Radiopharm Theranostics presented data at EMIM 2025 demonstrating the effectiveness of RAD202, a HER2-targeting single domain antibody, for both imaging and therapy. Preclinical studies showed 68Ga-RAD202 effectively imaged HER2-positive tumors and 177Lu-RAD202, in both single and fractionated doses, reduced tumor volume and improved survival in mouse models. This research builds on previous studies that established the safety and biodistribution of a related compound, 99mTc-RAD202, in humans.
This development is critical because it validates the continued clinical development of 177Lu-RAD202 as a potential treatment option for HER2-positive cancers. It offers the possibility of a more effective and potentially less toxic treatment for patients who have progressed on or cannot tolerate existing therapies. The improved tumor targeting and efficacy of the modified RAD202 without the His-tag, as highlighted in the imaging data, is particularly promising for optimizing patient outcomes. This refined approach could lead to more precise and effective treatment delivery.
The data presented at EMIM 2025 focused on improved tumor targeting with a modified RAD202, specifically showing a high tumor-to-background ratio in imaging studies. Fractionated dosing of 177Lu-RAD202 showed greater efficacy compared to a single dose in preclinical models. This research is being translated into a Phase 1 clinical trial in Australia, which is currently recruiting patients with advanced HER2-positive solid tumors.
The positive preclinical data and the ongoing Phase 1 trial suggest a promising future for RAD202 as a potential therapeutic and diagnostic agent. The results of the clinical trial will be crucial for determining the next steps in the development of this radiopharmaceutical and its potential to improve treatment options for patients with HER2-positive cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.

