Bizengri
zenocutuzumab · HER2 x HER3Mouse xenografts: HER2+ breast cancer (JIMT-1) and NRG1 fusion-positive lung and pancreatic patient-derived xenografts
Lunsumio: animal efficacy model or human cells?
mosunetuzumab · CD20 x CD3
Efficacy evidence
Human CD20/CD3 double-transgenic mice: peripheral and tissue B-cell depletion and T-cell activation (comparable to analogue 2H7v16/40G5c)
“In the double-transgenic mouse model, it was also shown that 2H7v16/40G5c and mosunetuzumab have comparable profiles in potently depleting peripheral and tissue B cells as well as activation of T cells.”
Why that model
Cross-reacts with CD20 and CD3 in humans and cynomolgus monkeys but not in rodents
“2H7v16/40G5c displays the same properties as mosunetuzumab, as it cross-reacts with CD20 and CD3 in both humans and cynomolgus monkeys, but not in rodents.”
Reviewer's view of the efficacy data
EMA: pharmacology thoroughly described in the non-clinical package
“The pharmacology of mosunetuzumab was thoroughly described in the provided non-clinical package.”
Same question, other bispecifics
Blincyto
blinatumomab · CD19 x CD3Blinatumomab in NOD/SCID mouse tumor xenograft models
Columvi
glofitamab · CD20 x CD3Human HSC-engrafted NOG/NSG mice, non-tumor-bearing and tumor-bearing
Elrexfio
elranatamab · BCMA x CD3Multiple myeloma xenograft models (MM.1S, OPM2, MOLP8) with varying BCMA expression
Epkinly
epcoritamab · CD20 x CD3Human lymphoma cell line-derived xenograft (CDX) mouse models and one patient-derived xenograft (PDX) model
Hemlibra
emicizumab · FIXa x FXCynomolgus monkey models of acute and chronic hemophilia A
Imdelltra
tarlatamab · DLL3 x CD3Xenograft models in NSG mice injected with activated, expanded human T cells
Kimmtrak
tebentafusp · CD3 x gp100 (TCR fusion)Mice engrafted with HLA-A*02:01/gp100+ Mel526 human melanoma cells plus human PBMCs; tumor growth inhibition
Korjuny
catumaxomab · EpCAM x CD3SCID mouse i.p. human ovarian carcinoma ascites xenograft treated with human PBMCs plus catumaxomab
Lynozyfic
linvoseltamab · BCMA x CD3NSG mice co-implanted with human PBMC and NCI-H929 or MOLP-8 myeloma xenografts
Ordspono
odronextamab · CD20 x CD3Lymphoma tumour models in humanized (BRG) mice and immunodeficient NSG mice
Removab
catumaxomab · EpCAM x CD3Human ovarian carcinoma xenograft (catumaxomab); syngeneic human-EpCAM mouse tumour model with surrogate BiLu
Rybrevant
amivantamab · EGFR x METPatient-derived tumor xenografts with EGFR exon 20 insertion mutations in mice
Talvey
talquetamab · GPRC5D x CD3Myeloma cell line xenografts (H929 prophylactic; MM.1S, RPMI 8226 established) in humanized immunodeficient mice
Tecvayli
teclistamab · BCMA x CD3Human MM xenografts (H929, RPMI-8226) in human PBMC/T-cell-engrafted NSG mice
Vabysmo
faricimab · VEGF-A x Ang-2Laser-induced choroidal neovascularization (nAMD model) in cynomolgus monkeys, IVT faricimab vs ranibizumab
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)HER2 3+ xenografts in nude mice (SKOV-3, NCI-N87, patient-derived GXA 3054); no effect in HER2-negative model