PureTech Health has secured a regulatory boost for its experimental blood cancer treatment in the United States.
The London-listed biotech said the US Food and Drug Administration had granted fast track status to LYT-200, a designation meant to speed up development of drugs for serious conditions with few existing options.
The company also came through an end-of-phase 1 meeting with the regulator, giving it a clear route into the next stage of testing.
LYT-200 is being developed for patients with high-risk myelodysplastic syndromes, a group of aggressive blood cancers where the bone marrow fails to make healthy blood cells.
The focus is on the hardest-to-treat cases, where patients have relapsed or stopped responding to standard therapy and typically survive only a few months.
Treatment options for that group are scarce, with just one drug approved in two decades and it works only for the roughly 3% of patients carrying a specific genetic mutation.
PureTech's pitch is that LYT-200 sidesteps that problem, since it targets the underlying biology rather than any single mutation, potentially widening the pool of patients it could help.
The drug is a monoclonal antibody, a lab-made protein designed to home in on a target called galectin-9 that helps tumours grow and suppresses the immune system.
Early results appear to support the case, with just over a quarter of patients on the higher dose achieving a complete response in a small phase 1b study.
The next trial, named STRIDE-MDS, will randomly assign around 125 patients to one of two doses or a placebo, all alongside standard chemotherapy.
LYT-200 is being advanced through Gallop Oncology, a wholly owned offshoot that reflects PureTech's model of spinning promising drugs into separate, externally funded companies.
To that end, PureTech said it intends to raise outside capital in the first half of 2027 to carry the drug through phase 2.
