Imaavy: what was done before first-in-human, and what came after?

“In the SAD portion of the study, six groups received a single IV infusion of placebo (N=10) or escalating doses of nipocalimab at 0.3 mg/kg (N=3), 3 mg/kg (N=3), 10 mg/kg (N=6), 30 mg/kg (N=6), or 60 mg/kg (N=6).”

“Pivotal GLP-compliant repeat-dose studies consisted of 4- and 26-week studies in which reversibility was evaluated for 9 and 8 weeks, respectively.”

“Pivotal GLP-compliant repeat-dose studies consisted of 4- and 26-week studies in which”

“An enhanced ePPND study consisting of two distinct phases was conducted in cynomolgus monkeys.”

“These infarcts were associated with fetal loss (one stillborn fetus) at 100 mg/kg and 300 mg/kg (two aborted fetuses).”

“An enhanced ePPND study consisting of two distinct phases was conducted in cynomolgus monkeys.”

“Nipocalimab is not pharmacologically active in mouse or rat; therefore, carcinogenicity studies were not conducted.”

“Nipocalimab is not pharmacologically active in mouse or rat; therefore, carcinogenicity studies were not conducted.”

“Overall, the carcinogenic potential has been adequately addressed and it is considered that the WoE submitted by the applicant lends support to the conclusion that the carcinogenic potential of nipocalimab is unlikely.”