INO-3107
An investigational treatment for Recurrent Respiratory Papillomatosis.
The same compound appears under different names depending on the context. Here is how to identify INO-3107 wherever you encounter it, plus the key facts at a glance.
- Generic name
- INO-3107
- Development code
- INO-3107
- Drug class
- DNA immunotherapy
- Manufacturer
- INOVIO Pharmaceuticals
- How it's taken
- 4 injections into the muscle (usually the upper arm) on day 0 and weeks 3, 6 and 9, each followed by electroporation with the CELLECTRA device.
An investigational DNA medicine from INOVIO for adults with recurrent respiratory papillomatosis, under FDA review with a decision due October 30, 2026. It is given as 4 injections into the muscle over 9 weeks, each followed by a brief electrical pulse from INOVIO's CELLECTRA device.
Where INO-3107 fits
If approved, INO-3107 would be the second treatment for adults with RRP after Papzimeos (August 2025). The 2 drugs were tested in different single-arm trials with different response measures, so their results cannot be compared directly. INOVIO highlights that its regimen does not require surgery during dosing and that repeat dosing is not blunted by immunity to a viral vector.
How INO-3107 works
INO-3107 is made of circular pieces of DNA (plasmids) carrying instructions for HPV 6 and HPV 11 proteins. After injection into muscle, a short electrical pulse from the CELLECTRA device opens the cells briefly so the DNA can enter. The cells make the viral proteins, and the immune system responds with T cells that seek out airway cells infected with HPV 6 or 11. In the trial, new T cell clones moved from the blood into the papillomas.
Mechanism: DNA plasmid immunotherapy encoding HPV 6 and HPV 11 antigens, delivered into muscle with electroporation to generate T cells against infected cells
Side effects and safety
In the Phase 1/2 trial, 13 of 32 patients (41%) had treatment-related side effects, all low grade. No serious adverse events were reported in the follow-up study.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking INO-3107
4 injections into the muscle (usually the upper arm) on day 0 and weeks 3, 6 and 9, each followed by electroporation with the CELLECTRA device. INOVIO says the regimen does not require additional surgeries during the dosing window.
Clinical trial results
The Phase 1/2 trial (NCT04398433) enrolled 32 adults who had needed at least 2 surgeries in the prior year (a median of 4). In the year after treatment, 81% (26 of 32) needed fewer surgeries, 28% needed none, and the median reduction was 3 surgeries. In a follow-up study of 28 of the patients, 50% needed no surgery in year 2 and the average number of surgeries fell from 4.1 before treatment to 1.7 in year 1 and 0.9 in year 2. Results were published in Nature Communications in February 2025 and The Laryngoscope in August 2025.
Development history
INOVIO completed a rolling biologics license application on November 3, 2025, seeking accelerated approval. The FDA accepted it on December 29, 2025 under standard review, setting an October 30, 2026 target date, and flagged its preliminary view that INOVIO had not justified eligibility for the accelerated approval pathway. INOVIO held mid-cycle and late-cycle meetings with the FDA in May and August 2026. INO-3107 has Orphan Drug and Breakthrough Therapy designations.
Explore Recurrent Respiratory Papillomatosis trials
Other Recurrent Respiratory Papillomatosis treatments
Common questions about INO-3107
▸What is INO-3107?
An investigational DNA medicine from INOVIO for adults with recurrent respiratory papillomatosis, under FDA review with a decision due October 30, 2026. It is given as 4 injections into the muscle over 9 weeks, each followed by a brief electrical pulse from INOVIO's CELLECTRA device.
▸How does INO-3107 work?
INO-3107 is made of circular pieces of DNA (plasmids) carrying instructions for HPV 6 and HPV 11 proteins. After injection into muscle, a short electrical pulse from the CELLECTRA device opens the cells briefly so the DNA can enter. The cells make the viral proteins, and the immune system responds with T cells that seek out airway cells infected with HPV 6 or 11. In the trial, new T cell clones moved from the blood into the papillomas.
▸What are the side effects of INO-3107?
In the Phase 1/2 trial, 13 of 32 patients (41%) had treatment-related side effects, all low grade. No serious adverse events were reported in the follow-up study.
▸How is INO-3107 taken?
4 injections into the muscle (usually the upper arm) on day 0 and weeks 3, 6 and 9, each followed by electroporation with the CELLECTRA device. INOVIO says the regimen does not require additional surgeries during the dosing window.
▸Is INO-3107 FDA approved?
INO-3107 is currently in phase 2 clinical trials for Recurrent Respiratory Papillomatosis. It has not yet received FDA approval.
▸When will the FDA decide on INO-3107?
The FDA's target action date is October 30, 2026. INOVIO is seeking accelerated approval for adults with RRP; in its acceptance letter the FDA said its preliminary view was that INOVIO had not yet justified eligibility for that pathway.
▸How is INO-3107 different from Papzimeos?
Both train T cells against HPV 6 and 11. Papzimeos uses a non-replicating adenovirus, given under the skin with surgery before doses; INO-3107 is DNA injected into muscle with an electrical pulse, and INOVIO says no surgery is needed during dosing. Their trials measured response differently, so the numbers are not directly comparable.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. Securities and Exchange Commission · 2025-12-29. INOVIO announces FDA acceptance of BLA for INO-3107. https://www.sec.gov/Archives/edgar/data/1055726/000119312525332322/d78035dex991.htm
- Nature Communications · 2025-02-12. DNA immunotherapy for recurrent respiratory papillomatosis (RRP): phase 1/2 study assessing efficacy, safety, and immunogenicity of INO-3107. https://www.nature.com/articles/s41467-025-56729-6
- INOVIO via PR Newswire · 2025-08-11. Data Published in The Laryngoscope Shows INO-3107 Resulted in Long-Term Surgery Reduction in RRP. https://www.prnewswire.com/news-releases/data-published-in-the-laryngoscope-shows-ino-3107-resulted-in-long-term-surgery-reduction-in-recurrent-respiratory-papillomatosis-rrp-302526066.html
- INOVIO via PR Newswire · 2026-08-12. INOVIO Reports Second Quarter 2026 Financial Results and Recent Business Highlights. https://www.prnewswire.com/news-releases/inovio-reports-second-quarter-2026-financial-results-and-recent-business-highlights-302849959.html