BioOra Limited and Wellington Zhaotai Therapies Limited (WZTL) sign Heads of Terms to Advance their global expansion of CAR T-Cell Therapy

WELLINGTON, New Zealand, May 6, 2026 /PRNewswire/ -- BioOra Limited, a New Zealand-based company pioneering automated, cost-effective CAR T-cell manufacturing, today announced the signing of a binding Heads of Terms agreement with Wellington Zhaotai Therapies Limited (Wellington Zhaotai) 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.

This milestone agreement builds on BioOra's existing partnership with the Malaghan Institute of Medical Research through which BioOra already holds exclusive rights for commercialisation of WZTL-002 in New Zealand and Australia. The agreement with Wellington Zhaotai will provide BioOra the exclusive rights to commercialise the therapy in all markets outside of China and India, including USA, Europe and the UK.

BioOra have 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 (ENABLE-1, NCT04049513). 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 therapies¹. 

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 (ENABLE-2, NCT06486051)

BioOra's automated manufacturing process, utilising the Cocoon ® platform developed by the Octane Medical Group, is a core competitive advantage, enabling more consistent, scalable, and lower-cost production of CAR T-cells compared to manual methods. This technology supports the transition from clinical development to commercial supply, addressing key barriers in CAR-T accessibility, such as high costs and manufacturing complexity.

John Robson, CEO of BioOra Limited said, "This agreement positions BioOra to expand Atla-cel into high-value global markets and marks an important commercial milestone for the company. At its heart is the opportunity to bring CAR-T to more patients in more markets. Too many people around the world still have limited access to these personalised cell therapies, largely because of cost. Combining Wellington Zhaotai's innovative science with BioOra's automated manufacturing expertise creates the pathway to change that. To date, Atla-cel has demonstrated remarkable safety outcomes, which are central to its clinical and commercial potential."

Dr Peter Crabree, Chairman of BioOra Limited said, "CAR T-cell therapy represents one of the most consequential advances in oncology of the past decade, yet access remains profoundly unequal. This agreement with Wellington Zhaotai is a concrete step toward changing that, bringing technology developed through world-class international collaboration, and further advanced here in New Zealand, to patients across the globe. For BioOra, this is about more than commercial expansion; it is about ensuring that patients with blood cancers and B-cell mediated diseases have access to therapies that can genuinely alter the course of their disease".

About BioOra Limited
BioOra is a commercial-stage cell therapy company headquartered in Wellington, New Zealand, focused on developing and commercialising next-generation cell therapies for patients across New Zealand, Australia and beyond. Its lead programme, Atla-cel, is a CD19-directed CAR-T therapy, currently being studied in a Phase 2 registration trial for adults with relapsed or refractory B-cell lymphoma. BioOra was formed in 2021 as a partnership between the Malaghan Institute of Medical Research and US investment firm, the Bridgewest Group, through its venture arm, Bridgewest Ventures NZ LP.

About Wellington Zhaotai Therapies Limited
Wellington Zhaotai Therapies Limited is a New Zealand incorporated cell therapy company established in 2017 by Hunan Zhaotai Enterprise Management Limited (Zhaotai) and the Malaghan Institute of Medical Research to develop and commercialise differentiated CAR T-cell therapies for international markets.

The joint venture was founded on a proprietary third-generation Chimeric Antigen Receptor (CAR) construct incorporating intracellular signalling domains which serve to both preserve or enhance anti-tumour activity while improving safety outcomes relative to earlier generation CAR constructs.

Through their shareholder Zhaotai, WZTL has access to a broad innovation platform of translational research, clinical development and manufacturing capability in China that has delivered a substantive suite of innovative cell therapies, designed to treat a range of diseases including haematological cancers, auto-immune diseases and solid tumours. Together with its licensees and collaborators, WZTL's mission is to turn differentiated cell therapy innovation into commercially scalable treatments for patients in global markets. 

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SOURCE BioOra