Bizengri
zenocutuzumab · HER2 x HER313 weeks
Talvey: how long were the pivotal tox studies?
talquetamab · GPRC5D x CD3
Longest pivotal study
4 weeks
“The toxicity and toxicokinetics (TK) of JNJ-64024701 were evaluated in a GLP-compliant 1-month repeat”
Pivotal GLP studies
1-month GLP IV study of tool molecule in cynomolgus monkey (0, 10, 30 mg/kg weekly x4); non-GLP 4-week talquetamab tolerability study
“JNJ-64024701 (GCDB32 GPRC5DxCD3): A 1-Month GLP Intravenous Toxicity and Toxicokinetic Study in Cynomolgus Monkeys / Study T-2017-009”
Route in tox
IV in monkey tox (clinical route SC); SC local tolerance in rabbit
“This study evaluated the IV route of administration, whereas the intended clinical route of administration is SC injection.”
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
Tecvayli
teclistamab · BCMA x CD35 weeks
Vabysmo
faricimab · VEGF-A x Ang-226 weeks
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)13 weeks