Columvi
glofitamab · CD20 x CD3MABEL: monkey PK/PD IL-6 excursion model plus in vitro human/monkey whole-blood cytokine data; 5 ug flat dose
Bizengri: how was the first human dose set?
zenocutuzumab · HER2 x HER3
First-in-human starting dose
Not stated in public reviews
NOAEL / key findings
NOAEL 100 mg/kg/wk (1-month) and 101 mg/kg/wk (13-week) per applicant; FDA noted 2 early deaths/moribund, immune-mediated infusion reaction, GI lesions, skin, adrenal
“The Applicant suggests that these findings were unrelated to zenocutuzumab as comparable findings were not observed in animals that showed higher zenocutuzumab exposure compared to the mid-dose animal”
Same question, other bispecifics
Lunsumio
mosunetuzumab · CD20 x CD3MABEL-type: EC20 from in vitro human PBMC cytokine release / T-cell activation assay
Vabysmo
faricimab · VEGF-A x Ang-2Starting dose 0.5 mg/eye IVT supported by monkey tox data (6 mg/eye high dose not initially supported; dose escalation gated)
Blincyto
blinatumomab · CD19 x CD3Not stated in public reviews
Elrexfio
elranatamab · BCMA x CD3Not stated in public reviews
Epkinly
epcoritamab · CD20 x CD3Not stated in public reviews
Hemlibra
emicizumab · FIXa x FXNot stated in public reviews
Imdelltra
tarlatamab · DLL3 x CD3Not stated in public reviews
Kimmtrak
tebentafusp · CD3 x gp100 (TCR fusion)Not stated in public reviews
Korjuny
catumaxomab · EpCAM x CD3Not stated in public reviews
Lynozyfic
linvoseltamab · BCMA x CD3Not stated in public reviews
Ordspono
odronextamab · CD20 x CD3Not stated in public reviews
Removab
catumaxomab · EpCAM x CD3Not stated in public reviews
Rybrevant
amivantamab · EGFR x METNot stated in public reviews
Talvey
talquetamab · GPRC5D x CD3Not stated in public reviews
Tecvayli
teclistamab · BCMA x CD3Not stated in public reviews
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)Not stated in public reviews