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

“Genotoxicity studies were not conducted for sibeprenlimab, a monoclonal antibody, which lacks the ability to directly interact with DNA.”

“A carcinogenicity risk assessment was submitted by the applicant, which was reviewed under the IND. Rodent carcinogenicity studies were deemed not to be warranted to establish an adequate assessment of carcinogenicity risk for sibeprenlimab.”

“subcutaneous administration of sibeprenlimab once every 2 weeks to pregnant cynomolgus monkeys from gestation Day 20 through delivery did not result in any adverse effects on embryofetal or postnatal development at one tested dose of 101 mg/kg”

“No adverse effects related to sibeprenlimab were observed in qualitative neurological assessments, and there were no significant effects on heart rate, blood pressure, electrocardiogram parameters, or on respiratory function at any dose levels tested.”