PureTech Health PLC on Thursday said that the US Food & Drug Administration has granted fast track designation to its antibody LYT-200 for the treatment of acute myeloid leukemia.
The designation aims to expedite the development and regulatory review of drugs addressing serious conditions with unmet medical needs.
The Boston, Massachusetts-based biotechnology company said that this milestone follows prior FDA recognition of LYT-200, including orphan drug designation for AML and a separate fast track designation for recurrent metastatic head and neck cancers, granted last year.
‘Fast Track designation from the FDA reinforces our belief in the potential for LYT-200 to address the urgent needs of AML patients,’ said Luba Greenwood, entrepreneur-in-residence at PureTech and leader of its Gallop Oncology initiative.
LYT-200, which targets galectin-9 - a protein linked to cancer proliferation and immune suppression -exerts its effects by directly inducing cancer cell death via apoptosis and DNA damage while reactivating key components of the immune system. The antibody is currently being evaluated in two ongoing phase 1 and 2 trials.
Shares in PureTech were up 6.9% at 149.61 pence each in London on Thursday afternoon.
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