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Elrexfio: which tox species, and why?

elranatamab · BCMA x CD3
Species
Cynomolgus monkey only
“Cynomolgus monkey was identified as the only relevant nonclinical toxicology species based on elranatamab binding affinities for BCMA and CD3.”
✓ VerifiedFDA multi-discipline review, p. 56Source ↗
Why that species
Comparable binding to cyno and human BCMA and CD3; comparable BCMA+ cell frequency/phenotype
“Selection of cynomolgus as relevant species appears adequate, based on comparable binding affinity of elranatamab to cynomolgus and human BCMA and CD3, and a comparable frequency and phenotype of cynomolgus and human BCMA+ cells.”
✓ VerifiedEMA assessment report, p. 46Source ↗
Surrogate molecule
No surrogate; clinical molecule tested in monkey
“General toxicology studies were conducted in cynomolgus monkeys, a pharmacologically relevant species to assess the toxicity of elranatamab.”
✓ VerifiedFDA multi-discipline review, p. 48Source ↗

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

Epkinly

epcoritamab · CD20 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 →