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First Patient Dosed with PD-L1 Nanobody in Phase 1 Therapeutic Non-Small Cell Lung Cancer Trial

Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce the therapeutic dosing of the first patient in its Phase 1 clinical trial of RAD 204, a proprietary nanobody which targets Programmed death-ligand 1 (PD-L1)-positive expression in Non-Small Cell Lung Cancer (NSCLC), the most common type of lung cancer.

First patient dosed with RAD 204 (PD-L1 nanobody) in a Phase 1 therapeutic trial at Wollongong Hospital, New South Wales.16 patients previously dosed in Phase 1 diagnostic study demonstrated safety and effective biodistribution, and validate the strong potential for 177Lu-RAD204 for the treatment of advanced NSCLC.First patient dosed with RAD 204 marks a significant milestone in Radiopharm’s commitment to developing transformative oncology radiotherapeutics.

The open-label Phase 1 study, entitled “Study of the Safety and Tolerability of 177Lu-RAD 204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients with Metastatic Non-small Cell Lung Cancer”, is a First-In-Human dose escalation trial of 177Lu-RAD 2041, and is designed to evaluate the safety and preliminary efficacy of this novel radiotherapeutic in eligible individuals with advanced NSCLC. Previously published2 Phase I data of 16 NSCLC patients imaged with RAD 204 have demonstrated that the diagnostic is safe and associated with acceptable dosimetry.

The study is currently being conducted in Australia at Wollongong Hospital (NSW), Princess Alexandra Hospital (QLD), and Hollywood Private Hospital (WA), with the support of GenesisCare CRO.

“Radiopharm is delighted to announce this important milestone in our evolution to a clinical-stage company,” said Riccardo Canevari, CEO and Managing Director of Radiopharm. “Despite progressive improvements in the first-line setting for metastatic NSCLC, the majority of patients will progress and require further therapeutic options in the second-line setting. Current options following progression offer modest activity, making this setting an area of unmet need. With RAD 204, we hope to provide an alternative strategy that can improve clinical outcomes for NSCLC patients, while preserving quality of life.”

About Radiopharm Theranostics

Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021. The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes. The pipeline has been built based on the potential to be first-to-market or best-in-class. Learn more at Radiopharmtheranostics.com.

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