Bizengri
zenocutuzumab · HER2 x HER3Cynomolgus monkey only
Korjuny: which tox species, and why?
catumaxomab · EpCAM x CD3
Species
No relevant species; limited single-dose mouse, rat, one cynomolgus; BiLu mouse surrogate
“None of the animal species analysed is suitable for assessing the safety of catumaxomab.”
Why that species
No binding to cells from rodents, rabbit, dog or NHPs; CD3/EpCAM binding human-specific
“None of the studies demonstrated binding of catumaxomab to cells from non-clinical species.”
Surrogate molecule
Yes: BiLu (anti-human EpCAM x anti-mouse CD3) in mice; only partially reflects catumaxomab
“Since BiLu recognises only murine CD3 but not murine EpCAM, the surrogate mAb only partially reflects the functionality of catumaxomab.”
Same question, other bispecifics
Blincyto
blinatumomab · CD19 x CD3Chimpanzee (only relevant species, limited non-terminal studies) plus mouse with murine surrogate
Columvi
glofitamab · CD20 x CD3Cynomolgus monkey only
Elrexfio
elranatamab · BCMA x CD3Cynomolgus monkey only
Epkinly
epcoritamab · CD20 x CD3Cynomolgus monkey only
Hemlibra
emicizumab · FIXa x FXCynomolgus monkey only
Imdelltra
tarlatamab · DLL3 x CD3Cynomolgus monkey (pivotal); mouse surrogate muS757 for EFD and 1-month study
Kimmtrak
tebentafusp · CD3 x gp100 (TCR fusion)No relevant species; in vitro human cell/tissue assays only
Lunsumio
mosunetuzumab · CD20 x CD3Cynomolgus monkey only
Lynozyfic
linvoseltamab · BCMA x CD3Cynomolgus monkey only
Ordspono
odronextamab · CD20 x CD3Cynomolgus monkey only
Removab
catumaxomab · EpCAM x CD3No relevant species; in vitro human cells plus mouse surrogate (BiLu); limited single-dose rodent/monkey
Rybrevant
amivantamab · EGFR x METCynomolgus monkey only
Talvey
talquetamab · GPRC5D x CD3Cynomolgus monkey only (tool molecule for pivotal tox); no rodent tox
Tecvayli
teclistamab · BCMA x CD3Cynomolgus monkey only (rabbit used for SC local tolerance only)
Vabysmo
faricimab · VEGF-A x Ang-2Cynomolgus monkey only for pivotal tox (rabbit dropped after early studies)
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)Cynomolgus monkey only