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

Core Insights - Precigen, Inc. announced the FDA approval of PAPZIMEOS™ (zopapogene imadenovec-drba) as the first and only therapy for adults with recurrent respiratory papillomatosis (RRP) [1][4] - The approval was granted under an accelerated pathway, eliminating the need for a confirmatory clinical trial [1][4] - PAPZIMEOS is designed to target the root cause of RRP, which is chronic HPV 6 or HPV 11 infection, through a non-replicating adenoviral vector-based immunotherapy [1][10] Company Overview - Precigen specializes in innovative precision medicines aimed at improving patient lives and has a commitment to advancing scientific breakthroughs from discovery to commercialization [16] - The company has developed PAPZIMEOS using its proprietary AdenoVerse therapeutic platform, representing a new therapeutic paradigm for RRP [10][16] Industry Context - RRP is a rare and debilitating disease affecting approximately 27,000 adult patients in the US, leading to significant health burdens and reliance on repeated surgeries [4][9] - The approval of PAPZIMEOS is seen as a historic milestone for the RRP community, providing hope for patients who have endured extensive surgical interventions [3][4] Clinical Study Results - The pivotal study demonstrated that 51% of patients (18 out of 35) achieved a Complete Response, with no surgeries required in the 12 months following treatment [5] - The treatment was well-tolerated, with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2 [5] Future Plans - Precigen plans to promote PAPZIMEOS immediately and has established a patient support program to assist with access to the therapy [7] - A conference call is scheduled for August 18 to discuss the approval and commercialization details [8]