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Atlas/Bispecific antibodies/Blincyto/Skipped studies

Blincyto: genotox, carcinogenicity and repro: done or skipped?

blinatumomab · CD19 x CD3
Check my plan vs. these
Genotoxicity
Not conducted (ICH S6(R1); protein of natural amino acids)
“In vitro and in vivo genotoxicity studies were not performed in accordance with ICH S6 (R1).”
✓ VerifiedEMA assessment report, p. 31Source ↗
Carcinogenicity
Not conducted (ICH S9, advanced cancer indication)
“As it is being developed for advanced cancer indications, no carcinogenicity studies have been conducted, in accordance with ICH S9.”
✓ VerifiedEMA assessment report, p. 31Source ↗
Reproductive & developmental
Mouse EFD with surrogate: placental transfer, no embryo-fetal toxicity or teratogenicity; no fertility studies
“Studies in mice using the surrogate showed no drug-related effects in male or female reproductive organs and did not reveal any embryo-fetal toxicity or teratogenicity.”
✓ VerifiedFDA pharmacology/toxicology review, p. 5Source ↗
Safety pharmacology
CNS (Irwin, ICV infusion) and respiratory studies in mice with surrogate; CV in chimpanzee tox studies
“To evaluate the potential effects on the central nervous system (CNS), two CNS safety pharmacology studies were conducted with the murine surrogate muS103new in mice.”
✓ VerifiedFDA pharmacology/toxicology review, p. 82Source ↗

Same question, other bispecifics

Bizengri

zenocutuzumab · HER2 x HER3
Not conducted (ICH S6(R1))

Columvi

glofitamab · CD20 x CD3
Not conducted (ICH S6(R1))

Elrexfio

elranatamab · BCMA x CD3
Not conducted (ICH S6(R1))

Epkinly

epcoritamab · CD20 x CD3
Not conducted (ICH S6(R1), ICH S9)

Hemlibra

emicizumab · FIXa x FX
Not conducted (ICH S6)

Imdelltra

tarlatamab · DLL3 x CD3
Not conducted (ICH S6(R1))

Kimmtrak

tebentafusp · CD3 x gp100 (TCR fusion)
Not conducted (fusion protein; ICH S6/S9)

Korjuny

catumaxomab · EpCAM x CD3
Not conducted (ICH S6(R1))

Lunsumio

mosunetuzumab · CD20 x CD3
Not conducted (ICH S6(R1))

Lynozyfic

linvoseltamab · BCMA x CD3
Not conducted (antibody not expected to interact with DNA)

Ordspono

odronextamab · CD20 x CD3
Not conducted (antibody not expected to interact with DNA)

Removab

catumaxomab · EpCAM x CD3
Not conducted (not submitted; biologic, no relevant model)

Rybrevant

amivantamab · EGFR x MET
Not conducted (not appropriate for antibodies)

Talvey

talquetamab · GPRC5D x CD3
Not conducted (ICH S6; biotechnology-derived product)

Tecvayli

teclistamab · BCMA x CD3
Not conducted (ICH S6(R1))

Vabysmo

faricimab · VEGF-A x Ang-2
Not conducted (ICH S6(R1))

Ziihera

zanidatamab · HER2 x HER2 (biparatopic)
Not conducted (ICH S6(R1), ICH S9)

Summary across all 18 bispecifics →