Radiopharm Theranostics’ novel imaging small molecule, RAD 101, has detected brain metastases in all 22 patients enrolled in an observational trial examining the company’s combination method.
Results from the Australian biotech’s proof-of-concept trial (NCT04807582) found that its proprietary radiotracer 18F-RAD101, also known as 18F-Pivalate, was able to detect brain tumours in 12 treatment-naïve patients. It also detected metastases in a further ten patients who had previously undergone some form of radiotherapy.
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The methodology works by combining RAD 101 with positron emission tomography and multiparametric magnetic resonance imaging (PET-mpMRI) to target the fatty acid metabolism found in solid tumours.
Results of the study, which have been published in the European Journal of Nuclear Medicine & Molecular Imaging, have set the stage for Radiopharm’s upcoming Phase IIb trial designed to test the performance of 18F-RAD101 in patients living with suspected recurrent brain metastasis (NCT06777433). Enrollment for the trial is currently underway.
Eric Aboagye, lead inventor of RAD 101 and co-author of the study, said: “With a poor prognosis, there is a need for improved detection and characterisation of these metastases.
“Our work affirms the current understanding of how cancers of diverse origin utilise simple short-chain fatty acids compared to glucose and other nutrients in the brain environment, and how to employ this information to improve detection of metastases in the brain.”
Brain metastases occur when cancer cells from some other form of cancer within the body make their way to the brain, creating a tumour. Research by GlobalData’s Pharmaceutical Intelligence Center indicates that the overall global market for the treatment of brain metastases stood at $26.9bn by the end of last year, a figure expected to grow to a valuation of $34.3bn by the end of 2027.
GlobalData is the parent company of Clinical Trials Arena.
Radiopharm Theranostics CEO Riccardo Canevari said: “Contrast-enhanced MRI is the current standard of care (SoC) but provides limited sensitivity for distinguishing disease progression from radiotherapy versus treatment effects.
“This is the first clinical study with 18F-RAD101 PET-mpMRI that demonstrates potentially more sensitive detection of brain metastases compared to the current SoC, offering a strong potential to improve diagnostic accuracy of suspected recurrent brain metastases.”
Elsewhere in the treatment of cancers and brain metastases, Bristol Myers Squibb’s lung cancer monoclonal antibody BMS-986012 has nearly doubled overall survival (OS) rates in patients participating in a Phase II trial last year. In addition, NH TherAguix announced that it received validation from the Data Safety Monitoring Board (DSMB) in September 2024 to continue its Phase II NANOBRAINMETS trial of AGuIX.
