Zynyz: which tox species, and why?

“In vitro studies showed retifanlimab bound to human and cynomolgus monkey PD-1 with nanomolar affinity (0.6 and 3.6 nM, respectively) and did not cross react with rodent or canine PD-1, supporting the use of cynomolgus monkeys as the single pharmacologically relevant species for toxicity assessment.”

“In vitro studies showed retifanlimab bound to human and cynomolgus monkey PD-1 with nanomolar affinity (0.6 and 3.6 nM, respectively) and did not cross react with rodent or canine PD-1, supporting the use of cynomolgus monkeys as the single pharmacologically relevant species for toxicity assessment.”

“The Applicant evaluated the toxicity of retifanlimab in a 13-week GLP-compliant repeat-dose toxicology study in cynomolgus monkeys.”