PLYMOUTH MEETING, Pa., Oct. 21, 2014 -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today the Defense Advanced Research Projects Agency (DARPA) has awarded $12.2 million for a collaborative study that will be conducted by scientists from the Perelman School of Medicine at the University of Pennsylvania; Inovio Pharmaceuticals; and MedImmune, the global biologics research and development arm of AstraZeneca. The group will develop DNA-based monoclonal antibodies (mAbs) for infectious disease treatment. DARPA is an agency of the US Department of Defense that creates and supports novel technologies important for national security.
Together, the three organizations will develop and assess the DNA mAbs in preclinical studies using technology developed by Penn and licensed by Inovio. The collaboration will focus on three disease areas – influenza virus, Pseudomonas aeruginosa and Staphylococcus aureus.
Dr. J. Joseph Kim, Inovio's President and CEO, said, "Monoclonal antibody technology has already achieved multiple market-proven product successes, and we believe DNA-based mAb technology could significantly extend the medical benefits and efficiency of this concept. In previous preclinical studies our DNA-based mAbs demonstrated robust virus neutralization and protected treated animals challenged with a lethal virus. We look forward to working with our globally recognized collaborators to advance this potentially paradigm shifting technology."
MedImmune developed the first mAb approved by the U.S. Food & Drug Administration for the prevention of an infectious disease, and Inovio pioneered the development of optimized DNA-based vaccines and immunotherapies using an efficient delivery mechanism called electroporation. The project proposes an entirely new technology, initially developed at Penn in the lab of David Weiner, PhD, professor of Pathology and Laboratory Medicine, to provide a platform to rapidly protect people against emerging infections through the development of novel synthetic antibodies produced by the patients themselves.
Over the last few decades, monoclonal antibodies (mAbs) have become one of the most important approaches to treat a variety of diseases, however they remain expensive and time consuming to produce and study. They are manufactured outside the body, typically requiring costly large-scale laboratory development and production, and also require frequent repeat administrations and have a limited duration of potency in the body.
DNA-based mAbs have the potential to overcome these limitations by virtue of their simplified design, product stability, manufacturing, dosing frequency, and cost effectiveness, thereby providing potential new avenues for treatment of disease.
The shift seen in new mAb technologies is that the DNA for a monoclonal antibody is encoded in a DNA plasmid, which is produced using very cost effective and highly scalable fermentation techniques. These plasmids are delivered directly into cells of the body using electroporation and the encoded mAbs are then produced by these cells. Using this approach, previously published studies show that a single administration of a highly optimized DNA-based monoclonal antibody targeting HIV virus in mice generated antibody molecules in the bloodstream.
This collaboration aims to demonstrate that the DNA plasmids containing optimized DNA sequences encoded to generate disease-specific mAbs can activate sufficient quantities of specific antibodies in the body to be protective against a pathogen challenge. Using the capabilities and advantages of synthetic DNA plasmids delivered using electroporation, the team will construct and evaluate multiple DNA mAbs.
Successful completion of the initial preclinical activities under the DARPA grant aims to lead to clinical studies on selected product candidates to be funded under a future increment to the award.
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 endedJune 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.