Poteligeo: which tox species, and why?

“Toxicology studies were only conducted in cynomolgus monkeys due to the limited cross reactivity profile of mogamulizumab.”

“Biotinylated mogamulizumab specifically bound peripheral lymphocytes from humans and cynomolgus monkeys only; most the specific binding was in the CD4-positive subset. Similar binding in humans and cynomolgus monkeys is expected given the CCR4 amino acid sequence at the mogamulizumab binding region is identical in humans and cynomolgus monkeys.”

“Toxicology studies were only conducted in cynomolgus monkeys due to the limited cross reactivity profile of mogamulizumab.”

“Toxicology studies were only conducted in cynomolgus monkeys due to the limited cross reactivity profile of mogamulizumab.”

“In an embryo-fetal development study pregnant cynomolgus monkeys were administered mogamulizumab IV once weekly at 40 mg/kg (approximately 27 times the exposure in patients at the recommended dose, based on AUC) from the start of organogenesis until late 3rd trimester.”

“No carcinogenicity studies were conducted or are required to support a marketing application for the current indication.”

“Toxicology studies were only conducted in cynomolgus monkeys due to the limited cross reactivity profile of mogamulizumab.”