Core Insights - SELLAS Life Sciences Group, Inc. has received Rare Pediatric Disease Designation (RPDD) from the FDA for SLS009, a CDK9 inhibitor aimed at treating pediatric acute myeloid leukemia (AML) [3][8] - The RPDD allows SELLAS to potentially obtain a Priority Review Voucher (PRV) upon FDA approval of SLS009, which can be sold or transferred for expedited review of future marketing applications [1][8] - The prognosis for pediatric AML remains poor, with a 5-year overall survival rate of only 33% in relapsed cases, highlighting the urgent need for effective treatments [4] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications, including AML [5] - The company is also advancing another lead product candidate, GPS, which targets the WT1 protein and has potential applications in both hematologic malignancies and solid tumors [5] Clinical Development - The ongoing Phase 2 clinical trial for SLS009 has opened enrollment for pediatric AML patients, emphasizing the company's commitment to addressing the needs of this vulnerable population [1][8] - SLS009 is positioned as a potentially first-in-class small molecule CDK9 inhibitor, demonstrating a high response rate in AML patients with unfavorable prognostic factors [5]

Core Insights - SELLAS Life Sciences Group, Inc. has received Rare Pediatric Disease Designation (RPDD) from the FDA for SLS009, a CDK9 inhibitor aimed at treating pediatric acute myeloid leukemia (AML) [1][5] - This designation follows a previous RPDD for pediatric acute lymphoblastic leukemia, highlighting the company's focus on addressing urgent needs in pediatric oncology [8] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company dedicated to developing novel therapies for various cancer indications, including AML [6] - The company’s lead product candidate, GPS, targets the WT1 protein and has potential applications in both hematologic malignancies and solid tumors [6] Product Development - SLS009 is positioned as a potentially first-in-class small molecule CDK9 inhibitor, showing reduced toxicity and increased potency compared to existing CDK9 inhibitors [6] - The drug has demonstrated a high response rate in AML patients with unfavorable prognostic factors, such as ASXL1 mutations [6] Clinical Context - Acute myeloid leukemia is the second most common hematological malignancy in children, often associated with poor prognosis [5] - Current treatments for refractory and relapsed pediatric AML yield a 5-year overall survival rate of only 33%, with significantly lower rates for those with shorter remission periods [5] Regulatory Implications - If SLS009 receives FDA approval for pediatric AML, SELLAS may be eligible for a Priority Review Voucher (PRV), which can expedite the review process for future marketing applications [2][5] - PRVs have recently been valued at approximately $100 million, indicating significant financial implications for the company [2] Clinical Trials - The company has opened enrollment for pediatric AML patients in an ongoing Phase 2 clinical trial, emphasizing its commitment to developing SLS009 [8]

NEW YORK, July 08, 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 Commission, based on a positive opinion issued by the European Medicines Agency (EMA), has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of acute myeloid ...

NEW YORK, July 08, 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 Commission, based on a positive opinion issued by the European Medicines Agency (EMA), has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of acute myeloid ...

- Rare Pediatric Disease Designation (RPDD) Provides Eligibility for SLS009 to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be Transferred/Sold to Other Parties – - Acute Lymphoblastic Leukemia (ALL) is the Most Common Type of Cancer in Children – - Past Sales of PRVs Have Averaged More Than $100 Million - NEW YORK, June 24, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused ...

Managing Director LifeSci Advisors, LLC - Acute Lymphoblastic Leukemia (ALL) is the Most Common Type of Cancer in Children – - Rare Pediatric Disease Designation (RPDD) Provides Eligibility for SLS009 to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be Transferred/Sold to Other Parties – - Past Sales of PRVs Have Averaged More Than $100 Million - NEW YORK, June 24, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage cli ...

Core Insights - SELLAS Life Sciences Group, Inc. announced a positive review of the Phase 3 REGAL clinical trial for galinpepimut-S (GPS) in acute myeloid leukemia (AML) by the Independent Data Monitoring Committee (IDMC), which recommended the trial continue without modifications [1][7] - The IDMC's assessment indicated no safety or futility concerns, enhancing confidence in GPS as a potential treatment for AML patients [7] - An interim analysis is anticipated by the fourth quarter of 2024, with the IDMC projecting a high level of confidence in this timeline based on unblinded data [1][7] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications, with GPS being a lead product candidate licensed from Memorial Sloan Kettering Cancer Center [9] - GPS targets the WT1 protein, which is present in multiple tumor types, and has potential as both a monotherapy and in combination with other therapies for hematologic malignancies and solid tumors [9] - The company is also developing SLS009, a selective CDK9 inhibitor licensed from GenFleet Therapeutics for global therapeutic and diagnostic uses outside Greater China [9] Clinical Trial Details - The REGAL trial is an open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy [8] - The primary endpoint of the trial is overall survival, and the IDMC is responsible for monitoring patient safety and efficacy data, ensuring the study's validity and scientific merit [8]

– The Independent Data Monitoring Committee (IDMC) Recommends Continuation of Phase 3 REGAL Trial Without Any Modifications – – No Safety or Futility Concerns Were Raised Based on the Efficacy and Safety Assessment of All REGAL Patients – – Interim Analysis Anticipated by Q4 2024 – NEW YORK, June 17, 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 ra ...

- Overall Response Rate (ORR) of 33% and 50% Achieved to Date in 60 mg QW and 30 mg BIW Cohorts, Respectively - The Phase 2a clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels, 45 and 60 mg. In the 60 mg dose cohort patients were randomized into either a 60 mg dose once per week or a 30 mg dose two times per week. The target response rate at the optim ...

- Trial Continues with Two Expansion Cohorts of Patients with ASXL1 Mutations and Myelodysplasia-Related Molecular Mutations Other Than ASXL1; Additional Update Expected in Q3 2024 - Thirty heavily pretreated patients were recruited in 5 centers across the US, reflecting the high unmet need of this refractory/relapsed patient population. Except for one, all patients in this Phase 2a trial had unfavorable/poor cytogenetic and/or molecular genetics risk (97%) and were treated with continued venetoclax – azacy ...