INO-3107 Recurrent Respiratory Papillomatosis
Inovio Pharmaceuticals, Inc.'s INO-3107 DNA medicine vaccine candidate is being evaluated for the treatment of Recurrent Respiratory Papillomatosis (RRP), which is a rare disease caused by human papillomavirus (HPV) types 6 and 11 infections that are characterized by the growth of tumors in the respiratory tract caused by HPV. Inovio DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary handheld smart device, CELLECTRA®. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Administration with the CELLECTRA device ensures that DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response.
On February 10, 2020, the Company announced the U.S. Food and Drug Administration (FDA) had accepted its Investigational New Drug (IND) application to evaluate its DNA medicine INO-3107 in a Phase 1/2 trial for the treatment of RRP. In addition, the Company announced in October 2022 treatment with INO-3107 resulted in 16 of 21 (76%) participants with a reduction in the number of surgical interventions compared with the previous year; six participants required no surgical intervention during the trial, and INO-3107 demonstrated statistical significance based on the clinical endpoint of reduction in the overall number of surgical interventions compared with the previous.
On November 10, 2025, the Company confirmed the completed the rolling submission of its BLA for DNA immunotherapy candidate INO-3107 for the treatment of RRP in adults. INOVIO submitted the BLA under the FDA's accelerated approval program and has requested priority review, which, if granted, is expected to be completed within 6 months of file acceptance. Commercial preparations continue to advance for a potential launch in mid-2026. If approved, INO-3107 would be INOVIO's first commercial product and the first DNA medicine available in the U.S. INOVIO plans to conduct a confirmatory trial and expects to begin enrolling patients during the BLA review period. The trial is scheduled to be performed at approximately 20 sites across the United States.
Pennsylvania-based Inovio is a biotechnology company (NASDAQ: INO) focused on rapidly bringing to market precisely designed DNA medicines to treat, cure, and protect people from diseases, er-, inf-, ectiouinfectious-disease-associated. Inovio's DNA medicines do not interfere with or change in any way an individual's oNA.
INO-3107 Indication
RRP is rare; although benign, papillomas can cause severe, even life-threatening, airway obstruction and respiratory complications. A distinguishing aspect of feature disease is the tendency for the papilloma to recur after surgical procedures. The disease is currently incurable and is mainly treated by surgery, which temporarily restores the airway, says the Company. Left untreated, if RRP develops in the lungs, affected individuals can potentially experience recurrent pneumonia, chronic lung disease (bronchiectasis), and, ultimately, progressive pulmonary failure. In rare cases, papillomas can become cancerous (malignant transformation), developing into squamous cell carcinoma.
INO-3107 News
November 10, 2025 - "I'm very pleased to report that we've completed the rolling submission of our BLA for lead candidate INO-3107. We believe every patient deserves a treatment that reduces exposure to surgery, and INO-3107 has the potential to meet that significant need in the RRP community. The majority of patients in our Phase 1/2 trial required fewer surgeries after treatment and continued to improve through Year 2 without additional doses. Without surgical interventions during the treatment window to maintain minimal residual disease as required by other treatment modalities," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer.
May 11, 2023 - The Company announced additional positive data from the Phase 1/2 trial for INO-3107 in recurrent respiratory papillomatosis patients. The second cohort of the trial showed that 10 of the 11 (91%) patients saw a reduction in surgical interventions in the year following initial treatment. New combined safety and immunological data showed tolerability and durable immune response presented at ABEA/COSM.
January 31, 2023 - The Company announced: "Today's announcement is a reflection of measured efforts INOVIO has undertaken to assess the portfolio and prioritize those programs with the greatest benefit for patients and commercial potential," said INOVIO's President and CEO, Dr. Jacqueline Shea. "This decision followed thoughtful consideration and thorough diligence to position the organization better and ultimately realize the potential of DNA medicines. While this is a difficult decision, I want to recognize and thank my colleagues impacted by today's news for their contributions to INOVIO and their dedication to patients worldwide."
October 13, 2022 - Dr. Ted Mau, Professor of Otolaryngology, Head and Neck Surgery at UT Southwestern Medical Center and investigator for INOVIO's RRP Phase 1/2 clinical trial, said, " These preliminary results show great promise in this new therapy for patients with RRP. This is a potential game changer for our patients who have required multiple surgeries a year, especially those who have done so for many years."
November 23, 2020 - INOVIO announced it had dosed its first subject with DNA medicine INO-3107 in a Phase 1/2 clinical trial to treat RRP, a rare disease caused by HPV types 6 and 11 infection. This year, the US FDA granted INO-3107 Orphan Drug Designation.
July 29, 2020 - INOVIO today announced that the U.S. FDA granted orphan drug designation for INO-3107, its DNA medicine being evaluated in a Phase 1/2 trial to treat for the treatment oft respiratory papillomatosis.
February 10, 2020 - Inovio Pharmaceuticals, Inc. announced the U.S. FDA had accepted its Investigational New Drug application to evaluate its DNA medicine INO-3107 in a Phase 1/2 trial for the treatment of Recurrent Respiratory Papillomatosis.
INO-3107 Recurrent Respiratory Papillomatosis (RRP) Clinical Trials
Clinical Trial NCT04398433: INO-3107 was evaluated in a Phase 1/2 open-label, multicenter trial to assess its safety, tolerability, immunogenicity, and efficacy in 32 participants with HPV 6 and/or HPV 11-associated RRP. The trial demonstrated statistical significance based on the clinical endpoint of a reduction in the number of RRP surgical interventions following the administration of INO-3107 compared with the year before treatment in the initial cohort of 21 participants. The trial had a median decrease of 3 surgical interventions (95% confidence interval 1, 3). In addition, 16 of 21 (76%) participants showed a reduction in surgical interventions in the year following the administration of INO-3107 relative to the number of surgeries before the trial. Of the 16 participants, six (6) required no surgical intervention during the trial period.
In the trial, treatment with INO-3107 induced cell-mediated responses against both HPV 6 and HPV 11, including CD8 T cells. In addition, all 21 participants demonstrated increased peripheral T cells to one or more antigens in INO-3107 post-baseline. T-cell responses against HPV 6 and HPV 11 were also observed at Week 52, after treatment with INO-3107, indicating a persistent cellular memory response.