The FDA granted breakthrough therapy designation for Precigen’s (NASDAQ:PGEN) investigational PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP).
Standard-of-care for RRP consists of repeated surgical interventions, and there are currently no approved therapeutics. PRGN-2012 previously received orphan drug designation from the FDA for patients with RRP.
In a Phase 1 study, PRGN-2012 treatment resulted in 50% of patients (6 out of 12) in complete response, requiring no post-treatment surgeries with a minimum follow up of 12 months. PRGN-2012 treatment also resulted in a reduction of surgeries in 83% (10 out of 12) of patients in the 12 months following treatment.
PRGN-2012 is currently being evaluated in a Phase 2 study in adult patients with RRP. Precigen completed enrollment in the Phase 2 study with 23 patients dosed, bringing the total number of enrolled patients to 35 at the recommended Phase 2 dose.
Patient follow up is ongoing as are discussions with the FDA about potential rapid development paths to enable a future submission of a biologics license application.
