Voceryq (ino-3107)

Voceryq (INO-3107) is a DNA immunotherapy from INOVIO for adults with recurrent respiratory papillomatosis, given FDA accelerated approval on October 30, 2026^[9]. Its generic name is doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd, and it is the first plasmid DNA-based immunotherapy approved in the US^[9]. INOVIO expects it to be available to order in about 60 days, with a full launch in the first quarter of 2027^[7]. Voceryq is given as 4 injections into the muscle over 9 weeks, each followed by a brief electrical pulse from INOVIO's CELLECTRA 5PSP device.

Voceryq delivers 2 circular pieces of DNA (plasmids) into muscle cells. One carries instructions for HPV 6 and HPV 11 proteins, and the other carries instructions for IL-12, a molecule that strengthens the immune response^[9]. A short electrical pulse from the CELLECTRA device briefly opens the cells 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.

The most common side effects on the label were injection site reactions (34% of the 32 trial patients), headache (19%), fatigue (16%), high blood pressure (13%), nausea (6%) and dizziness (6%). The electrical pulse can cause brief muscle contractions, minor bleeding, redness or pain where it is given, anxiety, lightheadedness or fainting, and short-lived changes in a muscle enzyme called creatine phosphokinase^[8][9]. In the Phase 1/2 trial, 13 of 32 patients (41%) had treatment-related side effects, all low grade^[2], and no serious adverse events were reported in the follow-up study^[4].

The label dose is 1mL (6.25mg) injected into the deltoid muscle of the upper arm every 3 weeks for 4 doses, each followed by an electrical pulse from the CELLECTRA 5PSP device. The front of the thigh is used if neither upper arm is suitable, and only a healthcare provider trained on the device gives it. Surgery to remove visible growths comes before the first dose, and the trial protocol called for no further surgery during the 9-week dosing window. The label says to watch patients for at least 30 minutes after each dose and to avoid the electrical pulse in an arm on the same side as a pacemaker or implanted defibrillator, near metal implants, or on skin with problems at the injection site^[8].

Yes, INO-3107 (Voceryq) is FDA approved (2026) for the treatment of Recurrent Respiratory Papillomatosis.

On October 30, 2026, its target date. The FDA granted accelerated approval to Voceryq (INO-3107) for adults with recurrent respiratory papillomatosis, based on fewer surgeries after treatment, and INOVIO must run further trials to confirm the clinical benefit. ^[9]

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]

Yes. The FDA granted accelerated approval on October 30, 2026 to INO-3107, branded as Voceryq, for adults with recurrent respiratory papillomatosis. In the trial, 7 of the 26 patients who had at least 3 surgeries in the year before treatment needed no surgery in the year after (27%). It has Orphan Drug and Breakthrough Therapy designations. ^[9]

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]