BCB-276 / BrainChild Bio - LARVOL DELTA

Seattle-based BrainChild Bio…has closed a USD 116 million Series A financing to fund a pivotal registrational trial in diffuse intrinsic pontine glioma (DIPG)… (AllSci Corp) - "An undisclosed private family fund and foundation led the round, with participation from Seattle Children's...and WRF Capital, the investment arm of the Washington Research Foundation, as a new investor. Proceeds will primarily support the ILLUMINATE Phase II study (NCT07680439), a pivotal, single-arm registrational trial designed to support a future Biologics License Application (BLA) with the US FDA for BCB-276....Additional funds will advance BCB-214, a triple-targeting CAR T candidate directed at B7-H3, EGFR, and IL13Rα2 in glioblastoma, toward initial clinical testing."

Financing • Diffuse Intrinsic Pontine Glioma • Glioblastoma

Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG). (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: BrainChild Bio, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Diffuse Midline Glioma • Glioma • Oncology • Pediatrics • Solid Tumor

Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG). (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: BrainChild Bio, Inc

New P2 trial • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Diffuse Midline Glioma • Glioma • Oncology • Pediatrics • Solid Tumor

OmniaBio Inc…and BrainChild Bio Inc…announced their collaboration aimed at manufacturing BrainChild Bio's pivotal clinical trial therapeutic candidate BCB-276. (Yahoo Finance) - "BrainChild Bio is preparing to advance BCB-276 in a Phase 2 multi-center, pivotal registration trial to support a potential Biologics License Application (BLA) to the U.S. FDA for the treatment of children and young adults with DIPG. Manufacturing for BCB-276 will take place at the OmniaBio CGT production facility based in Hamilton, Ontario."

Licensing / partnership • Diffuse Intrinsic Pontine Glioma

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