Inovio Nears FDA Decision on INO-3107 as Oct. 30 PDUFA Date Looms

Inovio Pharmaceuticals NASDAQ: INO said its biologics license application for INO-3107, an investigational DNA medicine for recurrent respiratory papillomatosis, or RRP, remains under U.S. Food and Drug Administration review, with a target action date of Oct. 30.

President and CEO Jacqueline Shea said the clinical-stage biotechnology company is in the late stages of the regulatory process for INO-3107 under the FDA’s Accelerated Approval Program.

The company has completed its late-cycle review meeting and scheduled FDA inspections, she said.

Inovio expects label negotiations with the agency to begin in September.

RRP is a rare disease caused by human papillomavirus types 6 or 11 that produces wart-like growths in the respiratory tract, particularly in the larynx and vocal cords.

The condition can impair speaking, breathing and swallowing.

Shea said RRP affects an estimated 14,000 people in the United States, with about 1.8 new adult cases per 100,000 people annually.

Repeated surgery remains the standard treatment because surgical procedures remove growths but do not address the underlying viral infection, Shea said.

Some patients may require hundreds of surgeries over their lifetimes, and procedures can carry risks including irreversible vocal-cord damage.

INO-3107 was designed to generate an antigen-specific T-cell response against HPV types 6 and 11.

The company’s BLA is supported by its Phase I/II RRP-001 study and the RRP-002 follow-up study, which tracked patients after treatment without providing additional doses.

In RRP-001, enrolled patients had required at least two surgeries to manage their disease in the previous year.

Patients received four doses of INO-3107 after entering the study following a clinically required surgery, and any surgery needed after the initial treatment date, including during the dosing period, was counted toward the study endpoint.

Shea said 72% of patients achieved a 50% to 100% reduction in surgeries during the first year after treatment compared with the prior year.

That proportion rose to 86% in the second year.

Meanwhile, 28% of patients required no surgeries in the first 12 months after treatment, increasing to 50% in the second 12 months.

The extension study produced a median follow-up period of 2.8 years.

During a July informal clinical meeting with the FDA, Inovio presented its safety and efficacy data, its approach to RRP treatment and its rationale for accelerated approval eligibility, Shea said.

The FDA did not discuss a preliminary comment in the file acceptance letter concerning accelerated approval eligibility, according to Shea, but indicated that feedback on the design of a confirmatory trial would be forthcoming.