Utility and tolerability of new electroporation device supports Inovio's vision for preventive vaccine candidates against important infectious disease targets
Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, today unveiled its new clinical-grade, miniaturized electroporation device designed to be an easy-to-use, portable delivery product for DNA vaccines. Inovio believes the device may be used to inoculate large populations against infectious diseases such as influenza, dengue and malaria. This new skin electroporation technology has been used to deliver DNA vaccines in several preclinical animal models and generated strong, protective antibody responses, which are required to provide immunity against targeted diseases. Dr. Niranjan Sardesai, SVP, Research and Development, introduced this new technology and device in a presentation at Phacilitate Vaccine Forum Washington 2010 on Tuesday, January 26th, in Washington, DC.
Inovio has established that electroporation delivery of its SynCon™ DNA vaccines into skin tissue, an extension of its electroporation technology for delivering DNA vaccines into muscle, is able to facilitate potent neutralizing antibody responses that have protected ferrets in influenza challenge models and protected monkeys in a smallpox challenge model. Inovio's clinical studies of electroporation-based delivery of DNA vaccines into muscle of prostate and cervical cancer patients have been among the first to demonstrate generation of potent antigen-specific antibody responses in humans.
The patented design introduces a miniaturized array size and further optimization of electroporation conditions. A recent controlled study conducted in human volunteers showed that tolerability of the new skin vaccine delivery device was similar to conventional syringe-delivered flu vaccines. Inovio believes these important design outcomes could make such devices suitable for widely applied preventive vaccine regimens.
Dr. J. Joseph Kim, president and CEO, stated, "Our development team has been working diligently to bring about a 'pinky'-sized clinic-ready device. Coupled with our universal SynCon™ DNA vaccine technology, our new skin vaccine delivery device expands our powerful arsenal for targeting a broad array of infectious diseases caused by viruses and bacteria. Having already filed the device master file with the FDA, we expect to soon start IND-enabling toxicity studies using the new skin delivery device and are applying our unique platform to rapidly develop new vaccine programs."
The development of the skin clinical device was funded in part by a $1.9M US DOD contract and $23.5M US NIH contact, received by us in 2007 and 2008, respectively.
About Inovio Biomedical Corporation
Inovio Biomedical is focused on the design, development, and delivery of a new generation of vaccines, called DNA vaccines, to prevent and treat cancers and infectious diseases. The company's SynCon™ technology enables the design of "universal" vaccines capable of protecting against multiple – including newly emergent, unknown – 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 the first component of its universal influenza vaccine. Inovio is developing its universal influenza vaccines in collaboration with scientists from the University of Pennsylvania, the National Microbiology Laboratory of the Public Health Agency of Canada, and the NIH's Vaccine Research Center. 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, in addition to historical information, forward-looking statements. Such statements are based on management's current estimates and expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in the forward-looking statements. Inovio is providing this information as of the date of this press release, and expressly disclaims any duty to update information contained in this press release.
Forward-looking statements in this press release include, without limitation, express and implied statements relating to Inovio's business, plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and pre-clinical and clinical studies. Actual events or results may differ from the expectations set forth herein as a result of a number of risks, uncertainties and other factors, including but not limited to: Inovio has a history of losses; all of Inovio's potential human products are in research and development phases; no revenues have been generated from the sale of any such products, nor are any such revenues expected for at least the next several years; Inovio's product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing; uncertainties inherent in clinical trials and product development programs, including but not limited to the fact that pre-clinical and clinical results 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, that results from an animal study may not be indicative of results achievable in human studies, that clinical testing is expensive and can take many years to complete, that the outcome of any clinical trial is uncertain and failure can occur at any time during the clinical trial process, and that Inovio's electroporation technology and DNA vaccines may fail to show the desired safety and efficacy traits in clinical trials; all product candidates that Inovio advances to clinical testing will require regulatory approval prior to commercial use, and will require significant costs for commercialization; the availability of funding; the ability to manufacture vaccine candidates; the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop; whether Inovio's proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity; and the impact of government healthcare proposals. Readers are also referred to Inovio's Annual Report on Form 10-K for the year ended December 31, 2008 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2009 filed with the Securities and Exchange Commission which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements.
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Bernie Hertel, 858-410-3101
bhertel@inovio.com
or
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Jeff Richardson, 805-491-8313
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