PureTech Says FDA Grants Fast Track Designation For LYT-200 In Acute Myeloid Leukemia

PureTech Health

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(RTTNews) - Biotherapeutics company PureTech Health plc (PRTC) announced Thursday that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, for the treatment of acute myeloid leukemia (AML).

Fast Track designation is a process designed to streamline the development and accelerate the assessment of drugs that target serious conditions with unmet medical need.

LYT-200 exerts its therapeutic effects in AML by killing cancer cells directly via apoptosis and DNA damage as well as reactivating central anti-cancer effectors of the immune system.

LYT-200 is the most advanced clinical program against galectin-9 and is being evaluated in two ongoing clinical trials

The FDA has also granted orphan drug designation to LYT-200 for the treatment of AML as well as a separate Fast Track designation for the treatment of recurrent/metastatic head and neck squamous cell carcinomas, in combination with anti-PD1 therapy.

PureTech previously announced that it intends to advance LYT-200 via its Founded Entity, Gallop Oncology.