Pharma Focus Europe

RAD Granted Approval for Phase 1 Clinical Trial of PDL1-Nanobody in Non-Small Cell Lung Cancer

Tuesday, October 10, 2023

Radiopharm Theranostics (ASX:RAD) has obtained approval from the Human Research Ethics Committee (HREC) to initiate its Phase I study in Australia, marking the first human trials for the company's therapy designed to treat patients with PDL1-positive non-small cell lung cancer (NSCLC).

The Phase I trial involves dose escalation of RAD204 and aims to assess the safety and efficacy of this innovative radiotherapeutic approach in eligible individuals with lung cancer. The study will take place at Princess Alexandra Hospital in Brisbane, Australia, in collaboration with leading oncology care provider GenesisCare.

The foundation of this trial is Radiopharm's proprietary nanobody, derived from its NanoMab platform, which specifically targets PDL1 expression in NSCLC, the most prevalent form of lung cancer. This represents a significant advancement in addressing an area with substantial unmet medical needs, potentially establishing the treatment as a groundbreaking radiopharmaceutical therapy targeting PDL1.

The trial is set to commence shortly.

Radiopharm's CEO and Managing Director, Riccardo Canevari, expressed satisfaction with the approval, emphasizing the urgent need to improve the prognosis for NSCLC patients. He also acknowledged the invaluable support provided by GenesisCare Contract Research Organization.

In Australia alone, approximately 12,200 individuals are diagnosed with lung cancer annually, ranking it as the fifth most common cancer in the country. Globally, in 2020, there were an estimated 2.2 million cases of lung cancer, with NSCLC constituting approximately 85% of all instances².

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