INOVIO, a biotech firm developing DNA-based medicines for HPV-related diseases, cancer, and infectious diseases, has announced that the US FDA has accepted its Biologics License Application (BLA) for a potential treatment for adults with recurrent respiratory papillomatosis (RRP). 

 

The FDA has classified the review for INO-3107 as Standard.

 

The agency set a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2026, the target for taking action on the application. The FDA currently does not plan to hold an advisory committee meeting for the submission.

 

INOVIO submitted the BLA under the accelerated approval pathway, though the FDA noted a potential issue: the company may not have provided sufficient information to qualify for accelerated approval. INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway. The company does not plan to pursue traditional approval for INO-3107 at this time.

 

"We believe there remains a critical unmet need among patients diagnosed with this rare and devastating disease and that every RRP patient deserves access to a non-surgical treatment option that can work for them," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. 

 

"In clinical trials INO-3107 demonstrated it has the potential to expand the treatment options for RRP patients. This is based on a unique mechanism of action, clinical effectiveness and tolerability data and the simplicity of its patient centric treatment regimen, which does not require additional surgeries during the dosing window. Every surgery matters to patients and we look forward to continuing to collaborate with the FDA during the BLA review cycle."

 

The BLA includes Phase 1/2 trial data from adults with RRP who had two or more surgeries in the previous year. Long-term follow-up data showed most patients continued to benefit in the second twelve-month period without additional dosing. These results were published in Nature Communications and The Laryngoscope, a leading journal for otolaryngologists.