Radiopharm unveils landmark human lung cancer trial

Radiopharm Theranostics has kicked off the first phase of clinical trials testing its “RAD 204” treatment aimed at beating the most common type of lung cancer – non-small cell lung cancer (NSCLC) – after dosing its first patient in New South Wales.

The first in-human trial at the Wollongong Hospital has been designed to assess the safety and tolerability of the company’s innovative radiopharmaceutical therapy in a crucial step toward potentially revolutionising the treatment of cancer. The study is being conducted to assess a dose escalation from earlier diagnostic trials.

RAD 204 targets “PD-L1” – or programmed cell death-ligand 1 – which is a protein that allows cancer cells to evade the immune system. In earlier diagnostic trials involving 16 patients, RAD 204 demonstrated both safety and acceptable dosimetry, setting the stage for its therapeutic use.

The current phase-one trial, being conducted across several Australian hospitals, including Princess Alexandra Hospital in Queensland and Hollywood Private Hospital in Western Australia, seeks to build on the promising foundation.

Radiopharm Theranostics chief executive officer and managing director Riccardo Canevari said: "This is a landmark moment in our journey to become a clinical-stage company. Despite advances in initial treatments for metastatic NSCLC, many patients still face progression and limited second-line options. We believe RAD 204 offers a new hope to improve clinical outcomes while preserving quality of life for these patients."

Radiopharmaceuticals such as RAD 204 are radioisotopes attached to biological molecules and are capable of targeting specific organs, tissues, or cells within the human body. The radioactive drugs are increasingly used not only for diagnosis, but also for the therapy of various diseases.

RAD 204 is a Lutetium-177 radiolabelled nanobody. Lutetium-177 is a radioisotope of lutetium – a metal employed in theranostic medicine. As part of the lanthanide series in the Periodic Table, the metal has more than 40 known radioisotopes and plays a crucial role in Radiopharm's advanced cancer treatment technology.

The proprietary nanobody is specifically designed to target PD-L1-positive expression in NSCLC. PD-L1, a regulatory molecule in T cells, typically modulates the immune response by binding to complementary ligands and reducing immune activity.

In cancer, high levels of PD-L1 on or in cancer cells can be problematic. That is where immunotherapy medicines, known as "immune checkpoint inhibitors," come into play, blocking the PD-L1 protein from inhibiting T cells and allowing the immune system to effectively target and combat cancer cells.

Radiopharm has started phase-one clinical trials of its “RAD301” peptide for the treatment of aggressive pancreatic cancer and is also near completion of a phase-two trial for the use of “RAD101” in the treatment of brain metastases resulting from cancer growth elsewhere in the body.

The pioneering medical technology of radiopharmaceuticals is promising to soon revolutionise the way that cancer patients are treated, even in some of the more aggressive types of the disease such as lung and pancreatic cancer. And it appears that Radiopharm, as a leading radiopharmaceutical, is in a strong position to capitalise on its 100 per cent-owned intellectual property.

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