Cinqair: which tox species, and why?

“Pivotal nonclinical studies were conducted in CD-1 mice and Cynomolgus monkeys; both were identified as relevant species in a series of pharmacology studies.”

“Reslizumab binds with similar affinity to human, monkey, and mouse IL-5 (KD = 24, 20, and 31 pM; respectively, as determined by BIAcore biosensor assays).”

“The nonclinical program for reslizumab included studies conducted in mice, rabbits, and monkeys, which were all considered pharmacologically relevant species based on data from in vivo eosinophilia models in sensitized animals”

“The nonclinical general toxicology program with reslizumab was conducted in CD-1 mice and Cynomolgus monkeys, both of which were determined to be pharmacologically relevant test species.”

“Reproductive and developmental toxicology studies were conducted in CD-1 mice (fertility, embryo-fetal development, and pre-natal/post-natal development) and New Zealand rabbits (embryo-fetal development).”

“The applicant conducted a 26-week study in Tg.rasH2 mice to assess the carcinogenic potential of reslizumab.”

“The nonclinical program for reslizumab included studies conducted in mice, rabbits, and monkeys, which were all considered pharmacologically relevant species based on data from in vivo eosinophilia models in sensitized animals”