INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced the presentation of new data at scientific conferences for its lead candidate, INO-3107, for which the company is preparing a Biologics License Application for targeted submission in mid-2025 under the U.S. Food and Drug Administration's Accelerated Approval Pathway Program.

At AACR's Tumor and Immunology Conference on October 19, INOVIO presented new immunology data demonstrating the ability of INO-3107 to induce antigen-specific T cell responses against HPV-6 and HPV-11 and drive recruitment of those T cells into airway tissues and papilloma of RRP patients, which could ultimately slow or eliminate papilloma regrowth. Additionally, INOVIO will tomorrow present its full safety and efficacy data set for the Phase 1/2 trial for INO-3107 at the International Society of Vaccines Conference. In the trial, INO-3107 was found to be well tolerated and immunogenic. Of the 32 patients in the trial, 26 patients, or 81%, experienced a decrease in the number of surgical interventions in the year after treatment when compared to the year before treatment.

"The new immunology data support the proposed mechanism of action of INO-3107 which is to generate an immune response that can seek out and eliminate HPV-6 and HPV-11 infected cells that are the underlying cause of papilloma growth," said Dr. Matthew Morrow, INOVIO's Vice President of Translational Science. "Our analysis shows that INO-3107 induced significant clonal T cell expansion in the blood, including antigen-specific killer T cells. Investigators also observed T cell infiltration into airway tissue, which is positively associated with clinical response."

"The collective story these data sets provide is compelling. Over 81% of patients who received INO-3107 required fewer surgical procedures compared to baseline, a result that is further supported by the new immunology data demonstrating the ability of INO-3107 to stimulate the immune system and generate antigen-specific T cells that travel to the airways and could eliminate the underlying disease," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "We believe these data continue to demonstrate that INO-3107 has the potential to significantly improve the lives of patients living with RRP and become the preferred choice for the broadest number of RRP patients and healthcare providers."