Radiopharm Theranostics Launches First Human Trial of Novel Prostate Cancer Therapy
Radiopharm Theranostics has secured ethics approval to begin a Phase 1 clinical trial of RAD 402, a pioneering radiotherapeutic targeting advanced prostate cancer using terbium-161. This marks a significant step in developing a potentially safer, more effective treatment option.
- HREC approval granted for Phase 1 trial of RAD 402 in advanced prostate cancer
- RAD 402 combines a KLK3-targeting monoclonal antibody with terbium-161 radionuclide
- Preclinical studies show strong tumour targeting and favourable biodistribution
- First company-sponsored therapeutic trial employing terbium-161
- Supply agreements in place to support trial production and radiolabelling
Ethics Approval Unlocks Clinical Trial Milestone
Radiopharm Theranostics, a clinical-stage biopharmaceutical company listed on the ASX and NASDAQ, has announced a pivotal regulatory milestone, approval from the Bellberry Human Research Ethics Committee to initiate its first-in-human Phase 1 clinical trial of RAD 402. This novel radiotherapeutic is designed to treat metastatic or locally advanced prostate cancer, a disease with significant unmet medical needs.
Innovative Mechanism Targeting KLK3
RAD 402 is a humanized monoclonal antibody that binds with high affinity to Kallikrein Related Peptidase 3 (KLK3), a protein encoded by the gene responsible for Prostate Specific Antigen (PSA), a key biomarker in prostate cancer detection. By radiolabelling this antibody with terbium-161, a radionuclide emitting both beta particles and Auger electrons, the therapy aims to deliver a potent, dual-action antitumor effect directly to cancer cells while sparing healthy tissue.
Strong Preclinical Data and Strategic Partnerships
Preclinical proof-of-concept studies in mouse models have demonstrated RAD 402’s ability to selectively target prostate tumours with minimal uptake in bone marrow and other critical organs, suggesting a favourable safety profile. Radiopharm has secured supply agreements with Terthera for terbium-161 production and Cyclotek for radiolabelling services, ensuring robust support for the upcoming clinical trial.
A First for Terbium-161 Therapeutics
According to CEO Riccardo Canevari, this trial represents the first company-sponsored therapeutic study using terbium-161, highlighting Radiopharm’s pioneering role in radiopharmaceutical innovation. The dual emission properties of terbium-161 could offer a novel mechanism of action that enhances antitumor activity beyond current radiotherapeutics.
Looking Ahead
With the Phase 1 trial now approved to proceed, Radiopharm is positioned to advance RAD 402 through early clinical development, potentially opening new avenues for treating advanced prostate cancer. The company’s broader pipeline, which includes multiple clinical trials across various solid tumours, underscores its commitment to addressing critical oncology needs through radiopharmaceuticals.
Bottom Line?
RAD 402’s clinical debut could redefine prostate cancer treatment, but investors will watch closely for early safety and efficacy signals.
Questions in the middle?
- How will RAD 402’s safety profile compare to existing prostate cancer therapies?
- What timeline is Radiopharm targeting for Phase 1 trial completion and data readouts?
- Could terbium-161’s dual emission translate into superior clinical outcomes versus other radionuclides?
