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Radiopharm Theranostics Signs Supply Agreement With Cyclotek To Radiolabel RAD 402 With Terbium-161 In Australia, Which Supports Initiation Of Phase 1 Clinical Trial

Benzinga·06/24/2025 12:15:37
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RAD 402 preclinical data package complete; demonstrates safety and promising biodistribution profile

Ethics approval and Phase 1 clinical trial start in prostate cancer anticipated in 2H 2025

SYDNEY and BUNDOORA, Australia, June 24, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, NASDAQ:RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the signing of a supply agreement with Cyclotek to radiolabel RAD 402 with Terbium-161 (161Tb) in Australia, which supports the initiation of a Phase 1 clinical trial. RAD 402 is an anti-Kallikrein Related Peptidase 3 (KLK3) monoclonal antibody radiotherapeutic labelled with the radionuclide 161Tb for treatment of prostate cancer.

RAD 402 has been designed to target KLK3, which is highly expressed in the prostate, with very limited/no expression in other tissues and organs. Compared to 177Lu, 161Tb emits additional Auger and conversion electrons alongside its β-radiation, which can lead to potentially improved antitumoral therapeutic efficacy. 161Tb-RAD 402 is the first company-sponsored Phase I trial in prostate cancer using 161Tb.

Under the agreement, Cyclotek will produce and provide doses of 161Tb-labeled RAD 402 to support Radiopharm's upcoming Phase 1 clinical trial in prostate cancer in Australia. The Phase 1 trial is anticipated to start in the second half of 2025.