Progress Towards BLA Submission for INO-3107
Inovio remains on track to submit their BLA for INO-3107 for treating recurrent respiratory papillomatosis (RRP) with rolling submission in mid-2025 and completion by the end of the year. They aim for a PDUFA date in mid-2026 if priority review is granted.
Manufacturing Issue Resolved
The manufacturing issue involving the single-use array component of the CELLECTRA device has been resolved, and device design verification testing has begun.
Publication of Key Data
Clinical and immunology data from the Phase 1/2 trial of INO-3107 was published in Nature Communications in February.
Positive Interim Results for DMAb Technology
Promising interim results from a Phase 1 proof-of-concept trial evaluating DNA-Encoded Monoclonal Antibodies (DMAbs) were announced, showing sustained antibody production for COVID-19.
Market Opportunity and Commercial Readiness
Inovio's ongoing market research supports the potential of INO-3107 as the preferred product for RRP patients and physicians, with a significant market opportunity due to the lack of existing therapeutic options.
Reduction in Operating Expenses
Operating expenses decreased by 20% from $31.5 million in Q1 2024 to $25.1 million in Q1 2025.
Statistically Significant Reduction in Surgeries
In the first year, 72% of patients saw a 50% to 100% reduction in surgeries after starting treatment with INO-3107, increasing to 86% in the second year with half of the patients requiring no surgeries at all.