BioOra gains global CAR T-cell therapy rights from Wellington Zhaotai for Atla-cel development

BioOra Limited has signed a [binding Heads of Terms agreement](https://www.prnewswire.com/news-releases/bioora-limited-and-wellington-zhaotai-therapies-limited-wztl-sign-heads-of-terms-to-advance-their-global-expansion-of-car-t-cell-therapy-302763556.html) with Wellington Zhaotai Therapies Limited granting BioOra exclusive rights to develop and commercialize WZTL-002, a third-generation autologous anti-CD19 CAR T-cell therapy, in all markets outside China and India. The asset, developed under the proposed name Atla-cel (atlacabtagene autoleucel), is currently in a [Phase II pivotal trial ](https://app.allsci.com/clinical-trial/ASC-CT-0000000021675-1.0-1745700230)for relapsed or refractory large B-cell lymphoma. The agreement extends BioOra's existing commercialization rights in New Zealand and Australia — held through a prior partnership with the [Malaghan Institute of Medical Research](https://app.allsci.com/organization/ASC-OH-0000000068364-1.0-1772142984) — into the US, Europe, the UK, and other global markets. Financial terms were not disclosed, consistent with the early-stage nature of a Heads of Terms document. ### Deal context Atla-cel is an autologous CAR T-cell product directed against CD19, a B-cell surface antigen expressed across most B-cell malignancies. The construct incorporates patented co-stimulatory domains described by Wellington Zhaotai as a third-generation design intended to preserve anti-tumor activity while reducing toxicity relative to first- and second-generation CAR T architectures. CD19-directed CAR T therapies are an established class, with approved products including tisagenlecleucel and axicabtagene ciloleucel, but Wellington Zhaotai's construct adds CD28 and toll-like receptor 2 (TLR2) co-stimulatory signaling domains, a combination that distinguishes it structurally from earlier approved agents. Clinical validation was established through [ENABLE-1](https://clinicaltrials.gov/study/NCT04049513) (NCT04049513), a Phase I dose-escalation and expansion trial sponsored by the Malaghan Institute and conducted in collaboration with Wellington Zhaotai. Data from 30 patients presented at the American Society of Hematology 2024 annual meeting showed complete responses and fewer serious toxicities — including lower rates of neurotoxicity — than observed in comparable trials of first- and second-generation agents. BioOra and the Malaghan Institute are now running [ENABLE-2](https://clinicaltrials.gov/study/NCT06486051) (NCT06486051), a Phase II pivotal study in relapsed or refractory large B-cell lymphoma designed to support registration in New Zealand and Australia. A core component of BioOra's value proposition is its automated manufacturing process using the Cocoon platform developed by Octane Medical Group. The system executes all major steps of autologous CAR T manufacturing — T-cell selection, activation, transduction, expansion, and harvest — within a closed, single-use cassette, removing the open-system manual steps that characterize conventional production. BioOra describes the approach as enabling a vein-to-vein turnaround of approximately seven days, compared to the three to six weeks typical of centralized manufacturing for approved CAR T products. The shortened ex vivo culture is intended to preserve a less-differentiated T-cell phenotype associated with greater in vivo persistence. ENABLE-1 also served to validate BioOra's automated manufacturing process in a clinical setting. Wellington Zhaotai was established in 2017 as a joint venture between the Malaghan Institute and Hunan Zhaotai Enterprise Management Limited, a Chinese private enterprise with a cell therapy research and manufacturing platform in Changsha. Through that relationship, Wellington Zhaotai retains rights to WZTL-002 in China and India under this agreement. BioOra was formed in 2021 as a partnership between the Malaghan Institute and Bridgewest Ventures NZ LP, the venture arm of US investment firm Bridgewest Group. *** This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: [https://allsci.com/news/](https://allsci.com/news/) --- Spot something wrong? [Report an issue with this article](https://newsgen-prod.reframedata.com/feedback/car-t-cell-therapy-rights-bioora-gains-global)