A new partnership to scale up ground-breaking CAR T-cell cancer therapy in New Zealand has been announced today at the Malaghan Institute of Medical Research, with the arrival of state-of-the-art automated cell therapy manufacturing technology.
BioOra, a new company formed between the Malaghan Institute and Bridgewest Ventures NZ as part of Callaghan Innovation’s Technology Incubator Programme, will automate the manufacture of this revolutionary immunotherapy with a vision of delivering it at a fraction of current costs.
Malaghan Institute General Manager Mike Zablocki says the partnership is a major milestone in the Institute’s long term plan to help make CAR T-cell therapy a standard of cancer care in New Zealand.
“Bridgewest has extensive commercial pharmaceutical and biological manufacturing experience. It has the depth of capital to invest in the technology and infrastructure needed to scale up the CAR T-cell manufacturing processes that the Malaghan Institute has developed.”
John Robson, General Manager New Zealand of Bridgewest Ventures and Director of BioOra says the automation of CAR T-cell therapy will fundamentally transform how this therapy is delivered.
“Global research is focused on extending CAR T-cell therapy to solid cancers, and automation will allow us to bring more innovative therapies to New Zealand. Our goal is to make New Zealand a leading provider of CAR T-cell treatments by attracting developers of best-in-class therapies to access cost-effective manufacturing at BioOra for CAR T-cell clinical trials or future standard of care therapies.”
CAR T-cell therapy works by redirecting a patient’s own immune cells (T-cells) in the laboratory, to directly identify and kill cancer cells when returned to the patient. The Malaghan Institute is conducting a Phase I safety trial of a novel CAR T-cell construct for relapsed and refractory B-cell non-Hodgkin lymphoma, and plans to validate a new automated manufacturing process later this year.
Malaghan Institute Clinical Director Dr Robert Weinkove says an automated, closed-system method of manufacturing CAR T-cells, using the LONZA Cocoon® technology, will enable the Malaghan Institute to shorten manufacturing times and increase the number of trial participants. BioOra will provide contract manufacturing services to the Institute for future CAR T-cell clinical trials.
“We are planning a series of CAR T-cell manufacturing and clinical improvements – including automated manufacture – to improve patient experience and widen availability.”
Two LONZA Cocoon® platforms will be installed at the Malaghan Institute, one for research and development funded by donors, and one for manufacturing scale-up, owned by BioOra.
Dr Weinkove says philanthropic and government funding – including through MBIE’s Partnership Scheme – has been critical to the programme. This commercial investment reflects interest in the Institute’s current CAR T-cell therapy for lymphoma, developed in partnership with Wellington Zhaotai Therapies, and the potential of CAR T-cell therapies for other cancers in future.
“We now have an opportunity to scale-up CAR T-cell manufacture, with the goal of improving both affordability and availability of this potentially life-saving therapy in New Zealand.”
About BioOra Limited
BioOra Limited is a portfolio company of Bridgewest Ventures NZ LP, a deep tech incubator based in New Zealand. BioOra is a partnership between Bridgewest Ventures and the Malaghan Institute of Medical Research to automate the manufacturing of CAR T-cell immunotherapy and to build out the high-value manufacturing capability in New Zealand.
BioOra aims to scale-up to provide third party manufacturing attracting first-in-class therapies to New Zealand, charging significantly lower costs for CAR T-cell therapy compared to international prices to benefit New Zealanders and attract medical tourism.
Dr Neil Domigan has recently been appointed to the position of Chief Executive of BioOra Limited. Dr Domigan has held executive roles at Genesis Research and Development Corp Ltd, co-ran a government seed venture capital fund, was a Director at Cranleigh Merchant Bank and merchant banker with Mace Consultants in Asia. He is currently Commercial Manager at the Malaghan Institute and Chief Executive of Wellington Zhaotai Therapies, positions he will continue to hold.
New Zealand’s first CAR T-cell therapy clinical trial
The Malaghan Institute, in partnership with Wellington Zhaotai Therapies, is developing and trialling a ‘third generation’ Chimeric Antigen Receptor (CAR) T-cell therapy in New Zealand and undertaking parallel research focusing on improving CAR T-cell therapies and extending them to other cancers.
A Phase I safety trial – ENABLE – got underway at the end of 2019 for people with certain types of relapsed and refractory B-cell non-Hodgkin lymphoma who have exhausted other treatment options. To date, 9 patients have been treated on this trial. A trial extension is currently planned to validate a range of clinical improvements (including automated manufacturing) ahead of any phase II trial. Results from the Phase I trial will be shared when the trial is closed in the coming months.
Alongside support from a range of philanthropic sources including Freemasons New Zealand, the Thompson Family Foundation, David Downs’ Down with Cancer campaign, the trial and research has been funded through the Health Research Council’s IRO funding and MBIE’s Partnership Scheme (matched funding of $4.9M over 5 years).