Danyelza: which tox species, and why?

“Y-mAbs conducted a GLP-compliant 13-week toxicology study in nude rats.”

“Investigators reasoned that the use of nude rats rather than fully immune competent animals would allow for avoidance of the formation of anti-drug antibodies that would prevent long-term assessment of a human antibody in a rodent model.”

“Intravenous or intrathecal administration of a murine IgG2a isotype anti-GD2 monoclonal antibody (14.G2a) to adult immunocompetent Sprague Dawley rats led to mechanical allodynia, confirming the enhanced pain effect of anti-GD2 administration in animals.”

“The safety profile of naxitamab is based on a single-dose toxicity study in mice and repeat-dose toxicology studies (6- and 13-week) in Hsd: RH-Foxn1rnu nude rats.”

“In addition, because the age of the proposed patient population is primarily ≤5 years old, FDA did not request an embryo-fetal development study to support the use of naxitamab.”

“Y-mAbs has not conducted carcinogenicity studies with naxitamab.”

“Intravenous or intrathecal administration of a murine IgG2a isotype anti-GD2 monoclonal antibody (14.G2a) to adult immunocompetent Sprague Dawley rats led to mechanical allodynia, confirming the enhanced pain effect of anti-GD2 administration in animals.”