“the cynomolgus monkey (Macaca fascicularis) was the only pharmacologically relevant animal species for the assessment of pharmacokinetics (PK) and toxicology.”
✓ VerifiedFDA multi-discipline review, p. 176Source ↗
Why that species
Binds monkey and human PD-L1 with high affinity; no binding to murine PD-L1
“cosibelimab selectively binds to monkey and human PD-L1 with high affinities, but not to murine PD-L1.”
✓ VerifiedFDA multi-discipline review, p. 47Source ↗
Surrogate molecule
No surrogate; the clinical antibody was tested in cynomolgus monkeys
“One non-Good Laboratory Practice (GLP) PK study and 2 GLP toxicology studies (4- and 13-weeks, including TK) were conducted with cosibelimab in cynomolgus monkeys (Table 44).”
✓ VerifiedFDA multi-discipline review, p. 176Source ↗