“Toripalimab does not cross-react with mouse or rat PD-1, so that toxicity studies were performed in cynomolgus monkeys, the only relevant species.”
✓ VerifiedFDA multi-discipline review, p. 90Source ↗
Why that species
Similar binding to human and cynomolgus PD-1 on primary T cells; no binding to mouse or rat PD-1
“Toripalimab did not bind to the ECD of mouse or rat PD-1. On primary T cells, toripalimab had similar binding to human and cynomolgus PD-1 with EC50 values of 3.5 and 4.3 nM, respectively.”
✓ VerifiedFDA multi-discipline review, p. 80Source ↗
Surrogate molecule
No surrogate; the clinical antibody was tested in cynomolgus monkey
“Toripalimab does not cross-react with mouse or rat PD-1, so that toxicity studies were performed in cynomolgus monkeys, the only relevant species.”
✓ VerifiedFDA multi-discipline review, p. 90Source ↗