Gamifant: which tox species, and why?

“In in vitro studies, emapalumab (NI-0501) bound to human (hIFNγ) and cynomolgus monkey IFNγ with similar affinity, but did not bind to rodent IFNγ, supporting the use of cynomolgus monkeys as the single pharmacologically relevant species for toxicity assessment.”

“Emapalumab was cross-reactive to both cynomolgus and rhesus monkey, but no binding was detected in the dog, rat, or mouse.”

“The Applicant characterized a commercially available rat IgG1 anti-mouse IFNγ monoclonal antibody (mAb), XMG1.2, and used it as a surrogate of emapalumab to conduct studies in murine HLH models, as well as in their assessments of potential effects on embryofetal development.”