Vyloy: which tox species, and why?

“Pivotal toxicology studies with zolbetuximab included a 13-week GLP repeat-dose study in mice and a 4-week GLP repeat-dose study in cynomolgus monkey with once weekly intravenous administration.”

“Flow cytometry binding was observed for a mouse CLDN18.2 ortholog (KD=2.6 nM) and cynomolgus monkey (KD=2.22 nM).”

“A group of mice received the murine variant of zolbetuximab which exerts comparable Fc effector function to human IgG1.”

“Pivotal toxicology studies with zolbetuximab included a 13-week GLP repeat-dose study in mice and a 4-week GLP repeat-dose study in cynomolgus monkey with once weekly intravenous administration.”

“Reproductive and developmental toxicity studies were performed in mice. In line with ICH S9, only embryofoetal development was assessed; omission of studies on fertility and early embryonic development and on pre-/post-natal development is acceptable.”

“No carcinogenicity studies have been conducted. Zolbetuximab. is intended for the treatment of patients with advanced cancer in the scope of the ICH S9.”

“A group of mice received the murine variant of zolbetuximab which exerts comparable Fc effector function to human IgG1.”