Drug intelligence / Profile preview

68Ga-ABY-025

Development stage
Phase 2
Lead developer
Affibody
Modality
Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics, Peptides, Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

68Ga-ABY-025 is a radiopharmaceutical imaging agent consisting of the Affibody molecule ABY-025 labeled with the positron-emitting radioisotope gallium Ga 68. It is designed for use in positron emission tomography (PET) to non-invasively quantify human epidermal growth factor receptor type 2 (HER2) expression in solid tumors, particularly breast cancer and gastroesophageal cancer. Upon intravenous administration, the affibody binds specifically to HER2-expressing tumor cells, enabling visualization and quantification of HER2 status via PET imaging. This allows for improved staging and assessment of response to HER2-targeted therapies as well as identification of patients who may benefit from such treatments[1][3][5][6]. The drug has shown strong correlation between uptake on PET scans and biopsy-determined HER2 status[4][8]. Developed by Affibody in collaboration with academic partners such as Uppsala University and Karolinska Institutet[6], it is being evaluated in phase II clinical trials for its diagnostic utility.

Other names
ABY-025ABY025ABY 025ZHER2:2891-Cys-MMA-DOTA (as the labeled peptide)HER2 PET (contextual/clinical use)
02

Targets

ERBB2 (Erb-b2 receptor tyrosine kinase 2)

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