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Inovio Pharmaceuticals Demonstrates Positive Immune Responses in Phase I Clinical Trial of SynCon™ H5N1 Influenza Vaccine and Launches Multi-Subtype Influenza Vaccine Phase I
Date:7/14/2011

this goal in a modular manner and we look forward to generating data from this study using a multi-antigen vaccine, which we expect in the first quarter of 2012."

Positive data from Inovio's first universal influenza vaccine program clinical study

Inovio's VGX-3400X targets the pandemic influenza subtype H5N1. The vaccine consists of three distinct DNA plasmids coded for a consensus hemagglutinin (HA) antigen derived from different H5N1 virus strains; a consensus neuraminidase (NA) antigen derived from different N1 sequences; and a consensus nucleoprotein (NP) fused to a small portion of the m2 protein (m2E) based on a broader cross-section of influenza viruses in addition to H5N1 and H1N1.

In this first proof of principle study of Inovio's universal flu vaccine program, VGX-3400X was delivered with IM electroporation using Inovio's CELLECTRA® electroporation device. The primary objectives of this clinical trial were to assess safety and tolerability. The secondary objective was the measurement of antigen-specific T cell and antibody responses, including binding and hemagglutination inhibition (HI) responses.

The study assessed a total of 60 healthy volunteers, 30 in the US and 30 in Korea (in a separate, parallel clinical trial sponsored by Inovio affiliate VGX International). Three dose cohorts of 10 subjects were each given two injections of 0.2 mg, 0.67 mg, or 2.0 mg of each plasmid at months 0 and 1.

In the study, VGX-3400X was found to be generally safe and well tolerated at all dose levels. There were no vaccine-related serious adverse events. Reported adverse events and injection site reactions were mild to moderate and required no treatment.

Inovio tested for antibody responses against the target antigens and observed high levels of binding antibodies in 26 of 27 evaluated subjects (96%). Antibodies were generated against all three antigens, as tested by the enzyme-linked immunosorbent assay (ELISA). P
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SOURCE Inovio Pharmaceuticals, Inc.
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