Highlights
- Radiopharm and Cyclotek have signed a supply deal to advance RAD 402 for prostate cancer treatment.
- RAD 402 to feature in the first company-sponsored prostate cancer study using Terbium-161 (¹⁶¹Tb).
- Phase 1 clinical trial of RAD 402 is set to launch in Australia in 2H 2025.
- ¹⁶¹Tb offers potential advantages over ¹⁷⁷Lu through additional tumor-killing electrons.
- Collaboration marks the final step before ethics submission and trial initiation.
Radiopharm Theranostics Limited (ASX: RAD, Nasdaq: RADX), a clinical-stage biopharmaceutical company developing innovative radiopharmaceutical therapies for cancer, has reached a major milestone in the development of its novel radiotherapeutic RAD 402 for prostate cancer. The company has entered into a supply agreement with Cyclotek, a major radiopharmaceutical manufacturer. Under the deal, Cyclotek will produce and supply doses of 161Tb-labeled RAD 402 in Australia.
Phase 1 Trial Set for 2H 2025
The agreement paves the way for Radiopharm to launch its Phase 1 clinical trial, anticipated to begin in the second half of 2025. RAD 402 is an anti-Kallikrein Related Peptidase 3 (KLK3) monoclonal antibody radiotherapeutic labelled with the radionuclide 161Tb, for fighting prostate cancer
Designed specifically for prostate cancer, RAD 402 targets KLK3, a biomarker with high expression in prostate tissue and minimal expression elsewhere, enhancing the precision and potential safety of the treatment.
The Phase 1 clinical trial will be the first company-sponsored prostate cancer study using ¹⁶¹Tb.
RAD 402 is uniquely radiolabelled with ¹⁶¹Tb, a next-generation radionuclide that offers enhanced therapeutic potential. Compared to conventional agents such as Lutetium-177 (¹⁷⁷Lu), ¹⁶¹Tb emits additional Auger and conversion electrons, which may improve tumor-killing efficacy.
Greg Santamaria, CEO of Cyclotek, shared his enthusiasm for the collaboration: “We are pleased to partner with Radiopharm to facilitate the development of their innovative radiotherapeutic, RAD 402. Our mission is to improve access to radiopharmaceuticals to enhance patient outcomes, and we look forward to supporting this important step toward market approval.”
Radiopharm Theranostics continues to expand its clinical pipeline, which includes one Phase 2 and three Phase 1 trials across multiple solid tumour types. The company is focused on bringing advanced radiopharmaceutical therapies to patients with high unmet medical needs.
Shares of RAD were trading at AUD 0.023 at the time of writing on 24 June 2025.