SYDNEY, Australia I October 09, 2023 I Radiopharm Theranostics (ASX:RAD), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, is pleased to announce it has been granted Human Research Ethics Committee (HREC) approval to commence its First-In-Human Phase I study in Australia for the Company’s therapy for patients with PDL1-positive non-small cell lung cancer (NSCLC).

The dose escalation trial of RAD204, which targets PDL1-positive NSCLC, is designed to evaluate the safety and efficacy of this novel radiotherapeutic in eligible individuals with lung cancer. The study will be conducted at Princess Alexandra Hospital in Brisbane, Australia, with the support of leading oncology care provider GenesisCare.

The technology underpinning the trial is Radiopharm’s proprietary nanobody from its NanoMab platform, which targets the PDL1 expression in NSCLC, the most common type of lung cancer. This is an area of high unmet need and there is potential for the treatment to be the “first in class” radiopharmaceutical therapy targeting PDL1.

The trial is expected to start shortly.

Radiopharm’s Chief Executive Officer & Managing Director, Riccardo Canevari, said: “We’re very pleased to receive the necessary approval that allows us to get this therapeutic study underway. NSCLC carries a poor prognosis for patients currently and we’re striving to make a difference on that front, with excellent support being provided by our partners at GenesisCare Contract Research Organization.”

Within Australia, approximately 12,200 patients are diagnosed with lung cancer per year, making it the fifth most common in the country¹. Worldwide it was estimated that there are more than 2.2 million cases of lung cancer in 2020², with NSCLC accounting for approximately 85% of all lung cancer cases.

¹ https://www.cancervic.org.au/cancer-information/types-of-cancer/lung_cancer/lung-cancer-overview.html
² https://www.wcrf.org/cancer-trends/lung-cancer-statistics/