“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.”
99% ErbB2 amino acid homology human vs monkey; comparable binding affinity; no binding to rodent 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.”
✓ VerifiedFDA pharmacology/toxicology review, p. 14Source ↗
Surrogate molecule
No surrogate; the clinical antibody was tested in cynomolgus monkeys
“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.”