PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) has unveiled promising peer-reviewed results from its Phase 1/2 clinical trial for INO-3107, a cutting-edge DNA medicine designed to treat recurrent respiratory papillomatosis (RRP). Published in Nature Communications, the findings signal a potential breakthrough for patients suffering from this debilitating condition, characterized by the growth of benign tumors in the respiratory tract that often require repeated surgeries to manage.
The study revealed that 81% of patients required fewer surgeries after treatment with INO-3107, with nine patients (28%) needing no further surgical intervention during or after the dosing period. INO-3107 was also well-tolerated across all participants in the trial.
A T Cell Revolution in RRP Treatment
INO-3107 works by employing a T-cell-based mechanism to fight RRP, which is caused by human papillomavirus (HPV) types 6 and 11. Patients treated with the therapy experienced the emergence of new T-cell populations that targeted lesions in the airway and papilloma tissue, resulting in a measurable reduction in surgeries and demonstrating long-lasting immune responses.
“The Phase 1/2 study showed the majority of participants experienced a reduced need for surgery, providing great hope for RRP patients who face both risks of vocal cord damage and immense impact on their daily lives with every surgery,” said Dr. Peter Belafsky, Director of the Center for Voice & Swallowing at UC Davis Health and a principal investigator for the trial. “INO-3107 was designed with those patient needs in mind and has the potential to transform the treatment paradigm for RRP.”
Dr. Matthew Morrow, INOVIO’s Vice President of Translational Science, elaborated on the underlying science. “The publication describes in detail how INO-3107 engaged both the innate and adaptive arms of the immune system and directly points to the emergence of new T cell populations that traveled to infected tissue to fight RRP. This compelling story of a T-cell-based mechanism is driving clinical benefits and provides hope for a superior alternative to surgery.”
Encouraging Results and a Strong Safety Profile
The trial observed that 81.3% of participants experienced at least one fewer surgical intervention compared to the year prior, and 72% of patients achieved a 50% or greater reduction in surgeries. Importantly, the treatment maintained durable effects, with immune responses and clinical benefits observed into the second and third years following initial dosing.
INO-3107 was well-tolerated, with only 41% of patients reporting mild treatment-related adverse events, such as injection site pain. No severe treatment-related adverse effects were recorded, highlighting the therapy’s favorable safety profile.
Setting a Milestone in DNA Medicines
INOVIO plans to file a biologics license application (BLA) with the FDA in 2025, seeking priority review under the accelerated approval pathway. If approved, INO-3107 would hold the distinction of being the first DNA medicine approved for any indication in the United States. The potential approval would not only mark a significant milestone for the company but could also redefine treatment options for RRP patients.
“The primary goal for RRP patients is to reduce or eliminate the need for surgery, and INO-3107 has the potential to do just that for the majority of patients,” said Dr. Jacqueline Shea, INOVIO’s CEO and President. “Every surgery matters, and a safe and effective therapeutic alternative to surgery would be truly life-changing for RRP patients and their caregivers.”
A Bright Horizon for RRP Treatment
With INO-3107 demonstrating the ability to address both the symptoms and underlying causes of RRP, these trial results shine a light on the future of care for affected patients. Beyond reducing surgeries, the treatment provides hope for a more balanced lifestyle and improved quality of life.
The upcoming FDA application signals a significant turning point—not just for INOVIO, but for patients hoping to move beyond the cycle of repeated surgical intervention. If approved, INO-3107 could pave the way for further advancements in DNA medicines, potentially transforming how clinicians manage complex viral diseases.
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