What's Happening?
INOVIO 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.
RRP is a rare disease caused by HPV-6 and HPV-11, characterized by the growth of papillomas in the respiratory tract. INO-3107, which has received Orphan Drug and Breakthrough Therapy designations, is designed to elicit a T cell response to target and kill HPV-infected cells. In clinical trials, the treatment showed significant reductions in the need for surgeries among participants. The BLA submission is under the FDA's Accelerated Approval program, with a potential priority review that could lead to a commercial launch in 2026.
Why It's Important?
The submission of INO-3107 represents a potential breakthrough in the treatment of RRP, offering hope to patients who currently rely on repeated surgeries to manage the disease. If approved, INO-3107 would be the first DNA medicine available in the U.S., marking a significant advancement in biotechnology and personalized medicine. This development could improve the quality of life for RRP patients by reducing surgical interventions and associated risks. It also highlights the growing importance of DNA medicines in addressing unmet medical needs, potentially paving the way for new treatments for other HPV-related diseases.
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 commercial launch, contingent on FDA approval. Continued collaboration with the FDA will be crucial during the review process. The success of INO-3107 could encourage further research and development in DNA medicines, potentially expanding their application to other diseases and conditions.
