Over recent years, Peter Mac has maintained a substantial portfolio of CAR-T and cellular immunotherapy clinical trials, including those that are industry sponsored and investigator initiated.
One of the key goals of the Centre of Excellence in Cellular Immunotherapy (CoE CIT) is to facilitate the increase in cellular immunotherapy clinical trial activity. As such, the CoE CIT’s Pilot Clinical Trial Program was established as a pipeline to facilitate early phase investigator initiated and collaborative clinical trials. We do this by providing support and expertise to co-develop and manufacture innovative, cell-based immunotherapy concepts with our partners for rapid translation into pilot clinical trials with potential for commercial outcomes.
To be considered for the CoE CIT Pilot Clinical Trial Program, an application is required. This will be reviewed by our scientific advisory group (CSAC) and, if successful, a commercial agreement will negotiated and executed.
CoE CIT Pilot Clinical Trial Program Application Process:
FREQUENTLY ASKED QUESTIONS:
- Strong scientific and clinical rationale with demonstration of high scientific quality
- Innovative concept – we do not aim to fund replicas of existing therapies
- High degree of scientific and clinical feasibility
- Commercially viable concept with freedom to operate
- Novel targets
- Innovative platforms for delivery
- Novel combination approaches to increase persistence and potency
- Disease indications with unmet need for cell-based therapies
- Commercially viable concepts with potential to generate Australian-owned IP
- Required preclinical/safety development
- Tech transfer, manufacturing scale-up/process development
- Materials for manufacturing
- Regulatory and ethics approvals
- 6 patient proof-of-concept Peter Mac sponsored clinical trial/dose manufacture
- Medical research institutes
- Commercialisation units of the above institutions
- Australian for-profit enterprises such as pharmaceutical and biotechnology companies