FDA Grants Breakthrough Therapy Designation for BrainChild Bio’s CAR T-Cell Therapy for Incurable Pediatric Brain Tumors

BrainChild Bio announced that its investigational B7-H3 targeting autologous CAR T-cell therapy has received Breakthrough Therapy designation from the FDA for treating diffuse intrinsic pontine glioma, a deadly pediatric brain tumor. The designation was based on promising survival benefits seen in the BrainChild-03 Phase 1 trial, conducted by Seattle Children’s and published in Nature Medicine.