SITC 2022 Poster 106

A Preclinical Receptor Occupancy Assay for an Anti-PD-1 Monoclonal Antibody and an Anti-PD-1×CD47 Bispecific Antibody Utilizing hPD-1/hCD47 Dual Humanized Mice

Mingfa Zang, Hang Ke, Daniel X. He, Lei Zheng, Ruilin Sun, Jian Fei, Henry Li and Annie Xiaoyu An

The receptor occupancy (RO) of the PD1 receptor in peripheral T cells is often assayed during early clinical development, guiding dosing to achieve adequate and relevant efficacy. Each specific therapeutic requires a tailored RO assay, such as a PD-1 RO assay for an anti-PD-1 antibody treatment.

For bispecific antibody (BsAb) treatment, the RO assays required can include RO for each receptor and a total RO combining the two different receptors. Due to the complexity and challenges in developing such assays using clinical samples, it is prudent to develop a model system to test RO assay methods in vivo at the preclinical stage prior to clinical validation, since it may simulate dosing process in human and provide opportunity to correlate RO to tumor model efficacy, if tumor pharmacology is also conducted simultaneously.

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• The possibility and value of using preclinical model to simulate clinical RO assays

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