New Zealand-based BioOra and Cincinnati Children's Hospital announced a strategic partnership to advance atla-cel, a third-generation CD19-directed CAR-T cell therapy, into clinical development for children and adolescents with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).
BioOra’s atla-cel incorporates design advances intended to enhance anti-tumor activity and improve the tolerability profile compared with earlier-generation approaches. Results from the phase 1 ENABLE-1 study in adults with relapsed or refractory lymphoma, presented at the 2024 American Society of Hematology Annual Meeting, demonstrated promising complete response rates alongside a safety profile notable for low rates of serious CRS and markedly reduced ICANS.
The proposed pediatric B-ALL clinical program would enroll patients across the U.S., New Zealand, and potentially Australia, with trial management from Cincinnati Children's.
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