“The toxicity of crizanlizumab was evaluated in GLP-compliant 4- and 26-week toxicology studies in cynomolgus monkeys.”
✓ VerifiedFDA multi-discipline review, p. 30Source ↗
Why that species
Binds human and cynomolgus platelet P-selectin; no binding to dog or rat P-selectin
“Crizanlizumab bound to human and cynomolgus monkey platelets expressing P-selectin, but did not bind to platelets expressing P-selectin from dog or rat. Thus, monkey is an appropriate toxicological animal model to study crizanlizumab.”
✓ VerifiedFDA multi-discipline review, p. 34Source ↗
Surrogate molecule
No surrogate; the clinical antibody (earlier SelG1 material and commercial SEG101) was tested in cynomolgus monkeys
“The preclinical safety profile of crizanlizumab was mostly characterised using the previous CHO-K1-derived material (SelG1) in Cynomolgus monkeys. The current crizanlizumab SEG101 was tested in the enhanced pre- and postnatal developmental toxicity study.”