INOVIO Seeks FDA Nod for Novel RRP Therapy, Faces Competitive Landscape

NEW YORK, NY – November 03, 2025 – INOVIO Pharmaceuticals has completed its Biologics License Application (BLA) submission to the Food and Drug Administration (FDA) seeking accelerated approval for INO-3107, a novel DNA immunotherapy for adults with recurrent respiratory papillomatosis (RRP). The company is requesting priority review, a designation that, if granted, could expedite the evaluation of the treatment for a disease with limited options and a significant impact on patient quality of life.

A New Approach to RRP Treatment

RRP is a rare condition caused by the human papillomavirus (HPV) that results in the growth of papillomas in the respiratory tract. Current treatment relies heavily on repeated surgical interventions to remove these growths, a process that can be both physically demanding and emotionally taxing for patients. INO-3107 offers a fundamentally different approach, aiming to harness the body's own immune system to combat the underlying HPV infection and reduce the need for surgery. The treatment utilizes a DNA plasmid delivered via the company’s proprietary CELLECTRA® device, stimulating a targeted immune response against HPV-infected cells.

Phase 1/2 trial data has demonstrated promising results, with a significant percentage of patients experiencing a reduction in surgical interventions following treatment. “The data suggest a real possibility of lessening the burden of repeated surgeries for RRP patients,” said one investigator involved in the trials. “The ability to move away from simply managing symptoms to addressing the root cause of the disease is a paradigm shift.” In the study, 81% of patients experienced a reduction in surgeries in the year following treatment, and 28.1% required no surgical intervention. Longer-term data suggests the benefit is sustained, with improvements continuing into a second year for a majority of participants.

Navigating Financial Headwinds and Competition

Despite the promising clinical data, INOVIO faces significant financial challenges. Recent financial reports reveal a net loss for the third quarter of 2025 and a cash runway projected only into the second quarter of 2026. This creates pressure to secure additional funding or achieve commercial success with INO-3107 to sustain operations. “The company is at a critical juncture,” said a financial analyst covering the biotechnology sector. “Successful FDA approval and swift market penetration are essential to address the financial concerns.”

The competitive landscape is also evolving rapidly. Just recently, the FDA approved Papzimeos, a gene therapy developed by Precigen, for the treatment of RRP. This approval presents a direct challenge to INO-3107, as both therapies aim to address the underlying HPV infection. “The approval of Papzimeos has changed the game,” noted a medical expert specializing in RRP. “It establishes a clear precedent for immunotherapeutic approaches and raises the bar for new therapies.” While INO-3107’s DNA-based approach differs from Papzimeos’ gene therapy, both treatments will compete for market share in a relatively small patient population.

The Potential of DNA Medicine

If approved, INO-3107 would represent a significant milestone for INOVIO Pharmaceuticals and the broader field of DNA medicine. DNA-based therapies offer several potential advantages over traditional treatments, including the ability to precisely target disease-causing factors and stimulate a robust immune response. INOVIO’s CELLECTRA® device is designed to enhance DNA delivery and maximize therapeutic effect. The company is also advancing other DNA-based therapies for a range of diseases, including cancer and infectious diseases.

Beyond RRP, INOVIO is focusing on its next-generation DNA medicine candidates. These include DNA-Encoded Monoclonal Antibody (DMAb™) technology and DNA-Encoded Protein (DPROT) technology. Proof-of-concept data for the DMAb™ technology recently published in Nature Medicine highlights the potential of this approach. INOVIO is actively seeking partnerships and collaborations to accelerate the development and commercialization of its pipeline. The company's success with INO-3107 could pave the way for wider adoption of DNA-based therapies and unlock new possibilities for treating a variety of diseases.