Inovio Pharmaceuticals Moves Closer to "Universal" Influenza Vaccine by Demonstrating Protective Immune Responses Against Multiple H3N2 and Type B Strains in Animal Studies

BLUE BELL, Pa., Jan. 31, 2012 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE Amex: INO) announced today that its synthetic vaccines for influenza Type A H3N2 and Type B achieved protective antibody responses in immunized animals against multiple unmatched strains. Inovio previously reported that its H5N1 synthetic vaccine achieved hemagglutination inhibition (HI) titers against six unmatched strains of this influenza subtype in a Phase I human study. The new flu data was highlighted by Dr. Mark Bagarazzi, Inovio's Chief Medical Officer, in a presentation and panel session at Phacilitate Vaccine Forum Washington 2012.

The H3N2, H1N1, and Type B influenza strains represented in each year's seasonal influenza vaccine are updated annually, but only protect against a single strain within each of these subtypes. When the selected strain(s) mutates, the annual vaccine may not provide protection, as witnessed with the 2009 swine flu H1N1 pandemic. There is consequently a global need for a universal vaccine able to provide longer term protection against all existing and potential new strains within the influenza subtypes of concern to humans.

"These new data for H3N2 and Type B in animal models further validate our strategy to develop a universal vaccine to prevent known and unknown influenza strains, as well as our entire SynCon platform. We have in animals provided protection against all of the circulating influenza strains of the last 10 years," said Dr. J. Joseph Kim, Inovio's President and CEO. "We expect additional H5N1 human data by the end of the first quarter and look forward to human data from our combined H5N1 + H1N1 vaccine in the second quarter of 2012. We expect that data from these studies, coupled with this positive data for H3N2 and Type B, will enable us to launch a clinical study of a comprehensive universal influenza vaccine in 2013." 

In the study of Inovio's SynCon® H3N2 vaccine, investigators immunized small animals (mice and guinea pigs) with a synthetic vaccine designed to produce the influenza hemagglutinin (HA) antigen in the animals. Inovio investigators have to date tested blood samples from the animals for immune responses against unmatched strains from several clades of H3N2. (Like the branches of a tree, there are dozens of distinct strains within each of these clades). The animals immunized with the SynCon® H3N2 vaccine developed HI titers exceeding the 1:40 level commonly associated with protective immunity against several clades of H3N2 tested. These included strains circulating in the 2000-01, 2006-07, and 2008-09 influenza seasons which had necessitated a change in the composition of the seasonal flu vaccine for those years. Additional animal testing of the remaining few H3N2 clades will continue in 2012 and will include a new strain, H3N2v (A/Indiana/10/2011 X203), which was selected this month by the CDC as a pandemic vaccine target.

Similarly, in the study of Inovio's SynCon® Type B vaccine, investigators tested blood samples from immunized mice for immune responses against multiple, unmatched strains of Type B influenza. All the animals immunized with the SynCon® Type B vaccine developed HI titers exceeding the 1:40 level against all of the strains of Type B tested, including those circulating and consequently a part of the vaccine formulation in 2001-02, 2008-09, and 2011-12. Type B influenza mutates more slowly than Type A, but enough to preclude lasting immunity. Type B influenza can lead to life-threatening complications, including pneumonia, in young children, persons over 50, those with chronic diseases (e.g. diabetes) or suppressed immune systems, and others at risk for complications.

About SynCon® Influenza Vaccines
Inovio's novel SynCon® technology enables the Company to design synthetic vaccines with the potential to protect against unmatched sub-types and strains of pathogens, including newly emergent, unknown strains of a virus that will periodically emerge through mutation, as in the case of influenza. Inovio has created SynCon® vaccine "constructs" based on influenza HA, NA, and NP proteins from strains H1N1, H2N2, H3N2, and H5N1, which are the Type A seasonal and pandemic-potential influenza subtypes currently of greatest concern, as well as for the less common Type B influenza. By designing synthetic vaccines that unlike conventional vaccines do not need to match a virus in order to provide protection, Inovio is aiming to shift the paradigm for protection against infectious diseases such as influenza by providing true, long-lasting prevention against known and unknown strains of pathogen.

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 cross-strain protection against both known and newly-emergent 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, U.S. Dept. of Homeland Security, 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 synthetic 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 synthetic 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, 2010, our Form 10-Q for the quarter ended September 30, 2011, 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, Richardson & Associates 805-491-8313 [email protected] 

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SOURCE Inovio Pharmaceuticals, Inc.