PureTech's Anti-Galectin-9 Antibody LYT-200 Receives FDA Fast Track with a Hypomethylating Agent for Relapsed/Refractory High-Risk MDS; Phase 2 STRIDE-MDS Planned
PureTech Health announced on Monday, September 21, 2026 a successful end-of-Phase 1 meeting with the FDA and Fast Track designation for LYT-200 in combination with a hypomethylating agent (HMA) for relapsed/refractory high-risk myelodysplastic syndromes (HR-MDS). LYT-200 is a fully human monoclonal antibody against galectin-9, developed by PureTech's founded entity Gallop Oncology. In the Phase 1b study, 11 efficacy-evaluable patients who received 12 mg/kg LYT-200 with an HMA had an overall response rate of 45.5% and a complete response rate of 27.3%, with no dose-limiting toxicities. The planned Phase 2 STRIDE-MDS trial will randomize about 125 patients 2:2:1 to 12 mg/kg or 7.5 mg/kg LYT-200 with an HMA, or placebo with an HMA; LYT-200 also holds Fast Track designation in acute myeloid leukemia.