PureTech Health plc, a biotherapeutics company, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to LYT-200, a pioneering anti-galectin-9 monoclonal antibody, for the treatment of acute myeloid leukemia (AML).
The Fast Track designation is aimed at expediting the development and review process for medications that address serious conditions and cater to unmet medical needs.
LYT-200 operates in the treatment of AML by directly inducing apoptosis and DNA damage in cancer cells and by reactivating crucial anti-cancer components of the immune system.
Currently, LYT-200 is the most advanced clinical program targeting galectin-9 and is being assessed in two active clinical trials.
Additionally, the FDA has awarded orphan drug status to LYT-200 for AML treatment and granted a separate Fast Track designation for its use in treating recurrent or metastatic head and neck squamous cell carcinomas, in conjunction with anti-PD1 therapies.
PureTech has previously revealed plans to advance the development of LYT-200 through its Founded Entity, Gallop Oncology.
