Toxicity and Pharmacokinetic Profile for Single Dose Injection of ABY-029: A Fluorescent Anti-EGFR Synthetic Affibody Molecule for Human Use

摘要

PurposeABY-029, a synthetic Affibody peptide, Z03115-Cys, labeled with a near-infrared fluorophore, IRDye^® 800CW, targeting epidermal growth factor receptor has been produced under Good Manufacturing Practices for an FDA approved first-in-use human study during surgical resection of glioma, as well as other tumors. Here, the pharmacology, phototoxicity, receptor activity and biodistribution studies of ABY-029 were completed in rats, prior to the intended human use.