Penpulimab: how long were the pivotal tox studies?

“The Applicant evaluated the safety of penpulimab in cynomolgus monkeys in GLP-compliant repeat-dose toxicology studies of up to 13 weeks duration.”

“In 6-week repeat-dose toxicity study, no apparent toxicity was observed in cynomolgus monkeys following intravenous infusion of penpulimab at 4, 15, or 60 mg/kg once every two weeks for 6 weeks.”

“In the 6- and 13-week studies, monkeys received IV infusion of pempulimab at doses up to 60 mg/kg once every 2 weeks.”