Plymouth Meeting-based Inovio is delaying plans to seek Food and Drug Administration approval for its experimental DNA medicine as a treatment for recurrent respiratory papillomatosis before the end of the year due to a recent setback, writes John George for the Philadelphia Business Journal.

The biotechnology company stated in July it would file its first biologics license application for INO-3107 with the FDA by the end of 2024. However, last week, Inovio CEO Jacqueline Shea said that while the company will have the required non-device-related elements of its submission package ready before year’s end, it will need more time for the FDA application.

The delay is caused by a recently identified manufacturing issue with Cellectra, the disposable administration component of its drug-delivery device. Inovio believes the issue is resolvable, but will take more time to rectify.

“We’re taking corrective steps to address the issue,” said Shea. “We now expect to be able to submit the [biologics license application] in mid-2025.”

She added that the company has not altered the “ultimate expectations” it has for INO-3107, which is poised to become a potentially transformative therapeutic option for patients with recurrent respiratory papillomatosis.

Read more about Inovio in the Philadelphia Business Journal.