Radiopharm Theranostics Ltd (ASX:RAD) has completed a positive pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for its proprietary imaging agent, F18-pivalate (RAD 101).
This is a significant milestone towards Radiopharm’s IND application for late-stage clinical trials.
Based on positive guidance received from the U.S. FDA, Radiopharm will file an IND application to initiate a multi-centre trial for imaging brain metastasis during the third quarter of 2023 and anticipates having the first patient dosed by the end of the year.
Potential use to monitor cerebral metastasis
RAD 101 is a proprietary imaging agent composed of F18 radioisotope and pivalate, a small molecule that targets fatty acid synthetase.
In October 2022, positive data from the Imperial College of London’s Phase IIa imaging trial of RAD 101 in patients with brain metastases showed significant tumour uptake that was consistent with and independent from the tumour of origin.
This supports the potential use of pivalate to monitor cerebral metastasis.
“So close to late stage development”
Radiopharm CEO and managing director Riccardo Canevari said: “Pivalate represents a new class of targeted radiopharmaceuticals with RAD 101 data demonstrating very positive performance in brain metastasis.
“We are engaging with the FDA to expedite clinical development of RAD 101, considering the high unmet medical need in around 300,000 patients that are diagnosed with brain mets in the U.S. every year.
“Being so close to late stage development is highly exciting for us and for the medical community.”
Radiopharm holds an exclusive global license for the pivalate platform technology and also has a collaboration in place with Imperial College of London to develop a therapeutic candidate leveraging the same mechanism of action.