Blincyto
blinatumomab · CD19 x CD313 weeks
Bizengri: how long were the pivotal tox studies?
zenocutuzumab · HER2 x HER3
Longest pivotal study
13 weeks
“The Applicant evaluated the safety of zenocutuzumab in GLP-compliant 1-month and 13-week repeat-dose toxicology studies in cynomolgus monkeys with the intended IV route of administration.”
Pivotal GLP studies
GLP cynomolgus 1-month (5 weekly IV doses, 8-wk recovery) and 13-week (weekly IV, 6-wk recovery) studies; 10/30/101 mg/kg
“In the 13-week repeat-dose toxicology study in monkeys, zenocutuzumab was intravenously administered at 10, 30, and 101 mg/kg once weekly for 13 weeks, followed by a 6-week recovery period.”
Route in tox
IV infusion (1 h)
“Method of Administration: IV infusion (1 h) on Days 1, 8, 15, 22, and 29”
Same question, other bispecifics
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
Vabysmo
faricimab · VEGF-A x Ang-226 weeks
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)13 weeks