Bizengri
zenocutuzumab · HER2 x HER313 weeks
Epkinly: how long were the pivotal tox studies?
epcoritamab · CD20 x CD3
Longest pivotal study
5 weeks
“The toxicity and toxicokinetics (TK) of epcoritamab were evaluated in a 5-week toxicity study in cynomolgus monkeys.”
Pivotal GLP studies
GLP 5-week monkey study (weekly IV, single IV, monthly SC) with 6-week recovery; 3-month study waived (ADA)
“Study: A 5-Week Toxicity Study of GEN3013 by Intravenous Infusion and Subcutaneous Injection in Cynomolgus Monkeys with Bioavailability, Local Tolerance, and a 6 Week Recovery Period / 503484 / eCTD location 4.2.3.2”
Route in tox
IV infusion (weekly or single) and SC injection (Days 1 and 29)
“Monkeys were administered epcoritamab as a once weekly (QW x 5) IV infusion (0 [control], 0.01, 0.1, or 1 mg/kg), a single IV infusion (0.1 or 1 mg/kg), or a once monthly (Days 1 and 29) subcutaneous (SC) injection (0.1, 1, or 10 mg/kg).”
Same question, other bispecifics
Blincyto
blinatumomab · CD19 x CD313 weeks
Columvi
glofitamab · CD20 x CD34 weeks
Elrexfio
elranatamab · BCMA x CD313 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
Tecvayli
teclistamab · BCMA x CD35 weeks
Vabysmo
faricimab · VEGF-A x Ang-226 weeks
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)13 weeks