None relevant; only a single-dose rhesus monkey study for off-target toxicity
“Due to the lack of a pharmacologically-relevant animal species to conduct toxicology studies, the scope of the toxicological evaluation for elotuzumab was limited to a tissue cross-reactivity study and in vivo studies that assessed the potential for off-target toxicity and local tolerance.”
✓ VerifiedFDA pharmacology/toxicology review, p. 12Source ↗
Why that species
Binds only human CS1; no recognition of mouse or any nonhuman primate CS1 tested
“HuLuc63 specifically binds only to human CS1 and does not recognize CS1 from the mouse or any NHP species tested (see Figure 5).”
✓ VerifiedFDA pharmacology/toxicology review, p. 26Source ↗
Surrogate molecule
No surrogate; human SLAMF7 transgenic mouse generated but judged not a valid toxicology model
“However, the mouse characterization results indicated that the human SLAMF7 transgenic mouse was not a valid alternative animal model for toxicology testing due to a lack of human SLAMF7 expression in both resting and activated T cells in this mouse model as compared to humans.”