BOSTON - PureTech Health plc (NASDAQ:PRTC, LSE:PRTC) has announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its investigational drug LYT-200 for the treatment of acute myeloid leukemia (AML), a serious and life-threatening blood cancer with limited treatment options. This regulatory milestone aims to expedite the drug's development and review process due to the urgent need for new AML therapies.
LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, is currently undergoing evaluation in two Phase 1/2 clinical trials. It has shown potential in treating AML and myelodysplastic syndrome (MDS), as well as head and neck cancers. The FDA's Fast Track designation is based on preliminary data from these trials, which suggest LYT-200's capability to kill cancer cells and reactivate the immune system's anti-cancer effectors.
This recent FDA action follows other recognitions for LYT-200, including Orphan Drug designation for AML and another Fast Track designation for head and neck cancers, granted last year. The drug's dual approach, targeting both cancer cell proliferation and immune suppression, positions it as a novel therapeutic option for AML patients, as highlighted by Luba Greenwood, J.D., Entrepreneur-in-Residence at PureTech.
The ongoing trials for LYT-200 have reported favorable safety and tolerability profiles, with early signs of clinical activity both as a monotherapy and in combination with other cancer treatments. In addition to its therapeutic effects, preclinical data support the importance of galectin-9 as a target and suggest the opportunity for biomarker development, which could further guide LYT-200's clinical use.
PureTech, a clinical-stage biotherapeutics company, focuses on developing new classes of medicines for devastating diseases. Its R&D efforts have yielded a pipeline of 29 therapeutics, including three FDA-approved drugs. The company intends to advance LYT-200 through its Founded Entity, Gallop Oncology.
The information in this article is based on a press release statement.
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