Abstract| Volume 51, SUPPLEMENT 1, S7-S8, March 2015

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ITOC2 – 020. VGX-3100 Immunotherapy for CIN2/3 Induces regression of cervical lesions and viral clearance (Phase II study): Implications for treatment of HPV associated cancers

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      Immunotherapy that significantly impacts the clinical status of advanced cervical intraepithelial neoplasia (CIN) has the potential to provide physicians an important alternative to surgery to treat CIN 2/3 disease. Our previous two Phase I studies of VGX3100, a highly optimised DNA immunotherapy for HPV16/18, drove seroconversion to HPV antigens in 100% of patients while 78% of patients mounted an Interferon Gamma (IFNg) ELISpot response. Flow analysis revealed IFNg production from both CD4+ and CD8+ T cells, as well as the induction of patient CD8s with antigen specific CTL activity.
      This randomized, placebo-controlled, double-blind Phase II study assessed the safety and efficacy of VGX3100 in 167 women with biopsy-proven CIN 2/3 with concurrent HPV16 or 18 infection. The study evaluated cervical tissue changes after three 6 mg intramuscular doses of VGX-3100 with Inovio’s CELLECTRA® 2000 electroporation device at weeks 0, 4, 12. Cervical tissue was examined before starting blinded treatment and 9 months later.
      The study met its primary efficacy endpoint; Significantly higher percentage of VGX3100 treated patients versus placebo showed regression of CIN 2/3 to CIN 1 or no disease (p = 0.017). In addition, VGX3100 recipients demonstrated significantly stronger post-vaccination IFNg ELISpot responses and cleared HPV infection concurrent with regression of CIN lesions.
      The efficacy data with VGX3100 support the exciting possibility of treating HPV-associated cancers.
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