Precigen's immunotherapy candidate Papzimeos receives FDA approval for RRP treatment.

Precigen's shares surged 94% in the premarket after the FDA approved its immunotherapy candidate, Papzimeos, for recurrent respiratory papillomatosis. The treatment is designed to help patients with a tumor condition that causes benign growths in the airways. The FDA approval marks a significant milestone for Precigen and could lead to increased demand for the therapy.

Precigen's shares experienced a significant surge of 94% in the premarket session following the U.S. Food and Drug Administration's (FDA) full approval of its immunotherapy candidate, PAPZIMEOS (zopapogene imadenovec-drba), for the treatment of recurrent respiratory papillomatosis (RRP). This milestone approval marks a pivotal moment for the biopharmaceutical company and the RRP patient community.

The approval of PAPZIMEOS, which is the first and only FDA-approved therapy for RRP, represents a substantial advancement in the treatment landscape for this rare and debilitating condition. RRP is caused by chronic HPV 6 or HPV 11 infection, resulting in recurrent benign tumors in the respiratory tract. The disease can lead to severe voice disturbances, compromised airways, and recurrent post-obstructive pneumonias. Traditionally, management of RRP has relied on repeated surgeries, which do not address the root cause of the disease and can be associated with significant morbidity and patient burden.

PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against papilloma cells expressing HPV 6/11 proteins. The therapy is delivered via four subcutaneous injections over a 12-week interval. The pivotal study supporting the approval demonstrated that 51% of study patients achieved a Complete Response, requiring no surgeries in the 12 months following treatment. These responses were durable, with 15 out of 18 patients maintaining a Complete Response at the 24-month mark.

The FDA's full approval of PAPZIMEOS signifies a major achievement for Precigen, which completed the submission of its rolling Biologics License Application (BLA) under an accelerated approval pathway. The approval, which does not require a confirmatory clinical trial, reflects the success of the company's proprietary AdenoVerse therapeutic platform.

Precigen's President and CEO, Helen Sabzevari, PhD, noted that this approval represents a historic turning point for RRP patients, offering them the first and only approved therapy that targets the root cause of the disease. The company is committed to swiftly delivering PAPZIMEOS to the RRP community and has established a comprehensive patient support program, Papzimeos SUPPORT, to assist patients in accessing the therapy.

The approval of PAPZIMEOS could lead to increased demand for the therapy, potentially driving growth for Precigen. The company is expected to host a conference call on Monday, August 18, at 8:00 AM ET to provide additional details regarding the approval and commercialization plans.

References:
[1] https://investors.precigen.com/news-releases/news-release-details/precigen-announces-full-fda-approval-papzimeos-zopapogene