Viral Vector Manufacturing Facility Pty Ltd (VVMF), Australia’s only commercial viral vector Contract Development and Manufacturing Organisation (CDMO) and Peter MacCallum Cancer Centre (Peter Mac), a world-leading cancer research, education and treatment centre, have signed a Letter of Intent (LoI) that marks the first step in a broader collaboration aimed at advancing novel cellular immunotherapies and addressing unmet patient need.
The initial engagement will involve a manufacturing-readiness assessment of a novel CAR T-cell developed by Peter Mac as a potential treatment for solid tumour cancers. This experimental treatment uses an adeno-associated virus (AAV) vector in the manufacturing of the CAR T-cells.
Under the LoI, VVMF will conduct an initial development-scale pilot study to assess the productivity, recovery and relevant quality attributes of the AAV to be used in the CAR T-cell production. The study will include process feasibility assessment, small-scale production, recovery evaluation and analytical characterisation. The resulting data will help determine the candidate’s manufacturing feasibility and inform progress towards full GMP production supporting Phase 1 clinical trial activity.
The LoI builds on work led by Peter Mac’s Professor Paul Beavis and Professor Jane Oliaro, who recently received a $17.7M grant from the Medical Research Future Fund (MRFF) to develop a CAR T-cell therapy able to treat solid tumour cancers. If manufacturing-readiness is shown, the novel CAR T-cell therapy will advance to a first-in-human clinical trial in multiple myeloma as a validating step towards a later clinical trial in solid tumour cancers.
The collaboration brings together Peter Mac’s expertise in cancer research and the development of innovative therapies with VVMF’s specialised viral vector development and manufacturing capabilities. It reflects a shared commitment to strengthening Australia’s capacity to translate promising cell and gene therapy research into clinical programs and, ultimately, potential new treatments for patients.
Stephen Thompson, VVMF CEO said: “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 Jane Oliaro, Chief Scientist for the Centre of Excellence in Cellular Immunotherapy at Peter Mac said: “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.”