Southern RNA and Providence Therapeutics have announced their support for a world-first clinical trial evaluating personalised mRNA cancer vaccines for children with advanced and treatment-resistant brain tumours, in what the companies describe as a significant step for both clinical research and mRNA manufacturing capability.
The PaedNEO-VAX trial is funded by Providence Therapeutics in combination with the Australian Government and philanthropic donors.
It is the first multi-site paediatric study to test individualised mRNA vaccines designed specifically for each child’s cancer, according to the companies.
The trial is co-led by The University of Queensland and the South Australian Health and Medical Research Institute, and is sponsored by the Australia & New Zealand Children’s Haematology and Oncology Group.
It is scheduled to begin in March 2026 across eight paediatric hospitals in Queensland, South Australia, New South Wales, Victoria and Western Australia.
PaedNEO-VAX is open to children and adolescents with relapsed or refractory high-grade brain tumours, including high-grade glioma, diffuse midline glioma, medulloblastoma and ependymoma.
The companies noted that Phase I will focus on establishing safety and optimal dosing, while Phase II will assess clinical outcomes such as disease progression, survival and quality of life.
Using genome sequencing and advanced data analysis, tumour-specific targets will be identified for each participant. Personalised mRNA vaccines will then be manufactured in Australia by Southern RNA, with an expected turnaround of approximately 10 weeks from enrolment to dosing. Southern RNA said it will leverage its proprietary mRNA platform and GMP manufacturing expertise to support production of the patient-specific vaccines.
Chris Peck, founder and managing director of Southern RNA, said the organisation was established in 2022 to help address the need for sovereign mRNA manufacturing capability in Australia following the COVID-19 pandemic.
He said the company later expanded its focus to include personalised treatments for unmet medical needs such as cancer.
“This trial embodies our mantra of advancing a better health for Australians,” Peck said, adding that the company was honoured to support what it described as a world-first paediatric study.
Providence Therapeutics said it is contributing its proprietary mRNA vaccine platform and manufacturing expertise to the program.
Founder and chief executive Brad Sorenson said the company’s interest in paediatric brain cancer was shaped by his son’s experience with glioblastoma.
He said Providence was founded in 2015 with a mission to be prepared to respond if his son’s cancer returned, and that a personalised vaccine was later developed for him.
“This trial embodies our mantra of ‘Where Hope and Science Intersect,’” Sorenson said, adding that the company hopes the Australian study will pave the way for similar initiatives in Canada and the United States.
Providence described the trial as an example of collaboration between public investment, clinical leadership and patient-driven innovation, and said it welcomes dialogue with Canadian and US stakeholders interested in advancing comparable personalised cancer vaccine programs.
