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.

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.

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.

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.

Not yet. INO-3107 is under FDA review for Recurrent Respiratory Papillomatosis; INOVIO has filed an application and a decision is due October 30, 2026. The FDA calendar page tracks the outcome.

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. ^[1]

Both train T cells against HPV 6 and 11. Papzimeos uses a non-replicating adenovirus given under the skin, with surgery to remove growths before the first dose and again before doses 3 and 4 if any are visible. INO-3107 is DNA injected into muscle with an electrical pulse; trial patients had surgery to remove growths in the 14 days before the first dose, and INOVIO says no surgery is needed during dosing. Their trials measured response differently, so the numbers are not directly comparable. ^[2][4][5]

No. INO-3107 is not FDA-approved. It is an investigational DNA medicine that has completed a Phase 1/2 trial, and INOVIO's biologics license application was accepted by the FDA on December 29, 2025 under standard review with a target decision date of October 30, 2026. INO-3107 has Orphan Drug and Breakthrough Therapy designations. INOVIO reported in May 2026 that the FDA had completed its mid-cycle review and in August 2026 that its late-cycle meeting was done. ^[1][6][7]

The Phase 1/2 trial (NCT04398433) enrolled 32 adults with recurrent respiratory papillomatosis who had needed at least 2 surgeries in the prior year, a median of 4. In the year after INO-3107 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 patients, 50% needed no surgery in year 2 and the average number of surgeries fell from 4.1 before treatment to 0.9 in year 2. Treatment-related side effects occurred in 13 of 32 patients (41%) and were all low grade, with no serious adverse events in the follow-up study. Results were published in Nature Communications in February 2025 and The Laryngoscope in August 2025. ^[2][3]