Prostate Cancer Radiotherapy Faces Crucial Test with RAD 402 Trial Ahead
Radiopharm Theranostics has inked a clinical supply agreement with Cyclotek to support its Phase 1 trial of RAD 402, a novel radiotherapeutic targeting prostate cancer, set to commence in Australia in late 2025.
- Supply agreement signed with Cyclotek for radiolabelling RAD 402 with Terbium-161
- RAD 402 targets KLK3, highly expressed in prostate cancer cells
- Preclinical data confirms safety and promising biodistribution profile
- Phase 1 clinical trial anticipated to start in second half of 2025 in Australia
- Cyclotek to manufacture doses supporting the upcoming clinical trial
A Milestone in Prostate Cancer Radiotherapy
Radiopharm Theranostics, a clinical-stage biopharmaceutical company listed on both the ASX and Nasdaq, has taken a significant step forward in its development of RAD 402, an innovative radiopharmaceutical designed to treat prostate cancer. The company announced a clinical supply agreement with Cyclotek, a leading radiopharmaceutical manufacturer in Australia and New Zealand, to radiolabel RAD 402 with the radionuclide Terbium-161 (161Tb). This partnership is pivotal in enabling the commencement of a Phase 1 clinical trial in Australia, anticipated in the second half of 2025.
Targeted Innovation with RAD 402
RAD 402 is a monoclonal antibody therapeutic that targets Kallikrein Related Peptidase 3 (KLK3), a protein highly expressed in prostate tissue and prostate cancer cells, but with minimal presence in other organs. This specificity offers the potential for a more precise attack on cancer cells while sparing healthy tissue. The use of Terbium-161 as the radiolabel is particularly noteworthy; unlike other radionuclides such as Lutetium-177, Terbium-161 emits additional Auger and conversion electrons alongside beta radiation, which may enhance the therapeutic effect by delivering more potent, localized radiation damage to cancer cells.
Preclinical Promise and Next Steps
Radiopharm Theranostics has completed a comprehensive preclinical data package for RAD 402, demonstrating a favorable safety profile and promising biodistribution characteristics. These findings underpin the company’s confidence as it moves toward submitting for ethics approval, a critical regulatory step before patient enrolment can begin. The supply agreement with Cyclotek ensures that the necessary radiolabelled doses will be produced and available to support the clinical trial, underscoring the operational readiness of this next phase.
Strategic Partnership and Industry Implications
Cyclotek’s role extends beyond manufacturing; as a hub of innovation in radiopharmaceuticals, the company’s collaboration with Radiopharm Theranostics highlights a growing ecosystem focused on advancing targeted cancer therapies. Cyclotek’s CEO Greg Santamaria emphasized their commitment to improving patient outcomes by enhancing accessibility to these cutting-edge treatments. For Radiopharm, this partnership is a crucial enabler to bring RAD 402 closer to market approval and to demonstrate the broader value radiotherapeutics can offer in oncology.
Looking Ahead
With the Phase 1 trial slated to begin in the latter half of 2025, all eyes will be on Radiopharm Theranostics as it embarks on this clinical journey. The trial will provide the first human data on RAD 402’s safety and efficacy, potentially opening a new frontier in prostate cancer treatment. Success here could pave the way for further development and eventual regulatory approval, offering hope to patients with limited therapeutic options.
Bottom Line?
The upcoming Phase 1 trial of RAD 402 could redefine prostate cancer radiotherapy if early promise translates into clinical success.
Questions in the middle?
- Will RAD 402 demonstrate superior efficacy compared to existing prostate cancer radiotherapies?
- How quickly will ethics approval be granted to initiate the Phase 1 trial?
- What are the potential challenges in scaling production of Terbium-161 labelled therapeutics?
