Marseille, France, July 21, 2025 – ImCheck Therapeutics today 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, for the treatment of acute myeloid leukemia (AML). The designation in the EU follows the recently granted U.S. FDA ODD 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.

“Securing orphan drug designation from both the EMA and the FDA in close succession is a major regulatory milestone for ImCheck,”said Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics.“It reflects growing international recognition of ICT01’s potential and supports our objective to accelerate clinical development in both the U.S. and Europe. The EMA ODD’s broad market exclusivity for ICT01 once approved provides additional value as we consider our development strategy.”

“The EMA’s rapid decision reinforces the highly encouraging clinical data supporting ICT01 and its differentiated mechanism of action,” added Stephan Braun, MD, PhD, Chief Medical Officer of ImCheck Therapeutics. “By selectively activating γ9δ2 T cells, a powerful component of the immune system, ICT01 offers a novel therapeutic pathway in AML. This momentum brings us closer to our goal of delivering new therapeutic options to AML patients who currently have limited treatment options.”

The EMA’s orphan drug designation is granted to medicines intended for the treatment of life-threatening or chronically debilitating rare conditions affecting fewer than 5 in 10,000 people in the EU. Benefits of the designation include protocol assistance, reduced regulatory fees, and ten years of market exclusivity in Europe following approval.