Darzalex: which tox species, and why?

“The toxicology program for daratumumab consisted of a GLP 6-week repeat-dose toxicity study in chimpanzees, and in vitro tissue cross-reactivity studies using chimpanzee and human tissues.”

“Daratumumab binds to human and chimpanzee CD38, but not to CD38 of species typically used for nonclinical toxicology testing, ie, mouse, rat, rabbit, pig, and cynomolgus and rhesus monkey.”

“Additional supportive studies were conducted with HuMab-CD38, a mAb that binds cynomolgus CD38, and included a pilot, non-GLP 2-week repeat-dose toxicity study in cynomolgus monkeys, and an in vitro tissue cross-reactivity study with cynomolgus monkey tissues.”