Precigen’s BLA for PRGN-2012 in papillomatosis granted priority review by FDA

Precigen (PGEN) announced the FDA has accepted the company’s biologics license application, or BLA, for PRGN-2012, an investigational AdenoVerse gene therapy for the treatment of adults with recurrent respiratory papillomatosis, or RRP. The FDA granted priority review to the BLA and set a Prescription Drug User Fee Act target action date of August 27. The FDA has indicated that they are not currently planning to hold an advisory committee meeting to discuss this application. PRGN-2012 is designed to elicit immune responses directed against cells infected with human papillomavirus, or HPV, 6 or HPV 11. PRGN-2012 received Breakthrough Therapy Designation, Orphan Drug Designation, and an accelerated approval pathway from the FDA, and Orphan Drug Designation from the European Commission. If approved, PRGN-2012 would be the first and only FDA-approved therapeutic for the treatment of adults with RRP. RRP is a rare, difficult-to-treat, lifelong neoplastic disease of the upper and lower respiratory tracts caused by infection with HPV 6 or HPV 11 that can be fatal. Currently, there is no cure for RRP and the current standard-of-care is repeated surgeries.