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 targeting 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 [2] - SLS009 has shown a 36.4% response rate in PTCL patients during Phase 1 trials, outperforming the current standard of care, belinostat, which has a 25.8% response rate [2] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [4] - The company’s other lead product candidate, GPS, targets the WT1 protein and has potential applications in both hematologic malignancies and solid tumors [4] - SLS009 is positioned as a potentially first and best-in-class CDK9 inhibitor, with reduced toxicity and increased potency compared to existing options [4]