Ζopapogene imadenovec is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen of selected regions of human papillomavirus (HPV) proteins expressed in HPV 6- and HPV 11-infected cells. Ζopapogene imadenovec is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with recurrent respiratory papillomatosis.
The pharmacodynamic effect of zopapogene imadenovec was evaluated in Study PRGN-2012-201. In 28 patients evaluated at completion of treatment, the induction of HPV 6- and HPV 11-specific T cell responses in RRP patients, was higher in RRP patients demonstrating a clinical response to treatment, i.e. reduction in or elimination of the requirement for surgical debulking during the 12 months following completion of treatment, with mean fold-change from baseline of 164.9 versus 5.1 (p<0.018). This difference persisted at 12 weeks post-treatment, with mean fold-change of 61.5 in responders versus 11.5 in non-responders.
No biodistribution and vector shedding studies have been conducted with zopapogene imadenovec.
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