Needle-free, Contactless Electroporation Technology for DNA Vaccine Delivery

Inovio Pharmaceuticals Unveils Needle-free, Contactless Electroporation Technology for DNA Vaccine Delivery

Preclinical study demonstrating robust, sustained immune responses with non-invasive delivery device featured in journal Human Vaccines

BLUE BELL, Pa., Feb. 7, 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 its new generation DNA vaccine delivery technology, which provides the powerful enabling capabilities of electroporation without contacting the skin, is highlighted in a paper published in the scientific journal Human Vaccines. While current Inovio electroporation devices have been shown to be safe and well-tolerated in multiple human studies, Inovio has been advancing research to achieve the most optimal device characteristics to facilitate mass vaccinations.

Dr. J. Joseph Kim, Inovio's president and CEO, said, "Inovio continues to raise the bar in terms of technological innovation that will further optimize electroporation-based delivery of DNA-based therapeutics and vaccines for patients of all ages. While still enabling levels of vaccine potency that we have observed with our existing electroporation devices, this new contactless delivery method is non-invasive and amenable to the design of devices that are low-cost, portable, and extremely easy to use."



Drug delivery into skin, or dermal tissue, is the most attractive method given that the skin is the largest, most accessible, and most easily monitored organ of the human body, and it is highly immunocompetent (able to recognize antigens and mount an immune response to them). The paper appearing in Human Vaccines, "Piezoelectric permeabilization of mammalian dermal tissue for in vivo DNA delivery leads to enhanced protein expression and increased immunogenicity," authored by Inovio scientists, describes an innovative electroporation method optimized for delivery into skin. This new method is based on piezoelectricity, which is the generation of an electric field or electric potential by certain materials in response to applied mechanical stress.

In the study, Inovio researchers investigated whether the electrical field strength generated by piezoelectricity alone could elicit gene transfer in the skin of an animal. Researchers injected a plasmid encoding GFP (a type of protein that generates fluorescence) into guinea pig skin and delivered electrical pulses using the contactless electroporation device. Three days following treatment, researchers observed robust protein expression on the skin of pulsed animals. Furthermore, superior immune responses were achieved when a DNA vaccine expressing an influenza antigen was delivered and pulsed using this novel device, in contrast to a lack of immune response when the antigen was injected but not pulsed.

Employing piezoelectricity in this new technology also provides other desirable benefits. Eliminating the insertion of needles used in the conventional electroporation process and reducing the electrical pulsing to nanoseconds makes this contactless device even more tolerable than current and emerging electroporation device designs. The sensation experienced is similar to the feeling of static electricity. In addition, the nature of piezoelectricity preempts the need for a battery or electrical power source, which would be beneficial for mass vaccinations in the field, particularly in developing countries.

Inovio's electroporation delivery devices use controlled, brief electrical pulses to create permeability in cell membranes, which can dramatically increase cellular uptake of a DNA vaccine and resulting gene expression (production of the antigen coded by the DNA vaccine). Data achieved in animal and human studies has indicated that electroporation based delivery enables potent immune responses, which are considered vital to tackling challenging infectious diseases and cancers.

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.