A South Auckland raid leads to record meth bust, breakthrough cancer therapy steps up a gear and Donald Trump faces his fourth indictment in less than five months. Video / NZ Herald / Getty / AP
Scientists are scaling up production of a breakthrough cancer therapy undergoing a first-of-its-kind medical trial in New Zealand.
Over the past six years, a Malaghan Institute-led effort has been developing a new generation of CAR T-cell therapy, where a patient’s own immune or T-cells are genetically modified to recognise anddestroy their cancer.
As part of the ongoing “Enable” trial, patients with specific types of lymphoma have been treated in Wellington, using CAR T-cells created and manufactured at the institute.
Results have so far been promising, with preliminary data supporting an expansion of the clinical trial programme.
While today a standard therapy overseas for types of relapsed lymphoma, leukaemia and for myeloma, CAR T-cell therapy isn’t yet available as a funded treatment in New Zealand.
It’s hoped the Enable trial - arising from a joint venture between the institute and China’s Hunan Zhaotai Medical Group – will ultimately deliver a safer, affordable and effective option for Kiwis.
Months after entering a multimillion-dollar deal with India-based pharma giant Dr Reddy’s Laboratories, the homegrown effort has now reached another milestone.
With its start-up company BioOra, the institute has begun clinical production of its “next generation” CAR T-cells using a new automated process – a shift that its director, Professor Graham Le Gros, says is key to “taking it to the people”.
“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.”
Source / Malaghan Institute
The institute’s clinical director, Dr Robert Weinkove, said moving manufacture from a time-intensive manual process to an automated one would 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.”
Weinkove said the manufacturing process had been complex, involving multiple steps and 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,” Weinkove said.
“Automating the manufacture provides significant advantages including increased throughput and lower costs, while maintaining quality.”
At this point, Enable is still a phase 1 trial – which meant it was the first time this type of CAR T-cell has been given to people – with safety results due this year.
It is hoped that results from a phase 2 trial – expected to get under way next year – could lead to future approval for routine use of the treatment in New Zealand.
