Inovio's INO-3107 Wins FDA Approval for Transformative Treatment of Respiratory Papillomatosis

INOVIO, a biotechnology company, recently announced INO-3107, their latest breakthrough. It is claimed to be a potential treatment for patients with Recurrent Respiratory Papillomatosis (RRP) and has also been granted the designation of Breakthrough Therapy by the U.S. Food and Drug Administration (FDA).

The FDA's Breakthrough Therapy Designation is a special process that acts as a catalyst in the development and review of new drugs. The drugs that are developed and manufactured to cure severe or life-threatening conditions are strictly required to go through this process. A medicine can acquire the designation only if it can exhibit early evidence of the enhanced capacity in comparison to the existing treatments in a pivotal manner.

INOVIO is a biotechnology company, aimed at developing and commercializing DNA medicines to cure and protect people against HPV-related diseases, cancer, and infectious diseases. INOVIO uses its investigational proprietary device CELLECTRA® to deliver the DNA medicines that are currently under development. These medicines are used to produce immune responses against targeted pathogens and cancers.

"This is yet another important step for INO-3107 and recognition that this first-in-class DNA medicine candidate has the potential to improve the lives of patients with RRP," said INOVIO's President and Chief Executive Officer, Dr. Jacqueline Shea. "As we recently announced, we have been interacting with the FDA with the goal of launching a pivotal trial for INO-3107 in the near term. With this Breakthrough Therapy designation, we look forward to continuing to work with the agency so that we can generate the evidence needed to support approval of INO-3107 as quickly and efficiently as possible, with an ultimate aim to help RRP patients and deliver on the promise of DNA medicine."

INOVIO is further prepared to conduct a crucial trial of INO-3107 in the first quarter of 2024, if approved by the FDA. Due to the increasing awareness and benefits of taking the help of CROs, INOVIO has also managed to appoint a Clinical Research Organization to conduct this pivotal trial successfully and appropriately. INOVIO has also managed to engage some investigators as well as key opinion leaders, who are interested in developing a new treatment option for RRP patients.

The President of the Recurrent Respiratory Papillomatosis Foundation, Kim McClellan, said "RRP patients will tell you that even one reduction in the number of disruptive, invasive surgeries they face would be life changing. The potential impact of this treatment gives me great hope for the future and I'm happy to see that RRP is finally getting the attention it deserves."

The Breakthrough Therapy designation provided to the INO-3107 as a potential treatment was based on the data collected from INOVIO's Phase 1/2 open-label, multicentre trial, which was conducted to examine INO-3107's safety, tolerability, immunogenicity, and efficacy in patients with HPV-6 and/or HPV-11-related RRP. INO-3107 was well-tolerated by participants in the trial.

According to the trial data, nearly 81.3% (26/32) of patients experienced reduced surgical interventions in the year after INO-3107 administration compared to the prior year. These numbers also include the 28.1% (9/32) of patients who required no surgical intervention during or after the dosing window. Patients who were part of the trial had a median range of 4 surgeries (2-8) in the year prior to administration. After dosing, the median experienced a decrease of 3 surgical interventions (95% confidence interval -3, -2). Patients received four doses of INO-3107 on day 0, and weeks 3, 6, and 9.

Data from the INOVIO's completed Phase 1/2 open-label, multicentre trial, has been presented at some major scientific and medical conferences, including the 2023 Annual Meeting of the American Broncho-Esophageal Association (ABEA) in May and at the European Laryngological Association's Annual Meeting in June.

Data from the trial was also published in May in The Laryngoscope under the title "Interim Results of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6 and/or HPV-11–Associated RRP." The Laryngoscope is the official journal of the Triological Society (TRIO), the American Laryngological Association (ALA), and the ABEA.