Radiopharm Theranostics Ltd (ASX:RAD) is celebrating today after findings from its F18-Pivalate brain glioma imaging study were published in a prestigious peer-reviewed journal.
The biotech stock, which is developing a suite of diagnostic and therapeutic radiopharmaceutical products, had new data from its RAD 101 candidate documented in the European Journal of Nuclear Medicine and Molecular Imaging this week.
What is RAD 101?
RAD 101 is Radiopharm’s proprietary radiopharmaceutical imaging agent, composed of F18 radioisotope and pivalate — a small molecule that targets fatty acid synthetase.
Radiopharm is currently focused on filing an Investigational New Drug application for RAD 101 with the US Food and Drug Administration — a move it hopes will initiate a multi-centre trial for imaging brain metastasis in the current quarter.
The company hopes to have the first patient dosed by the end of the year.
Looking at the findings published this week, data presented from 10 adult glioma subjects in a first-in-patient pilot study showed significant tumour uptake in high-grade gliomas, with safety and tolerability in all patients dosed.
What’s more, results from the pivotal study support further investigation of RAD 101 pivalate for PET/MRI brain tumour imaging in a larger patient population.
Radiopharm holds an exclusive global licence for the pivalate platform technology, as well as a collaboration with Imperial College of London to develop a therapeutic candidate leveraging the same mechanism of action.
Complementary data
Radiopharm CEO and managing director Riccardo Canevari said the journal publication expanded the strong and growing body of scientific evidence behind pivalate.
“The results complement prior positive data from the Imperial College of London’s Phase 2a RAD 101 imaging trial in patients with brain metastases that showed significant tumour uptake consistent with and independent from the tumour of origin,” he explained.
Beyond RAD 101, Radiopharm is developing six distinct and highly differentiated platform technologies spanning cancer-combatting peptides, small molecules and monoclonal antibodies.
These candidates are undergoing pre-clinical or clinical development in the laboratories of some of the world’s leading universities and institutes.
RAD’s pipeline has been built based on the potential to be first to market or best in class. The company’s clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumour cancers, including breast, kidney and brain.