Positive Interim Data Available: INO-3107 for Recurrent Respiratory Papillomatosis


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
Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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