Radiopharm Theranostics expands lung cancer trial with second Australian site

Sydney-based clinical-stage biopharmaceutical company Radiopharm Theranostics (ASX: RAD) has gained further momentum for its trial of a potential treatment for non-small cell lung cancer (NSCLC) with approval for the use of an additional Australian study site.

The company has now received Human Research Ethics Committee (HREC) approval from the Hollywood private hospital in Perth, that will see it become the second local site for its RAD 204 Phase 1 therapeutic study targeting PD-L1-positive NSCLC.

The West Australian site will join the Princess Alexandra Hospital in Brisbane, where the trial will commence on 4 January 2024.

Positive trial validation

“It’s an excellent piece of validation for the interest in and potential of this trial to have another site already committed to participating,” said Radiopharm’s chief executive officer and managing director, Riccardo Canevari.

“It gives us added confidence in the speed at which we’ll be able to recruit as we aim to deliver a new and improved solution for one of the most common cancer diagnoses in Australia as well as worldwide.”

Supported by leading oncology care provider GenesisCare, the study is designed to evaluate the safety and efficacy of Radiopharm’s novel radiotherapeutic in eligible individuals with advanced NSCLC, the most common type of lung cancer.

Boost to trial recruitment

Radiopharm says the addition of the Perth site will provide the study with further geographic availability as the trial widens while also boosting patient recruitment.

Well-funded with $2.1 million in proceeds from a recently completed entitlement offer and a $4.8 million R&D tax return, Radiopharm will commence activities on the next phase of its trials within the first week of 2024 with results expected in early 2025.

The up-coming stage, first-in-human dose escalation trial of Radiopharm’s 177Lu-RAD 204 development is designed to evaluate the safety and efficacy of this novel radiotherapeutic in eligible individuals with advanced NSCLC, the most common type of lung cancer.

Radiopharm’s proprietary nanobody from its NanoMabs platform, targets programmed death-ligand 1 (PD-L1)-positive expression in NSCLC.

Global cancer issue

Non-small cell lung cancer is the most common type of lung cancer, accounting for around 85% of cases.

Approximately 300,000 new lung cancer cases are expected to be diagnosed in the US by the end of 2023, 81% of which are estimated to be NSCLC patients, while more than 2.2 million cases of lung cancer in 2020.

Lung cancer is the fifth most commonly diagnosed cancer in Australia, and it is estimated that one in 20 people will be diagnosed by the time they are 85.

Six distinct platforms under development

Radiopharm is currently progressing a pipeline of six 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.

Its clinical program includes one phase II and three phase I trials in a variety of solid tumour cancers including breast, kidney and brain.

In late November, Radiopharm’s work in these areas was recognised when it received a research and development (R&D) tax refund of $4,851,839 under the Australian Government’s R&D tax incentive.