Bizengri
zenocutuzumab · HER2 x HER313 weeks
Vabysmo: how long were the pivotal tox studies?
faricimab · VEGF-A x Ang-2
Longest pivotal study
26 weeks
“The 26-week IVT monkey study (report # 1057630) was submitted in draft form on 3/24/2015 (SD # 21), and in final form on 7/27/2015 (SD # 24).”
Pivotal GLP studies
GLP 2-month IVT/IV monkey study with 4-week recovery; 26-week monthly IVT monkey study with 13-week recovery
“Study # 1053361, 2-Month Toxicity and Toxicokinetic Study with RO6867461 Following Intravitreous and Intravenous Administration in Cynomolgus Monkeys with a 4-Week Recovery Phase”
Route in tox
Intravitreal (monthly, one eye) plus IV arms; IV for EFD study
“Safety pharmacology endpoints were included as part of the 2-month cynomolgus monkey study (neurological exam, respiration rate, body temperature) following IVT (1.5 to 6 mg/eye, once monthly, one eye dosed) and IV dosing (5 mg/kg once monthly)”
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
Lynozyfic
linvoseltamab · BCMA x CD314 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
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)13 weeks