Enabling Capabilities of Inovio Biomedical's Electroporation Delivery Technology with SIV DNA Vaccine Confirmed in Collaborative Study With National Cancer Institute

Preclinical Study Shows Decrease in Virus Spread in Bloodstream of Animals with HIV-Like Infection

SAN DIEGO--(BUSINESS WIRE)--Sep 3, 2009 - Inovio Biomedical Corporation (NYSE Amex:INO), a leader in DNA vaccine design, development and delivery, announced today that data generated from a pre-clinical collaborative study by National Cancer Institute (NCI) and Inovio scientists were published in the scientific journal Proceedings of the National Academy of Sciences in a paper entitled: “DNA vaccination in rhesus macaques induces potent immune responses and decreases acute and chronic viremia after SIVmac251 challenge.” The senior author of this study is Dr. George Pavlakis, Senior Investigator & Chief, Human Retrovirus Section Vaccine Branch, NCI (pavlakig@mail.nih.gov).

The primary aim of this study was to assess protective capabilities of optimized DNA vaccines delivered using Inovio's proprietary electroporation system against simian immunodeficiency virus (SIV), which is closely related to human immunodeficiency virus (HIV). Animals receiving an NCI vaccine were challenged 14 weeks after a four-dose vaccination regime with a highly pathogenic strain of SIV and followed for 32 weeks post-challenge. Vaccinated animals exhibited greatly reduced viremia (the spread of a virus via the bloodstream) during acute and chronic phases of infection compared to control animals, indicative of better control of infection.

Vaccinated animals developed strong cellular and humoral responses against the DNA vaccine antigens. Vaccination induced strong memory responses that were maintained at the day of challenge. Development of high levels of effector memory T cells suggested the potential for rapid immune system mobilization upon SIV challenge. These results demonstrate that DNA vaccines delivered using only electroporation, without a heterologous boost with, for example, an alternative vaccine modality such as a viral vector-based vaccine, can provide acute and chronic protection from high viremia that is comparable to other vaccine modalities that have been previously tested in this macaque model.

At a recent scientific conference, Dr. George Pavlakis, Senior Investigator & Chief, Human Retrovirus Section Vaccine Branch, NCI, stated that on the challenging path toward an HIV preventive vaccine, various alternative vaccine modalities have faced challenges including being unable to induce sufficiently strong immune responses, or inducing unwanted immune responses. In this study, an electroporation-delivered plasmid-based DNA vaccine achieved some of the highest levels of humoral and cellular immune responses against SIV ever achieved by a DNA vaccine, without the aforementioned issues. Dr. Pavlakis stated that he believes electroporation is presently the gold standard for DNA vaccine delivery, generating the best results in terms of immunogenicity of DNA vaccines and producing both antibodies and cytotoxic T cells in response to the DNA vaccination. The immune responses and level of protection achieved in this experiment are among the highest reported by any vaccine approach in this macaque model. Furthermore, Dr. Pavlakis indicated that the positive results of this study suggest that further research of this approach should be a high priority.

Dr. J. Joseph Kim, Inovio's CEO, said, “We are pleased to have achieved these important results with a prestigious research organization such as the NCI. This new knowledge will help advance Inovio's DNA vaccine technology platform and our broad preclinical and clinical pipeline encompassing human papillomavirus, influenza, and other infectious diseases. We look forward to initiating a human trial with our proprietary electroporation-delivered HIV DNA vaccine this fall.”

About National Cancer Institute (NCI)

The NCI is the US Government's principal agency for cancer research and training, including a requirement to assess the incorporation of state-of-the-art cancer treatments into clinical practice. The NCI coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and continuing care of cancer patients and families of cancer patients.

The NCI has a long-standing tradition of strength in retroviruses, due to their importance to cancer research. This tradition has carried over into AIDS research, and there are currently more than 20 research groups within the NCI and contract laboratories that devote at least part of their effort to the study of HIV. The studies currently underway range from basic research into how the virus interacts with its host cell to vaccine development and drug discovery.

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 SynCon™ 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, National Cancer Institute and HIV Vaccines Trial Network. 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 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 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 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 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 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 six months ended June 30, 2009, 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.

 

 

Contact: Investors:
Inovio Biomedical
Bernie Hertel, 858-410-3101
or
Media:
Richardson & Associates
Jeff Richardson, 805-491-8313

 

Posted: September 2009

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