RRP is a chronic and difficult to manage disease, marked by repeated surgical interventions and impaired quality of life. Papzimeos is designed to elicit a specific T-cell immune response against human papillomavirus (HPV) types 6 and 11, which cause RRP. This targeted mechanism addresses the underlying viral cause, potentially offering more durable control than current symptomatic treatments. Unlike antivirals or adjuvant therapies that primarily suppress lesion growth or inflammation, Prime KOLs suggest that Papzimeos could alter the natural history of RRP by enabling sustained immune surveillance. Additionally, by improving immune clearance of HPV-infected cells, Papzimeos may reduce papilloma recurrence, which should elicit a decrease in surgical intervention frequency. While Prime KOLs recognize that surgical intervention is the current standard of care, surgical interventions of all kinds carry risks, including those associated with anesthesia use and, in these patients, potential airway trauma.  

In contrast, our KOLs state that Papzimeos offers a non-surgical option that may reduce cumulative morbidity from repeated debulking procedures and airway scarring. Early data suggests that Papzimeos is generally well-tolerated, with fewer systemic side effects compared to off-label antivirals, such as cidofovir, or systemic bevacizumab, which Prime KOLs note are associated with nephrotoxicity and hypertension risks. 

As a novel therapy, Papzimeos has limited real-world data and has unknown long-term durability and safety beyond clinical trials. As an immune-stimulating therapy, there is an associated risk of inflammation, autoimmune reactions and local tissue irritation, which Prime KOLs argue may complicate management. Unlike surgery, which immediately removes lesions, Papzimeos requires time to elicit an immune response. As such, it is not suitable in cases with urgent airway obstruction. According to Prime KOLs, variable patient immune status and HPV viral load may also affect individual patient response, with some patients potentially not achieving sufficient immune activation.