Quantification of antibody–drug conjugate PYX-201 in rat and monkey plasma via ELISA and its application in preclinical studies

Keywords: • ADC • Aur0101 • ELISA • extra domain B fibronectin • oncology • preclinical • PYX-201 • toxicokinetic • validation • vc0101

Aim: PYX-201 is a novel antibody–drug conjugate targeting the extra domain B splice variant of fibronectin in the tumor microenvironment. Accurate quantification of PYX-201 is critical for PYX-201 pharmacokinetics profiling in preclinical studies. Materials & methods: ELISA was performed using reference standard PYX-201, mouse monoclonal anti-monomethyl auristatin E antibody, mouse IgG1, mouse monoclonal anti-human IgG horseradish peroxidase and donkey anti-human IgG horseradish peroxidase. Results: This assay was validated at 50.0–10,000 ng/ml in rat dipotassium EDTA plasma and 250–10,000 ng/ml in monkey dipotassium EDTA plasma. Conclusion: This is the first time for a PYX-201 bioanalytical assay in any matrix to be reported.

Read the full Preliminary Communication article via Bioanalysis