In a significant milestone for New Zealand’s first CAR T-cell clinical trial, partners at the Malaghan Institute and  BioOra have started the clinical production of CAR T-cells using a new automated process – a shift that is key  to scaling up this ground-breaking cancer therapy in New Zealand and “taking it to the people,” says  Malaghan Institute Director Professor Graham Le Gros. 

“This isn’t just a process change, this is a step change, it’s about democratising a cutting-edge cancer therapy  that New Zealanders deserve to have access to, and reducing inequities in cancer outcomes.”  

Malaghan Institute Clinical Director Dr Robert Weinkove says moving manufacture from a time-intensive manual process to an automated one will allow the team to manufacture CAR T-cells more consistently and at  scale. 

“This automation is critical to enable us to treat more patients – within our clinical trial programme at first and, we hope, as a future standard of care. This a huge milestone for our CAR T-cell programme, and  demonstrating that this can be done here will put New Zealand among leaders internationally in this field.” 

CAR (chimeric antigen receptor) T-cells are patients’ own immune cells that have been gene-engineered to  redirect them against their cancer. CAR T-cells have become a standard of care for certain blood cancers  overseas, but are not yet funded in New Zealand.  

Dr Weinkove says until recently, the  Malaghan Institute has manufactured patients’ CAR T-cells manually, a time intensive process requiring over 40 hours of skilled operator time inside a specialised clean room for each patient’s dose.  

“Working with BioOra, this process has now been largely automated with manufacture of patient CAR T-cells taking place in a closed system – Lonza’s Cocoon Cell Therapy Manufacturing Platform. Automating the manufacture provides significant advantages including increased throughput and lower costs, while maintaining quality.” 

The production of CAR T-cells is complex, involving multiple steps, so automation demanded careful  optimisation and validation, says Dr Weinkove. “Teams at the Malaghan Institute and BioOra worked closely  with New Zealand regulators to develop a world-leading process for manufacture of CAR T-cell products here  in Aotearoa.” 

In 2019, the Malaghan Institute began enrolling patients to ENABLE, a phase 1 safety trial of a novel ‘third  generation’ CAR T-cell construct for relapsed and refractory B-cell non-Hodgkin lymphoma, developed in  partnership with Wellington Zhaotai Therapies Ltd. More than 20 patients have been treated in the trial, with  the final patient in the ‘dose escalation cohort’ treated in January 2023. The phase 1 trial has been extended to add a ‘dose expansion cohort’, in which patients are receiving CAR T-cells manufactured using the new  automated process. The Malaghan Institute, BioOra and Wellington Zhaotai Therapies Ltd are planning a  larger phase 2 trial from 2024, to establish the effectiveness of these CAR T-cells. 

In 2021, the Malaghan Institute formed a new company with Bridgewest Ventures – BioOra – to automate the  manufacture of CAR T-cell therapy with a vision of delivering this new type of therapy locally, and at lower cost. The Malaghan Institute and BioOra will work together to complete the phase 1 trial using the automated  manufacturing process and during the planned phase 2 trial. 

BioOra CEO Andi Grant says affordability and accessibility of cell therapies is both a New Zealand and global  problem, largely caused by overseas companies adopting high cost, labour and capital intensive clinical and  manufacturing models.  

“BioOra and the Malaghan Institute are applying smart, digital, decentralised and automated clinical and  manufacturing approaches here in New Zealand, with the goal first and foremost to ensure affordable access  for New Zealanders,” she says.  

“Our strategic partners, Lonza, who have developed the Cocoon technology, tell us we are the first in the  Southern Hemisphere to treat patients using a GMP licensed manufacturing platform that has the Cocoon at  its base. That we are the first just affirms for us that, once again, that New Zealand is at the forefront of  innovation and BioOra will be successful in achieving our goal of applying these same approaches globally to  enable access to a breadth of CAR T products”. 

Digital assets 

A range of digital assets, including an infographic, photos and video footage of the Cocoon is available to  download via this Dropbox link. 

Media enquiries 

Gail Marshall | Head of Communications, Malaghan Institute of Medical Research 
gmarshall@malaghan.org.nz | +64 21 360 432 
malaghan.org.nz 
bioora.com