PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) revealed its strategic milestones for 2025, positioning the company for significant advancements as it aims to become a commercial-stage biotechnology leader. Central to this effort is INO-3107, a DNA-based therapeutic candidate targeting recurrent respiratory papillomatosis (RRP), a debilitating rare disease.
The company plans to submit a Biologics License Application (BLA) for INO-3107 to the U.S. Food and Drug Administration (FDA) by mid-2025, with a request for priority review. If approved, INO-3107 would become the first DNA medicine approved in the United States for any condition and could provide a non-surgical treatment option for RRP patients. INOVIO is also preparing for a confirmatory trial involving 100 patients at approximately 20 U.S. academic centers.
“We anticipate 2025 to be a transformational year as we move closer to becoming a commercial-stage company, delivering innovative solutions for patients suffering from devastating diseases,” emphasized Dr. Jacqueline Shea, INOVIO’s President and CEO.
Key accomplishments from 2024 bolster the momentum for INO-3107. Data from a Phase 1/2 study showed promising results, with 81% of patients experiencing a reduction in surgeries and half achieving a complete response after treatment. Durability data further highlighted that 95% of patients maintained their initial clinical benefits two years post-treatment, and 63% maintained them into the third year. Additionally, new immunology data demonstrated the therapy’s ability to trigger targeted immune responses, potentially slowing or stopping papilloma regrowth.
RRP patients often endure multiple surgeries annually to manage symptoms, making these findings significant for improving quality of life. INO-3107’s design also positions it for potential global market expansion, with encouraging feedback from European and U.K. regulators.
Beyond INO-3107, INOVIO is advancing other pipeline projects, including INO-3112 for HPV-related cancers and INO-4201 as a potential booster for the Ebola vaccine ERVEBO®. The company is also continuing clinical development for candidates targeting glioblastoma, cervical dysplasia, and COVID-19.
Commercial readiness remains a focus, with plans to launch INO-3107 by the end of 2025 if approved. Efforts include building a commercial organization, refining market strategies, and addressing pricing, access, and distribution needs.
With more than $84 million in cash reserves at the end of September 2024, bolstered by equity offerings, INOVIO appears positioned to execute its ambitious goals. The company’s proprietary DNA medicines platform, which uses advanced technology to design and deliver DNA plasmids, continues to drive its innovative approach.
If 2024 marked substantial progress for INOVIO, 2025 holds the potential to solidify its position as a pioneer in DNA-based therapeutics, with the broader biotech industry closely watching its next moves.
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