Researchers at Melbourne's Peter MacCallum Cancer Centre have spent years working on a problem that has frustrated cancer immunology. CAR T cell therapies have changed the outlook for some blood cancers, but they have largely failed against solid tumours. Now Peter Mac wants to find out whether its own experimental therapy can be manufactured reliably enough to go into people.
The centre has signed a letter of intent with the Viral Vector Manufacturing Facility, a Westmead company funded by the NSW Government that describes itself as Australia's only commercial viral vector contract development and manufacturing organisation. The agreement is the first step in what both organisations describe as a broader collaboration on new cellular immunotherapies.
The first piece of work tests manufacturing readiness. Peter Mac's CAR T cell is made using an adeno-associated virus, or AAV, vector. VVMF will run an initial pilot study at development scale to measure the AAV process productivity, how much material can be recovered, and whether it meets the relevant quality attributes. The study will cover process feasibility, small-batch production, recovery evaluation, and analytical characterisation. The results will show whether the candidate can realistically be manufactured and will guide the move towards full GMP production to support a Phase 1 clinical trial.
The therapy comes from the laboratories of Professor Paul Beavis and Professor Jane Oliaro, who recently received a $17.7 million grant from the Medical Research Future Fund to develop a CAR T cell therapy that can treat solid tumour cancers. If they answer the manufacturing questions, the first human trial will be in multiple myeloma rather than solid tumours. That trial is meant to validate the approach before a later trial in solid tumour cancers.
VVMF chief executive Stephen Thompson said the partnership aims to close a familiar gap in Australian medical research.
"Australia is home to world-class research in cancer, but translating promising discoveries into clinical programs requires access to specialised development and advanced GMP manufacturing expertise.
"We are pleased to be working with Peter Mac to evaluate the manufacturability of this AAV-based candidate and generate the process and analytical data required to inform its future development. This collaboration reflects VVMF's commitment to supporting Australian researchers as they advance innovative therapies towards the clinic."
Professor Oliaro, Chief Scientist for the Centre of Excellence in Cellular Immunotherapy at Peter Mac, said the manufacturing work was a necessary step before testing the therapy in patients.
"Professor Beavis and I are delighted to have engaged the services of VVMF for this critical step before advancing this experimental CAR T-cell therapy into the clinic. Ultimately, our goal is to target solid tumour cancers, an area where there is a huge unmet need. We look forward to building a strong and productive relationship with the VVMF team as we explore the potential of this and other novel approaches that could meaningfully improve outcomes for people living with cancer."
Both organisations say the deal reflects a shared commitment to strengthening Australia's capacity to turn promising cell and gene therapy research into clinical programs and, eventually, new treatments for patients.
