First-in-Human Whole-Body HER2-Receptor Mapping Using Affibody Molecular Imaging with ABY-025

Non-Regulatory

December 9, 2011

Results from a clinical study with the HER2-binding Affibody imaging agent [111In]ABY-025 in breast cancer patients were presented by Dan Sandberg, Dept. of Nuclear Medicine, Uppsala University Hospital. The study’s principal investigator is Henrik Lindman, Dept of Oncology, Uppsala University Hospital, and the study Sponsor is Jörgen Carlsson, Biomedical Radiation Sciences, Uppsala University, with support from the Swedish Cancer Society.

The clinical study was a Phase 1 first-in-human clinical trial in seven HER2-positive or -negative females with metastasized breast cancer, assessing safety of use, tissue distribution of [111In]ABY-025 and possibilities to discriminate low/high HER2- expression in lesions.

Excellent quality SPECT images and whole body scans were recorded and analyzed for tissue distribution in the two patient groups. Differences in uptake and kinetics between low/high HER2-expressing lesions were evident. No adverse drug reactions and no induced formation of antibodies against ABY-025 were observed.

The results indicate that ABY-025 can be used safely in humans with similar excellent whole body HER2-receptor molecular imaging capabilities as noted with a previous generation Affibody molecule. Promising indications of in vivo HER2-receptor status assessment capabilities were observed.

“These results demonstrate that the Affibody® HER2 imaging technology has the potential to provide a global assessment of HER2-expression and thereby guide treatment decisions.  It is also encouraging that no induced formation of antibodies against ABY-025 was observed,” says Affibody’s Chief Executive Officer David Bejker.