Lunsumio: how long were the pivotal tox studies?

“In the pivotal 26-week GLP toxicity study (16-1815), exposure was maintained in 7/7 animals in the 0.5 mg/kg target-dose group, and in 4/7 surviving animals past TK Day 84 in the 0.1 mg/kg group.”

“A step-up mosunetuzumab dosing regimen was used in the 4-week DRF study and the pivotal GLP 26-week repeat-dose toxicity studies (Study 16-2088 and 16-1815) by splitting the first 1 mg/kg dose to Day 1 (0.2 mg/kg) and Day 2 (0.8 mg/kg)”

“Mosunetuzumab and 2H7v16/40G5c were investigated after repeated dosing up to 26 weeks in cynomolgus monkeys following IV administration (slow bolus injection (½-1 min) or infusion (1h)) or SC injection.”