Imjudo: which tox species, and why?

“These results support the monkey as the only pharmacologically relevant species.”

“At a concentration of 10 µg/mL, tremelimumab bound human and cynomolgus T cells treated with phytohemagglutinin (PHA) to stimulate expression of CTLA‐4, but did not bind mouse, rat, hamster, or rabbit PHA‐stimulated T cells”

“The Applicant evaluated the safety of tremelimumab administered intravenously, the intended route of administration, using cynomolgus monkeys in GLP‐compliant 1‐ and 6‐month repeat‐dose toxicology studies.”

“The Applicant evaluated the safety of tremelimumab administered intravenously, the intended route of administration, using cynomolgus monkeys in GLP‐compliant 1‐ and 6‐month repeat‐dose toxicology studies.”

“Once weekly IV administration of tremelimumab to pregnant monkeys during the period of organogenesis did not result in maternal toxicity or embryo‐fetal development toxicity at doses ≤30 mg/kg (approximately ≤4 times the clinical AUC);”

“The Applicant did not conduct carcinogenicity or genetic toxicology studies as they are generally not appropriate for antibody therapies.”

“demonstrating pharmacological activity of murine surrogates for tremelimumab and durvalumab in mouse syngeneic tumour models”