Radiopharm Theranostics earns FDA approval for brain metastasis imaging agent RAD 101

Clinical-stage biopharmaceutical company Radiopharm Theranostics (ASX: RAD) has received clearance from the US Food and Drug Administration (FDA) for an investigational new drug (IND) application relating to F18-Pivalate (RAD 101).

RAD 101 is a proprietary imaging agent currently under clinical investigation for the detection and characterisation of brain metastases.

Labelled with the radioisotope F18, pivalate is a small molecule that targets synthetase—a fatty acid that is over-expressed in brain tumours but not in normal cells.

‘Clear recognition’

The approval, which follows an initial application submitted last year and is considered a “clear recognition” of the clinical data already generated for RAD 101, is seen as a significant milestone towards the commencement of a Phase 2b multi-centre trial for the imaging of brain metastases.

Positive data from Imperial College London’s Phase 2a imaging trial of pivalate in 17 patients with brain metastases had previously showed significant tumour uptake, consistent with and independent of the tumour of origin.

Radiopharm holds an exclusive global licence for the pivalate platform technology and has a collaboration in place with Imperial College to develop a therapeutic candidate leveraging the same mechanism of action.

Unique mechanism

Radiopharm managing director Riccardo Canevari said the FDA approval supports the potential use of pivalate to monitor cerebral metastases.

“Pivalate represents a potential new target for radiopharmaceutical brain imaging agents and its unique mechanism of action may offer eligible patients and the medical community an alternative to overcome the limitations of the current standard of care for imaging brain metastases,” he said.

“We are very pleased by this FDA approval as it allows us to commence late-stage clinical studies and address the high unmet medical need in around 300,000 US patients diagnosed with brain metastases every year.”

Radiopharm anticipates dosing the first patient before the year-end, with a 30-patient read-out by mid-2025 followed by a Phase 3 registrational study.

Differentiated pipeline

Radiopharm is developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need.

The company has a pipeline of distinct and highly differentiated technologies in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes.

The pipeline has been built based on the potential to be first-to-market or best-in-class.