Inovio, with path to market opening up, drafts accelerated approval talking points ahead of FDA meeting
Inovio has a line of sight on an accelerated approval. Weeks after getting the green light to use data from a completed single-arm phase 1/2 clinical trial to support a filing, the DNA medicine specialist has set out what the opening up of the regulatory pathway means for its rare disease drug.
In August, Precigen revealed a phase 1/2 study of its PRGN-2012 immunotherapy can serve as a pivotal trial to support accelerated approval in recurrent respiratory papillomatosis (RRP), a rare disease defined by small, wartlike growths in the upper respiratory tract that require surgical removal. The potential for PRGN-2012 to free patients from the need to undergo surgery led the FDA to offer a shortcut to market.
The FDA opened up the same shortcut to Inovio last month. Like Precigen, Inovio will be able to file for accelerated approval of a treatment for RRP, INO-3107, on the strength of data from a phase 1/2 clinical trial. Inovio shared more details of the impact of the FDA’s position Thursday,
“This news means that we no longer need to complete a phase 3 trial before BLA submission and will ultimately allow for a potentially much faster development pathway. We will, however, be required to initiate a confirmatory trial and satisfy all other FDA filing requirements prior to BLA submission, as is usual for the accelerated approval pathway,” Inovio CEO Jacqueline Shea said on a call with investors.
Full details of the impact of the new path to market are still emerging. Inovio has asked to meet with the FDA in the fourth quarter. Michael Sumner, chief medical officer at Inovio, told investors about what he hopes to get out of the meeting, explaining that the company will discuss key elements of its filing for accelerated approval such as the required immunology data and manufacturing plans.
Sumner also plans to seek “alignment on questions about our Cellectra delivery device.” The device, which uses electrical pulses to get Inovio’s DNA medicines into cells, was the cause of a partial clinical hold that held up its COVID-19 vaccine program for more than one year in the U.S. The outcome of the meeting with the FDA will inform the timeline for the accelerated approval submission.
Whatever the details, the accelerated approval option will significantly shorten Inovio’s path to market. The phase 1/2 trial that will support submission wrapped up late last year. Precigen expects to complete its phase 1/2 trial by the second quarter of next year. The timelines suggest the two treatments may now come to market around the same time.
Inovio is already working to differentiate its candidate. Shea told investors that “unlike other T-cell generating platforms, 3107 and DNA medicines in general don’t cause an antibacterial response, which means that 3107 could potentially be readministered over time to boost immune response if needed.” Inovio is yet to re-dose patients in the INO-3107 trial, but its work in oncology suggests re-dosing is possible.
Following the accelerated approval process will cut one quarter off Inovio’s cash runway, which is now set to end in the second quarter of 2025. Inovio filed a prospectus to raise up to $300 million Thursday.