Bizengri
zenocutuzumab · HER2 x HER3Not conducted (ICH S6(R1))
Removab: genotox, carcinogenicity and repro: done or skipped?
catumaxomab · EpCAM x CD3
Genotoxicity
Not conducted (not submitted; biologic, no relevant model)
“Genotoxicity studies have not been submitted.”
Carcinogenicity
Not conducted (not submitted)
“Carcinogenicity studies have not been submitted.”
Instead of carcinogenicity
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Instead of genotoxicity
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
DRG histopathology
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Reproductive & developmental
Not conducted (not submitted)
“Reproductive and developmental toxicity studies have not been submitted.”
Safety pharmacology
No in vivo studies; human tissue cross-reactivity and in vitro hepatocyte studies
“The safety pharmacology programme was defined by the accessibility of intact monoclonal antibodies in vivo to EpCAM positive tissue.”
Genotox: Ames
Not conducted (not submitted)
“Genotoxicity studies have not been submitted.”
Genotox: in vitro mammalian
Not conducted (not submitted)
“Genotoxicity studies have not been submitted.”
Genotox: in vivo
Not conducted (not submitted)
“Genotoxicity studies have not been submitted.”
Carcinogenicity model
Not conducted (not submitted)
“Carcinogenicity studies have not been submitted.”
Carcinogenicity timing
Not required: absence of studies accepted given no suitable animal models
“The absence of many nonclinical studies is considered acceptable for an antibody, given the absence of suitable animal models.”
hERG / QT
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Same question, other multispecifics
Blincyto
blinatumomab · CD19 x CD3Not conducted (ICH S6(R1); protein of natural amino acids)
Columvi
glofitamab · CD20 x CD3Not conducted (ICH S6(R1))
Elrexfio
elranatamab · BCMA x CD3Not conducted (ICH S6(R1))
Epkinly
epcoritamab · CD20 x CD3Not conducted (ICH S6(R1), ICH S9)
Hemlibra
emicizumab · FIXa x FXNot conducted (ICH S6)
Imdelltra
tarlatamab · DLL3 x CD3Not conducted (ICH S6(R1))
Kimmtrak
tebentafusp · CD3 x gp100 (TCR fusion)Not conducted (fusion protein; ICH S6/S9)
Korjuny
catumaxomab · EpCAM x CD3Not conducted (ICH S6(R1))
Lunsumio
mosunetuzumab · CD20 x CD3Not conducted (ICH S6(R1))
Lynozyfic
linvoseltamab · BCMA x CD3Not conducted (antibody not expected to interact with DNA)
Ordspono
odronextamab · CD20 x CD3Not conducted (antibody not expected to interact with DNA)
Rybrevant
amivantamab · EGFR x METNot conducted (not appropriate for antibodies)
Talvey
talquetamab · GPRC5D x CD3Not conducted (ICH S6; biotechnology-derived product)
Tecvayli
teclistamab · BCMA x CD3Not conducted (ICH S6(R1))
Vabysmo
faricimab · VEGF-A x Ang-2Not conducted (ICH S6(R1))
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)Not conducted (ICH S6(R1), ICH S9)