On October 1, 2025 OmniaBio Inc., a next generation contract development and manufacturing organization (CDMO) pioneering the manufacturing of cell and gene therapies (CGT) with robotics and artificial intelligence, and BrainChild Bio Inc, a clinical-stage biotechnology company developing Chimeric Antigen Receptor T-cell (CAR-T) therapies to treat solid tumors in the central nervous system, reported their collaboration aimed at manufacturing BrainChild Bio’s pivotal clinical trial therapeutic candidate BCB-276 (Press release, OmniaBio, OCT 1, 2025, View Source [SID1234656383]).
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BrainChild Bio is a kids-first biotechnology company, prioritizing treatments for pediatric brain tumors, with a pipeline that extends the technology platform to adult indications, including glioblastoma and brain metastases. BCB-276 represents a significant advance in the fight against pediatric diffuse intrinsic pontine glioma (DIPG), a rare, aggressive, and universally fatal brain cancer with limited treatment options and a median overall survival of less than 1 year according to the International DIPG/DMG Registry. This innovative autologous CAR-T therapy utilizes a patient’s own immune system by re-engineering their T-cells to recognize and kill cancer cells.
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.
"We’re proud to partner with BrainChild Bio, a company that exemplifies patient-centered innovation in pediatric oncology," said Michael May, President and CEO of OmniaBio. "While many CAR-T developers have solely prioritized clinical outcomes, often leaving manufacturing and supply considerations for later, BrainChild is redefining that approach—placing much needed emphasis on reliability, affordability, and thus patient access by working with OmniaBio."
Steven Brugger, CEO of BrainChild Bio added, "Establishing a scalable and reliable manufacturing pathway is critical for the success of our CAR-T therapy programs. OmniaBio’s deep expertise, commitment to our needs, and advanced facilities make them an ideal partner. This strategic collaboration will significantly augment our ability to scale production and provide reliable and efficient supply for clinical timelines, ultimately bringing hope to patients suffering from devastating brain tumors."
The collaboration will focus on the process development and GMP manufacturing of BrainChild Bio’s lead autologous CAR-T therapy candidate. Both companies anticipate expanding the scope of their collaboration to include additional programs as BrainChild Bio’s pipeline advances.