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Atlas/Bispecific antibodies/Elrexfio/First dose

Elrexfio: how was the first human dose set?

elranatamab · BCMA x CD3
Check my plan vs. these
First-in-human starting dose
Not stated in public reviews
NOAEL / key findings
No NOAEL in 3-month SC study (immunosuppression, infections, moribundity at all doses); NOAEL 0.3 mg/kg/wk in 1-month studies
“Immunosuppression led to secondary infections and moribund euthanasia at all doses; no NOAEL was identified; dose-dependence was evident by incidence and timing”
✓ VerifiedFDA multi-discipline review, p. 58Source ↗

Same question, other bispecifics

Columvi

glofitamab · CD20 x CD3
MABEL: monkey PK/PD IL-6 excursion model plus in vitro human/monkey whole-blood cytokine data; 5 ug flat dose

Lunsumio

mosunetuzumab · CD20 x CD3
MABEL-type: EC20 from in vitro human PBMC cytokine release / T-cell activation assay

Vabysmo

faricimab · VEGF-A x Ang-2
Starting dose 0.5 mg/eye IVT supported by monkey tox data (6 mg/eye high dose not initially supported; dose escalation gated)

Bizengri

zenocutuzumab · HER2 x HER3
Not stated in public reviews

Blincyto

blinatumomab · CD19 x CD3
Not stated in public reviews

Epkinly

epcoritamab · CD20 x CD3
Not stated in public reviews

Hemlibra

emicizumab · FIXa x FX
Not stated in public reviews

Imdelltra

tarlatamab · DLL3 x CD3
Not stated in public reviews

Kimmtrak

tebentafusp · CD3 x gp100 (TCR fusion)
Not stated in public reviews

Korjuny

catumaxomab · EpCAM x CD3
Not stated in public reviews

Lynozyfic

linvoseltamab · BCMA x CD3
Not stated in public reviews

Ordspono

odronextamab · CD20 x CD3
Not stated in public reviews

Removab

catumaxomab · EpCAM x CD3
Not stated in public reviews

Rybrevant

amivantamab · EGFR x MET
Not stated in public reviews

Talvey

talquetamab · GPRC5D x CD3
Not stated in public reviews

Tecvayli

teclistamab · BCMA x CD3
Not stated in public reviews

Ziihera

zanidatamab · HER2 x HER2 (biparatopic)
Not stated in public reviews

Summary across all 18 bispecifics →