Affibody Medical Investor Relations

Phase 2 HER2-targeting Study Presented at SABCS


December 9, 2021

Solna, Sweden, December 9, 2021. Affibody AB (“Affibody”) today announced that results of the Phase 2 study “A phase II study of 68Ga-ABY-025 PET for non-invasive quantification of HER2 expression in breast cancer” is presented at the San Antonio Breast Cancer Symposium 2021.

The aim of the study, which was led by Henrik Lindman (PI), Jens Sörensen (nuclear medicine), Ali Alhuseinalkhudhur and colleagues, was to investigate the role of 68Ga-ABY-025 PET imaging in relation to histopathology and treatment response. The results are presented as abstract P3-02-06 during the virtual poster presentation 3, at the 2021 San Antonio Breast Cancer Symposium®, December 7-10, 2021 hybrid meeting.

About the Phase 2 trial (Affibody-3 Study)
The Affibody-3 Study is a multi- center phase II/III study with 68Ga-ABY-025 PET and biopsies in patients with advanced HER2-positive breast cancer, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 68Ga-ABY-025 PET and standard histopathology from relevant tumor biopsies. 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. The Identifier is NCT03655353

About ABY-025
The PET imaging agent ABY-025 is based on an Affibody® molecule that binds strongly to HER2. The high affinity and rapid clearance of ABY-025 from blood and normal organs allows HER2 assessment within hours. Further information can be found in the following references: Sörensen et al Theranostics. 2016 Jan 1;6 (2):262-71, and Alhuseinalkhudhur A et al EJNMMI Res. 2020.10 (1):21.

About Affibody
Affibody is a clinical stage biopharmaceutical company with a broad product pipeline focused on developing innovative bi- and multi-specific next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod®.

The company operates a focused experimental medicine model and currently has two clinical stage programs. The first is izokibep that targets autoimmune diseases. The second program is a diagnostic imaging program that is directed primarily towards metastatic breast cancer.

Affibody AB is a holding of Patricia Industries.

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