Bizengri
zenocutuzumab · HER2 x HER313 weeks
Korjuny: how long were the pivotal tox studies?
catumaxomab · EpCAM x CD3
Longest pivotal study
0 (no in vivo tox study)
“Repeat-dose toxicity studies have not been performed with catumaxomab due to the lack of an appropriate animal species.”
Pivotal GLP studies
GLP single-dose IV: mouse, rat, one cyno (escalating 1-300 µg/kg); BiLu 4-dose escalating mouse; rabbit local tolerance
“Therefore, a limited toxicology programme was performed, i.e. single dose toxicity studies with catumaxomab in mice, rats and cynomolgus.”
Route in tox
IV (maximal systemic exposure) and i.p. (clinical route); rabbit local tolerance multiple routes
“The intraperitoneal (i.p.) route of administration corresponds to the intended therapeutic use in humans.”
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)
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