Briumvi: which tox species, and why?

“Therefore, cynomolgus monkey was determined to be the single relevant species for nonclinical evaluations.”

“Ublituximab binds with high affinity (low nM range) to CD20 on B cells from human and cynomolgus monkey. The product does not bind to rodent CD20.”

“In a subsequent study conducted in pregnant CD20 (huCD20) transgenic mice, a pharmacologically relevant animal model, intravenous administration of ublituximab-xiiy (0, 5, 20, or 50 mg/kg) during organogenesis (gestation day 6 and 12) resulted in no adverse effects on embryofetal development.”