Precigen Receives FDA Approval for PAPZIMEOS™, First Therapy for Recurrent Respiratory Papillomatosis

Precigen Achieves Landmark FDA Approval for RRP Therapy

Precigen, Inc. has reached a significant milestone with the U.S. Food and Drug Administration's (FDA) full approval of PAPZIMEOS™ (zopapogene imadenovec-drba), marking it as the first and only therapy for adults suffering from recurrent respiratory papillomatosis (RRP). Affecting approximately 27,000 adults in the U.S., RRP is a rare and potentially life-threatening condition caused by chronic infections with human papillomavirus (HPV) types 6 or 11. These infections lead to the formation of recurrent benign tumors in the respiratory tract, which can severely impact patients' quality of life. Traditional treatments typically involve repeated surgeries, which can be both invasive and insufficient in addressing the underlying condition.

PAPZIMEOS is a groundbreaking therapy that utilizes a non-replicating adenoviral vector-based immunotherapy approach, specifically designed to generate an immune response against HPV-infected papilloma cells. This innovative treatment represents a significant departure from conventional surgical interventions, as it targets the root cause of RRP rather than merely managing its symptoms. The FDA's decision to grant approval under an accelerated pathway eliminates the need for further confirmatory clinical trials, allowing adult RRP patients immediate access to this new therapy. Patients receive PAPZIMEOS through four subcutaneous injections over a 12-week period, providing a less invasive alternative to ongoing surgical procedures.

Helen Sabzevari, PhD, President and CEO of Precigen, emphasizes the importance of this approval, describing it as a pivotal moment in the management of RRP. With over a century of reliance on surgical treatments, the introduction of PAPZIMEOS signals a transformative shift in treatment paradigms. This approval not only highlights the efficacy of Precigen's AdenoVerse platform but also reaffirms the company's dedication to enhancing patient outcomes in the realm of rare diseases. As Precigen prepares to discuss this milestone further in an upcoming conference call, the pharmaceutical landscape anticipates the potential impact of PAPZIMEOS on the standard of care for adult patients suffering from RRP.

In addition to its implications for patient care, the approval of PAPZIMEOS positions Precigen at the forefront of therapeutic innovation for rare diseases. The favorable safety profile and efficacy demonstrated in clinical trials underscore the treatment's promise as a long-needed solution for patients with RRP. With this significant advancement, Precigen not only addresses an unmet medical need but also enhances its reputation as a leader in developing precision medicines that improve quality of life for patients facing challenging health conditions. The company’s commitment to tackling rare diseases sets a new standard in biopharmaceutical development.