Loqtorzi: which tox species, and why?

“Toripalimab does not cross-react with mouse or rat PD-1, so that toxicity studies were performed in cynomolgus monkeys, the only relevant species.”

“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.”

“Toripalimab does not cross-react with mouse or rat PD-1, so that toxicity studies were performed in cynomolgus monkeys, the only relevant species.”

“Toripalimab does not cross-react with mouse or rat PD-1, so that toxicity studies were performed in cynomolgus monkeys, the only relevant species.”

“no reproductive and development toxicity studies have been conducted as there is public information indicating that antibodies targeting PD-1 may cause fetal harm when administered to a pregnant woman, obviating the need for reproductive studies.”

“No carcinogenicity studies were conducted. In accordance with ICH S6(R1) “Standard carcinogenicity bioassays are generally inappropriate for biotechnology-derived pharmaceuticals””

“Toripalimab had antitumor activity in human PD-1 knock-in (KI) mice generated by swapping mouse PD-1 exon 2 with human PD-1 exon 2 encoding the entire extracellular domain”