- 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
Development Program
The Centre of Excellence in Cellular Immunotherapy Development Program provides access to a full spectrum of specialised cellular immunotherapy preclinical know-how, product manufacturing development and clinical trial capabilities.
The Development Program
The Development Program aims to expand the offering of ground-breaking cellular immunotherapy clinical trials that are available to Australians with cancer. It acts as an IP accelerator program, designed to speed up the process of getting new, cutting-edge therapies into early-phase clinical trials.
Our goals
Identify and rapidly advance novel Australian research in cell-based immunotherapy through a comprehensive translational development program
Increase the number and variety of advanced cellular immunotherapy clinical trials in Australia, providing more options for people living with cancer
Create commercial opportunities for innovative Australian research by co-developing and accelerating Australian intellectual property
Model
The Development Program aims to collaboratively develop new technologies for proof-of-concept clinical trials.
This may include:
- Preclinical, manufacturing and clinical development activities that continue where discovery research ends
- Provision for CAR-T or other cellular immunotherapy doses by the Centre’s GMP manufacturing partners, Cell Therapies Pty. Ltd.
- Supply of clinical/GMP grade materials including vector
- Necessary regulatory and governance expertise for TGA, HREC and associated governance approvals
- Peter Mac sponsored clinical trial with a Peter Mac Cancer Centre clinician as a Principal Investigator (PI)
Translation Lab Pre-Clinical Development
Manufacturing PQ runs
Product Manufacturing
Regulatory Applications & Approvals
Clinical Trial Development
First Patient
Ongoing patient recruitment
Stages of Entry
Projects can enter the Development Program at any stage of the development process. Once accepted, you will collaborate with our dynamic team on a milestone-driven timeline, charting the path towards a Phase I clinical trial.
Program Entry Points
Novel Target
Novel CAR
In vitro data
In vivo data
Manufacturing (MoM)
Pilot Clinical Trial
CAR Generation Program
Preclinical Program: in vitro development
Validated target or Novel target
Preclinical Program: in vivo development
Clinically-relevant model?
Clinical Development Program
Tech-transfer ready (MoM)?
Manufacturing Development Program
Pilot Clinical Trial Development Program
Proposal Acceptance
The Development Program application assessment process is overseen by the Centre of Excellence in Cellular Immunotherapy Clinical and Scientific Advisory Committee (CSAC). This Committee is made up of national and international experts in leading-edge cellular immunotherapy research and its clinical application, along with expertise in manufacturing development and commercialisation.
This Committee is responsible for choosing the most promising project applications based on selection criteria, which include aspects of:
- strong scientific rationale
- innovative concept, avoiding replica studies
- clinical feasibility
- commercial viability with a path to potential commercialisation
Our team invites discussions around projects prior to application. Please contact us for more information.
The Centre of Excellence in Cellular Immunotherapy invites discussions around projects prior to application. Please contact us for more information.
Frequently Asked Questions
What are the key selection criteria?
What is the scope of cellular immunotherapy programs for development?
- 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 Intellectual Property (IP)
What does the Centre of Excellence in Cellular Immunotherapy funding support?
- Required preclinical/safety development
- Tech transfer, manufacturing scale-up/process development
- Materials for manufacturing
- Regulatory and ethics approvals
- A 6-12 patient Peter Mac sponsored clinical trial with patient dose manufacture
Who can apply?
- Universities
- Medical research institutes
- Hospitals
- Commercialisation units of the above institutions
- Australian for-profit enterprises such as pharmaceutical and biotechnology companies
Expression of Interest
Please tell us about your project and we will come back to you.
If you have any questions, please contact us.
