Tzield: which tox species, and why?

“As teplizumab was shown to only cross-react with CD3+ T cells from humans, gorillas, chimpanzees, and gibbons, minimal nonclinical investigations were conducted with teplizumab itself.”

“As teplizumab was shown to only cross-react with CD3+ T cells from humans, gorillas, chimpanzees, and gibbons, minimal nonclinical investigations were conducted with teplizumab itself.”

“evaluation continued in mice with a surrogate antibody in a GLP 6 days repeat dose toxicology (RDT) study, male/female fertility and early embryonic (FEED) studies, embryonic development (EFD) and a pre-postnatal development (PPND) study.”

“One GLP repeated dose toxicology study of 6 days duration with 6 weeks of recovery have been performed in CD-1 mice (study 7608-797).”

“GLP-compliant reproductive studies were conducted with the surrogate antibody in mice and included separate fertility and early embryonic (FEED) studies in males and females, an embryo-fetal development (EFD) study and a prenatal and postnatal development (PPND) study.”

“Due to the absence of toxicologically relevant species and the use of a surrogate leading to immunogenicity, a carcinogenicity study in mice would not be feasible.”

“evaluation continued in mice with a surrogate antibody in a GLP 6 days repeat dose toxicology (RDT) study, male/female fertility and early embryonic (FEED) studies, embryonic development (EFD) and a pre-postnatal development (PPND) study.”