Clinical Trial Results Support BioOra’s Automated CAR T-Cell Manufacturing for Next Phase
New clinical results from the ENABLE phase 1 trial have shown strong safety and efficacy outcomes for a third-generation CD19-specific CAR T-cell therapy—marking a major step forward for the future of automated cancer immunotherapy in New Zealand and beyond.
The data, presented by Dr Rob Weinkove, Clinical Director of the Malaghan Institute, at the 2023 American Society of Hematology (ASH) Annual Meeting in San Diego, reflects outcomes from 25 patients with relapsed or refractory B-cell non-Hodgkin lymphomas treated with the investigational CAR T-cell product WZTL-002.
Promising Results from ENABLE Phase 1
Zero cases of severe cytokine release syndrome (CRS) (grade ≥ 3)
Zero cases of neurotoxicity (ICANS) of any grade
52% complete response rate at three months
These results suggest that the treatment is not only effective but also exceptionally safe—key factors that could help this therapy become more widely accessible.
Three of the patients in a phase 1 expansion cohort received CAR T cells manufactured using BioOra’s automated platform. The treatment was delivered outpatient at the recommended phase 2 dose, with no dose-limiting toxicity or serious side effects reported.
“ENABLE achieved anti-tumour effects on par with commercial CAR T cells,” said Professor Carl June, CAR T-cell pioneer and BioOra board member. “The trial’s results show an improved safety profile with no patients experiencing severe CRS or neurotoxicity. I believe this opens the door to providing this therapy as outpatient treatment which means more patients in more geographies can receive these CAR T-cells.”
Moving Toward Phase 2 and Commercialisation
With this success, the Malaghan Institute and BioOra are planning a Phase 2 efficacy trial, where BioOra’s automated manufacturing platform will be used to produce all CAR T-cell therapies. The goal: scalable, cost-effective production to enable broader access, especially in Australasia.
“By automating CAR T-cell production, we can manufacture at speed, reduce costs, and treat more patients,” said BioOra CEO Andi Grant.
What’s Next?
BioOra and the Malaghan Institute are working together to bring the WZTL-002 product to regulatory approval and clinical use. Their approach offers a unique advantage: combining innovative manufacturing with clinical excellence, making this life-saving treatment more affordable and accessible.