BLUE BELL, Pa., Oct 25, 2010 (BUSINESS WIRE) -- Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that a peer-reviewed research article describing the development of a new intradermal, minimally-invasive DNA vaccine delivery device was published in the prestigious journal Gene Therapy. This very low voltage device, which does not penetrate the skin, further enhances the previously established tolerability of Inovio's electroporation devices. Moreover, DNA vaccines delivered using this device produced strong antibody and T-cell immune responses and achieved protection from lethal challenge in multiple animal models including non-human primates. The lead author of the paper, "Prototype development and preclinical immunogenicity analysis of a novel minimally invasive electroporation device," was Dr. Niranjan Y. Sardesai, Senior Vice President, Research & Development. Other collaborators included Dr. David B. Weiner, Chair of Inovio's Scientific Advisory Board and Professor, Department of Pathology & Laboratory Medicine, University of Pennsylvania.
Inovio's new minimally-invasive intradermal device is based on its electroporation delivery platform in which controlled, millisecond electrical pulses create permeability in cell membranes and enable dramatic uptake of biological material previously injected into targeted muscle or skin tissue. Inovio's electroporation systems have been shown to increase cellular uptake of a DNA vaccine 1000-fold or more and to increase levels of gene expression (production of the antigen coded by the DNA vaccine) and immune responses to the antigen up to 100-fold.
While current Inovio electroporation devices have been shown to be safe and well-tolerated in multiple human studies, Inovio has been advancing research into more portable and patient-friendly next-generation delivery devices. In this context, the study reported in Gene Therapy used voltages averaging roughly seven times less than its current devices. The paper noted that the use of non-penetrating needle electrodes and lower-voltage parameters encompassed in this device concept further improves tolerability of this delivery platform. By enabling simple delivery into the skin, this device can serve to expand applications for DNA delivery in humans to broader prophylactic settings, i.e. for mass vaccinations, and may extend the range of immunizations to both older and younger populations. This new device also facilitates the delivery of more complex formulations and antigen mixtures that may better address targeted diseases.
The authors investigated the delivery of candidate influenza DNA vaccines, demonstrating that DNA delivered intradermally via the minimally-invasive (equivalent to a slight scratch of the skin), low-voltage device conferred 100% protection in a mouse model to the vaccinated animals against a lethal challenge of influenza H5N1. Influenza DNA vaccine delivered via the device also produced HA-inhibition (HAI) titers significantly over 1:40 in two other large animal models including in non-human primates. While these large animals were not subsequently challenged in this study, titers greater than 1:40 are considered to be protective in the influenza model in a number of species.
Dr. J. Joseph Kim, CEO of Inovio Pharmaceuticals, said, "Inovio is the clear leader in DNA vaccine development and delivery. This important study unveils our exciting, next generation minimally-invasive drug delivery technology and enables the development of a new generation of preventive vaccines against many challenging diseases and for a broad spectrum of the population. We look forward to continuing our R&D leadership in this field."
About the Journal Gene Therapy
Gene Therapy belongs to the Nature Group of publications. At the forefront of medicine, Gene Therapy brings the latest research into genetic and cell-based technologies to treat disease. It also publishes Progress & Prospects reviews and News and Commentary articles, which highlight the cutting edge of the field.
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(TM) 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, HIV Vaccines Trial Network, National Microbiology Laboratory of the Public Health Agency of Canada, 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 six months ended June 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.
SOURCE: Inovio Pharmaceuticals, Inc.