Precigen adenoviral vector immunotherapy gets FDA nod for HPV-related respiratory disease

The FDA has approved Precigen’s non-replicating adenoviral vector-based immunotherapy, Papzimeos, for the treatment of adults with recurrent respiratory papillomatosis (RRP).

Papzimeos is the first and only FDA-approved therapy for adults with RRP a rare, debilitating, and potentially life-threatening disease caused by chronic HPV 6 or HPV 11 infection, which results in recurrent benign tumors in the respiratory tract. Papzimeos is administered via subcutaneous injection and is designed to stimulate an immune response against cells infected with HPV types 6 and 11.

The therapy offers a novel mechanism of action distinct from traditional treatments, which have relied primarily on repeated surgical interventions. The approval is based on results from a single-arm, open-label trial evaluating Papzimeos in patients with RRP who required three or more surgeries per year. Patients received four injections of Papzimeos over 12 weeks following surgical debulking procedures. In the pivotal portion of the study, 51.4% of patients (18/35) achieved a complete response — defined as no need for surgical intervention in the 12 months following treatment. Follow-up data showed that durable responses were maintained in most patients through two years.

Precigen completed submission of a rolling BLA in December 2024 under an accelerated approval pathway; however, the FDA granted Papzimeos full approval, with no confirmatory clinical trial needed.