Voceryq (INO-3107) Approved as the Second Treatment for Recurrent Respiratory Papillomatosis

Kim McClellan was 5 years old in 1971 when doctors found wart-like growths in her throat. She has written that the next 50 years brought about 250 surgeries, growths that spread into her lungs, and a permanent tracheostomy, a breathing tube through the neck (Global Genes, 2022). She now leads the Recurrent Respiratory Papillomatosis Foundation, and for almost all of those years there was no drug to offer anyone with her disease, only the next operation.

That changed on August 14, 2025, when the FDA approved Papzimeos, the first treatment for recurrent respiratory papillomatosis (RRP). A second arrived on October 30, 2026, when the FDA granted accelerated approval to INOVIO's Voceryq, the DNA medicine known through its trials as INO-3107 (FDA, 2026). Adults with RRP now have 2 immunotherapies that train the body to attack the virus behind their growths, while children are still waiting for their first.

FDA decision pageVoceryq (INO-3107) for recurrent respiratory papillomatosisThe approval, what the FDA based it on, the review history and the RRP treatments now available, kept current as label and coverage details arrive.Open the decision page →

Recurrent Respiratory Papillomatosis Is HPV in the Airway, and Surgery Only Resets the Clock

RRP is caused by 2 types of human papillomavirus, HPV 6 and HPV 11, the same low-risk types behind genital warts. In the airway they produce benign growths called papillomas, most often on the vocal cords, and the most common symptom is a hoarse or changing voice. Children are thought to pick up the virus from their mother at birth; adults are thought to acquire it through sexual contact (NIDCD). CDC estimates put new US cases at 2 or fewer per 100,000 children and 2 to 3 per 100,000 adults (NIDCD), and the FDA counts about 1,000 new cases a year (FDA, 2025).

The growths are not cancer, but they will not stay gone. Surgeons remove them with a laser or a microdebrider, a small rotating blade, and the virus left in the surrounding tissue grows new ones. Some patients return to the operating room every few weeks (NIDCD). Drugs such as cidofovir have been tried alongside surgery with mixed results, and doctors now use the cancer drug bevacizumab for severe or lung disease; in a national survey of 8 patients treated that way, all 8 responded, 1 of them completely (Best et al., The Laryngoscope, 2017).

For Morgan Toll, the disease eventually threatened her airway itself. She was diagnosed at 8 months old and had more than 200 surgeries by age 11, according to Johns Hopkins, which treated her. The disease went quiet for more than a decade and came back when she was 22, and by 25 scarring at her vocal cords had narrowed her airway to 3mm. She needed an emergency tracheotomy and a series of 7 surgeries to remove the scar tissue before the tube could come out (Johns Hopkins Medicine, 2016).

“Until today, no therapies have been approved for RRP.”

U.S. Food and Drug Administration, August 14, 2025

Precigen's Papzimeos (zopapogene imadenovec) uses a modified adenovirus that cannot copy itself to deliver pieces of HPV 6 and 11 proteins, so the immune system learns to attack the infected cells. Adults get 4 injections under the skin over 12 weeks, on days 1, 15, 43 and 85. The papillomas are removed surgically before the first dose, and any visible growth is removed again before doses 3 and 4 (FDA prescribing information).

In the pivotal trial of adults who had needed at least 3 surgeries a year, 18 of 35 (51.4%) needed no surgery at all in the 12 months after treatment. Most of those responses held: Precigen reported in May 2026 that 15 of the 18 were still surgery-free, with every responder followed for at least 36 months and 5 of them past 4 years (Precigen, 2026). The FDA granted full approval with no confirmatory trial required. At the approval, McClellan called it "a momentous milestone for the RRP community" (Precigen, 2025).

Voceryq (INO-3107) Reaches the Same Virus Through DNA and an Electrical Pulse

Voceryq goes after the same 2 viral types by a different route. It delivers 2 plasmids, small circles of DNA, into muscle cells. One carries instructions for HPV 6 and 11 proteins, and the other carries IL-12, a molecule that strengthens the immune response (FDA, 2026). Each dose is injected into a muscle, usually the upper arm, with INOVIO's CELLECTRA 5PSP device. Its brief electrical pulse opens the cells long enough for the DNA to get in. The cells then make the viral proteins, and the immune system answers with T cells that hunt down infected airway cells. In the trial, researchers could see new groups of T cells travel from the blood into the papillomas themselves (Morrow et al., Nature Communications, 2025).

The Phase 1/2 trial (NCT04398433) enrolled 32 adults who had needed at least 2 surgeries in the year before treatment, a median of 4. In the year after treatment, 81% (26 of 32) needed fewer surgeries and 28% (9 of 32) needed none. The median patient had 3 fewer procedures that year (Morrow et al., 2025). The FDA's own summary looked at the 26 patients who had needed at least 3 surgeries, the same bar Papzimeos's trial used. Of those, 7 (27%) needed no surgery in the first year (FDA, 2026).

Read on its own, the chart favors Papzimeos on the strictest measure, and the gap remains when the Voceryq figure is limited to patients who had needed 3 or more surgeries, 27% surgery-free against 51%. INOVIO argues the comparison is incomplete for 2 reasons it states publicly. Its regimen does not require surgery during the dosing window. A DNA medicine is also not weakened by the immune system learning to recognize a viral vector, which could matter if patients need repeat courses (INOVIO, 2025 and 2026). Only a trial that treats similar patients the same way could settle which works better, and none is running.

What Accelerated Approval Means for People Considering Voceryq

INOVIO finished its application on November 3, 2025 and asked for accelerated approval, a pathway that lets the FDA approve a drug on early evidence if a confirmatory trial follows. When the FDA accepted the application on December 29, 2025, it chose standard review. It also said its preliminary view was that INOVIO had not justified eligibility for that pathway (INOVIO, 2025).

The FDA granted accelerated approval anyway on October 30, 2026, and it named the basis. The drop in surgeries counts as an intermediate clinical endpoint, a measure the agency considers reasonably likely to predict real benefit. INOVIO must now run post-approval trials to verify and describe that benefit (FDA, 2026). INOVIO says the FDA wants a draft plan for that confirmatory study by the end of 2026, with the final design agreed by mid-2027 (INOVIO, 2026). Accelerated approvals can be withdrawn if those trials fall short, as has happened with other drugs. It is fair to ask your doctor what is known so far and what the new studies will measure.

Side Effects the FDA Listed for Voceryq

The most common side effects were reactions where the injection was given, headache, tiredness, high blood pressure, nausea and dizziness, according to the FDA. The electrical pulse brings its own short list, including brief muscle twitching, a little bleeding, redness or pain at the site, anxiety and lightheadedness or fainting (FDA, 2026). In the trial, side effects linked to treatment occurred in 41% of patients and were all low grade (Morrow et al., 2025). The label tells clinics to watch patients for at least 30 minutes after each dose, and it advises against the pulse in people with a pacemaker or implanted defibrillator on the same side, metal implants, or skin problems where the dose is given (INOVIO, 2026).

9 RRP Clinical Trials Are Open, and 8 Have US Sites

As of November 2, 2026, RRP has 9 studies recruiting or not yet recruiting on ClinicalTrials.gov, and 8 of them have a US site. The newest, registered on October 28, 2026, is Precigen's Phase 3 trial of Papzimeos in children, the age group still without an approved drug. None of them is testing Voceryq, and we could not yet find the post-approval trial the FDA requires listed on ClinicalTrials.gov.

Washington, DC: Papzimeos in children (NCT07901738)

Precigen's Phase 3 study of Papzimeos in about 15 children ages 1 to 17 at Children's National Hospital. Not yet recruiting, with a planned start of December 31, 2026.

Atlanta, Bethesda and Cincinnati: Papzimeos retreatment (NCT06538480)

Precigen's Phase 4 study of giving Papzimeos again and of whether the vector is shed from the body. Recruiting.

Scottsdale, Arizona: dendritic cell vaccine (NCT07317154)

Mayo Clinic's Phase 1 study of a vaccine made from each patient's own immune cells. Recruiting.

New Haven, Connecticut: pembrolizumab and lenvatinib (NCT04645602)

A Yale Phase 2 study combining a cancer immunotherapy with a targeted pill. Recruiting.

Columbus, Ohio: Gardasil-9 booster (NCT07339163)

An Ohio State study of whether an HPV vaccine booster lengthens the time between surgeries in adults. Not yet recruiting.

Bethesda, Maryland: bevacizumab plus PRGN-2012 (NCT07756840)

A Phase 2 study at the NIH Clinical Center pairing bevacizumab with PRGN-2012, the drug approved as Papzimeos. Not yet recruiting.

New Haven, Connecticut: pulmonary RRP natural history (NCT06412172)

A Massachusetts General Hospital study of RRP that has spread to the lungs. Recruiting.

Sioux Falls, South Dakota: rare disease registry (NCT01793168)

Sanford Health's CoRDS registry, open to many rare diseases including RRP. Recruiting.

Paris, France: juvenile RRP cohort (NCT06000527)

A French national cohort of children with RRP at Necker hospital. Recruiting.

HPV Vaccination Is Making Childhood RRP Rarer

The strongest tool against juvenile RRP may already exist. The HPV vaccines in routine use protect against types 6 and 11, and fewer young women carrying those types means less virus to pass to babies at birth. A CDC-led study of 576 US children with RRP, born between 2004 and 2013, found the rate of new cases fell by 75% (Meites et al., Clinical Infectious Diseases, 2021).

For families already living with RRP, the vaccine will not clear an existing infection, and the trial at Ohio State is only now asking whether a booster helps adults who have the disease. For the next generation, though, the math has already changed. The Recurrent Respiratory Papillomatosis Foundation is the main US patient organization for families living with RRP, and the RRP disease page collects the treatments and trials in one place.

Frequently Asked Questions About INO-3107 and RRP