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
Lunsumio: how was the first human dose set?
mosunetuzumab · CD20 x CD3
First-in-human starting dose
MABEL-type: EC20 from in vitro human PBMC cytokine release / T-cell activation assay
“The results (EC20 values) were used to inform the starting dose in the first in human study.”
NOAEL / key findings
No NOAEL; overall LOAEL 0.01 mg/kg (CRS effects at all doses); CNS perivascular infiltrates, liver, infections, one convulsion
“As CRS related effects were observed at all dose levels, a LOAEL was derived for all studies at the lowest dose levels resulting in an overall LOAEL of 0.01 mg/kg/day in cynomolgus monkeys.”
Same question, other bispecifics
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)
Bizengri
zenocutuzumab · HER2 x HER3Not stated in public reviews
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