AdenoVerse Platform Receives FDA Designation for HPV-Associated Cancers

The FDA has granted platform technology designation to the AdenoVerse immunotherapeutic platform, which is already used in a commercial product, zopapogene imadenovec-drba (Papzimeos), according to a news release from the developer, Precigen.¹ The designation reflects the platform's potential to be applied across a broad range of indications, including human papillomavirus (HPV)–positive malignancies such as head and neck, cervical, anal, vulvar, and vaginal cancers, as well as other diseases that may be targeted by future AdenoVerse-based product candidates.

What does platform technology designation mean for AdenoVerse?

To qualify for platform technology designation, a platform must already be used in an FDA-approved product, and the available evidence must demonstrate that the platform is well characterized, reproducible, and has the potential to be adaptable across multiple products without compromising quality, manufacturing, or safety. In granting the designation, the FDA determined that AdenoVerse can be applied consistently across multiple products and is reasonably likely to generate meaningful efficiencies in the development, manufacturing, and regulatory review process.

The designation creates a pathway to leverage data generated for zopapogene imadenovec-drba in recurrent respiratory papillomatosis to potentially accelerate development of future AdenoVerse programs by using existing manufacturing and preclinical knowledge to support future marketing applications and reduce duplication of development work. It also provides opportunities for early FDA engagement, timely advice through additional interactions with the agency during development, and consideration of prior FDA manufacturing inspections for future applications.

“This designation has the potential to accelerate the development of Precigen's broader AdenoVerse portfolio by allowing us to build on the technology established through [zopapogene imadenovec-drba], which was approved by the FDA in August 2025,” stated Helen Sabzevari, PhD, president and chief executive officer of Precigen, in the press release.^1,2 “We expect the near-term impact will be especially meaningful for PRGN-2009 across multiple HPV-associated cancers, including cervical cancer and oropharyngeal squamous cell carcinoma. Importantly, the potential extends beyond PRGN-2009 to future AdenoVerse candidates such as those targeting additional cancers and other diseases.”

What is in Precigen's AdenoVerse clinical portfolio for HPV-associated cancers?

The AdenoVerse portfolio includes a phase 2 study (NCT05996523) of PRGN-2009 in combination with pembrolizumab (Keytruda) in newly diagnosed patients with HPV-associated oropharyngeal squamous cell carcinoma and a phase 2 study (NCT06157151) of PRGN-2009 in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer.^3,4

What is AdenoVerse and how does it work?

AdenoVerse utilizes a library of proprietary adenovectors, including gorilla adenovectors, for the efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens designed to modulate the immune system.⁵ The platform's gorilla adenovectors are derived from an adenovirus originally isolated from a healthy gorilla; because they are not recognized by human sera from healthy donors the way common human adenoviral vectors often are, they may be less susceptible to preexisting immunity that can blunt vaccine efficacy. Gorilla adenovectors also allow for repeat administration, are unable to replicate in vivo, which may improve their safety profile, and can deliver a large genetic payload.

“We thank the FDA for recognizing the potential of the AdenoVerse platform,” Sabzevari added.¹ “This designation will enable us to leverage prior data and engage with the FDA earlier and more frequently, creating opportunities to reduce duplicative work and bring greater speed, efficiency and predictability to the development of future AdenoVerse therapies.”

References

1. Precigen receives FDA platform technology designation for AdenoVerse platform. News release. Precigen, Inc. September 21, 2026. Accessed September 22, 2026. https://investors.precigen.com/news-releases/news-release-details/precigen-receives-fda-platform-technology-designation-adenoverse
2. FDA approves first immunotherapy for recurrent respiratory papillomatosis. News release. FDA. August 14, 2025. Accessed September 22, 2026. https://tinyurl.com/4vurtjxk
3. Phase II trial of immunotherapeutic HPV vaccine PRGN-2009 with pembrolizumab before standard treatment in subjects with newly diagnosed HPV-associated oropharyngeal cancer. ClinicalTrials.gov. Updated June 23, 2026. Accessed September 22, 2026. https://tinyurl.com/4rhy3n96
4. PRGN-2009 in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer. ClinicalTrials.gov. April 23, 2026. Accessed September 22, 2026. https://tinyurl.com/mtse6vty
5. Advanced targeting with precision. Precigen. Accessed September 22, 2026. https://tinyurl.com/mt8en9e4