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.”

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

“Standard fertility and early embryonic development, embryofetal development and pre- and postnatal development studies have not been conducted with retifanlimab as not required for advanced cancer therapeutics (ICH S9 2009).”

“Carcinogenicity studies were not warranted.”

“Retifanlimab cross reacts with PD-1 from cynomolgus and rhesus monkeys, but not with PD-1 from non￾primate species. Thus, in vivo studies were limited to cynomolgus monkeys with retifanlimab delivered by IV infusion.”