BCB-276 / BrainChild Bio - LARVOL DELTA

FDA Grants Regenerative Medicine Advanced Therapy Designation for BrainChild Bio’s B7-H3 CAR T-cell Therapy for Incurable Pediatric Brain Tumors (Businesswire) - "BrainChild Bio advancing BCB-276 towards BLA submission with a single pivotal Phase 2 trial planned to commence in Q4 2025...BrainChild Bio...announced that the investigational B7-H3 targeting autologous CAR T-cell therapy has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S Food and Drug Administration (FDA) for the treatment of diffuse intrinsic pontine glioma (DIPG), an incurable pediatric brain tumor....This approach to administering an autologous B7-H3 CAR T-cell therapy has been successfully implemented and resulted in the promising overall survival benefit in patients with brain tumors observed in the BrainChild-03 Phase 1 trial (NCT04185038)..."

FDA event • New P2 trial • Diffuse Intrinsic Pontine Glioma

FDA Grants Breakthrough Therapy Designation for BrainChild Bio’s B7-H3 CAR T-Cell Therapy for Incurable Pediatric Brain Tumors (Businesswire) - "BrainChild Bio advancing BCB-276 towards BLA submission with a single pivotal Phase 2 trial planned to commence in Q4 2025...BrainChild Bio...announced that the investigational B7-H3 targeting autologous CAR T-cell therapy has been granted Breakthrough Therapy designation (BTD) by the U.S Food and Drug Administration (FDA) for the treatment of diffuse intrinsic pontine glioma (DIPG), an incurable pediatric brain tumor. This FDA designation was based on the promising overall survival benefit in patients with brain tumors treated with an autologous B7-H3 CAR T-cell therapy observed in the BrainChild-03 Phase 1 trial (NCT04185038), conducted by BrainChild Bio’s academic partner, Seattle Children’s..."

Breakthrough therapy • New P2 trial • Diffuse Intrinsic Pontine Glioma

ScaleReady Announces a G-Rex Grant has been awarded to BrainChild Bio (PRNewswire) - "ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation and CellReady, today announced that BrainChild Bio has been awarded a $300,000 G-Rex Grant. The G-Rex Grant will support expeditious process development and commercial readiness of BCB-276, BrainChild Bio's lead autologous CAR-T therapy for the treatment of diffuse intrinsic pontine glioma (DIPG), an incurable type of pediatric brain tumor. BrainChild Bio plans to advance BCB-276 into a multi-center Phase 2 pivotal clinical trial in 2025 for the treatment of children and young adults with DIPG."

Financing • New P2 trial • Diffuse Intrinsic Pontine Glioma

BrainChild Bio, Inc. to Clinically Advance BCB-276, an Autologous B7-H3 Targeting CAR T-cell Therapy for Incurable Pediatric Brain Tumors (Businesswire) - "BrainChild Bio, Inc...announced the clinical development plan to advance BCB-276, its lead autologous CAR T-cell therapy targeting the immune checkpoint B7-H3, for diffuse intrinsic pontine glioma (DIPG), a type of incurable pediatric brain tumor. The company plans to advance BCB-276 in a single pivotal registration trial designed to accelerate the path to submit a Biologics License Application for the treatment of children and young adults with DIPG. This clinical plan is based on alignment with the U.S. Food and Drug Administration (FDA) at a Type B meeting to proceed directly to a multi-center Phase 2 pivotal clinical trial....'We look forward to continuing to work with the FDA and to generate the additional data required to support a successful IND submission leading to the initiation of the BCB-276 pivotal trial by the end of 2025'."

New P2 trial • Diffuse Intrinsic Pontine Glioma