What's Happening?
INOVIO, a biotechnology company, has completed the rolling submission of its Biologics License Application (BLA) for INO-3107, a DNA immunotherapy candidate aimed at treating recurrent respiratory papillomatosis (RRP) in adults. This submission is under
the FDA's Accelerated Approval program, with a request for priority review. If granted, the review could be completed within six months following the 60-day filing period. INO-3107 has previously received Orphan Drug and Breakthrough Therapy designations. The treatment targets HPV-6 and HPV-11, aiming to reduce the need for surgeries, which are currently the standard care for RRP. Clinical trials have shown promising results, with a significant reduction in surgeries required by patients.
Why It's Important?
The submission of INO-3107 for FDA approval is significant as it represents a potential new treatment option for RRP, a rare and debilitating disease. If approved, INO-3107 would be the first DNA medicine available in the U.S., marking a milestone for INOVIO and the field of DNA-based therapies. The treatment could significantly improve the quality of life for RRP patients by reducing the frequency of surgeries, which carry risks of vocal cord damage and financial burdens. The approval could also pave the way for further advancements in DNA medicine, potentially benefiting other HPV-related diseases and cancers.
What's Next?
INOVIO anticipates receiving file acceptance by the end of 2025, with a potential PDUFA date in mid-2026 if priority review is granted. The company is preparing for a potential commercial launch in 2026, pending FDA approval. Continued communication with the FDA will be crucial during the review process. The outcome of this submission could influence future regulatory strategies for DNA medicines and impact the broader biotechnology industry.
