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

Solna, Sweden, April 30, 2013. 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 metastatic breast cancer.

The Department of Oncology and PET Center at Uppsala University Hospital have included the first patient in a clinical study, ABY-025-MI105, using 68Ga-labeled ABY-025 for PET imaging of HER2 expression in subjects with metastatic breast cancer.

This study will expand on the previous clinical experience with ABY-025 imaging obtained with indium-111 and gamma camera (Sandberg et al 2011). The new study will provide PET camera images and include a comparison of two doses as well as a repeated image in HER2-positive patients at a clinically relevant point in their disease management. The Sponsor of this clinical study is the Department of Biomedical Radiation Sciences at Uppsala University and the study is supported by a grant from the Swedish Cancer Society.

“It is exciting to initiate this study as a continuation of our previous clinical investigation with ABY-025 and we look forward to the first results with great confidence”, says Professor Jörgen Carlsson, Department of Biomedical Radiation Sciences at Uppsala University.

Affibody and GE Healthcare are collaborating on the development of HER2-targeted PET imaging agents, including ABY-025. This study hopes to increase the 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.

"This study will further investigate the potential of ABY-025 imaging to provide a global assessment of HER2-expression and thereby guide treatment decisions” says Affibody's Chief Executive Officer David Bejker.

Breast cancer is the most frequent cancer in women and accounted for more than 450,000 deaths worldwide in 2008 (IARC Globocan 2008). The receptor HER2 is overexpressed in a subset of breast cancers and is the target for a number of drugs. Standard treatment for HER2 expressing metastatic breast cancer includes the monoclonal antibody trastuzumab and new HER2-targeting products have recently been approved. There are, however, currently no available non-invasive diagnostic methods that can offer guidance for treatment decisions.