The company announced last week that a major Nordic study will begin using their PET imaging agent ABY-025.

ABY-025 is a novel Affibody molecule imaging tracer that can identify HER2 status in breast cancer patients. The researchers will be investigating a new ABY-025 based method developed at Uppsala University and the PET center at Uppsala University Hospital that has the potential to improve personalized breast cancer treatment, states the company.

“Since 2015, we have performed two smaller studies at Uppsala University Hospital with more than 20 patients showing very promising results. If we can demonstrate that the method works in larger scale, we believe it can quickly become a new “gold” standard worldwide. This would mean that difficult and stressful biopsies can be avoided for many breast cancer patients,” says Henrik Lindman, Physician at the Oncology Clinic, Uppsala University Hospital, who is running the study together with Dr. Jens Sörensen, Physician at the PET center in the hospital.

ABY-025

In patients with so-called HER2-positive breast cancer, a large amount of the HER2 protein is present on the surface of the cancer cells. The more concentrated the protein, the more aggressive the disease. The new PET method involves a small protein-tracer, ABY-025, labeled with radioactive gallium. This procedure is done at the PET center at Uppsala University Hospital. ABY-025 is administered to the patient, finding and attaching to the HER2 protein. The PET camera then records the tracer signals and calculates the patient’s exact HER2 status, enabling the physician to prescribe medication more accurately.

“Several drugs effective against HER2 positive breast cancer have been available many years now. However, when selecting treatment, it is extremely important to know if the woman has HER2-positive metastases and how much HER2 protein is present on the cell surface. Our new method has two major advantages – you do not have to take tissue samples to get answers, an unpleasant experience for the patient, and we can also simultaneously map all tumors in the body,” says Dr. Lindman.

Affibody-3

Affibody-3 is a pan-Nordic clinical study led from Uppsala University Hospital. In total, 120 women with breast cancer from 7-8 hospitals in Sweden, Denmark and Finland will be included in the study. Eligible patients should have HER2 positive or borderline HER2 positive, breast cancer with proliferation in the body or only in the breast. The purpose is to find out if the patients have HER2-positive tumors with the aid of a radioactively labeled tracer, ABY-025, and PET camera, something which is of great importance for the correct choice of treatment.