お知らせ • Jun 02
Precigen Presents New Long-Term Durability Data for Papzimeos and Receives Seven-Year Market Exclusivity
Precigen announced updated long-term follow-up data from the pivotal study of PAPZIMEOS (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS was granted full approval by the United States Food and Drug Administration (FDA) and was subsequently granted seven-year market exclusivity, further strengthening its position as the first and only approved therapy for the treatment of adults with RRP. 15 out of 18 complete responders, or 83%, demonstrated ongoing complete responses as of the April 30, 2026 data cutoff. Patients did not receive any additional treatments for RRP, including surgery or off-label investigational treatments, during this follow-up period. All complete responders had at least 36 months of follow-up, with a median follow-up of 36 months (range: 36 to 51 months) and a mean follow-up of 40 months. 5 complete responders have ongoing responses beyond 4 years. Median duration of complete response has not yet been reached. No new safety events were observed during long-term follow-up. PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP and the first and only approved therapy to address the root cause of RRP. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins. PAPZIMEOS is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. PAPZIMEOS represents a new therapeutic paradigm for RRP. PAPZIMEOS is a type of immunotherapy used to treat a condition called recurrent respiratory papillomatosis (RRP) in adults. Some people may have a reaction to the shot. Signs and symptoms may include redness, pain, swelling, itching, or warmth where the shot was given. After your first treatment, your healthcare provider will watch you for at least 30 minutes to make sure you're feeling okay. Please contact your doctor immediately if you develop an infection, the reaction to your shot worsens, or you experience any of the below symptoms, which may indicate a systemic allergic reaction: Difficulty breathing, Widespread rash, Facial swelling. Thrombotic events (blood clots that block your blood vessels) may occur after your PAPZIMEOS shot. Please notify your doctor immediately if you have the following symptoms: Shortness of breath, Chest pain, Leg swelling, Persistent abdominal pain, Severe or persistent headaches, Blurred vision. Before taking PAPZIMEOS, tell your healthcare provider about all of your medical conditions, including: If you are pregnant or plan to become pregnant because it is not known if PAPZIMEOS will harm the unborn baby. If you are breastfeeding or plan to breastfeed. It is unknown if PAPZIMEOS is present in breast milk, or how it affects the breastfeeding child or milk production. Talk to your healthcare provider about the best way to feed your baby during treatment with PAPZIMEOS. The most common side effects include: Pain, redness, or swelling where the shot was given, Feeling tired, Chills, Fever, Muscle aches, Nausea (feeling sick), Headache, Increased heart rate, Diarrhea, Vomiting, Sweating a lot. These are not all of the possible side effects of PAPZIMEOS.