Posted by Michael Wonder on 16 May 2025
FDA grants regenerative medicine advanced therapy designation for BrainChild Bio’s B7-H3 CAR T-cell therapy for incurable paediatric brain tumours
15 May 2025 - BrainChild Bio advancing BCB-276 towards BLA submission with a single pivotal Phase 2 trial planned to commence in Q4 2025.
BrainChild Bio today announced that the investigational B7-H3 targeting autologous CAR T-cell therapy has been granted regenerative medicine advanced therapy designation by the US FDA for the treatment of diffuse intrinsic pontine glioma, an incurable paediatric brain tumour.
