Radiopharm Theranostics has stepped closer to kicking off what it says could be a “game-changing” trial for patients with non-small cell lung cancer (NSCLC) after a successful initiation site visit to Brisbane’s Princess Alexandra Hospital.
The important visit was made ahead of the trial that will evaluate the safety and efficacy of the company’s radiotherapeutic treatment, known as “177Lu-RAD 204”, for advanced NSCLC – the most common type of lung cancer. The “177Lu” part refers to a theranostic medicine that includes the element lutetium.
The study, which is set to launch on January 4, will be conducted at the Brisbane hospital’s clinical site, with the support of leading oncology care provider GenesisCare. In addition to the recent site initiation visit, Radiopharm has also conducted the pre-screening of eligible NSCLC patients, while phase-one imaging completed on 16 patients confirmed the safety and appropriate biodistribution of its therapy.
The hospital has now confirmed it is ready to start dosing patients with RAD 204 from next month.
Radiopharm Theranostics chief executive officer and managing director Riccardo Canevari said: “Approximately 300,000 new lung cancer cases will be diagnosed in the US by the end of 2023, 81 per cent of which are estimated to be NSCLC patients. 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 encouraged by the initial findings from the preclinical studies and Phase I imaging data in humans for 177Lu-RAD 204, and so we believe this radiotherapeutic agent may be a game changer, as a monotherapy or in combination, for the treatment of advanced NSCLC.”
Lutetium is a radioactive element in the Lanthanide Series of the periodic table of the elements. More than 40 lutetium radioisotopes have been identified.
Breaking that down a bit further, Radiopharm explains that the fundamental technology that will underpin the coming trial 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.
The arrangement was strategically timed for Radiopharm’s initiation of its upcoming trial, with the company and Lantheus agreeing to cross-reference each other's data to speed up their mutual development plans for the PD-L1 assets, including the development and regulatory process with the US Food and Drug Administration (FDA) and other key regulatory agencies.
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.
In all, Radiopharm could just be on the right path to wiping out one or more of the current scourges of cancer.
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By Doug Bright
