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A sensitive LC–MS/MS assay to quantitatefree payload Aur0101 from ADC PYX-201 inrat and monkey plasma: supplementary materials

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posted on 2023-08-16, 11:28 authored by Feng Yin, Farah Ahsan, Jan Pinkas, Biplab Das, Frank Wang, Nancy Zheng, David Hahn, Aniruddha Amrite, Jianwen Feng, Diana Adhikari, Jack Sikora, Elizabeth Shaheen, Shawn Harriman

Aim: Aur0101 is a cytotoxic and small-molecule microtubule depolymerizing agent, and is the payload conjugated to antibody–drug conjugate PYX-201. Developing and validating a sensitive bioanalytical method to quantitate Aur0101 was novel and crucial in preclinical PYX-201 studies. Materials & methods: Reference standard Aur0101 and its stable isotope labelled internal standard Aur0101-d8 were used in this LC–MS/MS method. Results: This sensitive assay was validated at a lower limit of quantitation of 15 pg/ml and successfully applied to support preclinical rat and monkey toxicology studies. Preclinical plasma toxicokinetic parameters were presented. Conclusion: A sensitive and robust LC–MS/MS assay was validated for Aur0101 in rat and monkey plasma.

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