Radiopharm Theranostics

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Radiopharm has commenced its Phase 1 clinical trial for RAD 204, a proprietary nanobody targeting PD-L1 in advanced Non-Small Cell Lung Cancer (NSCLC), with the first patient now dosed. This open-label, first-in-human dose escalation trial, titled “Study of the Safety and Tolerability of 177Lu-RAD 204,” is designed to assess the safety and preliminary efficacy of the Lutetium-177 radiolabelled antibody in patients with metastatic NSCLC. Conducted across multiple hospitals in Australia and supported by GenesisCare CRO, the study received Human Research Ethics Committee (HREC) approval in October 2023.

Radiopharm presented encouraging preclinical and clinical data at the 2024 European Molecular Imaging Meeting, highlighting the diagnostic and therapeutic promise of its RAD 301 program. In a lung cancer mouse model study led by Prof. Susanne Kossatz, succinylated gelatin was shown to reduce kidney uptake of αvβ6-integrin-targeted agents, potentially enhancing the safety of RAD 302 for treating multiple cancers. A clinical study comparing RAD 301 to traditional PET/CT in 33 patients demonstrated a superior Tumor to Background Ratio for pancreatic and head and neck cancers, reinforcing its potential as a radiotherapeutic biomarker. Additionally, an extensive analysis of 3,200 specimens confirmed high αvβ6-integrin expression across fourteen cancer types, supporting its broad therapeutic applicability.

A pilot study in February demonstrated that Terbium-161 (Tb-161) may be more effective than Lutetium-177 (Lu-177) for treating metastatic castration-resistant prostate cancer, with Tb-161-PSMA-617 delivering a significantly higher tumor-absorbed dose in six patients. These results support Radiopharm’s development of Tb-161-based radiotherapeutics for advanced cancers, beginning with RAD 402. Radiopharm, through its partnership with TerThera, is the first public company to secure a Tb-161 supply for clinical development, having expanded its supply agreement with TerThera to support these initiatives.

In February 2024, Radiopharm began a Phase 1 clinical trial for 68Ga-Trivehexin (RAD 301), a diagnostic radiopharmaceutical targeting αvβ6 integrin in patients with Pancreatic Ductal Adenocarcinoma (PDAC). This nine-participant study, conducted at Montefiore Medical Center in New York, aims to evaluate the safety and dosimetry of RAD 301. The trial follows a “safe to proceed” clearance from the FDA, and previous compassionate use cases and investigator-initiated studies with RAD 301 have shown no safety concerns across 99 patients.