BioOra Secures Rights to Third-Generation CAR T-Cell Therapy Outside China and India, Using Automated Manufacturing to Address the Cost Barrier

Ahead of their appearance at SynBioBeta 2026, May 4-7th in San Jose, BioOra announces a binding agreement with Wellington Zhaotai Therapies to secure exclusive rights to Atla-cel, a third-generation anti-CD19 CAR T-cell therapy, in all markets outside China and India, including the US, Europe, and the UK.

CAR T-cell therapy is one of the most consequential advances in oncology in the last decade. It is also one of the most expensive and difficult to manufacture. Current commercial CAR-T products require complex, manual, patient-specific cell processing. That limits access.

The product, Atla-cel, is autologous and incorporates patented co-stimulatory domains designed for robust efficacy with a favorable safety profile, including low rates of neurotoxicity. The third-generation design has been tested in ENABLE-1, New Zealand's first CAR T-cell clinical trial. Results from 30 patients showed a complete response rate with fewer serious toxicities than comparable first- and second-generation CAR-T trials.

A pivotal Phase 2 registration trial, ENABLE-2, is now underway for relapsed/refractory large B-cell lymphoma in New Zealand and Australia.

"Too many people around the world still have limited access to these personalised cell therapies, largely because of cost" said John Robson, CEO of BioOra. "Combining Wellington Zhaotai's innovative science with BioOra's automated manufacturing expertise creates the pathway to change that."

BioOra's manufacturing uses the Cocoon® platform (Octane Medical Group), an automated system designed for more consistent, scalable, and lower-cost CAR-T production than manual methods. The ENABLE-1 trial confirmed the platform's capabilities in a clinical setting.

BioOra was formed in 2021 as a partnership between the Malaghan Institute of Medical Research and US investment firm Bridgewest Group. Wellington Zhaotai was established in 2017 by Hunan Zhaotai Enterprise Management and the Malaghan Institute, with access to a broad translational research and manufacturing platform in China.