SAN DIEGO, CA November 18, 2009 -- Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today that the company’s SynCon™ Chikungunya virus DNA vaccine induced protective neutralizing antibody responses in a preclinical non-human primate model. Dr. David B. Weiner, Professor, University of Pennsylvania and Chairman, Inovio Scientific Advisory Board, discussed the data at the VACCINES EUROPE conference in Brussels, Belgium, in a presentation entitled, “Engineering DNA vaccine potency in vivo results in improved immunity: improving vaccine immunogenicity and efficacy.”
Chikungunya virus (CHIKV) is an emerging mosquito-borne alpha-virus native to tropical Africa and Asia. Attack rates (the cumulative incidence of infection in a group of people observed over a period of time) of up to 45% have been reported (WHO). While CHIKV is rarely life-threatening, it causes severe human morbidity. Acute illness is characterized by severe fever and debilitating joint pain, and recovery can take a year or longer. Recent evidence suggests that CHIKV can be transmitted by several types of mosquitos commonly found in developed countries, raising concerns about the spread of this pathogen outside its natural endemic areas to new regions including Europe and the United States.
There are no commercialized vaccines or therapeutics against CHIKV. In fact, very little is known about the basis for CHIKV-based disease, including the mechanism of immune-based viral clearance and the causes of clinical symptoms. Considering the potential for global spread of CHIKV, understanding the virus’s pathogenic mechanism and developing effective treatment options are paramount.
Inovio scientists used its proprietary SynCon™ approach to develop a universal CHIKV DNA vaccine. The candidate vaccine is delivered as a single DNA plasmid construct containing consensus sequences of key surface antigens. The universal CHIKV vaccine was designed by aligning numerous primary sequences of key surface antigens and choosing the most common amino acid or base pair at each site. In previous mice studies, Inovio scientists found that this universal vaccine induced protective neutralizing antibody responses and demonstrated protection from both death and illness in a challenge-protection model (published in Vaccine (2008) 26:5128).
In the present study, the vaccine efficacy was further tested in a monkey model, the closest animal model to humans. In this model, 100% of the vaccinated animals developed protective neutralizing antibody responses against native CHIKV, demonstrating the utility and effectiveness of this vaccine in an advanced preclinical model.
Dr. J. Joseph Kim, Inovio’s President and CEO, said, “Chikungunya virus represents a clear unmet need because it is endemic in many regions of the world and has epidemic potential. With our recent clinical trial data showing our vaccine platform’s ability to induce strong antibody responses in vaccinated subjects, we hope to be able to translate these preclinical successes presented in the current study into clinical progress in the near future.”
Inovio’s novel SynCon™ technology enables the company to design DNA-based vaccines with the potential to protect against known and unknown strains of pathogens. Inovio’s design process synthetically defines antigens and gene sequences common across different viral sub-types or taxonomic groups (families) of diseases such as HIV, HCV, human papillomavirus (HPV), and influenza.
Inovio recently announced interim data from a Phase I therapeutic HPV/cervical cancer vaccine trial showing significant and robust T-cell and antibody immune responses, results that highlight the potential broad utility of its DNA vaccine technology platform and applicability to many diseases, such as Chikungunya virus.
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 an avian influenza vaccine. Inovio is developing its universal and avian 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.
