Inovio Pharmaceuticals Universal H1N1 Influenza Vaccine Achieves Protective Immune Responses Comparable to Conventional Vaccine in Phase I Study

BLUE BELL, Pa., April 18, 2013 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that its SynCon® universal H1N1 influenza vaccine generated protective antibody levels comparable to a current FDA-approved seasonal influenza vaccine against a currently circulating influenza strain. The SynCon® vaccine is designed to protect against a spectrum of viral strains and is not matched to the currently circulating H1N1 strain targeted by the current "conventional" vaccine. This is the first demonstration of a broadly-targeted SynCon® influenza vaccine achieving a protective immune response rate comparable to a conventional seasonal vaccine that is matched to a circulating influenza strain. The data generated in a phase 1 study of healthy volunteers (18 – 55 years) using Inovio's skin-targeted electroporation device was presented today at the World Vaccine Congress in Washington, DC, by Dr. Niranjan Sardesai, Inovio's Chief Operating Officer.

The current FDA-approved trivalent influenza vaccines are designed to protect against only the three strains included in their formulation and are therefore incapable of addressing the inevitable and frequent shift and drift of influenza viral strains that can occur from season to season. However, scientists have questioned whether an influenza vaccine designed to be broadly protective against multiple, unmatched influenza virus strains could provide the same level of protection as the currently licensed trivalent vaccines that are typically matched to two different influenza A strains and a single influenza B strain. In this 100 patient phase I study assessing multiple SynCon® DNA constructs and dose levels, 6 of 10 (60%) volunteers that received the highest (1.8 mg) dose at least two times achieved a protective HAI titer of at least 1:40 with at least a four-fold increase in titer over pre-vaccination levels (i.e. levels considered protective in humans or "seroconverted") against the currently circulating H1N1 A/California/07/09 strain. This response rate was comparable to that seen in volunteers who received the matched seasonal influenza vaccine, where 6 of 10 (60%) seroconverted against H1N1 A/California/07/09.

"We couldn't be more pleased with the results from this proof-of-principle and dose-finding study of our H1N1 universal influenza vaccine," said Dr. J. Joseph Kim, Inovio's President and CEO. "We have already demonstrated that we can generate protective antibodies against the important H1N1 strains of the last century using our H1N1 universal vaccine. The new data shows that our universal approach can achieve protection rates comparable to the current seasonal vaccines, which require annual changes to try to match the predicted circulating strains. Collectively, these results further support our mission to develop a universal influenza vaccine capable of providing years of true preemptive protection across subtypes and strains. These results add significantly to the advancement of our seasonal universal flu vaccine program. They will also help fine-tune dosing for our pandemic avian H5N1 program and support our research for the new H7N9 subtype that has emerged even more rapidly than H5N1."

Inovio previously reported interim results from this phase I study showing that its SynCon® universal H1N1 influenza vaccine generated protective HAI titers against some of the most prevalent strains of H1N1 influenza from the past 100 years. The vaccine recipients from this study generated protective HAI responses against the H1N1 A/South Carolina/1/18 strain (so-called 1918 Spanish flu) as well as all the H1N1 strains that were part of the seasonal trivalent inactivated flu vaccines (TIV) since 1986, including: A/Taiwan/1/86, A/Texas/36/91, A/Bayern/07/95, A/Beijing/262/95, A/New Caledonia/20/99, A/Solomon Islands/03/06, A/Brisbane/59/07, and A/California/07/09.

Demonstrating Inovio's synthetic vaccine's broad protective coverage against unmatched strains, a significant percentage of subjects immunized with lower doses of Inovio's SynCon® vaccine had an HAI titer of 1:40 or higher against each of the nine H1N1 strains tested, ranging from a 30% protective rate to the A/Solomon Islands/03/06 strain to a 70% protective rate to the A/Beijing/262/95 strain. Overall, those immunized with Inovio's vaccine at lower doses ranging from 0.3 mg to 0.9 mg generated a higher seroconversion rate (HAI titer levels associated with protection) against all of the strains except for A/California/07/09 compared to the seasonal TIV (trivalent influenza vaccine)-immunized control group.

This open label phase I study evaluated two synthetic H1N1 hemagglutinin (HA) plasmids designed to broadly protect against unmatched influenza strains within different branches of the H1N1 subtype. These plasmids were delivered in ~90 healthy adults with Inovio's CELLECTRA® intradermal electroporation device with doses of 0.3, 0.45, 0.9 and 1.8 mg separately and in combination up to three times over six months. A ten subject control group was vaccinated with a single injection of the licensed seasonal trivalent influenza vaccine targeting the matched HA antigen sequence of the currently circulating H1N1 strain, A/California/07/09.

Inovio's H1N1 DNA vaccine delivered with electroporation was well tolerated. All reported adverse events and injection site reactions were mild to moderate and required no treatment. The favorable safety profile is consistent with multiple studies in different disease areas in which Inovio DNA vaccines delivered with Inovio electroporation delivery devices have been administered to over several hundred subjects.

About Inovio's Universal Influenza DNA Vaccine Program

Inovio aims to leverage the greater breadth of immune responses achievable using its SynCon® vaccine design to revolutionize the flu vaccine market.

We are advancing the development of a universal seasonal flu vaccine to protect against H1N1, H3N2, and Type B influenza strains, the subtypes comprising today's FDA-approved seasonal vaccines. In addition to the ongoing H1N1 study in elderly subjects (65+ years), for which we reported positive interim data in December, the company is completing immunogenicity testing across multiple strains in animal models of its vaccine constructs for A/H3N2 and Type B influenza.

We are also advancing development initiatives focused on the pandemic influenza subtypes H5N1 and H7N9. Our goal is to access the pandemic stockpiling market, which is dominated by government buyers.

About Inovio Pharmaceuticals, Inc.

Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon® vaccines are designed to provide universal protection against known as well as new unmatched strains of pathogens such as influenza. These synthetic vaccines, in combination with Inovio's proprietary electroporation delivery, have been shown in humans to generate best-in-class immune responses with a favorable safety profile. Inovio's clinical programs include phase II studies for cervical dysplasia, leukemia and hepatitis C virus and phase I studies for influenza and HIV. Partners and collaborators include the University of Pennsylvania, Merck, ChronTech, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, US Dept. of Homeland Security, University of Manitoba and PATH Malaria Vaccine Initiative. More information is available at www.inovio.com.

This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2012, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.

CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, [email protected]
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, [email protected]

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SOURCE Inovio Pharmaceuticals, Inc.