Unloxcyt: which tox species, and why?

“the cynomolgus monkey (Macaca fascicularis) was the only pharmacologically relevant animal species for the assessment of pharmacokinetics (PK) and toxicology.”

“cosibelimab selectively binds to monkey and human PD-L1 with high affinities, but not to murine PD-L1.”

“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).”

“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).”

“A literature-based risk assessment of developmental and reproductive risk was conducted in lieu of performing developmental and reproductive toxicology studies.”

“Per ICH S9, no carcinogenicity study or carcinogenicity risk assessment was performed.”

“Similarly, the cynomolgus monkey (Macaca fascicularis) was the only pharmacologically relevant animal species for the assessment of pharmacokinetics (PK) and toxicology.”