Radiopharm receives approval for Phase 1 therapeutic study of NSCLC

Radiopharmaceutical products developer Radiopharm Theranostics (ASX: RAD) has continued its run of medical successes with the granting of approval for the next stage of testing of a potential treatment for lung cancer.

The company is now able to move ahead to further examine the potential of its RAD204 treatment after receiving approval from the Human Research Ethics Committee (HREC) to undertake the first-in-human phase I study in Australia of its therapy for patients with PDL1-positive non-small cell lung cancer (NSCLC).

The approval allows for a dose escalation trial of RAD204, which targets PDL1-positive NSCLC.

Safety and efficacy evaluation

To be conducted at Princess Alexandra Hospital in Brisbane, the new trial is designed to evaluate the safety and efficacy of this novel radiotherapeutic in eligible individuals with lung cancer.

The study is being supported under a collaboration with leading oncology care provider GenesisCare.

Radiopharm’s proprietary nanobody technology is part of its NanoMab platform which targets the PDL1 expression in NSCLC, the most common type of lung cancer.

The trial is expected to start shortly.

‘First in class’

Radiopharm’s chief executive officer and managing director, Riccardo Canevari, said 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.

“We’re very pleased to receive the necessary approval that allows us to get this therapeutic study underway,” Mr. Canevari said.

“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 organisation.”

Safe radioactive drugs

Radiopharmaceutical technology uses safe radioactive drugs that can be used as diagnostic or therapeutic tools.

For therapeutics, patients are given a very small amount of safe radioactive medication injected into the bloodstream.

In the case of therapeutic application, it allows the mechanism to be extremely selective to precisely deliver a radioactive payload to the tumor.

High cost of cancer

Within Australia, approximately 12,200 patients are diagnosed with lung cancer per year, making it the 5th most common in the country.

According to Lung Foundation Australia, the economic burden of lung cancer alone for new patients diagnosed in 2018 was estimated to be $297.3 million in direct (treatment, travel, and out-of-hospital costs) and indirect costs (absenteeism).

Worldwide, it was estimated that there are more than 2.2 million cases of lung cancer in 2020, with NSCLC accounting for approximately 85% of all lung cancer cases.

Cancer has been forecast to be set to cost the world around $40 trillion over the next 30 years.

More success for Radiopharm

The RAD204 study approval follows on from Radiopharm’s recent success in expanding an agreement with TerThera to supply the company with Terbium-161 (Tb-161).

The Tb-161 isotope will be linked to a proprietary monoclonal antibody (mAb) to form RAD 402, a radiotherapeutic that is being developed by Radiopharm to target KLK3 expression.

Radiopharm is planning to initiate a Phase I dose escalating trial evaluating the safety and efficacy of RAD 402 in patients with advanced prostate cancer during the second half of 2024.

The company says Terbium-161 is a highly promising isotope for targeted cancer treatment due to its unique characteristics of radiation emitted, which include both Auger electrons and short-range beta particles.