Bizengri
zenocutuzumab · HER2 x HER313 weeks
Tecvayli: how long were the pivotal tox studies?
teclistamab · BCMA x CD3
Longest pivotal study
5 weeks
“The toxicity and toxicokinetics (TK) of teclistamab were evaluated in a 5-week repeat-dose toxicity study in cynomolgus monkeys.”
Pivotal GLP studies
GLP 5-week weekly IV monkey study (1, 10, 30 mg/kg) with 8-week recovery; 3-month study waived; rabbit SC local tolerance
“Monkeys were administered teclistamab (0 [control], 1, 10, or 30 mg/kg/dose, IV) once weekly for five total doses followed by an 8-week recovery period.”
Route in tox
IV in monkey (clinical route SC); single SC dose in rabbit for local tolerance
“This study evaluated the IV route of administration, whereas the clinical route of administration is subcutaneous (SC).”
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
Kimmtrak
tebentafusp · CD3 x gp100 (TCR fusion)0 (no in vivo tox study)
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
Vabysmo
faricimab · VEGF-A x Ang-226 weeks
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)13 weeks