Precigen announces FDA approval of Papzimeos for RRP treatment

Precigen (PGEN) announced that the FDA has approved Papzimeos, or zopapogene imadenovec-drba, for the treatment of adults with recurrent respiratory papillomatosis, or RRP. Papzimeos is the first and only FDA-approved therapy for the treatment of adults with RRP. Precigen completed submission of the rolling Biologics License Application, or BLA, in December 2024 under an accelerated approval pathway; however, the FDA has granted PAPZIMEOS full approval, which does not require a confirmatory clinical trial. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus, or HPV, types 6 and 11 proteins-the root cause of RRP. Papzimeos is delivered via four subcutaneous injections over a 12-week interval. RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, a compromised airway, and recurrent post-obstructive pneumonias. The approval is supported by data from the open-label, single-arm, pivotal study in adult patients with RRP: 51% of study patients achieved Complete Response, requiring no surgeries in the 12 months after treatment with Papzimeos. These Complete Responses remained durable for over 12 months. Of the 18 patients with a Complete Response in the ongoing study, 15 patients evaluated at 24 months demonstrated continued Complete Response. Papzimeos was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2. Precigen will begin promoting PAPZIMEOS immediately and is committed to helping patients with RRP access the therapy. Precigen has established Papzimeos SUPPORT, a comprehensive patient support program offering personalized services, including insurance navigation, financial assistance, and ongoing access support, which can be accessed by calling 866-827-8180.