OmniaBio Inc. and BrainChild Bio Inc are to collaborate on manufacturing BrainChild Bio’s pivotal clinical trial therapeutic candidate BCB-276.
BrainChild Bio is a kids-first biotechnology company, prioritising treatments for paediatric brain tumours, 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 paediatric 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 one year according to the International DIPG/DMG Registry. This innovative autologous CAR-T therapy utilises a patient’s own immune system by re-engineering their T-cells to recognise and kill cancer cells.
BrainChild Bio is preparing to advance BCB-276 in a phase 2 multi-centre, 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-centred innovation in paediatric 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, said: “Establishing a scalable and reliable manufacturing pathway is critical for the success of our CAR-T therapy programmes. 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 tumours.”
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 programmes as BrainChild Bio’s pipeline advances.
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