SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SLS009 for the Treatment of Pediatric Acute Myeloid Leukemia

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]