RAD402 / Radiopharm Theranostics - LARVOL DELTA

A Study of Terbium 161 (161Tb)-RAD402 in Participants With CRPC (clinicaltrials.gov) - P1/2 | N=73 | Not yet recruiting | Sponsor: Radiopharm Theranostics, Ltd

New P1/2 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Radiopharm Theranostics…announced that it has been granted Bellberry Human Research Ethics Committee (HREC) approval in Australia to initiate its First-In-Human (FIH) Phase 1 clinical trial of its Kallikrein Related Peptidase 3 (KLK3)-targeting radiotherapeutic, RAD 402, for the treatment of metastatic or locally advanced prostate cancer (GlobeNewswire)

First-in-human • New P1 trial • Prostate Cancer

Radiopharm Theranostics and Cyclotek Sign Clinical Supply Agreement for ¹⁶¹Tb-KLK3-mAb Phase I Clinical Trial in Australia (GlobeNewswire) - "Radiopharm Theranostics...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....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."

Commercial • New P1 trial • Prostate Cancer

Completion of preclinical data package for RAD 402 (Radiopharm Theranostics Press Release) - "Radiopharm Theranostics...is pleased to announce the completion of a comprehensive preclinical proof-of-concept dataset for its proprietary Kallikrein Related Peptidase 3 (KLK3)-targeting radiotherapeutic, RAD 402. The preclinical toxicology reported positive data, with no observed adverse effects. Biodistribution studies of 161 Tb-RAD 402 in mouse xenografts showed high tumor targeting, limited kidney and bone marrow uptake, and a hepatic excretion profile as expected for a monoclonal antibody. The safety findings from the toxicology and biodistribution studies provide a strong rationale for First-In-Human (FiH) clinical studies. GMP manufacturing of RAD 402 and the conjugate are currently ongoing and are expected to be completed in Q1 2025. Radiopharm’s clinical development plans for RAD 402 continue to advance, and the Company is on track to commence the Phase I FiH study in H2 2025."

Preclinical • Oncology • Prostate Cancer • Solid Tumor

Radiopharm Theranostics Expands Supply Agreement With TerThera for Terbium-161 Isotope Use in Prostate Cancer (GlobeNewswire) - "Radiopharm Theranostics...is pleased to announce an expanded agreement with TerThera to supply the Company with Terbium-161 (Tb-161)....The initial order with TerThera is expected to occur during Q4 2023. The effective date of the supply agreement is 28 August 2023 and there are no material preconditions. The supply agreement is for an initial period of 3 years and may be extended for additional two years, unless agreed otherwise by either party. Cancellation provisions are at industry standard rates. Radiopharm will own all data generated and all inventions and discoveries made or conceived from its clinical trials."

Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor