“The in vivo toxicology of axatilimab was assessed in the cynomolgus monkey, the only toxicology species in which axatilimab binds to CSF-1R and blocks CSF-1-mediated signaling of the receptor.”
✓ VerifiedFDA multi-discipline review, p. 42Source ↗
Why that species
Only toxicology species in which axatilimab binds CSF-1R and blocks CSF-1 signaling
“The in vivo toxicology of axatilimab was assessed in the cynomolgus monkey, the only toxicology species in which axatilimab binds to CSF-1R and blocks CSF-1-mediated signaling of the receptor.”
✓ VerifiedFDA multi-discipline review, p. 42Source ↗
Surrogate molecule
Yes: murine anti-CSF-1R surrogate antibody, used for an investigative mouse acetaminophen hepatotoxicity study
“In addition, an investigative mouse study was conducted, using a surrogate murine anti-CSF-1R antibody, to assess whether administration of an anti-CSF-1R antibody would influence the toxicity induced by a known hepatotoxin”
✓ VerifiedFDA multi-discipline review, p. 42Source ↗