Biopharmaceutical company Precigen Inc (Nasdaq: PGEN) disclosed on Monday that it has received US Food and Drug Administration platform technology designation for its AdenoVerse immunotherapeutic platform, which underpins its first commercial product, PAPZIMEOS. The designation could accelerate development of current and future AdenoVerse-based therapies across multiple indications, including HPV-positive cancers.

The designation allows Precigen to potentially leverage manufacturing and preclinical data generated for PAPZIMEOS in future marketing applications, reducing duplicated development work. It also provides opportunities for earlier FDA engagement, additional development advice and consideration of previous manufacturing inspections.

Precigen's AdenoVerse portfolio includes Phase 2 studies of PRGN-2009 with pembrolizumab in newly diagnosed HPV-associated oropharyngeal cancer and recurrent or metastatic cervical cancer. PAPZIMEOS, the first FDA-approved therapy for adults with recurrent respiratory papillomatosis, is also being evaluated in an open-label redosing study.