“dostarlimab (TSR‐042) bound to human and cynomolgus monkey PD‐1 with similar affinity (KD = 1.8 and 1.5 nM, respectively) but did not bind to mouse PD‐1, supporting the use of cynomolgus monkey as the single pharmacologically relevant species for toxicity assessment.”
✓ VerifiedFDA multi-discipline review, p. 37Source ↗
Why that species
Similar PD-1 affinity in human and monkey (KD 1.8 vs 1.5 nM); no binding to mouse PD-1
“dostarlimab (TSR‐042) bound to human and cynomolgus monkey PD‐1 with similar affinity (KD = 1.8 and 1.5 nM, respectively) but did not bind to mouse PD‐1”
✓ VerifiedFDA multi-discipline review, p. 37Source ↗
Surrogate molecule
No surrogate; the clinical antibody was tested in cynomolgus monkey
“The Applicant evaluated the safety of dostarlimab in cynomolgus monkeys in GLP‐compliant repeat‐dose toxicity studies of up to 13 weeks duration.”
✓ VerifiedFDA multi-discipline review, p. 36Source ↗