Inovio Pharmaceuticals Targets Transformation of Monoclonal Antibody Therapies

BLUE BELL, Pa., Sept. 24, 2013 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today the publication of a peer-reviewed paper demonstrating the success of its new DNA plasmid technology in generating therapeutic monoclonal antibodies. In this study in mice, a prototype monoclonal antibody construct encoding for an established anti-HIV monoclonal antibody (VRC01) was created as a DNA plasmid using Inovio's patented DNA optimization technology, including codon/RNA optimization and leader sequence utilization, and delivered with its CELLECTRA® adaptive electroporation device. The results were published in a paper entitled, "Optimized and enhanced DNA plasmid vector based in vivo construction of a neutralizing anti-HIV-1 envelope glycoprotein Fab," in the peer-reviewed Human Vaccines and Immunotherapeutics.

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®). In contrast, polyclonal antibodies, which are generated by the body through natural exposure to an antigen or through vaccination, target multiple epitopes. They are effective at binding to antigens but tend to be less potent and less specific than monoclonal antibodies. Monoclonal antibodies, with their designer capabilities and potency, have consequently become a powerful class of products against cancers, autoimmune diseases such as rheumatoid arthritis, and neurological diseases such as multiple sclerosis.

However, mAb technology does have limitations. Delivered by passive administration, meaning they are manufactured outside the body, they typically require costly large-scale laboratory development and production. Additional limitations include the necessity for repeat administrations and their limited length 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 approach, the published data from this study demonstrated that a single administration of a highly optimized DNA-based monoclonal antibody 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 for at least 7 days. Importantly, this DNA delivery strategy resulted in a rapid increase (i.e. in as little as 24 to 48 hours) in antibody levels in mice. All of these feats were not previously achievable with other DNA-based or viral delivery technologies. Although the published proof-of-concept experiments were specifically conducted with a VRC01 monoclonal antibody for HIV, 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 is one of the most innovative and scientifically productive biotechnology companies in our industry. Since the merger that created Inovio Pharmaceuticals over four years ago, we along with our collaborators have published over 70 peer-reviewed papers. At the same time we remain focused on the rapid development of our novel vaccines and immunotherapies for cancer and infectious diseases as well as attracting premier pharmaceutical partners to co-develop some of our product candidates," stated Dr. J. Joseph Kim, President and CEO.

"What makes me particularly excited about this new published data is that, although early, the results clearly demonstrate the utility and potential of Inovio's patented DNA plasmid and electroporation technology to generate and develop a new class of active monoclonal antibody products with tremendous therapeutic and market potential. These advancements represent a new area of value enhancement for Inovio stakeholders and we are now developing multiple important monoclonal product candidates."

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, Merck, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, University of Southampton, US Dept. of Homeland Security, University of Manitoba 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 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, 2012, our Form 10-Q for the quarter ended June 30, 2013, 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.