Enjaymo: genotox, carcinogenicity and repro: done or skipped?

“No genotoxicity studies were performed with sutimlimab, as monoclonal antibodies are generally considered devoid of mutagenic or clastogenic risk.”

“Given the absence of proliferative lesions observed at either dose tested in the chronic monkey study and the lack of any identified tumorigenic risk based on the mechanism of action and a search of the relevant scientific literature, it is unlikely that sutimlimab possesses significant tumorigenic potential.”

“There were no adverse effects on reproductive or developmental outcomes at 180 mg/kg/week, which represents 4 times the human exposure at the 7.5 g clinical dose.”

“Safety pharmacology endpoints incorporated into the repeat-dose toxicology study in monkeys did not identify any sutimlimab-related adverse effects on cardiovascular, respiratory or central nervous system endpoints at either dose.”

“No genotoxicity studies were performed with sutimlimab, as monoclonal antibodies are generally considered devoid of mutagenic or clastogenic risk.”

“No genotoxicity studies were performed with sutimlimab, as monoclonal antibodies are generally considered devoid of mutagenic or clastogenic risk.”

“No genotoxicity studies were performed with sutimlimab, as monoclonal antibodies are generally considered devoid of mutagenic or clastogenic risk.”

“The applicant’s non-clinical package did not include a traditional in vivo carcinogenicity assessment. Instead, the applicant provided a weight-of-evidence (WOE)-based assessment of carcinogenic potential (per ICH S6).”

“CDER’s Executive Carcinogenicity Assessment Committee concurred with this assessment, and no additional studies of the carcinogenic potential of sutimlimab are warranted at this time.”

“Cardiovascular and respiratory function testing included heart rate monitoring, body temperature, oxygen saturation, ECG testing and evaluation of respiration, which were unremarkable at doses up to 180 mg/kg weekly for 26 weeks”