Ocrevus: which tox species, and why?

“Toxicology studies of ocrelizumab were conducted in cynomolgus monkey, the only pharmacologically relevant species”

“Ocrelizumab specifically binds CD20 in humans and nonhuman primates. It does not bind CD20 in rodents. Therefore, cynomolgus monkey was selected as the relevant species for nonclinical investigation.”

“Toxicology studies of ocrelizumab were conducted in cynomolgus monkey, the only pharmacologically relevant species”

“Toxicology studies of ocrelizumab were conducted in cynomolgus monkey, the only pharmacologically relevant species”

“Reproductive and developmental toxicology (fertility assessments [male, female] and embryofetal and pre- and postnatal development studies in monkey)”

“Assessment of carcinogenic potential was deemed not feasible and the sponsor’s waiver request was granted.”

“Tissue distribution studies in mice engineered to express huCD20 (huCD20 transgenic mice) demonstrated that, while ocrelizumab does not recognize CD20 in wild-type mice, there was clear binding of ocrelizumab with B cells in huCD20 transgenic mice.”