#United States #Plymouth Meeting #INO-3107 #RRP #INOVIO Pharmaceuticals

INOVIO Advances Towards Accelerated Approval for INO-3107

INOVIO Pharmaceuticals, a biopharmaceutical company specializing in DNA medicines, has recently announced the completion of its rolling submission for a Biologics License Application (BLA) for INO-3107, an innovative treatment for Recurrent Respiratory Papillomatosis (RRP) in adults.

RRP is a rare but devastating disease caused primarily by the human papillomavirus (HPV), particularly strains HPV-6 and HPV-11. Patients suffering from RRP develop small, wart-like growths in their respiratory tract that can cause significant airway obstruction and complications. Most standard treatments currently focus on surgical intervention, which carries its own risks and often leads to repeated surgeries.

Through the FDA's Accelerated Approval program, INOVIO is seeking to expedite the approval process of INO-3107 to provide much-needed relief to the RRP community. If granted, the priority review could potentially lead to an approval decision around mid-2026, which would mark INO-3107 as not only INOVIO’s first commercial product but also the first DNA medicine available in the U.S. market.

Kim McClellan, President of the RRP Foundation, expressed hope that INO-3107 could be a game changer for the community: “The potential to have a meaningful new treatment for RRP brings me so much hope for the RRP community, which has been desperate for relief from the risks and costs of repeated surgery.” This sentiment echoes the urgent need for effective therapies that reduce the frequency of surgical procedures, which often inflict permanent damage to patients’ vocal cords and present substantial financial burdens.

Understanding INO-3107's Mechanism of Action

INO-3107 is engineered to stimulate a robust immune response specifically targeting the HPV-6 and HPV-11 proteins. In a completed Phase 1/2 clinical trial, known as RRP-001, 72% of the patients demonstrated a remarkable reduction in surgeries ranging from 50% to 100% after one year of treatment with INO-3107. Follow-up results from a retrospective study (RRP-002) indicated that this success rate increased to 86% after two years without additional dosing.

Participants in the trial exhibited a marked immune response, generating activated CD4 and CD8 T cells capable of eliminating HPV-infected cells. The long-lasting effects of this immune activation were seen even after a year, indicating potential durability of the response generated by INO-3107. The treatment was generally well tolerated, with most adverse effects reported as low-grade and manageable.

Regulatory Recognitions and Future Implications

Given the promising data, the FDA has awarded INO-3107 with both Orphan Drug and Breakthrough Therapy designations. These recognitions signal that INOVIO's candidate has substantial potential benefits for patients who lack effective treatment options. Additionally, INOVIO has received the Innovation Passport in the UK, further smoothening the pathway for faster access to their innovative treatments.

Looking forward, INOVIO is focused on finalizing their preparations for a potential commercial launch of INO-3107 in 2026, along with ongoing communication and collaboration with the FDA during the review process. As INOVIO continues its mission to pioneer DNA medicines for cancer and infectious diseases, the industry watches closely to see how INO-3107 could reshape the landscape of RRP treatment, potentially alleviating the burdens faced by patients and improving their quality of life.

For more information about INOVIO and their DNA medicines platform, visit INOVIO’s website.