Posted by Michael Wonder on 22 Apr 2025
FDA grants breakthrough therapy designation for BrainChild Bio’s B7-H3 CAR T-cell therapy for incurable paediatric brain tumours
22 April 2025 - Breakthrough therapy designation is based on the encouraging survival data from the Phase 1 BrainChild-03 trial in children and young adults with diffuse intrinsic pontine glioma.
BrainChild Bio today announced that the investigational B7-H3 targeting autologous CAR T-cell therapy has been granted breakthrough therapy designation by the US FDA for the treatment of diffuse intrinsic pontine glioma, an incurable paediatric brain tumour.
