Voyxact: which tox species, and why?

“Given >99% homology with human APRIL and comparable binding affinity, the cynomolgus monkey was considered a pharmacological relevant species for safety evaluation.”

“In cross-species comparison studies, binding affinity for APRIL was comparable between cynomolgus monkeys, rabbits, and humans whereas binding to APRIL could not be detected in rodents (mouse or rat).”

“The impact of blocking APRIL interaction with its receptors was evaluated in a grouped ddY (gddY) IgA mouse nephropathy model using the mAb 4540 mouse surrogate and in healthy cynomolgus monkeys with sibeprenlimab.”

“Given >99% homology with human APRIL and comparable binding affinity, the cynomolgus monkey was considered a pharmacological relevant species for safety evaluation.”

“The potential maternal and developmental effect on pregnant cynomolgus monkeys and their offspring was evaluated in an enhanced pre- and postnatal development study.”

“A carcinogenicity risk assessment was submitted by the applicant, which was reviewed under the IND. Rodent carcinogenicity studies were deemed not to be warranted to establish an adequate assessment of carcinogenicity risk for sibeprenlimab.”

“The impact of blocking APRIL interaction with its receptors was evaluated in a grouped ddY (gddY) IgA mouse nephropathy model using the mAb 4540 mouse surrogate and in healthy cynomolgus monkeys with sibeprenlimab.”