Portrazza: which tox species, and why?

“Necitumumab bound to EGFR from humans and cynomolgus monkeys with similar affinity, thus, general toxicology studies were conducted in cynomolgus monkeys.”

“As indicated, the binding affinity for EGFR ECD is comparable between human and cyno. Lower affinities were achieved against rodent and rabbit isoforms.”

“The pharmacological and pharmacokinetic data comparing necitumumab and cetuximab are reasonable to support the use of cetuximab as a surrogate for the purpose of investigating the potential for necitumumab to have effects on a developing organism.”