Yervoy: which tox species, and why?

“The cynomolgus monkey was selected as the toxicology species because ipilimumab binds specifically to macaque CTLA-4, but not to homologous CTLA-4 in other traditional toxicology species (mouse, rat, rabbit), and has pharmacologic activity only in primates.”

“The cynomolgus monkey was selected as the toxicology species because ipilimumab binds specifically to macaque CTLA-4, but not to homologous CTLA-4 in other traditional toxicology species (mouse, rat, rabbit), and has pharmacologic activity only in primates.”

“Since ipilimumab is administered intravenously to humans, the IV route was evaluated in all monkey studies.”

“The cynomolgus monkey was selected as the toxicology species because ipilimumab binds specifically to macaque CTLA-4, but not to homologous CTLA-4 in other traditional toxicology species (mouse, rat, rabbit), and has pharmacologic activity only in primates.”

“In a combined study of embryo-fetal and peri-postnatal development, pregnant cynomolgus monkeys received ipilimumab every 3 weeks from the onset of organogenesis in the first trimester through parturition.”

“Carcinogenicity studies for ipilimumab were not conducted.”

“An assessment of the effect of dexamethasone on the anti-tumour activity of anti-mouse CTLA-4 monoclonal antibody (mAb) was made (study MDX-010-001-R).”