If, in the future, a New Drug Application (NDA) for SLS009 for the treatment of pediatric AML is approved by the FDA, SELLAS might be eligible to rece ...