Inovio announces U.S. FDA Breakthrough Therapy designation for INO-3107

INOVIO announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy designation for INO-3107 as a potential treatment for patients with Recurrent Respiratory Papillomatosis, RRP. “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 to launch 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.” INO-3107 is an investigational DNA medicine candidate designed to elicit a targeted T cell response against HPV-6 and HPV-11, the HPV types that cause RRP and other HPV-related disease. This Breakthrough Therapy designation for INO-3107 follows receipt of Orphan Drug designation from the European Commission in May 2023 and from the FDA in 2020. INOVIO plans to initiate a pivotal trial of INO-3107 in the first quarter of 2024, subject to FDA clearance. As part of its development efforts, the company has engaged a leading Clinical Research Organization to help run the pivotal trial, as well as key opinion leaders and investigators interested in developing a new treatment option for RRP patients.