Radiopharm Theranostics (ASX: RAD) Receives HREC Approval to Expand RAD204 Study Across Multiple Cancer Indications

Highlights

• Radiopharm has received approval from the Australian Ethics Committee to expand its PD-L1 nanobody (RAD204) phase 1 trial in several types of tumor.
• The ongoing Phase 1 first-in-human study aims to evaluate the safety and tolerability of ¹⁷⁷Lu-RAD204 in patients with PD-L1-positive advanced solid tumors.
• Phase I imaging data for RAD204 showed that the diagnostic compound is safe and has acceptable dosimetry.

Radiopharm Theranostics (ASX:RAD)  shares rose approximately 4% to AU$0.027 on Tuesday. This positive movement follows the announcement that the company has received approval from the Australian Ethics Committee to expand its PD-L1 nanobody (RAD204) Phase 1 Trial in multiple tumor types.

The ongoing Phase 1 first-in-human study aims to evaluate the tolerability and safety profile of ¹⁷⁷Lu-RAD204 in patients with PD-L1-positive advanced solid tumors.

“The implications of including additional PD-L1 expressing tumor types beyond NSCLC in this study is far-reaching,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “Patients with five additional PD-L1 expressing tumor types are now eligible for this basket trial, supporting the potential of 177Lu-RAD204 for a tumor-agnostic indication and as an effective radioimmunotherapy based on a pan-tumor predictive biomarker. With RAD204, we hope to provide an alternative strategy that can improve clinical outcomes for patients with PD-L1 positive advanced cancers, while potentially preserving their quality of life.”

Phase I imaging data for RAD204, published previously, involved 16 NSCLC patients. The results showed that the diagnostic compound is safe and has acceptable dosimetry. Tumor targeting with radioimmunotherapies such as 177Lu-RAD204 holds the potential to address resistance mechanisms to current standard-of-care treatment options.

The trial is currently underway and recruiting participants at four sites across New South Wales, South Australia, and Western Australia. It is being supported by GenesisCare CRO, a prominent provider of oncology care.