Radiopharm Theranostics set to launch pioneering trial for lung cancer treatment in 2024

Clinical-stage biopharmaceutical company Radiopharm Theranostics (ASX: RAD) is ready to kick off an active 2024 with the next steps in a trial investigating potential treatments for patients with deadly non-small cell lung cancer (NSCLC).

Cashed-up with $2.1 million in proceeds from a recently completed entitlement offer and a $4.8 million research and development (R&D) tax refund, Radiopharm is on target to commence activities on the next phase of its trials within the first week of the new year.

That follows the recent successful completion of a site initiation visit for the RAD 204 phase 1 study.

The study will be conducted at Princess Alexandra Hospital in Brisbane, with the support of leading oncology care provider GenesisCare.

Novel treatment

The next stage, a 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 treatment 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.

The clinical site is currently pre-screening eligible NSCLC patients in readiness to dose them with 177Lu-RAD 204.

The trial is slated to be formally activated on 4 January 2024, with the first patient expected to be dosed in the same month.

NSCLC a major focus

Radiopharm chief executive officer and managing director Riccardo Canevari said finding a successful treatment for NSCLC is a major focus for the global medical industry.

“Approximately 300,000 new lung cancer cases will be diagnosed in the US by the end of 2023, 81% of which are estimated to be NSCLC patients,” Mr Canevari said.

“Despite the major progress in advancing anti-PD1/PD-L1 immunotherapy agents for eligible NSCLC patients, we are still struggling to understand how to treat them once they become refractory to these agents.”

“We are highly encouraged by the initial findings from the preclinical studies and Phase I imaging data in humans for 177Lu-RAD 204 and, as such, we believe this radiotherapeutic agent may be a game changer, as monotherapy or in combination, for the treatment of advanced NSCLC,” he said.

Results of the upcoming studies of Radiopharm’s developments are expected in early 2025.

Development pipeline

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 the refund under the Australian Government’s R&D tax incentive scheme.

The payment noted Radiopharm’s R&D activities during the 2023 financial year, with the tax return providing important funding for continued development of the company’s portfolio of radiopharmaceutical products for diagnostic and therapeutic applications.