Radiopharm Theranostics (ASX: RAD) Progresses Prostate Cancer Therapy to Clinical Trials in 2025

Highlights

• Radiopharm has completed preclinical proof-of-concept studies for RAD 402, targeting advanced prostate cancer treatment.
• Promising safety and biodistribution results from ¹⁶¹Tb-labelled RAD 402  support its advancement to first-in-human trials.
• The company expects to commence the Phase I first-in-human study for RAD 402 in the second half of 2025.
• GMP manufacturing of RAD 402 is on track for completion by 1Q 2025.

Australia-based clinical-stage radiotherapeutics company Radiopharm Theranostics Limited (ASX:RAD) has announced the completion of a comprehensive preclinical proof-of-concept dataset for RAD 402.

RAD 402 is the company’s proprietary KLK3-targeting radiotherapeutic, designed as a next-generation treatment for advanced prostate cancer. KLK3 is expressed in the prostate and in most prostate adenocarcinomas, including their metastases.

Preclinical studies with ¹⁶¹Tb-labelled RAD 402 have shown promising results, demonstrating both safety and an encouraging biodistribution profile. The comprehensive dataset supports the potential of ¹⁶¹Tb-RAD 402 for advancing into First-In-Human therapeutic trials, which could mark the first-ever company-sponsored study utilising Tb161, a next-generation isotope with significant therapeutic potential.

The toxicology and biodistribution studies showed favourable outcomes, with no adverse effects. Specifically, biodistribution studies in mouse xenografts revealed the following:

• high tumour targeting
• limited uptake by kidney and bone marrow
• a hepatic excretion profile as expected for a monoclonal antibody

Reflecting on the development, Riccardo Canevari, CEO and Managing Director of Radiopharm said, “There is an ongoing unmet need for next-generation radiotherapeutic in advanced prostate cancer. RAD 402 has been specifically designed as a next-generation radiotherapeutic with a novel target and isotope, reinforcing its first-in-class potential as a novel treatment option in advanced prostate cancer. We believe that our preclinical data reaffirms our clinical development strategy for RAD 402 and provide translational support for advancing this program into FiH studies."

GMP manufacturing of RAD 402 and its conjugate is underway and is expected to be completed by 1Q 2025. The company is on track to begin the Phase I First-in-Human study in the second half of 2025.

The share price of RAD was AU$0.035 apiece at the time of writing on 10 December 2024.