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.”