BLA Submission for INO-3107 on Track
Inovio is on track to submit the Biologics License Application (BLA) for INO-3107 in the second half of 2025. The company plans to request a priority review, potentially leading to a PDUFA date in mid-2026.
Publication of Clinical Data
Data from Inovio's retrospective study on the long-term clinical effect of INO-3107 were published in The Laryngoscope, demonstrating significant clinical benefits for RRP patients, including a reduction in surgeries.
Operating Expenses Reduction
Inovio significantly reduced its operating expenses by 31% in Q2 2025 compared to Q2 2024, reflecting strategic fiscal management.
Successful FDA Inspection
The FDA inspection of Inovio as the clinical sponsor of the Phase I/II trial was successfully completed, marking an important step in the regulatory process.
Expansion of Next-Generation DNA Medicine Technology
Inovio highlighted the potential of their next-generation DNA medicine technology, including DNA-encoded monoclonal antibodies and protein replacement therapies, with ongoing partnerships and data sharing.