Bizengri
zenocutuzumab · HER2 x HER313 weeks
Kimmtrak: how long were the pivotal tox studies?
tebentafusp · CD3 x gp100 (TCR fusion)
Longest pivotal study
0 (no in vivo tox study)
“Tebentafusp can only recognize human HLA; therefore, all nonclinical toxicology studies were conducted in vitro.”
Pivotal GLP studies
No in vivo tox; GLP human tissue cross-reactivity (35 tissues) plus in vitro normal-cell, alloreactivity, whole-blood cytokine, platelet assays
“Tebentafusp was also investigated in toxicology studies to assess its cross‐reactivity with normal tissues in a GLP‐compliant tissue cross‐reactivity study.”
Route in tox
None for tox (in vitro); single IV or SC dose in non-GLP mouse PK/biodistribution studies
“These studies were non-GLP, PK and /or biodistribution studies and administered as single intravenous (IV) or subcutaneous (SC) dose.”
Same question, other bispecifics
Blincyto
blinatumomab · CD19 x CD313 weeks
Columvi
glofitamab · CD20 x CD34 weeks
Elrexfio
elranatamab · BCMA x CD313 weeks
Epkinly
epcoritamab · CD20 x CD35 weeks
Hemlibra
emicizumab · FIXa x FX26 weeks
Imdelltra
tarlatamab · DLL3 x CD313 weeks
Korjuny
catumaxomab · EpCAM x CD30 (no in vivo tox study)
Lunsumio
mosunetuzumab · CD20 x CD326 weeks
Lynozyfic
linvoseltamab · BCMA x CD314 weeks
Ordspono
odronextamab · CD20 x CD316 weeks
Removab
catumaxomab · EpCAM x CD30 (no in vivo tox study)
Rybrevant
amivantamab · EGFR x MET13 weeks
Talvey
talquetamab · GPRC5D x CD34 weeks
Tecvayli
teclistamab · BCMA x CD35 weeks
Vabysmo
faricimab · VEGF-A x Ang-226 weeks
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)13 weeks