Cyclotek, Australia’s leading radiopharmaceutical CDMO, is proud to announce its successful application for a Cooperative Research Centres Projects (CRC-P) Round 16 grant, awarded by the Australian Government to support collaborative industry-led research that delivers commercial outcomes.
Cyclotek, in partnership with the University of Melbourne, international biotechnology company Revela Bio Inc., and local SMEs Precision Molecular Imaging & Theranostics (MTIC), iPHASE Technologies, and Preflight, will lead the validation of a nanobody-based theranostic platform designed to improve the diagnosis and treatment of cancer.
Our lead nanobody targets the Fibroblast Activation Protein (FAP), a biomarker highly expressed in many common and aggressive tumour types, including lung, pancreatic and ovarian cancer. Nanobodies combine the precision targeting of antibodies with pharmacokinetics more like small molecules. When paired with a diagnostic or therapeutic radioisotope, nanobodies show promise as a highly selective and scalable theranostic platform.
“This initiative will accelerate research towards a flexible theranostic development platform that can be tuned to multiple cancer targets and radioisotopes,” commented Dr Rob Ware, Cyclotek’s Chief Medical Officer. “By validating this platform, we are building the foundations for supply of a new class of theranostic radiopharmaceuticals, while creating strong commercial opportunities for theranostics throughout the Asia Pacific region.
The CRC-P program will run until mid-2027 and aims to achieve the following milestones:
1. Develop advanced chelation chemistry for radiolabelling nanobodies
2. Pre-clinical evaluation of multiple diagnostic candidates in vivo
3. Conduct first-in-human clinical trials
Cyclotek holds key commercialisation rights for this platform across Australia, New Zealand and select markets throughout the Asia Pacific region, positioning the company to scale and commercialise project outcomes internationally. The success of this program will expand Cyclotek’s existing portfolio of theranostic products, with the potential to extend into other cancer targets.
The project reinforces Cyclotek’s position as a leader in radiopharmaceutical manufacturing, and development, with a commitment to improving patient outcomes through supply of next-generation diagnostics and therapies. Strengthened by our established radiopharmaceutical compounding, testing and quality system matched with our logistics network, Cyclotek is well positioned to strengthen Australia’s sovereign radiopharmaceutical capacity by expanding local expertise and infrastructure, and leveraging international collaborations.
We thank the Department of Industry, Science and Resources for supporting this project through the CRC-P initiative, which is instrumental in translating Australian innovation into global impact.
Cyclotek is the leading radiopharmaceutical manufacturer in Australia and New Zealand. We manufacture diagnostic and therapeutic radiopharmaceuticals for supply into clinical trials and for clinical use.
At Cyclotek, we are committed to improving patient outcomes by making diagnostic and therapeutic radiopharmaceuticals accessible. PET tracers provide patient specific insights into their disease state, leading to earlier diagnosis, more accurate assessment of disease extent, and improved treatment planning and monitoring. Paired with radionuclide therapies, these products offer a comprehensive, non-invasive disease management option.
This helps provide our customers a growing range of tools that enhance the understanding of each patient’s health, contributing to more cost-effective healthcare solutions.
At Cyclotek, we are not just a manufacturer, we are a hub of innovation. Our commitment to quality, safety, supply and customer service ensures that healthcare providers have the best tools available for precise diagnostics and therapies, fostering improved patient care.
Through our unwavering focus on excellence, we aim to make a lasting, positive impact on healthcare.
The University of Melbourne is a key partner in this CRC-P through Professor Paul Donnelly. Building on its recently announced Strategic Partnership with Cyclotek to establish a radiopharmaceutical research and development facility at its Parkville campus, the University brings significant expertise in synthetic chemistry, radiolabelling and translational research. Professor Donnelly and his team will lead the development of novel chemistry techniques underpinning the use of nanobodies as theranostic agents, and collaborate with Cyclotek and iPHASE to establish robust QC and radiolabelling methods.
Precision Molecular Imaging & Theranostics (MTIC) is an Australian SME dedicated to advancing research which will accelerate patient access to novel radiopharmaceuticals. As part of this CRC-P, MTIC led by Professor Rod Hicks, will provide strategic expertise in pre-clinical and clinical trial design, as well as manage participant recruitment, trial execution and clinical data collection. The project will also leverage MTIC’s Siemens Biograph Vision Quadra PET/CT scanner and nuclear medicine therapy facilities.
Revela Bio Inc, headquartered in Cambridge, Massachusetts, is a biotechnology company specialising in the development of nanobody-based imaging and therapeutic agents for cancer. With proprietary expertise in overcoming the challenges of specificity and organ retention, Revela’s technology offers significant potential to advance molecular imaging and therapy. In this CRC-P, Revela will collaborate with Cyclotek, PreMIT and the University of Melbourne to guide pre-clinical studies and support clinical translation of novel FAP-targeting nanobody therapeutics.
Preflight is a Melbourne-based SME specialising in the design and development of digital content and data management systems. Within this CRC-P, Preflight will collaborate with Cyclotek and PreMIT to develop a bespoke, GCP-compliant data management platform tailored for theranostic clinical trials. This platform will streamline the monitoring, storage, and analysis of FIHT data, with built-in encryption and access controls to ensure patient data is ethically and securely managed. Preflight has an established relationship with Cyclotek, having designed, developed, and validated Cyclotek’s online ordering and analytics platforms since 2020.
iPHASE Technologies is an Australian company specialising in the design and manufacture of bespoke automated solutions for PET radiochemistry. Since 2003, iPHASE has combined advanced automation technologies with intelligent design and software interfaces to deliver customised radiochemistry instruments for clients worldwide. Within this CRC-P, iPHASE will collaborate with Cyclotek and the University of Melbourne to adapt manual radiolabelling methods into fully automated synthesis processes, and to establish safe, automated QC protocols in preparation for GMP manufacturing.
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