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Epkinly: which tox species, and why?

epcoritamab · CD20 x CD3
Species
Cynomolgus monkey only
“The nonclinical toxicity profile of epcoritamab was established in a series of nonclinical safety studies in cynomolgus monkeys, the only cross-reactive toxicology species.”
✓ VerifiedFDA multi-discipline review, p. 53Source ↗
Why that species
Similar affinity for human and monkey CD3/CD20; no binding to dog, pig, rat, mouse CD20; CD3 not expected in other species
“The epcoritamab binding data indicates that among the species tested, the cynomolgus monkey is the only pharmacologically relevant species for toxicology studies.”
✓ VerifiedFDA multi-discipline review, p. 43Source ↗
Surrogate molecule
No surrogate; clinical molecule tested in monkey
“We agree that the cynomolgus monkey is a pharmacologically relevant nonclinical species to assess the toxicity of epcoritamab, and general toxicology studies in other species are not warranted.”
✓ VerifiedFDA multi-discipline review, p. 56Source ↗

Same question, other bispecifics

Bizengri

zenocutuzumab · HER2 x HER3
Cynomolgus monkey only

Blincyto

blinatumomab · CD19 x CD3
Chimpanzee (only relevant species, limited non-terminal studies) plus mouse with murine surrogate

Columvi

glofitamab · CD20 x CD3
Cynomolgus monkey only

Elrexfio

elranatamab · BCMA x CD3
Cynomolgus monkey only

Hemlibra

emicizumab · FIXa x FX
Cynomolgus monkey only

Imdelltra

tarlatamab · DLL3 x CD3
Cynomolgus 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 CD3
No relevant species; limited single-dose mouse, rat, one cynomolgus; BiLu mouse surrogate

Lunsumio

mosunetuzumab · CD20 x CD3
Cynomolgus monkey only

Lynozyfic

linvoseltamab · BCMA x CD3
Cynomolgus monkey only

Ordspono

odronextamab · CD20 x CD3
Cynomolgus monkey only

Removab

catumaxomab · EpCAM x CD3
No relevant species; in vitro human cells plus mouse surrogate (BiLu); limited single-dose rodent/monkey

Rybrevant

amivantamab · EGFR x MET
Cynomolgus monkey only

Talvey

talquetamab · GPRC5D x CD3
Cynomolgus monkey only (tool molecule for pivotal tox); no rodent tox

Tecvayli

teclistamab · BCMA x CD3
Cynomolgus monkey only (rabbit used for SC local tolerance only)

Vabysmo

faricimab · VEGF-A x Ang-2
Cynomolgus monkey only for pivotal tox (rabbit dropped after early studies)

Ziihera

zanidatamab · HER2 x HER2 (biparatopic)
Cynomolgus monkey only

Summary across all 18 bispecifics →