Biotechnology company INOVIO (NASDAQ:INO) announced on Tuesday that the US Food and Drug Administration (FDA) has notified INOVIO that it agrees with its rolling submission timeline for the Biologics License Application (BLA) for INO-3107 as a treatment for adults with Recurrent Respiratory Papillomatosis (RRP).

INOVIO anticipates completing its submission to the FDA in the coming months and requesting priority review, with the goal of file acceptance by the FDA by the end of 2025.

INO-3107 is an investigational DNA medicine designed to elicit an antigen-specific T cell response against both HPV-6 and HPV-11 proteins. These targeted T cells seek out and kill HPV-6 and HPV-11 infected cells, with the aim of potentially preventing or slowing the growth of new papillomas.

In a Phase 1/2 trial of 32 participants, 72% of patients saw a 50-to-100% reduction in the number of surgeries after starting treatment with INO-3107 at the end of the first year. A retrospective study involving 28 of the original trial participants showed this number increasing to 86% at the end of the second 12-month period with no additional dosing.

The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations and has advised INOVIO that it can submit a BLA under the FDA's accelerated approval pathway using data from INOVIO's completed Phase 1/2 trial. The European Commission has also granted INO-3107 Orphan Drug designation.