ImCheck doubles up on orphan designations for ICT01 in AML

French biotech ImCheck Therapeutics has announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A) monoclonal antibody designed to selectively activate γ9δ2 T cells, in acute myeloid leukemia (AML).

The designation in the European Union comes just days after the US Food and Drug Administration (FDA) granted ODD to the same drug candidate, and provides additional validation of the therapeutic potential of ICT01 in AML, a disease with high unmet medical need and limited treatment options for older or unfit patients who are not eligible for intensive chemotherapy.

 Pierre d’Epenoux, chief executive of ImCheck, said: “Securing orphan drug designation from both the EMA and the FDA in close succession is a major regulatory milestone for ImCheck.