Bizengri
zenocutuzumab · HER2 x HER3Cynomolgus monkey only
Vabysmo: which tox species, and why?
faricimab · VEGF-A x Ang-2
Species
Cynomolgus monkey only for pivotal tox (rabbit dropped after early studies)
“She agreed, as the Applicant proposed, that the monkey alone should be used in the planned 6-month chronic toxicity study.”
Why that species
100% VEGF sequence homology and comparable Ang-2 binding affinity in monkey; rabbit unsuitable (severe toxicity, ADA)
“The monkey was selected as the most relevant species based on 100% sequence homology (VEGF) and binding affinity (Ang-2) comparable to humans.”
Surrogate molecule
No surrogate; clinical molecule tested in monkey (and rabbit in early studies)
“Faricimab (RO6867461) bound to full length Ang 2 with high affinity across species including human, cynomolgus monkey, rabbit, and mouse, measured by Surface Plasmon Resonance (SPR).”
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
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)
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)Cynomolgus monkey only