INOVIO Begins Rolling Submission of BLA for INO-3107 in Treating Adults with RRP

INOVIO to begin rolling submission of BLA for INO-3107, a treatment targeting Recurrent Respiratory Papillomatosis (RRP) in adults. The company aims for FDA acceptance by end of 2025 with a priority review request. INO-3107 has Breakthrough Therapy designation and has shown significant potential in reducing surgeries for RRP patients. Clinical trial results have been promising, with 72-86% of participants experiencing a 50-100% reduction in surgeries.

INOVIO Pharmaceuticals, Inc. (NASDAQ: INO) has announced that it will begin the rolling submission of its Biologics License Application (BLA) for INO-3107, an investigational DNA medicine designed to treat Recurrent Respiratory Papillomatosis (RRP) in adults. The company aims to complete the submission to the U.S. Food and Drug Administration (FDA) in the coming months and request priority review, with the goal of achieving FDA acceptance by the end of 2025.

INOVIO's President and Chief Executive Officer, Dr. Jacqueline Shea, expressed satisfaction with the FDA's agreement to their rolling submission timeline. She stated, "We are pleased the FDA agreed to our rolling submission plan. We are also encouraged by their recent activity in recognizing the importance of accelerating the full approval of new technologies that can bring life-changing therapeutic options to patients suffering from rare diseases such as RRP."

RRP is a debilitating and rare disease primarily caused by HPV-6 and/or HPV-11. It is characterized by the development of small, wart-like growths, or papillomas, in the respiratory tract, which can cause severe, life-threatening airway obstruction and respiratory complications. Surgery to remove papillomas is the standard of care, but the papillomas often grow back, leading to multiple surgeries and significant risks to the patient's vocal cords and quality of life.

INO-3107 is an investigational DNA medicine designed to elicit an antigen-specific T cell response against both HPV-6 and HPV-11 proteins. In a Phase 1/2 trial of 32 participants (RRP-001), 72% of patients saw a 50-to-100% reduction in the number of surgeries after starting treatment with INO-3107 at the end of the first year. A retrospective study involving 28 of the original trial participants (RRP-002) showed this number increasing to 86% at the end of the second 12-month period with no additional dosing. The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations, which aim to expedite the development and approval of therapies for rare diseases and serious or life-threatening conditions.

INOVIO's DNA medicines platform uses precisely designed DNA plasmids delivered by its proprietary investigational medical device, CELLECTRA. The company's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. The company has also CE-marked its CELLECTRA® delivery device in the EU and received the Innovation Passport designation from the UK, which serves as the entry point to the Innovative Licensing and Access Pathway (ILAP).

INOVIO's forward-looking statements include the possibility that actual events or results may differ from expectations due to various factors, including uncertainties in clinical trials, product development, commercialization activities, and the availability of funding. The company's success in bringing INO-3107 to market will depend on the completion of clinical trials, regulatory approvals, and market acceptance.

References:
[1] https://ir.inovio.com/news-releases/news-releases-details/2025/INOVIO-to-Begin-Rolling-Submission-of-BLA-for-INO-3107-for-the-Treatment-of-RRP-in-Adults/default.aspx