FDA grants fast track designation to IO-202 for advanced acute myeloid leukemia
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The FDA granted fast track designation to IO-202 for treatment of relapsed or refractory acute myeloid leukemia.
IO-202 (Immune-Onc Therapeutics) is a first-in-class myeloid checkpoint inhibitor that targets leukocyte immunoglobulin-like receptor B4 (LILRB4), an immune inhibitory transmembrane protein found on monocytic myeloid cells.
LILRB4 — also expressed on certain hematologic cancer cells and monocytic myeloid cells in the solid tumor microenvironment — inhibits antigen-presenting cell activation, which results in immune tolerance.
Fast track designation is intended to facilitate the development of and expedite the review of drugs intended to treat serious conditions and fulfill an unmet medical need.
“We look forward to working closely with the FDA to accelerate the clinical development of IO-202, which is currently being evaluated as a monotherapy and in combination with other agents in a phase 1 dose escalation and expansion trial in patients with AML with monocytic differentiation and in chronic myelomonocytic leukemia,” Paul Woodard, MD, chief medical officer of Immune-Onc, said in a company-issued press release.
The FDA previously granted orphan drug designation to IO-202 for treatment of AML.
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