BioOra Limited, a New Zealand-based company pioneering automated, cost-effective CAR T-cell manufacturing, has announced the signing of a binding Heads of Terms agreement with Wellington Zhaotai Therapies, under which BioOra secures global rights to develop and commercialise Wellington Zhaotai's novel third-generation anti-CD19 CAR T-cell therapy for the treatment of multiple conditions (WZTL-002), including haematological malignancies and auto-immune diseases.
BioOra has combined the unique CAR-T asset developed by Wellington Zhaotai, with BioOra's manufacturing and commercialisation expertise to deliver Atla-cel, an autologous CAR T-cell product incorporating patented co-stimulatory domains designed to deliver robust efficacy with a favourable safety profile, including low rates of neurotoxicity.
The clinical value of the third-generation design has been demonstrated through New Zealand's first CAR T-cell clinical trial, sponsored by Malaghan Institute and conducted in collaboration with Wellington Zhaotai. This study also confirmed BioOra's capabilities in automated manufacturing in a clinical setting. Results from 30 patients showed a complete response rate and fewer serious toxicities than those observed in similar clinical trials of first- and second-generation CAR T-cell therapies.
Through their partnership, BioOra and the Malaghan Institute are now confirming the safety and efficacy of Atla-cel in patients with relapsed/refractory large B-cell lymphoma in a pivotal Phase 2 study designed to enable registration in New Zealand and Australia.
