Bizengri
zenocutuzumab · HER2 x HER313 weeks
Ordspono: how long were the pivotal tox studies?
odronextamab · CD20 x CD3
Longest pivotal study
16 weeks
“once weekly IV infusions of 0.1 and 1 mg/kg for 16 weeks (total of 17 doses) with a 14-week recovery period.”
Pivotal GLP studies
GLP cynomolgus single-dose, 4-week (0.01/0.1/1 mg/kg) and 16-week (0.1/1 mg/kg) weekly IV studies with recovery
“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”
Route in tox
IV infusion (repeat-dose); IV and SC (single-dose)
“following a single dose of 0.1 or 1 mg/kg SC or 1 mg/kg IV (Phase I) or escalating doses of 1/25/100 mg/kg (IV and SC; Phase II) with an 8-week recovery period.”
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
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