Coprelotamab Biosimilar - Research Grade (ICH5448) is an unconjugated, non-therapeutic research analog of the originator antibody coprelotamab, built around the ERBB2 (HER2/CD340) target. It is supplied as a human IgG1, kappa immunoglobulin for research use only and is not a clinical drug. As a biosimilar reagent, it is intended to reproduce the antigen-binding behavior of the reference molecule so investigators can use it as a benchmark or reference antibody in in-vitro and functional assays, without any conjugated payload, label, or therapeutic formulation. Like other ichor.bio research biosimilars, it is manufactured to research-grade specifications with low endotoxin (typically less than 1 EU/mg) and is available in bulk milligram-to-gram quantities suitable for assay standardization, comparability studies, and mechanism-of-action work. Because ERBB2 is a human tumor antigen, this reagent is primarily applied to human-target systems rather than routine mouse in-vivo dosing. It provides a cost-effective, well-characterized reference tool for laboratories studying HER2 biology, HER2-directed binders, and antibody-based assay development. All descriptions here are guidance for ichor.bio to review.
ERBB2 (HER2, also known as CD340; UniProt P04626) is a receptor tyrosine kinase of the EGFR/ErbB family. Unlike its family members, HER2 has no known direct ligand and instead acts as the preferred heterodimerization partner for other ErbB receptors, amplifying downstream signaling through the RAS-MAPK and PI3K-AKT pathways to drive cell proliferation and survival. HER2 is overexpressed or amplified in a substantial fraction of breast cancers and in subsets of gastric, ovarian, and other solid tumors, where it correlates with aggressive disease. This overexpression, combined with limited expression in most normal adult tissues, makes HER2 a validated target for antibody-based approaches. Antibodies against HER2 can block receptor dimerization and signaling, and can recruit immune effector functions such as antibody-dependent cellular cytotoxicity against HER2-positive cells.