Precigen Receives FDA Approval for First Immunotherapy for HPV-Related Recurrent Respiratory Papillomatosis

On August 14, 2025, the FDA granted full approval to Precigen’s Papzimeos (zopapogene imadenovec-drba), marking it as the first and only approved therapy for adults with recurrent respiratory papillomatosis (RRP), a disorder caused by HPV types 6 or 11.135

Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to express specific regions of HPV 6 and 11 proteins, directly targeting the root cause of RRP.13

FDA approval was based on data from a pivotal open-label trial:
51.4% of treated patients required no surgical intervention for at least 12 months after therapy, and most maintained this response beyond two years. The overall reduction in surgeries was 86% compared to pre-treatment levels.125

The standard of care for RRP previously consisted solely of repeated surgeries, sometimes dozens a year, with no approved curative therapies, highlighting a significant unmet need.245

The therapy demonstrated a favorable safety profile, with most adverse events being mild to moderate and no treatment-related serious or dose-limiting toxicities observed.12

Papzimeos received Priority Review, Orphan Drug designation, and Breakthrough Therapy status to expedite its development and review process.12

The therapy leverages Precigen's AdenoVerse platform, which uses adenoviral vectors to induce durable immune responses by targeting HPV-infected cells.2

FDA approval provides immediate access to all adult RRP patients in the US, ending dependency on repeated surgical intervention and offering potential for long-term remission.35

This historic approval was lauded by patient advocacy organizations and represents a milestone for gene therapy in rare HPV-related diseases.5

Sources:

1. https://www.fda.gov/news-events/press-announcements/fda-approves-first-immunotherapy-recurrent-respiratory-papillomatosis

2. https://www.ainvest.com/news/precigen-prgn-2012-rare-disease-breakthrough-awaits-fda-decision-august-2025-2507/

3. https://www.thepharmaletter.com/biotechnology/precigen-soars-on-full-fda-approval-of-papzimeos

4. https://www.genengnews.com/topics/genome-editing/fda-accepts-for-review-precigen-rrp-gene-therapy-candidate/

5. https://www.prnewswire.com/news-releases/precigen-announces-full-fda-approval-of-papzimeos-zopapogene-imadenovec-drba-the-first-and-only-approved-therapy-for-the-treatment-of-adults-with-recurrent-respiratory-papillomatosis-302530957.html