Inovio Pharmaceuticals (Formerly Known as Inovio Biomedical Corporation)’ Foot-and-Mouth Disease DNA Vaccine Introduces Critical Advantages in Fight Against Most Serious Farm Animal Disease

BLUE BELL, Pa., March 2, 2011 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it achieved compelling results in a study of its DNA vaccine for foot-and-mouth disease administered by Inovio’s proprietary vaccine delivery technology. The preclinical data was highlighted by Dr. Niranjan Y. Sardesai, Inovio’s Sr. VP of Research and Development, at the Vaccine World Summit being held in New Delhi, India, March 13. The presentation, entitled “Electroporation Mediated Delivery of DNA Vaccines: Translating the Promise to Prophylactic Vaccination,” focused on Inovio’s recent developments to advance novel vaccines for several emerging pathogens, including foot-and-mouth disease (FMD), Chikungunya, and dengue viruses.

The FMD virus is one of the most infectious diseases affecting farm animals including cattle, swine, sheep and goats, and is a serious threat to global food safety. Once an area is exposed to FMD, livestock & dairy exports are ceased and herds are culled. For example, in a major FMD outbreak in the UK in 2001, more than 4 million animals were slaughtered, resulting in more than $10 billion (USD) in economic losses. In a current FMD epidemic in South Korea, more than 3.3 million animals, mostly swine, have been culled in an attempt to keep the disease from spreading.

Because FMD can spread rapidly and beyond regional boundaries there is a need to develop vaccines that can simultaneously target different regional serotypes of FMD in a single vaccine. Inovio’s SynCon technology enables rapid development of vaccines that can cover multiple serotypes simultaneously with a single formulation. Inovio, its subsidiary, VGX Animal Health (VAH), and its academic collaborators generated and tested SynCon DNA vaccine constructs targeting all seven main FMD virus serotypes, moving from antigen design to large animal testing in only a few months.

In a study conducted in pigs, just a single vaccination with an Inovio FMD vaccine comprising four of the most common FMD serotypes generated high titer, antigen-specific antibody responses for each serotype in the vaccinated animals. The responses were boosted even higher with a second immunization. High levels of T-cell responses were also measured in the vaccinated animals. All vaccines were administered intramuscularly with Inovio’s CELLECTRA® electroporation delivery system.

There are several potential advantages of Inovio’s FMD DNA vaccine:

• Inovio’s SynCon DNA vaccine cannot cause disease, which is a possibility using current killed viral FMD vaccines due to incomplete virus inactivation. This limits current vaccination to herds that may be imminently exposed to FMD. Inovio’s vaccine would permit truly preventive vaccination.
• Inovio’s SynCon universal vaccine is designed to generate broader, cross-protective immune responses across different FMD serotypes, unlike existing vaccines that must be matched to the FMD serotype.
• Current FMD vaccines display the same multiple proteins as the actual virus. Healthy vaccinated animals can therefore not be distinguished from infected animals, frequently leading to the slaughter of uninfected herds. Inovio’s SynCon vaccine is encoded for a single antigen (VP1 protein) common across FMD serotypes. Because it is a synthetic consensus antigen unmatched to naturally existing FMD strains, a blood test can distinguish non-infected vaccinated animals from naturally infected animals. This could potentially reduce the slaughter of healthy animals in outbreak areas.
• Better thermal stability of Inovio’s product overcomes the challenge of expensive and/or unavailable cold storage and transport in developing countries at high risk of FMD outbreaks.

Dr. J. Joseph Kim, Inovio’s President and CEO, said: “Foot-and-mouth pandemics are a great threat to global food supply and society. Recent outbreaks in Europe and Asia have wreaked havoc in those areas and caused billions of dollars worth of damage. We at Inovio and VGX Animal Health are extremely pleased with the advancement of our new SynCon DNA vaccine for FMD through large animal pilot testing and we look forward to the further development of this important vaccine.”

About Foot-and-Mouth Disease

Foot-and-mouth disease (FMD) affects cloven-hoofed animals such as cattle, pigs, sheep, goats and water buffalo, and is capable of rapidly infecting large numbers of animals. Seven main types of FMD virus are believed to exist today. Like other viruses, the FMD virus continually evolves and mutates. To date there has been no cross-protection between strains even within the different types of FMD virus. Vaccine viruses which are not completely killed have resulted in FMD outbreaks, hence vaccines used today are administered to the herd only once an outbreak is detected in an area in order to limit the rapid spread of infection, thus limiting the potential utility of such vaccines.

While death rates are generally low, the highly infectious nature of the virus has a profound negative economic impact, such as in the dairy industry where cattle may experience reduced milk production, poor growth and permanent hoof damage. An FMD outbreak typically leads to economic sanctions, including the loss of export markets, and can negatively impact tourism as restrictions are placed on the movement of people and animals. This was the case in the 2001 outbreak in the UK.

About VGX Animal Health, Inc.

VGX Animal Health is developing DNA-based therapies for food and companion animals utilizing proprietary plasmid-based DNA delivery and expression technology to optimize an animal’s natural biological and immunological potential. The company is a majority-owned subsidiary of Inovio Pharmaceuticals, Inc.

About Inovio Pharmaceuticals, Inc.

Inovio is developing a new generation of vaccines, called DNA vaccines, to treat and prevent cancers and infectious diseases. These SynCon vaccines are designed to provide broad cross-strain protection against known as well as newly emergent strains of pathogens such as influenza. These vaccines, in combination with Inovio’s proprietary electroporation delivery devices, have been shown to be safe and generate significant immune responses. Inovio’s clinical programs include HPV/cervical dysplasia and cancer (therapeutic), avian flu (preventive), and HIV vaccines (both preventive and therapeutic). Inovio is developing universal influenza and other vaccines in collaboration with scientists from the University of Pennsylvania. Other partners and collaborators include Merck, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, 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 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, our ability to successfully integrate Inovio and VGX Pharmaceuticals, 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, 2009, our Form 10-Q for the nine months ended September 30, 2010, 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.

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SOURCE Inovio Pharmaceuticals, Inc.