First Patient Included in PET Imaging Study of HER2 Expression in Breast Cancer

Non-Regulatory

April 28, 2014

Solna, Sweden, April 28, 2014. Affibody is pleased to announce that the first patient has been enrolled in a clinical study to evaluate ABY-025 for PET imaging of HER2 expression in subjects with breast cancer.

Herlev University Hospital has included the first patient in a clinical study using 68Ga-labeled ABY-025 for PET imaging of HER2 expression in subjects with breast cancer.

This study will expand on the previous clinical experience with ABY-025 imaging and investigate HER2 expression in breast cancer patients before and after treatment. The new study will provide information about the treatment’s effect on HER2 expression as well as a comparison with FDG-PET. The Sponsor of this clinical study is Herlev University Hospital.

“We are very happy to initiate this interesting study. In time we might be able to use this molecule both as a non-invasive diagnostics of HER2 positive tumors/metastases, and in the control of treatment efficacy” says Inge-Lis Kanstrup, Senior Physician, Department of Clinical Physiology and Nuclear Medicine at Herlev University Hospital.

This study hopes to increase the accumulated clinical experience of HER2-specific medical imaging and pave the way for better targeting of anti-HER2 therapies to those patients most likely to benefit.

“We believe that this study is a good example of addressing the need for further clinical investigation of global HER2 expression imaging with the view to ultimately guide treatment decisions and improve the care of breast cancer patients” says Affibody’s Chief Executive Officer David Bejker.