#United States #Germantown #RRP #Precigen #PAPZIMEOS

Long-Term Efficacy of PAPZIMEOS in Treating RRP

In a remarkable presentation of long-term outcomes, Precigen, Inc. has provided evidence that its innovative therapy PAPZIMEOS™ (zopapogene imadenovec-drba) continues to deliver durable complete responses among adults suffering from recurrent respiratory papillomatosis (RRP). This groundbreaking medication, which gained FDA approval in August 2025, represents the first and only targeted therapy addressing the root causes of this challenging disease.

During the American Academy of Otolaryngology–Head and Neck Surgery Foundation’s (AAO-HNSF) 2025 Annual Meeting, it was revealed that 83% of the 18 complete responders in the pivotal study maintained their complete response with an impressive median follow-up of 36 months. These results underscore the efficacy and promise of PAPZIMEOS in managing RRP, a condition characterized by the proliferation of benign tumors in the airways, often requiring repeated surgeries.

Sustained Responses and Reduced Surgical Interventions

Detailed analysis from long-term follow-up data highlighted several key outcomes:

• - Sustained Complete Responses: 15 out of 18 patients achieved lasting complete responses, with no new safety issues reported throughout the follow-up period.
• - Surgery Reduction: Following treatment with PAPZIMEOS, a marked reduction in the necessity for surgical interventions was noted:

- 86% reduction in surgeries in Year 1
- 91% in Year 2
- 95% by Year 3

This data not only highlights the immediate therapeutic benefits but reflects a significant shift towards decreasing the surgical burden on patients, thereby potentially enhancing their quality of life.

Understanding RRP: An Urgent Medical Need

Recurrent respiratory papillomatosis poses a unique challenge within medical practice. Caused by chronic HPV infections, particularly HPV types 6 and 11, RRP can lead to life-threatening complications, including airway obstruction and severe voice disturbances. Despite its rarity, the disease can necessitate hundreds of surgeries over a patient’s lifetime, often leading to debilitating health issues and decreased quality of life. Current management options have primarily involved repetitive surgical procedures, which do not address the underlying viral factors fueling the condition.

Given the significant healthcare burden associated with RRP, the advent of PAPZIMEOS marks a crucial development. Dr. Helen Sabzevari, President and CEO of Precigen, articulated the profound implications of these results, emphasizing how sustained responses can free patients from the cycle of surgeries that pose additional health risks. She reinforced that PAPZIMEOS not only tackles disease symptoms but significantly alleviates long-term care demands on healthcare systems by reducing the frequency of surgeries and related complications.

Clinical Insights and Path Forward

The endorsement of PAPZIMEOS by the FDA was predicated on robust clinical trial outcomes demonstrating its safety and efficacy. The pivotal study, as published in The Lancet Respiratory Medicine, reported no serious adverse events beyond Grade 2, suggesting a favorable safety profile. The foundation of PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy, which elicits an immune response against HPV proteins implicated in RRP.

Continued monitoring and research into PAPZIMEOS will be vital in establishing further outcomes and understanding its long-term impact. The expected increase in patients benefiting from this therapy signals a transformative moment in the treatment landscape for RRP, potentially leading to expanded options for RRP patients globally.

As further data emerges, it is hoped that PAPZIMEOS will pave the way for future breakthroughs in the treatment of HPV-related diseases, showcasing the potential of targeted biologics in managing complex conditions.

In summary, Precigen’s PAPZIMEOS has shown promising, sustained effects in treating RRP, presenting a new horizon for those affected and setting a precedent in the field of biopharmaceutical innovation.