Bizengri
zenocutuzumab · HER2 x HER3Cynomolgus monkey only
Kimmtrak: which tox species, and why?
tebentafusp · CD3 x gp100 (TCR fusion)
Species
No relevant species; in vitro human cell/tissue assays only
“There are no pharmacologically relevant animal species to evaluate tebentafusp toxicity.”
Why that species
TCR recognizes only human gp100:HLA-A*02:01; anti-CD3 scFv binds human T cells only, not mouse or monkey
“In vitro, the scFv portion of tebentafusp bound to T cells in human PBMCs but did not bind PBMCs from mouse or monkey.”
Surrogate molecule
No surrogate; in vitro human-cell approach instead of animal tox
“Tebentafusp can only recognize human HLA; therefore, all nonclinical toxicology studies were conducted in vitro.”
Species: general tox
None (no relevant species; all toxicology studies in vitro)
“Tebentafusp can only recognize human HLA; therefore, all nonclinical toxicology studies were conducted in vitro.”
Species: DART
Not conducted (specificity for human targets)
“Due to the specificity for human targets, embryo-fetal development (EFD) studies cannot be conducted in nonclinical species.”
Species: carcinogenicity
Not conducted
“No carcinogenicity or genotoxicity studies have been conducted with tebentafusp-tebn.”
Surrogate used in
No surrogate used; no relevant animal species, in vitro human-cell assays instead
“Since, tebentafusp is specific for human gp100 and CD3 with no affinity to e.g. monkey, rat or mice, secondary and safety pharmacology was evaluated using in vitro methods on human tissues and cells..”
Same question, other multispecifics
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
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)
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