Enjaymo: which tox species, and why?

“The cynomolgus monkey was the only nonclinical species demonstrated to be pharmacologically relevant, and the nonclinical program was conducted only in that species.”

“Sutimlimab binds cynomolgus monkey and human C1s with comparable affinity (EC50, 0.13 nM and 0.15 nM, respectively)”

“The cynomolgus monkey was the only nonclinical species demonstrated to be pharmacologically relevant, and the nonclinical program was conducted only in that species.”

“The cynomolgus monkey was the only nonclinical species demonstrated to be pharmacologically relevant, and the nonclinical program was conducted only in that species.”

“An enhanced pre- and post-natal developmental (ePPND) toxicity study was conducted in pregnant monkeys with intravenous administration of 60 and 180 mg/kg/week sutimlimab (during organogenesis to parturition) to evaluate the potential for embryo-fetal and pre/post-natal developmental toxicity.”

“The applicant’s non-clinical package did not include a traditional in vivo carcinogenicity assessment. Instead, the applicant provided a weight-of-evidence (WOE)-based assessment of carcinogenic potential (per ICH S6).”

“The cynomolgus monkey was the only nonclinical species demonstrated to be pharmacologically relevant, and the nonclinical program was conducted only in that species.”