SELLAS Receives EMA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas

Core Insights - SELLAS Life Sciences Group, Inc. has received Orphan Drug Designation from the European Medicines Agency for SLS009, a selective CDK9 inhibitor aimed at treating relapsed/refractory peripheral T-cell lymphomas [1][2] - The company has previously obtained Orphan Drug and Fast Track Designations from the FDA for SLS009, indicating strong regulatory recognition for its potential in treating aggressive lymphomas with limited options [2] - SLS009 has shown promising clinical efficacy in a Phase 1 trial, achieving a 36.4% response rate in PTCL patients, compared to a 25.8% response rate for the current standard of care, belinostat [2] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications, including its lead product candidate GPS, which targets the WT1 protein [4] - SLS009 is positioned as a potentially first and best-in-class CDK9 inhibitor, with data suggesting a high response rate in AML patients with poor prognostic factors [4]