Margenza: which tox species, and why?

“The Applicant conducted GLP-compliant 6-week (doses up to 150 mg/kg/dose) and 13-week (doses up to 100 mg/kg/dose) repeat-dose toxicology studies of margetuximab in cynomolgus monkeys.”

“In a molecular binding study applying SPR, margetuximab Fc domain showed enhanced binding to activating cynomolgus Fc receptors CD16A and CD32A but also increased binding to inhibitory Fc receptor CD32B.”

“Margetuximab was administered through IV infusion once weekly. No target organs for margetuximab were identified”