Zopapogene Imadenovec: First Approval

<p dir="ltr"><b>Declarations</b></p><p dir="ltr"><b>Funding</b> The preparation of this review was not supported by any external funding.</p><p dir="ltr"><b>Authorship and Conflict of interest</b> Arnold Lee is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.</p><p dir="ltr"><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</b> not applicable</p><p dir="ltr">Additional information about this Adis Drug Review can be found <a href="https://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank">here</a></p><p dir="ltr"><b>Abstract</b></p><p dir="ltr">Zopapogene imadenovec (PAPZIMEOS™; zopapogene imadenovec-drba) is a novel non-replicating adenoviral vector-based immunotherapy that stimulates an immune response against human papillomavirus (HPV) types 6 and 11. It is being developed by Precigen, Inc. for the treatment of recurrent respiratory papillomatosis, as these HPV types are causative agents for this condition. Treatment with zopapogene imadenovec resulted in complete responses in approximately half of treated patients and was associated with a papillary microenvironment that was conducive to T cells in complete responders. This article summarizes the milestones in the development of zopapogene imadenovec leading to this first approval for the treatment of adult patients with recurrent respiratory papillomatosis.</p><p dir="ltr">© Springer Nature Switzerland AG 2025</p>