Inovio Pharmaceuticals (INO) FDA announcement summary

Approval and indication

• VOCERYQ received FDA accelerated approval to reduce surgical papilloma excisions in adults with recurrent respiratory papillomatosis (RRP); continued approval may depend on confirming clinical benefit.

• The adult indication is broad; FDA’s efficacy analysis focused on patients with at least 3 surgeries in the prior 12 months.

• The plasmid DNA immunotherapy targets HPV-6 and HPV-11, encoding viral E6/E7 proteins and human IL-12 to promote an antigen-specific T-cell response; it is delivered with CELLECTRA 5PSP.

Clinical evidence and safety

• RRP-001 enrolled 32 adults with at least 2 prior-year surgeries; patients received 4 doses over 9 weeks, with no additional papilloma excisions required during the dosing window.

• The efficacy population included 26 patients with at least 3 prior-year surgeries; median baseline surgeries were 4.5 (range 3–8).

• At 12 months after treatment, 7 of 26 patients achieved complete response, defined as no surgical intervention: 27% (95% CI: 12%–48%).

• VOCERYQ was generally well tolerated; most reactions were Grade 1 or 2. Common reactions included injection-site reactions, headache, fatigue and hypertension; no Grade 4 or 5 common adverse events occurred.

Confirmatory study

• The planned confirmatory study is expected to enroll at least 50 adults and pediatric patients with at least 3 prior-year surgical interventions, with efficacy followed for at least 3 years.

• The study may compare surgical interventions with an external control group or scientifically justified threshold; a draft protocol was due by end-2026, with final alignment targeted by June 2027.

• Continued treatment may be explored for patients without sustained complete response; pediatric development is planned to begin with adolescents.