PRGN-2009 AdenoVerse

Sept. 21, 2026: Precigen, Inc. (NASDAQ: PGEN) said the FDA granted platform technology designation to its AdenoVerse immunotherapeutic platform, used in PAPZIMEOS. The designation is intended to let the company leverage data from PAPZIMEOS to support future AdenoVerse-based programs, with potential efficiencies in manufacturing, preclinical work, and regulatory review, as well as earlier and more frequent FDA engagement.

The company said PAPZIMEOS (zopapogene imadenovec-drba; formerly PRGN-2012) was approved by the FDA in August 2025 for adults with recurrent respiratory papillomatosis (RRP). An open-label study of PAPZIMEOS redosing in adults with RRP is currently enrolling (NCT06538480).

Precigen highlighted PRGN-2009 as a near-term beneficiary of the designation. Ongoing Phase 2 studies are evaluating PRGN-2009 plus pembrolizumab in newly diagnosed HPV-associated oropharyngeal squamous cell carcinoma (NCT05996523) and in recurrent or metastatic cervical cancer (NCT06157151).

The company said the platform could also support future AdenoVerse candidates targeting additional HPV-positive malignancies, including head and neck, cervical, anal, vulvar, and vaginal cancers, as well as other diseases.