FDA Grants Immune-Onc’s IO-202 Fast-Track Status for Treating AML

The FDA has granted Fast-Track designation to Immune-Onc Therapeutics’ IO-202, an experimental myeloid checkpoint inhibitor developed for treating patients with relapsed or refractory acute myeloid leukemia (AML).

Immune-Onc is currently assessing IO-202 alone and in combination with other therapies in a phase 1 trial in patients with AML and chronic myelomonocytic leukemia.

IO-202 works by targeting the leukocyte immunoglobulin-like receptor B4 involved in immune suppression and tumor infiltration. The therapy previously won FDA’s Orphan Drug designation for treating AML in 2020.