Gazyva: which tox species, and why?

“Toxicology studies were conducted solely using cynomolgus monkeys because other species available for toxicity testing are not pharmacologically responsive to obinutuzumab.”

“Obinutuzumab binds to Cynomolgus monkey (but not rodent) CD20 with an affinity and ADCC potency similar to that of human CD20; consequently, the Cynomolgus monkey was considered the only appropriate species in which to assess the safety of obinutuzumab.”

“Toxicology studies were conducted solely using cynomolgus monkeys because other species available for toxicity testing are not pharmacologically responsive to obinutuzumab.”

“Toxicology studies were conducted solely using cynomolgus monkeys because other species available for toxicity testing are not pharmacologically responsive to obinutuzumab.”

“An enhanced pre and postnatal development (ePPND) toxicity study in pregnant Cynomolgus monkeys showed no evidence of teratogenic effects.”

“Evaluation of the genotoxicity, carcinogenicity and dedicated safety pharmacology studies were not conducted and were not needed for this application.”

“Vaccination studies in huCD20 mice and Cynomolgus monkeys showed that the enhanced efficacy in terms of B-cell depletion of obinutuzumab translated into stronger suppression of de novo antibody responses, but left the protective humoral memory responses intact (Report 1053638).”