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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

ection against unmatched flu strains . . . Launching a second flu clinical study, for a multi-subtype vaccine against both H5N1 and H1N1

In conjunction with completing the interim assessment of Inovio's first human influenza study with its single subtype SynCon vaccine, the company is advancing its universal influenza vaccine strategy with the initiation of a second Phase I influenza vaccine study. This trial is assessing INO-3510, Inovio's multi-subtype SynCon DNA vaccine consisting of the H5N1 and H1N1 subtypes delivered exclusively with its new ID electroporator. This Phase I for INO-3510 introduces three strategic components for its universal influenza program, which is funded in part by a recent grant from the National Institutes of Health. First, this vaccine adds the H1N1 seasonal/pandemic influenza subtype to the H5N1 pandemic subtype. Second, it will be Inovio's first clinical study solely using ID electroporation delivery. Third, this study will test the SynCon vaccine's ability to provide cross-strain protection against H1N1 and H5N1 viruses.

In this study, 90 subjects will receive two or three doses of the DNA vaccines over 1 to 6 months. The Investigational New Drug submission for this study has been approved by the FDA and all 90 subjects are currently being screened and randomized. Preliminary safety and immune response data are expected in 1Q 2012.

About Inovio's Universal Influenza DNA Vaccines

Of three broad types of influenza (A, B, C), influenza A is the most deadly and the causative agent of pandemics. Two of the eight proteins associated with influenza A are HA (hemagglutinin) and NA (neuraminidase). H1, H2, and H3 are the HAs and N1 and N2 are the NAs that have caused the majority of disease in man, with the specific combinations of concern to man being H1N1, H2N2, and H3N2. H5N1 is pathogenic and quite lethal but has not been shown to transmit from person to person.

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SOURCE Inovio Pharmaceuticals, Inc.
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