“In in vitro studies, penpulimab bound to human and cynomolgus monkey PD-1 but did not bind rodent PD-1, supporting the use of cynomolgus monkeys as the single pharmacologically relevant species for toxicity assessment.”
✓ VerifiedFDA multi-discipline review, p. 41Source ↗
Why that species
Binds human and cynomolgus PD-1 (EC50 0.053 and 0.215 nM) but not mouse or rat PD-1
“with EC50 values of 0.053 and 0.215 nM, respectively, but did not bind to mouse or rat PD-1, supporting the use of cynomolgus monkeys as a pharmacologically relevant species for toxicity assessment.”
✓ VerifiedFDA multi-discipline review, p. 43Source ↗
Surrogate molecule
No surrogate; the clinical antibody was tested in cynomolgus monkeys (human PD-1 knock-in mice used only for efficacy)
“Given that pempulimab does not bind mouse PD-1, the Applicant investigated the in vivo antitumor activity of pempulimab in a human PD-1 knock-in genetically engineered mouse model (HuGEMM)”
✓ VerifiedFDA multi-discipline review, p. 41Source ↗