Radiopharm Theranostics has been given the nod of approval by the United States Food and Drug Authority to use its brain cancer-fighting technology in late-stage trials, with a first patient expected to be dosed later this year.
The company’s “F18-Pivalate” agent is designed to seek out and define a fatty acid that is overexpressed in brain tumours, but not in normal cells. It has not received the FDA’s crucial investigational new drug (IND) clearance for the company’s phase-2b imaging trial targeting brain metastases.
F18-Pivalate, also known as RAD 101, is an imaging agent (radiotracer) that combines a molecule and the F18 radioisotope for the detection, characterisation and monitoring of brain metastases and glioblastoma – an aggressive form of brain cancer. The mechanism is a unique tool in the precise detection and characterisation of brain metastases, leading to better treatment options for patients.
The FDA's approval is a crucial step in being able to use clinical data amassed for RAD 101 and initiating the multi-centre phase-2b trial. Radiopharm expects to dose its first patient by the end of the year, with a 30-patient rollout expected by mid-2025, which will then take it into a phase-three registrational study.
The Imperial College of London’s earlier phase-2a trial of Pivalate, which was presented at a cancer conference in Barcelona, showed a strong tumour uptake in 17 patients with brain metastases, independent of where tumours originated.
Radiopharm Theranostics chief executive officer and managing director Riccardo Canevari said: "Pivalate signifies a breakthrough in radiopharmaceutical brain imaging, offering a much-needed alternative to current imaging standards for brain metastasis. This FDA approval enables us to advance late-stage clinical trials, addressing the urgent need among the approximately 300,000 US patients diagnosed with brain metastases annually."
Management believes RAD 101 demonstrates imaging performance superior to the current clinical standard in positron imaging tomography of prostate and brain cancers. The company holds an exclusive global license for its Pivalate platform technology and has a collaboration agreement in place with the Imperial College in London to develop a therapeutic candidate leveraging the same mechanism of action.
The estimated market value for imaging brain metastases is in the region of a whopping US$1.25 billion (AU$1.91 billion).
In June, the company also attracted the interest of US Pharma giant Lantheus – a US$5.5 billion (AU$8.2 billion) Nasdaq-listed company that bought $7.5 million of new shares in Radiopharm and prepaid $3 million to secure rights on two preclinical assets known as RAD 206 and RAD 502.
Radiopharm’s mission is to develop products that transmit low levels of radiation directly to cancerous cells in a patient’s body, both for diagnostic and therapeutic purposes. As almost 10 million people die annually from lung, breast, bowel and prostate cancer alone, its current pipeline of specific radiotracers targeting a wide range of cancerous tumours seems truly relevant.
With the radiopharmaceutical sector at the absolute cutting edge of cancer detection and therapy and with so much success to date, it appears likely that Radiopharm will continue to attract the interest of the major pharmaceutical players as it nears its phase-three trials for several of its products.
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By James Pearson
