INOVIO Says FDA Grants Breakthrough Therapy Designation For INO-3107; Stock Up 15%
Biotechnology company Inovio Pharmaceuticals, Inc. (INO) announced Thursday 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).
The FDA’s Breakthrough Therapy designation is a process designed to expedite the development and review of drug candidates that are intended to treat a serious or life-threatening condition.
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.
The Breakthrough Therapy designation is supported by data from INOVIO’s completed Phase 1/2 open-label, multicenter trial that assessed INO-3107’s safety, tolerability, immunogenicity, and efficacy in patients with HPV-6 and/or HPV-11-related RRP (NCT:04398433).
Overall, 81.3% patients in the trial had a decrease in surgical interventions in the year after INO-3107 administration compared to the prior year, including 28.1% that required no surgical intervention during or after the dosing window.
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