Niktimvo: which tox species, and why?

“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.”

“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.”

“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”

“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.”

“While no animal studies were conducted to assess the reproductive and developmental risks of axatilimab, a WoE-based risk assessment report was submitted.”

“Because axatilimab is not active pharmacologically in rodents, conventional carcinogenicity studies in mice or rats are not relevant for axatilimab.”

“Ab535, the murine surrogate of axatilimab, did not potentiate the hepatotoxicity of acetaminophen in mice when evaluated in a 14-day hepatotoxicity study (CXR1316).”