FDA Approves Inovio's Voceryq Plasmid DNA Immunotherapy

The U.S. Food and Drug Administration has granted accelerated approval to Voceryq, developed by Inovio Pharmaceuticals, to reduce the frequency of surgical interventions in adults with recurrent respiratory papillomatosis (RRP), according to mychesco.com mychesco.com. This regulatory decision establishes the product as the first plasmid DNA-based immunotherapy authorized in the United States mychesco.com. Administered as an intramuscular injection combined with the proprietary Cellectra 5PSP electroporation device, the therapy delivers genetic sequences directly into host cells via brief electrical pulses mychesco.com.

Clinical Trial Findings

The regulatory clearance was based on data from an open-label, multicenter trial that enrolled 32 adult patients diagnosed with RRP who had undergone at least two surgical procedures within the preceding year mychesco.com. Within a primary evaluation cohort of 26 patients requiring three or more surgeries prior to intervention—with a baseline median of 4.5 annual excisions—seven individuals (27%) required no further surgeries during the 12-month post-treatment observation period mychesco.com. The clinical protocol lacked a randomized control group, necessitating a confirmatory trial under the accelerated pathway to verify long-term efficacy mychesco.com. Inovio must submit a draft study protocol by the end of 2026, targeting final agreement by mid-2027 mychesco.com.

Molecular Target and Administration

Recurrent respiratory papillomatosis is triggered by human papillomavirus (HPV) types 6 and 11, causing benign yet obstructive epithelial growths across the larynx and respiratory tract mychesco.com. Voceryq consists of two distinct plasmid formulations: doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd mychesco.com. These constructs deliver encoding sequences for specific HPV-targeted viral antigens along with interleukin-12 to amplify immune system activation mychesco.com.

All 32 enrolled participants completed the clinical investigation mychesco.com. Documented adverse reactions were predominantly mild to moderate, including localized injection-site pain, fatigue, headache, hypertension, nausea, and dizziness, alongside transient effects specific to electroporation such as localized muscle contractions and bleeding mychesco.com.

FDA Grants Accelerated Approval to Inovio's Plasmid DNA Therapy Voceryq

Clinical Trial Findings

Molecular Target and Administration

Sources · 2

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