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