Inovio Pharmaceuticals Breakthrough DNA-Based Monoclonal Antibody Therapy Completely Protects Animals From Lethal Viral Challenge

BLUE BELL, Pa., May 27, 2014 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that its novel DNA-based therapeutic monoclonal antibody targeting Chikungunya virus (CHIKV) completely protected mice from a lethal CHIKV challenge. In this preclinical study, a prototype DNA plasmid construct encoding for a monoclonal antibody for CHIKV envelope protein was created using Inovio's patented DNA optimization technology and delivered with its CELLECTRA^® device. The results were presented as a poster at the 17th Annual Meeting of the American Society of Gene & Cell Therapy in Washington, DC.

Chikungunya virus (CHIKV) has re-emerged as a serious mosquito-borne alpha-virus responsible for several recent epidemics in tropical Africa and Asia. Recent evidence suggests that CHIKV, which is primarily transmitted to humans from mosquitoes, could spread to other parts of the world. There is no vaccine or therapeutic against this virus.

In this presented study, Inovio scientists and collaborators developed a novel DNA plasmid encoding a highly engineered immunoglobulin encoding a CHIKV monoclonal antibody (mAb) to directly generate in vivo production of an anti-CHIKV mAb in mice. They demonstrated that the serum of transfected animals exhibited the specific ability to bind to the CHIKV envelope antigen and this serum possessed CHIKV-neutralizing activity. Importantly, the treatment of the animals with anti-CHIKV mAb plasmids protected 100% of the treated animals from a lethal injection of CHIKV virus while 100% of the control animals died. The treated animals were also spared of virus-related morbidity, as measured by dramatic weight loss and lethargy.

Monoclonal antibodies (mAb) were a transformational scientific innovation designed to enhance the immune system's ability to regulate cell functions. They are designed to bind to a very specific epitope (area) of an antigen or cell surface target and can bind to almost any selected target. mAbs have the unique ability to alert the immune system to attack and kill specific cancer cells (as in the case of Yervoy®) or block certain biochemical pathways (such as those leading to rheumatoid arthritis, as in the case of Remicade®). However, mAb technology has limitations. Delivered by passive administration, meaning they are manufactured outside the body, mAbs typically require costly large-scale laboratory development and production. Additional limitations include the necessity for repeat administrations and their limited duration of in vivo potency.

The paradigm shift of Inovio's technology is that the DNA for a monoclonal antibody is encoded in a DNA plasmid, delivered directly into cells of the body using electroporation, and the mAbs are "manufactured" by these cells. Using this patent-protected approach, Inovio previously published that a single administration of a highly optimized DNA-based monoclonal antibody targeting HIV virus in mice generated antibody molecules in the bloodstream possessing desirable functional activity including high antigen-binding and HIV-neutralization capabilities against diverse strains of HIV viruses. This new work further demonstrates the capability of this technology using a CHIKV challenge model.

All of these feats were not previously achievable with other DNA-based or viral delivery technologies. Inovio's transformational approach could be applied to develop active monoclonal antibody products against multiple therapeutically important diseases including cancers as well as inflammatory and infectious diseases. Combined with the significantly favorable cost structure of Inovio's DNA-based technology in comparison to conventional monoclonal antibody technology, active in-body generation of functional monoclonal antibodies in humans has the potential to significantly expand the range of targetable diseases.

"Inovio continues to demonstrate that it is one of the most innovative and scientifically productive biotechnology companies in our industry," stated Dr. J. Joseph Kim, President and CEO. "We have again shown that we can design a novel mAb construct capable of providing therapeutic benefit and are confident we can create DNA-based monoclonal antibodies against any infectious disease or cancer. These advancements represent a new area of value enhancement for Inovio stakeholders and we plan to develop multiple important monoclonal product candidates, alone or with new partners."

Monoclonal antibodies have become one of the most valuable therapeutic technologies of recent years. In 2012, global sales value of monoclonal antibodies exceeded $50 billion. Among the top 10 best-selling drugs in 2012, six of them were monoclonal antibodies, each with annual sales exceeding $5 billion.

About Inovio Pharmaceuticals, Inc.

Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon^® vaccines, in combination with its proprietary electroporation delivery, are generating best-in-class immune responses, with therapeutic T-cell responses exceeding other technologies in terms of magnitude, breadth, and response rate. Human data to date have shown a favorable safety profile. Inovio's lead vaccine, a therapeutic against HPV-caused pre-cancers and cancers, is in phase II. Other phase I and preclinical programs target prostate, breast, and lung cancers as well as HIV, influenza, malaria and hepatitis. 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. 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 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, 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 March 31, 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.

CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com

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SOURCE Inovio Pharmaceuticals, Inc.