In an October 13, 2022 news release from biotechnology company INOVIO, the company shared that positive interim data was available from a Phase 1/2 study. Within the study, researchers are evaluating INO-3107 for adults with recurrent respiratory papillomatosis (RRP) related to HPV 6 and HPV 11. The study is ongoing; this data is from a cohort consisting of 21 participants, and data from a cohort with 11 participants should be available in 2023.

Within the first cohort of this study, researchers found that INO-3107 was safe, effective, immunogenic, and relatively well-tolerated. Findings from the study show that:

• 76% of participants within the first cohort were able to decrease the number of surgical interventions following INO-3107 treatment compared to the prior year.
• 28.5% of patients required no surgical interventions during the trial. Additionally, there was a median decrease of three surgeries following treatment throughout the entire cohort.
• INO-3107 was safe and well-tolerated. Some side effects did occur, including fatigue and injection site discomfort.
• This treatment increased peripheral T-cells and their response against HPV 6 and 11. Ultimately, this response was also sustained over time.

Given that there are no FDA-approved therapeutic options for those with RRP, INO-3107 has the potential to fill an unmet need and greatly improve patient outcomes. However, the trial isn’t over yet.

INO-3107: An Overview

Precision Vaccinations explains that INO-3107 is:

a DNA medicine…[that] delivers optimized plasmids directly into cells intramuscularly or intradermally using INOVIO’s proprietary hand-held smart device called CELLECTRA. INO-3107 is designed to destroy and clear tumors caused by HPV 6 and 11 infections from the body exactly where they are hiding.

The FDA has granted Orphan Drug designation to INO-3107. This designation is granted to drugs or biologics intended to treat, prevent, or diagnose rare diseases.

What is Recurrent Respiratory Papillomatosis (RRP)?

As described above, HPV 6 and 11 infections can cause recurrent respiratory papillomatosis (RRP), a rare disorder which causes small, wart-like growths in the respiratory tract. Not everyone who has HPV will develop RRP. Additional risk factors include being a first-born child, being delivered vaginally after prolonged labor, or being born to a mother under 20 years old. While the papillomas may form anywhere along the respiratory tract, they most commonly affect the larynx and vocal cords. In a majority of cases, these papillomas are benign (non-cancerous), though they can become malignant (cancerous) in rare cases. Symptoms of RRP can (but do not always) include:

• Hoarseness (which may become progressively worse)
• Failure to thrive (in infants)
• A weak cry (in infants)
• Chronic cough
• Difficulty breathing and/or swallowing
• Noisy breathing
• Shortness of breath
• Issues with speaking
• Episodes of choking
• Recurrent pneumonia
• Chronic lung disease
• Pulmonary failure