Inovio Biomedical Universal Influenza Vaccines Demonstrate 100% Protection Against Current Pandemic A/H1N1 Influenza Viruses in Animal Studies
Inovio Consensus DNA Vaccine Approach Demonstrates 100% Protection Against Unmatched Flu Virus Strains Currently in Circulation
SAN DIEGO--(BUSINESS WIRE)--Jul. 29, 2009-- Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today that the company's SynConTM H1N1 influenza DNA vaccines achieved protection against current circulating swine origin influenza A/H1N1 viruses in animal studies.
The company had previously reported interim data from an ongoing study in a pig model in which the SynConTM based H1N1 vaccines achieved hemagglutination inhibition (HI) titers above the protection threshold in 100% of the vaccinated animals against the swine influenza virus (A/Iowa/35233/1999). In a continuation of this study, Inovio investigators tested the immune sera for responses against a virus isolated from the current circulating strain of swine origin influenza A/H1N1 (Swine A/Mexico/InDRE4487/2009). All the animals immunized with the SynConTM H1N1 vaccine developed HI titers exceeding the 1:40 level commonly associated with protective immunity.
In a second study, the investigators immunized mice with the NP and m2E components of the vaccine and challenged these animals with a second related strain also isolated from the current circulating influenza A/H1N1 (A/Canada/AB/RV1532/2009). While all mice showed effects of virus challenge as judged by significant weight loss, the vaccinated mice recovered from virus infection-induced morbidity significantly faster compared to the non-immunized control animals.
In a previous study, the Inovio team demonstrated that mice immunized with Inovio's SynConTM H1N1 DNA vaccine provided 100% protection in a lethal challenge study against an unmatched H1N1 virus that caused the 1918 Spanish flu, which killed over 40 million people worldwide.
The challenge of current seasonal influenza vaccines is they are not effective against new strains that emerge, like the present swine origin influenza A/H1N1. The CDC reported low human prevaccination response rates and cross-reactivity to swine origin influenza (A/California/04/2009), suggesting that current H1N1 seasonal flu vaccines were likely to be ineffective against the new 2009 A/H1N1 strains. Similarly, the USDA recently reported there was limited cross-reactivity against the new 2009 A/H1N1 virus in pig herds vaccinated with existing swine influenza vaccines.
Dr. J. Joseph Kim, Inovio's CEO, said, "The latest data further underscores the potential of the SynConTM technology to create vaccines capable of protecting against emerging pandemic influenza viruses. Our SynConTM influenza vaccines were developed prior to the emergence of the current swine flu strains and have yielded strong protective responses in animal models against a variety of unmatched influenza strains. This is an advantage for our universal flu program over conventional influenza vaccines, which are strain-specific. Inovio, along with its collaborators, is amongst the first groups to report on the successful protection of vaccinated animals against a virus challenge with the 2009 influenza A/H1N1 virus. We are also one of the first groups to report on preclinical results regarding this virus using a large-animal model like pigs, a more natural host for the current influenza pandemic."
Inovio's novel SynConTM technology enables the company to design DNA-based vaccines with the potential to protect against unmatched sub-types and strains of pathogens and provides the opportunity to have vaccines on hand against new strains that perpetually emerge, as in the case of influenza. Inovio has created SynConTM DNA vaccines based on influenza HA, NA, and NP proteins from strains H1N1, H2N2, H3N2, and H5N1, which make up the majority of seasonal and pandemic influenza. Resulting vaccines could target seasonal as well as pandemic-potential influenza strains such as avian influenza and swine-origin flu, which has already been designated pandemic status. Significantly, being based on a common set of antigens derived from a broad range of flu strains, a universal vaccine would have the potential to provide greater protection against new, unmatched flu strains.
About Inovio Biomedical Corporation
Inovio Biomedical is engaged in the design, development, and delivery of a new generation of vaccines, called DNA vaccines, focused on cancers and infectious diseases. The company's SynConTM technology enables the design of DNA-based vaccines capable of providing cross-protection against new, unmatched strains of pathogens such as influenza. Inovio's proprietary electroporation-based DNA vaccine delivery technology has been shown by initial human data to safely and significantly increase gene expression and immune responses. Inovio's clinical programs include HPV/cervical cancer (therapeutic) and HIV vaccines. An IND has been filed for an avian influenza vaccine. Inovio is developing its universal and avian influenza vaccines in collaboration with scientists from the University of Pennsylvania and the National Microbiology Laboratory of the Public Health Agency of Canada. Other partners and collaborators include Merck, Tripep, University of Southampton, University of Pennsylvania, and HIV Vaccines Trial Network. Inovio's product candidates and technologies are protected by an extensive global intellectual property portfolio. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in 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 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 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 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 combined 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 companies' combined 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, our ability to maintain listing of our common stock under the rules and regulations of the NYSE Amex and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2008, our Form 10-Q for the three months ended March 31, 2009, and other regulatory filings from time to time, including our current report on Form 8-K reporting the closing of the merger transaction with VGX Pharmaceuticals, Inc. 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.