Perjeta: which tox species, and why?

“The Cynomolgus monkey was the preferred toxicity species based on the comparable in vitro human and monkey binding affinity and due to lack of binding to the rodent (mouse) ortholog, neu.”

“The amino acid homology of human and monkey ErbB2 was 99%. Therefore, the cynomolgus monkey was selected as the appropriate model for nonclinical evaluation.”

“The Cynomolgus monkey was the preferred toxicity species based on the comparable in vitro human and monkey binding affinity and due to lack of binding to the rodent (mouse) ortholog, neu.”

“The Cynomolgus monkey was the preferred toxicity species based on the comparable in vitro human and monkey binding affinity and due to lack of binding to the rodent (mouse) ortholog, neu.”

“Pregnant cynomolgus monkeys were treated on Gestational Day (GD)19 with loading doses of 30 to 150 mg/kg pertuzumab, followed by bi-weekly doses of 10 to 100 mg/kg.”

“There were no nonclinical genotoxicity or carcinogenicity studies performed with pertuzumab, as per the guidance provided in the International Conference on Harmonisation (ICH) guidance S6”

“Nonclinical studies investigating the pharmacology, pharmacokinetics and toxicology of pertuzumab in xenograft mouse models and cynomolgus monkeys”