Precigen's PAPZIMEOS™ Demonstrates Lasting Efficacy in RRP Treatment at AAO-HNSF 2025

Pioneering Advances in RRP Treatment: Precigen’s PAPZIMEOS™ Shows Lasting Efficacy

Precigen, Inc., a biopharmaceutical company dedicated to developing innovative precision medicines, presents promising long-term follow-up data for its approved therapy, PAPZIMEOS™ (zopapogene imadenovec-drba), at the American Academy of Otolaryngology–Head and Neck Surgery Foundation (AAO-HNSF) 2025 Annual Meeting. The data focuses on adults suffering from recurrent respiratory papillomatosis (RRP), a disease characterized by the growth of benign tumors in the respiratory tract, which often necessitates multiple surgical interventions. With a median follow-up of 36 months, the results reveal that 15 out of 18 patients who initially achieved a complete response continue to maintain that response, underscoring the therapy's sustained efficacy and potential to transform patient care.

Notably, the pivotal study leading to PAPZIMEOS's full approval by the FDA in August 2025 demonstrates remarkable outcomes. Within the first year of treatment, 51% of participants—18 out of 35—achieve a complete response, which is defined as the absence of disease. Over the following years, the frequency of surgical interventions significantly diminishes, with a staggering reduction of 86% in Year 1, 91% in Year 2, and 95% in Year 3 compared to the period before treatment. These findings highlight not only the drug's effectiveness in controlling the disease but also its capacity to alleviate the burden of recurrent surgeries, ultimately enhancing the quality of life for patients.

Dr. Helen Sabzevari, President and CEO of Precigen, emphasizes the importance of these findings, stating that PAPZIMEOS addresses the root cause of RRP and fosters confidence among healthcare professionals regarding its safety and efficacy. The absence of new safety events, alongside reports of well-tolerated treatment with no serious adverse events greater than Grade 2, further solidifies PAPZIMEOS’s role as a groundbreaking solution within the RRP community. The data presented marks a significant milestone for Precigen, potentially altering the standard of care for RRP patients and paving the way for future innovations in the field.

In addition to the promising clinical data, the approval of PAPZIMEOS establishes Precigen as a leader in the biopharmaceutical industry, particularly in developing targeted therapies for rare diseases. With its focus on precision medicine, the company aims to continue its commitment to advancing treatments that improve patient outcomes.

As the healthcare landscape evolves, the sustained efficacy and safety of PAPZIMEOS may not only change the management of RRP but also inspire further research into similar biopharmaceutical solutions that address unmet medical needs.