Ordspono: which tox species, and why?

“Binding to human and cynomolgus CD20 and CD3 was confirmed in in vitro studies. Cynomolgus monkey was considered the pharmacological relevant species further used in toxicology studies.”

“An additional binding study showed that odronextamab did not bind to either B-cells or T-cells isolated from mouse and rat.”

“The safety profile of odronextamab was evaluated in cynomolgus monkeys in 2 GLP-compliant repeat”

“The safety profile of odronextamab was evaluated in cynomolgus monkeys in 2 GLP-compliant repeat-dose toxicology studies following once weekly IV infusions of 0.01, 0.1, and 1 mg/kg for 4 weeks (total of 5 doses) with a 12-week recovery period and following once weekly IV infusions of 0.1 and 1 mg/kg for 16 weeks (total of 17 doses) with a 14-week recovery period.”

“There were no odronextamab-related findings in fertility endpoints or microscopic assessment of reproductive organs at doses of up to and including 1 mg/kg/week IV. Embryo-fetal developmental toxicology studies with odronextamab were not conducted as such studies are expected to have limited value in further understanding and communicating risks to patients with advanced cancer.”

“As odronextamab is intended for use in patients with advanced malignancies, carcinogenicity studies were not conducted with odronextamab, consistent with ICH guideline S9 on non-clinical evaluation for anticancer pharmaceuticals”

“Cynomolgus monkey was considered the pharmacological relevant species further used in toxicology studies.”