Cyclotek is excited to announce a contract development and manufacturing agreement with Radiopharm Theranostics, to support the company’s first-in-human, Phase 1 trial of RAD 402, a novel terbium-161 (¹⁶¹Tb) radiolabelled monoclonal antibody for the treatment of prostate cancer.
Cyclotek, a leading Contract Development and Manufacturing Organization (CDMO) in radiopharmaceuticals, has been supporting commercially sponsored clinical trials since 2009, in addition to reliable clinical and commercial supply across Australia and New Zealand, and more recently into the Asia Pacific region.
Under the agreement, Cyclotek will manufacture and supply ¹⁶¹Tb RAD 402, an anti-Kallikrein Related Peptidase 3 (KLK3) radionuclide therapy, for use in Radiopharm Theranostic’s clinical trial in Australia, expected to begin in the second half of 2025.
This trial represents Cyclotek’s first CDMO agreement of a radionuclide therapy labelled with ¹⁶¹Tb, highlighting Cyclotek’s growing capacity to advance innovative radiopharmaceutical research through novel radioisotopes and biological targets.
“Cyclotek is proud to bring novel theranostic trials into Australia. By leveraging our investment in Queensland’s sovereign radiopharmaceutical manufacturing infrastructure, we are able to accommodate next generation isotopes such as terbium-161”, commented Greg Santamaria, CEO of Cyclotek. “Through this project, we are supporting the clinical translation of a new era of targeted radionuclide therapies, that are both accessible and scalable across the region.”
¹⁶¹Tb offers potential advantages that may translate into greater therapeutic potency, particularly in the treatment of micrometastatic disease.
The agreement with Radiopharm Theranostics reinforces Cyclotek’s strategic commitment to translating scientific innovation into clinical impact, by supporting international and domestic pharmaceutical and biotech companies through every stage of the radiopharmaceutical development journey.
Marc Couperthwaite, Operations Manager at Cyclotek Queensland, stated “Cyclotek has significantly strengthened its ability to manufacture critical radionuclide therapies for clinical trials with the additional infrastructure recently positioned at our Princess Alexandra Hospital facility, and with our new facility coming on line in Q3-2026. This project exemplifies the value of our national logistics network, enabling reliable supply of novel products to trial sites across Australia, ensuring rapid, seamless clinical translation for our partners.”
For further information, please contact: Mr Greg Santamaria – enquiries@cyclotek.com
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.
Our dedication to innovation drives our continuous development of new radiopharmaceuticals.
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.
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