Carcinogenicity, mutagenicity, reproductive toxicity, and impairment of fertility studies have not been conducted with BEQVEZ. In a 2-year vector integration study in NHPs administered 5 × 1012 vg/kg, vector DNA was mostly detected in the form of episomal DNA that was not integrated into the host genome. The integration sites were generally random with a low frequency, and there was no indication of significant clonal expansion.
Carcinogenicity, mutagenicity, reproductive toxicity, and impairment of fertility studies have not been conducted with BEQVEZ. In a 2-year vector integration study in NHPs administered 5 × 1012 vg/kg, vector DNA was mostly detected in the form of episomal DNA that was not integrated into the host genome. The integration sites were generally random with a low frequency, and there was no indication of significant clonal expansion.
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