Bizengri
zenocutuzumab · HER2 x HER313 weeks
Lynozyfic: how long were the pivotal tox studies?
linvoseltamab · BCMA x CD3
Longest pivotal study
14 weeks
“The subsequent toxicology study was initially programmed for 26 weeks of treatment but due to declining clinical condition that necessitated early sacrifice of a number of animals for welfare reasons, the study was stopped after 9 (total of 9 doses; 20 mg/kg group) or 14 weeks”
Pivotal GLP studies
GLP cynomolgus 5-week IV (0.1/1/10 mg/kg, 12-wk recovery) and 9- or 14-week IV (1/5/20 mg/kg, 13-wk recovery) studies
“Study R5458-TX-17179: A 5-Week Intravenous Infusion Toxicity and Toxicokinetic Study in Cynomolgus Monkeys With a 12-Week Dose-Free Recovery Phase”
Route in tox
IV (infusion/bolus)
“Male and female Cynomolgus monkeys, assigned to 4 groups, were administered once weekly for 5 weeks via intravenous infusion”
Same question, other bispecifics
Blincyto
blinatumomab · CD19 x CD313 weeks
Columvi
glofitamab · CD20 x CD34 weeks
Elrexfio
elranatamab · BCMA x CD313 weeks
Epkinly
epcoritamab · CD20 x CD35 weeks
Hemlibra
emicizumab · FIXa x FX26 weeks
Imdelltra
tarlatamab · DLL3 x CD313 weeks
Kimmtrak
tebentafusp · CD3 x gp100 (TCR fusion)0 (no in vivo tox study)
Korjuny
catumaxomab · EpCAM x CD30 (no in vivo tox study)
Lunsumio
mosunetuzumab · CD20 x CD326 weeks
Ordspono
odronextamab · CD20 x CD316 weeks
Removab
catumaxomab · EpCAM x CD30 (no in vivo tox study)
Rybrevant
amivantamab · EGFR x MET13 weeks
Talvey
talquetamab · GPRC5D x CD34 weeks
Tecvayli
teclistamab · BCMA x CD35 weeks
Vabysmo
faricimab · VEGF-A x Ang-226 weeks
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)13 weeks