Bizengri
zenocutuzumab · HER2 x HER3Cynomolgus monkey only
Ordspono: which tox species, and why?
odronextamab · CD20 x CD3
Species
Cynomolgus monkey only
“Binding to human and cynomolgus CD20 and CD3 was confirmed in in vitro studies. Cynomolgus monkey was considered the pharmacological relevant species further used in toxicology studies.”
Why that species
Binds CD20 and CD3 on human and monkey cells (CD3 affinity ~100-fold weaker in monkey); no binding to mouse/rat cells
“An additional binding study showed that odronextamab did not bind to either B-cells or T-cells isolated from mouse and rat.”
Surrogate molecule
No surrogate; clinical molecule (REGN1979) tested in cynomolgus monkey
“The safety profile of odronextamab was evaluated in cynomolgus monkeys in 2 GLP-compliant repeat”
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
Korjuny
catumaxomab · EpCAM x CD3No relevant species; limited single-dose mouse, rat, one cynomolgus; BiLu mouse surrogate
Lunsumio
mosunetuzumab · CD20 x CD3Cynomolgus monkey only
Lynozyfic
linvoseltamab · BCMA 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