On Friday, the U.S. Food and Drug Administration (FDA) approved Precigen Inc.’s (NASDAQ:PGEN) Papzimeos (zopapogene imadenovec-drba) for adult patients with recurrent respiratory papillomatosis (RRP).
RRP is a rare chronic disease caused by the human papillomavirus (HPV) and wart-like tumors grow on and around the vocal cords.
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 (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.
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Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins—the root cause of RRP. Papzimeos is delivered via four subcutaneous injections over a 12-week interval.
Data from the open-label, single-arm, pivotal study in adult patients with RRP support the approval.
The pivotal study successfully met its primary safety and pre-specified primary efficacy endpoints.
51% (18 out of 35) 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 or treatment-related adverse events greater than Grade 2.
Papzimeos induced HPV 6/11-specific T cell responses in RRP study patients, with a significantly greater expansion of peripheral HPV-specific T cells in responders compared to non-responders.
Precigen will begin promoting Papzimeos immediately.
Price Action: PGEN stock is up 44.32% at $2.67 during the premarket session at the last check on Friday.
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