Radiopharm Theranostics is poised to open a second site for conducting human trials of its RAD 204 treatment for advanced non-small cell lung cancer (NSCLC) having received the green light from Perth’s Hollywood Private Hospital Human Research Ethics Committee.
The approval comes only a week after the company announced it had taken a step closer to kicking off the trial for patients with NSCLC at its initial site after a successful site initiation visit to Brisbane’s Princess Alexandra Hospital.
The first clinical phase trial is slated to open at the Princess Alexandra Hospital on 4 January, where it aims to evaluate the safety and efficacy of the company’s radiotherapeutic treatment, known as RAD 204, which targets PD-L1-positive patients with advanced non-small cell lung cancer for advanced NSCLC – the most common type of lung cancer.
Radiopharm Theranostics chief executive officer and managing director, Riccardo Canevari said: “It’s an excellent piece of validation for the interest in and potential of this trial to have another site already committed to participating. 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.”
With the company now set to conduct clinical trials on both sides of the country it says plans are in place to accelerate patient recruitment accordingly.
Radiopharm currently has a cohort of 21 patients lined up across its proposed trial sites, has conducted pre-screening of eligible NSCLC patients and confirms it is ready to start dosing patients with RAD 204 from next month in Brisbane and start Hollywood recruitment shortly.
The study, formally titled “Study of the Safety and Tolerability of 177Lu-RAD 204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients with Metastatic Non-small Cell Lung Cancer”, is being supported by leading oncology care provider GenesisCare.
Lutetium-177 is a radioisotope of the metal lutetium which is employed in theranostic medicine. Radiopharm says it is a first in-human dose escalation trial to evaluate the safety and efficacy of this novel radiotherapeutic in eligible individuals with advanced NSCLC.
Management says the fundamental technology underpinning the trials is the proprietary nanobody from its NanoMabs platform, which targets what is known as programmed death-ligand 1 (PD-L1)-positive expression in NSCLC.
PD-L1 is a regulatory molecule expressed in T cells, which has an immunoregulatory function by dampening the immune response when bound to one of its complementary ligands.
If high amounts of PD-L1 are found on or in cancer cells, immunotherapy medicines known as "immune checkpoint inhibitors" may be used. Those medicines prevent the PD-L1 protein from putting the brakes on T cells and frees them to fight cancer.
In August last year, Radiopharm confirmed it had entered a collaboration agreement with US-based Lantheus for the development of “NM-01” – a nanobody made using genetically-engineered, single-domain antibodies capable of being tagged or labelled with radioisotopes to potentially diagnose and treat multiple tumour types.
In a separate agreement, Radiopharm acquired from NanoMab the imaging rights of NM-01 for the strategic Chinese market and worldwide IP rights for any therapeutic use.
Under the collaboration agreement, Lantheus will provide the diagnostic product candidate of NM-01 to Radiopharm for use in its therapeutic clinical trials, and NM-01 will be used to assess PD-L1 expression during patient selection.
Both Radiopharm and Lantheus have the option to expand their collaboration to additional assets and potential licensing opportunities in the former’s pipeline.
About 300,000 new lung cancer cases are expected to be diagnosed in the US alone by the end of 2023, 81 per cent of which are estimated to be NSCLC patients. It is estimated that there were more than 2.2 million cases of lung cancer in 2020.
Along with last week’s revelation that Radiopharm was on the cusp of beginning the human trials in Brisbane next week, the latest news just days later confirming the addition of a second site in Perth highlights the rapid development taking place at Radiopharm as it pursues what it sees as a viable path towards an effective treatment of one of the most pernicious of cancers.
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By Doug Bright
