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Inovio Pharmaceuticals HPV Immunotherapy Achieves Primary Efficacy Endpoint in Randomized Phase II Cervical Dysplasia Trial
Date:7/23/2014

40.2%) VGX-3100 recipients compared to 5 of 35 (14.3%) placebo recipients (p<0.025).

As in the phase I study, VGX-3100 elicited robust HPV-specific T cell responses in the majority of treated subjects. A comprehensive analysis of T cell responses is ongoing.

The treatment was generally well-tolerated, with only administration site redness occurring significantly more frequently in the VGX-3100 group compared to the placebo group in the 7- and 28-day periods following treatment.

"Beyond the direct clinical implications of this phase II study, these results are a breakthrough for the field of immunotherapies. This efficacy and T cell data provide evidence that our SynCon® immunotherapy technology can activate the immune system to fight chronic infections, pre-cancers — and ultimately, cancers," said Dr. J. Joseph Kim, Inovio's President and CEO. "These results significantly de-risk our product and business development strategy for VGX-3100 and our broad pipeline of SynCon® active immune therapy and vaccine products.

"We thank the women who participated and the clinical investigators who provided patient care and made this trial possible."

Topline results will be presented at the 2014 International Society of DNA Vaccines Conference in San Diego, on July 23, 2014. Detailed study findings will be submitted for publication in a peer-reviewed scientific journal.

About VGX-3100

Inovio's VGX-3100 is an immunotherapy containing two DNA plasmids targeting the E6 and E7 oncogenes of HPV types 16 and 18. The treatment is administered to patients by injection into muscle (typically in the arm), followed by electroporation using Inovio's CELLECTRA® device. VGX-3100 has been shown to induce a robust immune response against the E6 and E7 oncogenes associated with HPV types 16 and 18. These oncogenes are responsible for tran
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SOURCE Inovio Pharmaceuticals, Inc.
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