Ilumya: which tox species, and why?

“Toxicology studies with tildrakizumab were conducted in cynomolgus monkeys which were shown to be a relevant species, based on the binding of tildrakizumab to cynomolgus IL-23p19.”

“Comparison of the amino acid sequences of IL-23p19 between human and various preclinical species revealed that cynomolgus monkeys had a 98% homology to humans.”

“Due to the lack of cross-reactivity with mouse IL-23p19 and in order to test the potency efficacy in vivo a surrogate antibody, SCH 900598, was generated against the mouse IL-23p19.”

“Toxicology studies with tildrakizumab were conducted in cynomolgus monkeys which were shown to be a relevant species, based on the binding of tildrakizumab to cynomolgus IL-23p19.”

“Reproductive and developmental toxicity of tildrakizumab was evaluated in cynomolgus monkeys.”

“Classical carcinogenicity animal studies were not conducted; instead the risk of carcinogenicity was assessed based on a weight of evidence approach. To this end, the applicant has conducted several in vivo studies in mouse tumour models and an extensive analysis of current literature.”

“Due to the lack of cross-reactivity with mouse IL-23p19 and in order to test the potency efficacy in vivo a surrogate antibody, SCH 900598, was generated against the mouse IL-23p19.”