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Epkinly: animal efficacy model or human cells?

epcoritamab · CD20 x CD3
Efficacy evidence
Human lymphoma cell line-derived xenograft (CDX) mouse models and one patient-derived xenograft (PDX) model
“The in vivo antitumor activity of epcoritamab was evaluated in various human lymphoma cell line-derived xenograft (CDX) mouse models and in one patient-derived xenograft (PDX) mouse model.”
✓ VerifiedFDA multi-discipline review, p. 44Source ↗
Why that model
Epcoritamab does not bind dog, pig, rat or mouse CD20
“Epcoritamab bound a cell line transfected with rabbit CD20 (KD=6.93 nM), but did not bind cells expressing dog, pig, rat, or mouse CD20 under the conditions tested.”
✓ VerifiedFDA multi-discipline review, p. 43Source ↗
Reviewer's view of the efficacy data
FDA: antitumor activity in prophylactic, established and late-treatment settings, but relative activity could not be established due to varied study designs
“Antitumor activity was observed in each of the prophylactic, established, and late treatment settings, but the relative antitumor activities could not be established due to the varied study designs and treatments.”
✓ VerifiedFDA multi-discipline review, p. 44Source ↗

Same question, other bispecifics

Bizengri

zenocutuzumab · HER2 x HER3
Mouse xenografts: HER2+ breast cancer (JIMT-1) and NRG1 fusion-positive lung and pancreatic patient-derived xenografts

Blincyto

blinatumomab · CD19 x CD3
Blinatumomab in NOD/SCID mouse tumor xenograft models

Columvi

glofitamab · CD20 x CD3
Human HSC-engrafted NOG/NSG mice, non-tumor-bearing and tumor-bearing

Elrexfio

elranatamab · BCMA x CD3
Multiple myeloma xenograft models (MM.1S, OPM2, MOLP8) with varying BCMA expression

Hemlibra

emicizumab · FIXa x FX
Cynomolgus monkey models of acute and chronic hemophilia A

Imdelltra

tarlatamab · DLL3 x CD3
Xenograft 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 CD3
SCID mouse i.p. human ovarian carcinoma ascites xenograft treated with human PBMCs plus catumaxomab

Lunsumio

mosunetuzumab · CD20 x CD3
Human CD20/CD3 double-transgenic mice: peripheral and tissue B-cell depletion and T-cell activation (comparable to analogue 2H7v16/40G5c)

Lynozyfic

linvoseltamab · BCMA x CD3
NSG mice co-implanted with human PBMC and NCI-H929 or MOLP-8 myeloma xenografts

Ordspono

odronextamab · CD20 x CD3
Lymphoma tumour models in humanized (BRG) mice and immunodeficient NSG mice

Removab

catumaxomab · EpCAM x CD3
Human ovarian carcinoma xenograft (catumaxomab); syngeneic human-EpCAM mouse tumour model with surrogate BiLu

Rybrevant

amivantamab · EGFR x MET
Patient-derived tumor xenografts with EGFR exon 20 insertion mutations in mice

Talvey

talquetamab · GPRC5D x CD3
Myeloma cell line xenografts (H929 prophylactic; MM.1S, RPMI 8226 established) in humanized immunodeficient mice

Tecvayli

teclistamab · BCMA x CD3
Human MM xenografts (H929, RPMI-8226) in human PBMC/T-cell-engrafted NSG mice

Vabysmo

faricimab · VEGF-A x Ang-2
Laser-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

Summary across all 18 bispecifics →