FDA Reviews INOVIO's Biologics License Application for INO-3107 in RRP Treatment

FDA Reviews INOVIO's Biologics License Application for INO-3107

INOVIO Pharmaceuticals, a biotech company focused on innovative DNA therapies, has recently made headlines after the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for INO-3107. This investigational therapy targets adults suffering from recurrent respiratory papillomatosis (RRP), a rare and debilitating condition primarily caused by the human papillomavirus (HPV).

RRP is characterized by the abnormal growth of wart-like lesions in the respiratory tract due to HPV types 6 and 11. These papillomas can lead to severe respiratory complications and adversely affect the patient's quality of life, often requiring repeated surgical interventions to manage the condition. As the risk of complications from surgery increases with each procedure, INOVIO’s goal is to provide a non-surgical treatment option that could significantly benefit these patients.

The FDA has categorized the review of INO-3107 as standard, giving it a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2026. However, initial feedback from the FDA raised concerns over whether INOVIO submitted sufficient data to justify eligibility for the accelerated approval pathway, which the company had intended to pursue based on the promising results of their clinical trials. INOVIO remains optimistic that INO-3107 fulfills the necessary criteria for this pathway, indicating that they will seek a dialogue with the FDA to address these concerns.

Dr. Jacqueline Shea, CEO of INOVIO, expressed her belief in the necessity of offering RRP patients a non-surgical treatment option, emphasizing that the clinical trials for INO-3107 have shown a promising therapeutic benefit. In these trials, a substantial percentage of participants experienced reduced needs for surgeries after beginning treatment with INO-3107. The unique mechanism of action of this medicine makes it a compelling option, as it potentially allows the immune response to combat the disease effectively.

Data supporting the BLA comes from a Phase 1/2 trial involving adult patients who had undergone multiple surgeries for RRP. The findings suggest that after one year of treatment with INO-3107, 72% of participants observed a significant decrease—ranging from 50% to 100%—in the number of surgeries required. Further results from a retrospective analysis indicated that this percentage increased to 86% after an additional year of treatment, highlighting long-term clinical benefits for these patients.

RRP poses not only a physiological challenge but also a financial burden for patients due to the costs and risks associated with repeated surgical procedures. INOVIO’s research has indicated that even reducing the number of surgeries by one can significantly improve patient outcomes, as each procedure carries the risk of permanent damage to the vocal cords and further complications.

INO-3107 specifically works by triggering an immune response against HPV-6 and HPV-11, which could help prevent the growth of new papillomas or slow down their development. Clinical trials have demonstrated that this DNA medicine induces a robust immune response, characterized by the activation of T cells that are essential in targeting and eliminating HPV-infected cells. This approach distinguishes INO-3107 from traditional treatment methods, which often rely on surgical interventions and are less sustainable in the long run.

The FDA has granted INO-3107 multiple designations, including Orphan Drug and Breakthrough Therapy, highlighting the unmet medical needs associated with RRP. In addition, INOVIO's CELLECTRA® delivery device has received CE marking in the EU, further paving the way for future commercialization opportunities. This innovative technology enhances the delivery of INO-3107 without requiring traditional delivery methods, ensuring improved outcomes for patients.

As INOVIO navigates the regulatory landscape surrounding INO-3107, the upcoming discussions with the FDA will be crucial in determining the future of this promising treatment option. With ongoing research and clinical trials, INOVIO aims to expand access to therapies that have the potential to alleviate the suffering of RRP patients. The commitment to innovative healthcare solutions continues to drive INOVIO's mission for a better quality of life for patients affected by HPV-related diseases.