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

“No genetic toxicology studies have been conducted with teplizumab or the surrogate.”

“The short duration of treatment, the absence of pharmacologic activity in the rodent (for teplizumab itself), and the observations of anaphylaxis and hypersensitivity following various dosing regimens in the rodent limit the utility of carcinogenic assessments”

“In an embryofetal development study there was an increased incidence of post-implantation loss at the HD of 20 mg/kg that included the loss of the entire litter for multiple females leading to identifications of the MD (0.3 mg/kg) as the NOAEL.”

“No treatment-related effects on safety pharmacology endpoints, including body temperature, ECGs, heart rate, blood pressure, or respiratory rate were seen.”