PLYMOUTH MEETING, Pa., Sept. 24, 2014 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced it will advance its DNA vaccine for Ebola into a phase I clinical trial in a collaboration with GeneOne Life Science Inc. (KSE: 011000), an international DNA vaccine manufacturer in which Inovio holds a minority interest.
In the collaboration Inovio and GeneOne will co-develop Inovio's DNA-based Ebola vaccine through a phase I clinical trial. The companies are currently conducting pre-IND activities and plan to start the clinical study in the first half of 2015. Upon successful completion of the phase I, the companies will jointly seek additional third party support and resources to further develop and commercialize this product.
Along with the escalating spread of Ebola and related deaths, this virus is also mutating into diverse strains. There are no preventive vaccines or effective therapeutic approaches to Ebola; the ease with which Ebola is generating genetic variations will complicate the process of creating such solutions. In addition, various experimental approaches have already been associated with undesirable side effects and limited ability to scale manufacturing.
Inovio's SynCon® technology has been the basis for immunotherapy and vaccine products which have demonstrated the ability to activate immune responses against multiple disease-specific antigens and elicit broad protection against diverse unmatched strains of pathogens in humans. These DNA-based immunotherapy products have demonstrated a very favorable safety profile. Furthermore, these synthetic immunotherapies are manufactured using established production processes. Inovio's Ebola vaccine was designed using the SynCon technology to provide broad protective antibody and T-cell responses against multiple strains of Ebola virus.
In published preclinical testing of its Ebola vaccine, Inovio observed that 100% of vaccinated guinea pigs and mice were protected from death after being exposed to the Ebola virus. Unlike the non-vaccinated animals, vaccinated animals were also protected from weight loss, a measure of morbidity. Researchers found significant increases in neutralizing antibody titers and strong and broad levels of vaccine-induced T-cells, including "killer" T-cells, suggesting that this product could provide both preventive and treatment benefits.
J. Joseph Kim
, President and CEO, said, "Inovio's SynCon® DNA-based immunotherapy and vaccine technology offers an advantageous set of characteristics and capabilities to generate and direct powerful immune responses against a target disease. There are no proven agents to check the spread of Ebola, which is now becoming a health threat of global concern. We are therefore taking the steps with our collaborator to establish the safety and immunogenicity of our Ebola vaccine in humans and be in a position to further advance these agents to help fight this challenging disease."
More than 2,622 people have died in the worst outbreak of Ebola virus in history, which has so far infected at least 5,335 people in West Africa, according to the World Health Organization (WHO). In a recent update on the epidemic, which is raging through Guinea, Sierra Leone and Liberia and has spread into Nigeria and Senegal, the WHO said there were no signs yet of it slowing. There is no vaccine or standard of care treatment for people infected with the Ebola virus.
GeneOne Life Science Inc. is a leading contract manufacturer of DNA plasmid based agents for pre-clinical and clinical trials for global companies and institutions. In addition, it researches and develops DNA vaccines to prevent and treat incurable diseases in South Korea and internationally. The company is headquartered in Seoul, South Korea.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of cancer immunotherapies and clinical studies, the company is advancing a growing product pipeline. Partners and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, US Dept. of Homeland Security, and University of Manitoba. For more information, visit 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, including safety and efficacy for VGX-3100, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, 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, our ability to support our broad pipeline of SynCon® active immune therapy and vaccine products, 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, 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, 2013, our Form 10-Q for the quarter ended June 30, 2014, 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.
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