Chimpanzee (only relevant species, limited non-terminal studies) plus mouse with murine surrogate
“General toxicology studies included non-terminal repeat-dose studies of intravenous administration of blinatumomab in chimpanzees and repeat-dose studies of subcutaneous and intravenous administration of a murine surrogate in mice.”
✓ VerifiedFDA pharmacology/toxicology review, p. 12Source ↗
Why that species
Binds only human and chimpanzee CD3/CD19; no binding to mouse, rat, dog, cynomolgus, rhesus or other NHP PBMC
“Blinatumomab bound to B and T lymphocytes from human and chimpanzee peripheral blood mononuclear cells (PBMC) but it did not bind to PBMC from the mouse, rat, beagle dog, squirrel monkey, African Green monkey, cynomolgus monkey, rhesus monkey, and baboon.”
✓ VerifiedFDA pharmacology/toxicology review, p. 12Source ↗
Surrogate molecule
Yes: murine surrogate BiTE muS103new (anti-mouse CD19 x CD3) used for most tox, repro and safety pharm
“Because blinatumomab binds only to human and chimpanzee CD3 and CD19, the Applicant generated the murine surrogate muS103new for toxicology studies in mice and compared its activity to blinatumomab.”
✓ VerifiedFDA pharmacology/toxicology review, p. 81Source ↗