Beyfortus: which tox species, and why?

“The non-clinical safety programme consisted of a 1-month repeat-dose toxicity study in cynomolgus monkeys and tissue cross-reactivity studies in human tissues”

“Therefore, use of cynomolgus monkeys as the relevant animal species for the non-clinical in vivo program of nirsevimab is endorsed based on the comparable affinity of nirsevimab to human and cynomolgus FcRn and the fact that the YTE substitution decreases antibody exposure in rodents.”

“A repeat-dose toxicology study was conducted in cynomolgus monkeys to evaluate the potential toxicity of nirsevimab (study No 1468-038).”

“The non-clinical safety programme consisted of a 1-month repeat-dose toxicity study in cynomolgus monkeys and tissue cross-reactivity studies in human tissues”

“Dedicated in vivo DART studies have not been conducted with nirsevimab. In accordance with ICH S6(R1), DART studies are generally not needed for biologics to exogenous targets.”

“Carcinogenesis, mutagenesis and reproductive toxicity studies have not been performed with BEYFORTUS.”

“Therefore, the parental molecule, 1G7, was utilized for nonclinical pharmacology studies conducted in rodents.”