Radiopharm Theranostics has received approval from the Australian Ethics Committee for the inclusion of additional tumour types in the company’s ongoing open-label phase one, clinical trial of its exciting new cancer treatment drug.
The trial is the first in-human study to assess the safety and tolerability of Radiopharm’s “Lu-RAD204” monoclonal antibody drug in patients living with some types of advanced solid tumours, extending the existing trial beyond just those with non-small cell lung cancers (NSCLC).
The approval means patients with a further five tumour types will be able to participate in the trial, including those with lung, breast, melanoma, head and neck or endometrial cancers. Radiopharm’s trial is recruiting patients at four sites in NSW, South Australia and WA and has the support of oncology care provider GenisisCare CRO.
Radiopharm’s drug targets the “PD-1” protein found on immune cells, known as “T cells”, which helps keep the body’s immune responses under control.
When PD-1 is bound to another protein, called “PD-L1”, it can block the body’s immune response, preventing the T cells from killing other cells, including cancer cells.
Some anti-cancer drugs, called immune checkpoint inhibitors, can block PD-1 thus releasing the “brakes” on the immune system, increasing the T cells’ ability to kill the cancer cells.
Radiopharm Theranostics chief executive officer and managing director Riccardo Canevari said: “The implications of including additional PD-L1 expressing tumour types beyond NSCLC in this study is far-reaching. With RAD204, we hope to provide an alternative strategy that can improve clinical outcomes for patients with PD-L1 positive advanced cancers, while potentially preserving their quality of life.”
Management says PD-L1 is often over-expressed in many solid cancers, making RD204 an attractive therapeutic target option for the types of tumours now included in the trial.
Lutetium-177 is a radioactive isotope used in targeted radio-nuclide therapy to treat cancer. It is the most commonly-used isotope for this type of therapy because it is commercially available and has been shown in other tests to be clinically successful.
It is used in two types of cancer treatments in which Lutetium-177 is attached to a molecule that binds to specific receptors or proteins on the surface of tumour cells. The cancer cell then engulfs the molecule, which then delivers sufficient radiation to kill the cancer cell while keeping healthy cell damage to a minimum.
Radiopharm says16 patients have already been treated with the drug, demonstrating its safety and how it travels around the body.
Tumour targeting with radio-immunotherapies such as 177Lu-RAD204 has the potential to achieve a “work-around” of some aspects of resistance to treatments when compared with current standard-of-care treatments.
The company views the initial outcome from the 16 patients as an indication of the potential for 177Lu-labelled RAD204 to successfully treat advanced PD_L1 cancers, providing another treatment option while also potentially preserving a patient’s quality of life.
Those living with any harder-to-treat tumours can hang onto the hope of the next treatment breakthrough, so any news of positive steps, such as Radiopharm being able to incorporate additional cancers into its trials regimen, will no doubt be welcomed.
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By Doug Bright
