Australian clinical-stage biopharmaceutical company Radiopharm Theranostics (ASX:RAD) has announced a poster presentation at the European Molecular Imaging Meeting.
The company said the poster includes findings that support the clinical utility of imaging and therapy with 68Ga-RAD202 and 177LuRAD202 and validate an optimised therapeutic dosing regimen in murine models.
Dr Felix Mottaghy, Dr Betul Altunay, and colleagues from the University Hospital RWTH Aachen in Germany did the poster presentation.
The imaging data reported that 68Ga-RAD202 binds specifically to the Human Epidermal growth factor Receptor 2 (HER2) in HER2-positive xenografts, with a high tumour-to-background ratio. The removal of a His-tag from the RAD202 nanobody, a modification that impacts biodistribution and tumour targeting, was shown to be superior for PET imaging due to the higher tumour-to-organ ratio. The company said treatment with 177Lu-RAD202 was well-tolerated, demonstrating significantly prolonged survival time. Fractionated dosing proved more effective in inhibiting tumour growth compared to single-dose therapy.
HER2 is overexpressed in breast cancer as well as several other solid tumours and represents a validated target in oncology.
Race said previous data demonstrated the safety and bio-distribution of 99mTc-RAD202 in humans. Preclinical findings examining the therapeutic effect in HER2-positive xenografts were also recently reported with 177Lu-RAD202. It said the data justify first-in-human dose-finding studies. An open-label dose escalation phase one study of 177Lu-RAD202 is recruiting in Australia. The trial is designed to evaluate the safety and preliminary activity of this novel radiotherapeutic in eligible individuals with advanced HER2-positive solid tumours.
“These data support the potential for RAD202 to address an unmet need for HER2-positive metastatic patients that are progressing on current standard of care, or unable to tolerate current treatment options,” said Riccardo Canevari, CEO and managing director of Radiopharm Theranostics. “The current comprehensive data with RAD202 further support our rationale for the Phase 1 FIH therapeutic dose-escalating trial with 177Lu-RAD202, currently recruiting in HER2- positive advanced solid tumours.”