PureTech’s LYT-200 receives FDA fast track for blood cancer

London - PureTech Health plc's Gallop Oncology unit has secured Fast Track designation from the U.S. Food and Drug Administration for LYT-200, a fully human monoclonal antibody targeting galectin-9, in combination with a hypomethylating agent. This designation, intended for drugs addressing serious conditions with unmet medical need, enables more frequent FDA communications and expedites review processes.

LYT-200 is set to undergo Phase 2 STRIDE-MDS trial, aiming to enroll around 125 patients with relapsed/refractory high-risk myelodysplastic syndromes. The randomized, double-blind, placebo-controlled study will assess the efficacy of LYT-200 at two different doses, either combined with a hypomethylating agent or a placebo plus the same agent. The trial will be divided into three groups, with a 2:2:1 ratio.

A Phase 1b trial previously demonstrated promising results, with 27.3% complete response rate, 36.3% complete plus partial response, and 45.5% overall response rate in patients receiving LYT-200 at 12 mg/kg with a hypomethylating agent. No dose-limiting toxicities or myeloid suppression were reported.

Myelodysplastic syndromes affect approximately 60,000-170,000 people in the United States, with 30-40% of cases being high-risk. Currently, only one FDA-approved therapy exists for relapsed/refractory high-risk myelodysplastic syndromes, targeting a genetic mutation found in about 3% of patients. PureTech aims to raise external capital in the first half of 2027 to support LYT-200 development through the Phase 2 trial completion.