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Removab: how long were the pivotal tox studies?

catumaxomab · EpCAM x CD3
Longest pivotal study
0 (no in vivo tox study)
“Repeat-dose toxicity studies have not been submitted.”
✓ VerifiedEMA assessment report, p. 14Source ↗
Pivotal GLP studies
No repeat-dose studies; single-dose catumaxomab in mice, rats, one cynomolgus; BiLu single-dose mouse; rabbit local tolerance
“In the few studies performed in rats, mice and one cynomolgus monkey, no acute toxicity was seen even at very high doses of catumaxomab.”
✓ VerifiedEMA assessment report, p. 14Source ↗
Route in tox
IV (single-dose, escalating monkey infusion); i.p. and other routes in rabbit local tolerance
“Administration of 150 µg i.p. catumaxomab showed an histopathological moderate subchronic inflammation of skin and abdominal muscle after administration of the test item in one animal.”
✓ VerifiedEMA assessment report, p. 15Source ↗

Same question, other bispecifics

Bizengri

zenocutuzumab · HER2 x HER3
13 weeks

Blincyto

blinatumomab · CD19 x CD3
13 weeks

Columvi

glofitamab · CD20 x CD3
4 weeks

Elrexfio

elranatamab · BCMA x CD3
13 weeks

Epkinly

epcoritamab · CD20 x CD3
5 weeks

Kimmtrak

tebentafusp · CD3 x gp100 (TCR fusion)
0 (no in vivo tox study)

Korjuny

catumaxomab · EpCAM x CD3
0 (no in vivo tox study)

Lunsumio

mosunetuzumab · CD20 x CD3
26 weeks

Ordspono

odronextamab · CD20 x CD3
16 weeks

Talvey

talquetamab · GPRC5D x CD3
4 weeks

Tecvayli

teclistamab · BCMA x CD3
5 weeks

Vabysmo

faricimab · VEGF-A x Ang-2
26 weeks

Ziihera

zanidatamab · HER2 x HER2 (biparatopic)
13 weeks

Summary across all 18 bispecifics →