INOVIO Presents New INO-3107 Data for RRP Treatment at Conferences

PLYMOUTH MEETING, Pa., Oct. 21, 2024 /PRNewswire/ -- INOVIO, a biotechnology company specializing in DNA medicines for HPV-related diseases, cancer, and infectious diseases, revealed new data regarding its lead candidate, INO-3107, at recent scientific conferences. The company is preparing a Biologics License Application (BLA) for INO-3107 targeting submission in mid-2025 under the FDA's Accelerated Approval Pathway.

At the American Association for Cancer Research (AACR) Special Conference on Tumor Immunology and Immunotherapy held on October 19, INOVIO shared immunology data showing that INO-3107 can induce T cell responses specific to HPV-6 and HPV-11. The treatment also facilitated the recruitment of T cells into airway tissues and papillomas in patients with Recurrent Respiratory Papillomatosis (RRP). This finding suggests that INO-3107 might help slow or prevent papilloma regrowth.

Additionally, comprehensive safety and efficacy data from a Phase 1/2 clinical study of INO-3107 in adult RRP patients will be presented at the International Society of Vaccines Conference. In this study involving 32 patients, INO-3107 was found to be well-tolerated and immunogenic. Significantly, 81% of trial participants required fewer surgical interventions in the year following treatment compared to the prior year.

Dr. Matthew Morrow, INOVIO's Vice President of Translational Science, noted that the new immunology data support INO-3107's proposed mechanism of action, which involves generating an immune response to eliminate HPV-6 and HPV-11 infected cells responsible for papilloma growth. He emphasized that the treatment induced substantial clonal T cell expansion in the blood, including antigen-specific killer T cells, and promoted T cell infiltration into airway tissue, which is linked to clinical response.

Dr. Jacqueline Shea, INOVIO's President and CEO, highlighted the compelling nature of the data, pointing out that over 81% of patients treated with INO-3107 required fewer surgeries. This result is bolstered by immunology data demonstrating that INO-3107 stimulates the immune system to produce antigen-specific T cells that travel to the airways and may eradicate the underlying disease. She expressed confidence that INO-3107 has the potential to significantly enhance the lives of patients with RRP and become the preferred treatment for a broad patient population and healthcare providers.

The AACR presentation data indicated that INO-3107 induces T cell responses specific to HPV-6 and HPV-11, expansion of antigen-specific T cell populations, and inflammatory responses in papilloma and airway tissues. This includes interferon, cytokine, and chemokine signaling, and infiltration of adaptive and innate immune cells, particularly T cells. Clinical activity was not impacted by the immunosuppressive papilloma microenvironment.

At the International Society of Vaccines Conference, the clinical results from the Phase 1/2 study showed an overall clinical response rate (OCR) of 81%, with 26 of 32 patients experiencing a reduction in surgical interventions post-treatment. Notably, 28% of patients required no surgical intervention during or after the dosing period, and 44% had a partial response, with a reduction of at least 50% in the number of surgeries compared to the prior year. The overall response rate was 72%.

Further key data points revealed that INO-3107 was well tolerated, causing mostly low-grade treatment-related adverse events, such as injection site pain and fatigue. The study also showed improved Derkay-Pransky severity scores and durable cellular responses, with T cells targeting HPV-6 and HPV-11.

Recurrent Respiratory Papillomatosis (RRP) is a rare disease primarily caused by HPV-6 and HPV-11, characterized by small wart-like growths in the respiratory tract. These growths can cause life-threatening airway obstruction and significantly impact the patient's quality of life. Surgery to remove papillomas is the standard treatment, but the growths often recur.

INO-3107 is designed to generate an antigen-specific T cell response against HPV-6 and HPV-11, potentially preventing or slowing new papilloma growth. In a Phase 1/2 clinical trial, 81.3% of patients had a decrease in surgical interventions post-treatment. Importantly, the treatment induced strong immune responses, with persistent cellular memory response observed at Week 52. INO-3107's ability to generate antigen-specific T cells without being affected by anti-vector immunity makes it a promising therapeutic option for RRP patients.

The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations, allowing INOVIO to submit its BLA under the accelerated approval program. The European Commission also granted INO-3107 Orphan Drug designation, and the UK awarded it the Innovation Passport, facilitating quicker market access and patient availability.

INOVIO's DNA medicines platform utilizes precisely designed DNA plasmids delivered by the CELLECTRA® device to target and combat diseases. This platform aims to teach the body to produce its own disease-fighting tools, enhancing patient care for HPV-related diseases, cancer, and infectious diseases.