Imaavy: genotox, carcinogenicity and repro: done or skipped?

“No genetic toxicology studies were conducted.”

“Nipocalimab is a mAb which does not cross-react with rodent FcRn, precluding the conduct of traditional carcinogenicity studies. In line with ICH guideline S6(R1) and based on a WoE approach it was concluded that nipocalimab does not pose an increased carcinogenic risk.”

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

“Safety pharmacology assessments were incorporated into the 4-week and 26-week IV toxicity studies in monkey; there were no effects of nipocalimab on cardiovascular, respiratory, or central nervous system parameters.”