FDA Grants Accelerated Approval to Voceryq, the First Plasmid DNA-Based Immunotherapy for Recurrent Respiratory Papillomatosis

An Immune Response to Repeated Surgery: Voceryq, HPV and Respiratory Papillomatosis

On October 30, 2026, the US Food and Drug Administration (FDA) granted accelerated approval to a treatment called Voceryq for adults with recurrent respiratory papillomatosis (RRP) caused by HPV 6 and 11. Voceryq is the first plasmid DNA-based immunotherapy approved in the United States: small rings of DNA, delivered into cells with an injection into the muscle and brief electrical pulses, train the immune system to recognize HPV-infected cells. In the study that supported the approval, 7 of 26 adults who needed at least three surgeries a year required no surgery at all in the first year after treatment. In this article, we explain what RRP is, how Voceryq works, what the results mean, how it differs from Papzimeos (approved in 2025) and the role of the HPV vaccine in preventing this disease. An important note: RRP is usually a benign disease; this is not the approval of a "cancer vaccine." We previously covered the disease itself in our article on laryngeal papillomatosis and the first approval in 2025 in our Papzimeos news story.

Why does this matter?

RRP is rare, but it deeply affects patients' lives. As papillomas grow on the vocal cords, the voice becomes hoarse, and cough and shortness of breath develop; in severe cases, the airway can become blocked. For years, the only effective treatment was surgery: the papillomas are removed, but because the virus remains in the tissue, they soon grow back. Some patients undergo surgery several times a year and dozens of times over their lifetime; each operation carries a risk of permanent scarring of the vocal cords. Among people who rely on their voice for work, job loss, social withdrawal and anxiety are also common (psychological effects of HPV-related diseases).

For this reason, treatments that use the immune system to target the HPV-infected cells that cause the disease represent an important change in approach. Because Voceryq is also one of the first licensed applications of DNA-based drug technology, it is being closely watched in the field of therapeutic vaccines and therapeutic vaccines against HPV. On the other hand, an accelerated approval and a small single-arm study mean the results must be interpreted with caution (the drug approval process).

What is Voceryq?

Voceryq is a plasmid DNA-based immunotherapy developed to reduce the need for surgery in adults with recurrent respiratory papillomatosis caused by HPV 6 and 11. It is given by injection into the muscle together with brief electrical pulses, and it trains the immune system to recognize cells carrying HPV. The FDA granted accelerated approval in October 2026.

What is recurrent respiratory papillomatosis?

RRP is a chronic disease in which HPV 6 and 11, the wart-causing "low-risk" types of human papillomavirus (HPV), cause wart-like growths (papillomas) in the respiratory tract, most often in the larynx and on the vocal cords. Unlike HPV 16 and 18, which cause cervical and throat cancer, these types usually do not cause cancer; rarely, however, papillomas can undergo malignant transformation (HPV and head and neck cancers).

The disease has two peaks in two age groups. The juvenile-onset form usually develops when the virus passes from the mother to the baby during birth; it most often appears before age 5 and requires surgery more often. The adult-onset form is most often seen between ages 20 and 40 and is usually sexually transmitted. Symptoms are hoarseness, chronic cough and shortness of breath; especially in children, the diagnosis may be delayed because the symptoms are mistaken for asthma or bronchitis; rarely, blood may appear in the sputum (coughing up blood). The diagnosis is made by examining the larynx with a thin camera (laryngoscopy; what is endoscopy?) and by biopsy.

How does Voceryq work?

Voceryq contains two plasmids. Plasmids are small, ring-shaped pieces of DNA first obtained from bacteria. The first carries the genetic recipe for specific proteins of HPV 6 and 11, and the second carries the recipe for a molecule called interleukin-12 (IL-12), which strengthens the immune response. The drug is injected into the muscle with a device called CELLECTRA 5PSP. At the same time, the device delivers very brief electrical pulses; this method is called electroporation. The electrical pulses open temporary, reversible pores in the cell membrane, making it easier for the DNA to enter the muscle cells.

Using this recipe, the muscle cells produce the HPV proteins and IL-12. The immune system recognizes these proteins as "foreign" and generates T cells specific to HPV 6 and 11. These T cells reach the airway and target the cells carrying the virus. The study showed that the HPV-specific cytotoxic T cells (cells that destroy their target cells) generated by the treatment were still present in the blood at week 52 and that new groups of T cells reached the papilloma tissue. The goal, therefore, is not only to remove the papilloma but also to use the immune system to reduce the virus-infected cells that are the source of recurrence (immunotherapy and vaccines).

Treatment begins with standard surgery to remove the papillomas; this is followed by a dosing period of about 9 weeks, during which no additional surgery is needed. This approach turns a DNA technology method previously used only in experimental vaccines and clinical trials into a licensed treatment for the first time (mRNA and DNA-based vaccine studies). The idea of a therapeutic vaccine against HPV is also being investigated in HPV 16-associated head and neck cancer (the PDS0101 trial, Dr. Refika Yiğit's therapeutic vaccine research).

The evidence: what did the study show?

The FDA approval is based on an open-label, multicenter, single-arm study of 32 adults with RRP. Patients were required to have had at least two surgeries in the 12 months before treatment. The key result for the approval comes from the most severely affected group, that is, the 26 patients who had had at least three surgeries in the previous year: 7 of these patients (27%) needed no surgery at all in the first year after treatment. Before treatment, these patients had undergone a median of 4.5 surgeries a year.

According to the results for all patients, published in Nature Communications in 2025, the number of surgeries fell by at least one compared with the previous year in 81% of the 32 patients and was cut at least in half in 72%; the median reduction was 3 surgeries a year. The manufacturer reports that the benefit continued in the second and third years; however, these long-term data are not yet part of the FDA review.

How should these results be interpreted? The course of RRP can vary from patient to patient and over time; in some patients, the disease may slow down on its own. In a study without a comparison group, it is difficult to say with certainty how much of the reduction in surgeries is due to the drug. This is also why the approval was accelerated: the reduction in surgery frequency was accepted as an intermediate outcome "reasonably likely to predict" real clinical benefit, and the manufacturer was asked to conduct new studies to confirm the benefit.

How does it differ from Papzimeos?

The first treatment approved for RRP is Papzimeos (zopapogene imadenovec), which received full FDA approval in August 2025. Papzimeos also generates immunity against HPV 6 and 11 proteins, but it does so with a non-replicating adenovirus vector and is given as 4 subcutaneous injections over 12 weeks. In its approval study, 18 of 35 patients (51%) achieved a complete response, meaning no surgery was needed in the first year. With Voceryq, this rate was 27% in the approval group. However, the patient populations, definitions of complete response and treatment designs of the two studies differ; the drugs have not been compared directly.

Safety and side effects

The most common side effects in the study were pain and redness at the injection site, headache, fatigue, increased blood pressure, nausea and dizziness. Most side effects were mild to moderate and temporary; all patients completed the study. Related to electroporation, brief muscle contractions, temporary bleeding at the administration site, anxiety, a feeling of faintness and temporary increases in muscle enzymes may occur. After administration, the patient is observed for at least 30 minutes. The treatment should not be given at a site on the same side as a pacemaker or defibrillator, or at a site with a metal implant or a skin problem.

Other treatment options for RRP

Voceryq and Papzimeos complement existing treatments rather than replacing them. The mainstay of treatment is still surgical removal of the papillomas while protecting the vocal cords. In frequently recurring disease or disease that spreads to the lower airways, additional treatments such as bevacizumab, given intravenously or directly into the lesion, may be used; these are not approved for RRP, and their use is based on experience.

Prevention: the role of the HPV vaccine

The most effective solution for RRP is to keep the disease from developing in the first place. Vaccines that cover HPV 6 and 11 (the quadrivalent and 9-valent vaccines) provide strong protection against these types. Vaccinating future mothers in adolescence reduces transmission of the virus to the baby at birth and lowers the rate of childhood RRP; in adults, vaccination may also help prevent adult-onset RRP (Gardasil 9, 20 years of the HPV vaccine).

Vaccinating boys as well reduces the spread of the virus in the community, helping to prevent both RRP and HPV-related cancers (HPV vaccination for boys, important vaccines, including HPV). Current vaccines are preventive; they do not treat existing RRP. However, some centers have reported that vaccination after surgery in patients with RRP may reduce recurrences; this use is not yet standard.

The situation in Türkiye

Questions to ask your doctor

• Has the HPV type in my papillomas been determined? Is there dysplasia (cell changes)?
• How many times a year am I having surgery, and is this frequency increasing?
• Which surgical method is being used to protect my vocal cords?
• Is an additional treatment (e.g., bevacizumab) right for me?
• Is there an option for immunotherapy abroad or a clinical trial?
• Should I or my family members get the HPV vaccine?

Frequently Asked Questions

What is Voceryq?

Voceryq is a plasmid DNA-based immunotherapy developed to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis caused by HPV 6 and 11. It is given by injection into the muscle together with brief electrical pulses. The FDA granted accelerated approval on October 30, 2026.

What is recurrent respiratory papillomatosis (RRP)?

RRP is a chronic disease in which HPV 6 and 11 cause wart-like growths in the respiratory tract, most often on the vocal cords. It causes hoarseness, cough and shortness of breath. It is usually benign, but it often comes back even after surgical removal.

How effective is Voceryq?

Of 26 adults who had at least three surgeries a year, 7 (27%) needed no surgery at all in the first year after treatment. In 81% of 32 patients, the number of surgeries decreased. The study had a single arm; the benefit needs to be confirmed in new studies.

Can RRP be prevented?

Yes, to a large extent. Vaccines that cover HPV 6 and 11 protect against these types. In Australia, after the national vaccination program, the rate of childhood RRP fell from 0.16 to 0.02 per 100,000 children.

Glossary

RRP

Recurrent respiratory papillomatosis; a disease in which HPV 6 and 11 cause recurrent wart-like growths in the respiratory tract.

Papilloma

A wart-like, benign tissue growth.

HPV 6 and 11

"Low-risk" HPV types that cause warts and rarely lead to cancer.

Plasmid

A small, ring-shaped piece of DNA first identified in bacteria; used as a drug to carry a genetic recipe.

Electroporation

A method that uses brief electrical pulses to open temporary pores in the cell membrane so that DNA can enter the cell.

IL-12

Interleukin-12; a molecule that strengthens the immune response by stimulating T cells.

Therapeutic immunotherapy

A treatment that activates the immune system against an existing infection or disease.

Accelerated approval

An FDA approval for serious diseases that is based on an intermediate outcome thought to predict real benefit and that requires a confirmatory trial.

Laryngoscopy

Examination of the larynx and vocal cords with a thin camera.

Complete response

In this study, needing no surgery at all in the 12 months after treatment.