Imaavy: which tox species, and why?

“Toxicology studies evaluating weekly IV (15-minute infusion) administration of nipocalimab were conducted in cynomolgus monkeys.”

“and pH 7.4 with KD of ≤57.8 pM, 58 pM for human and cynomolgus monkey, respectively and did not bind to mouse or rat FcRn.”

“No studies were conducted in rodents, based on the absence of pharmacologic activity.”

“Toxicology studies evaluating weekly IV (15-minute infusion) administration of nipocalimab were conducted in cynomolgus monkeys. No studies were conducted in rodents, based on the absence of pharmacologic activity.”

“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.”

“In vivo studies were performed using humanized FcRn mice (also called Tg32 mice,”