BLUE BELL, Pa.--()--Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that Inovio Pharmaceuticals and the University of Pennsylvania have received a grant of $3.1 million from the National Institutes of Health (NIH) Director’s Office to further fund Inovio’s universal SynCon™ flu vaccine development.
“Complex research projects, even exceptionally high impact ones, are tough to get funded without the necessary resources to assemble teams and collect preliminary data. The TR01 awards provide a way for these high impact projects to be pursued”
Inovio’s influenza vaccine aims to bypass current requirement for annual strain and subtype-specific influenza vaccines by developing a single vaccine to potentially protect against all strains within multiple targeted subtypes, such as H5N1 and H1N1, posing risk to humans. Inovio is already evaluating its SynCon H5N1 targeted vaccine (VGX-3400X) in a Phase I clinical study. This new award will be utilized to further develop a universal seasonal influenza vaccine. If successful, these SynCon vaccines could establish a new paradigm for flu vaccination.
The award is part of the “Director’s Transformative Research Projects” from the Office of the NIH Director and the NIH’s Common Fund, which supports bold research initiatives that have the potential to catapult medical science forward and speed the translation of research into improved health. The grants are designed to help innovators pursue high-impact medical innovations that no single NIH institute could tackle alone.
Dr. David B. Weiner, Professor of Pathology & Laboratory Medicine at the University of Pennsylvania and Chairman of Inovio’s Scientific Advisory Board, will lead the research collaboration involving scientists from the University of Pennsylvania and Inovio. Inovio licensed the DNA vaccine technology from the university in 2007.
“Complex research projects, even exceptionally high impact ones, are tough to get funded without the necessary resources to assemble teams and collect preliminary data. The TR01 awards provide a way for these high impact projects to be pursued,” said NIH Director Francis S. Collins, M.D., Ph.D.
Dr. J. Joseph Kim, Inovio’s CEO, said: “We are honored that the NIH Director’s Office has chosen to support Inovio's SynCon DNA vaccine technology. It is imperative that the world achieve much broader protection against the constantly changing influenza virus. Our SynCon technology has already shown it can generate significant immune responses in humans, as recently reported with our therapeutic HPV DNA vaccine. Furthermore, our SynCon influenza vaccine candidates have demonstrated in animals the ability to generate broad protective immune responses against multiple unmatched strains. We look forward to advancing this research with the goal of achieving a universal influenza vaccine.”
About Inovio's SynConTM Universal Influenza Vaccines
Vaccines provide protection against a virus by introducing to the immune system proteins, or antigens, uniquely associated with that virus. The immune system recognizes these antigens as being foreign and mounts a protective response. Unfortunately, conventional influenza vaccines can only provide protection when there is a substantial match with the genetic makeup of the circulating virus strain(s) -- and only one to three specific strains can be included in each year’s vaccine. Therefore current vaccines have limited ability to protect against genetic shifts of the influenza virus within a subtype and no ability to protect against influenza strains from other subtypes. As a result, a new vaccine is created each year with the aim to match the anticipated strain(s) of the next flu season. If a significantly different new strain emerges, such as the 2009 H1N1 ("swine flu") strain, then the vaccine will provide little or no protective capability.
Inovio's SynConTM universal influenza vaccine approach has two basic elements: within and across different subtypes. Within influenza subtypes, such as H1N1, variant strains share genetic roots. For each targeted subtype, Inovio has designed a DNA vaccine construct representing a consensus of the genetic makeup of the HA, NA, and m2E-NP proteins from multiple strains within the subtype. Animal data has shown that these DNA constructs, which do not match any single influenza strain, provide broad cross-reactive protection against existing and newly emergent influenza strains within the subtype.
Inovio has created constructs for influenza subtypes H1N1, H2N2, and H3N2, which are responsible for the majority of the last century's seasonal and pandemic influenza outbreaks, as well as H5N1, which has affected very few humans but been highly lethal to those infected. Individual SynConTM DNA vaccine constructs will be combined to form a single vaccine with the potential to fulfill the goal of universal protection against influenza.
About the NIH
The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
About Inovio Pharmaceuticals, Inc.
Inovio is developing a new generation of vaccines, called DNA vaccines, to treat and prevent cancers and infectious diseases. These SynCon™ vaccines are designed to provide broad cross-strain protection against known as well as newly emergent strains of pathogens such as influenza. These vaccines, in combination with Inovio’s proprietary electroporation delivery devices, have been shown to be safe and generate significant immune responses. Inovio’s clinical programs include HPV/cervical dysplasia and cancer (therapeutic), avian flu (preventive), and HIV vaccines (both preventive and therapeutic). Inovio is developing universal influenza and other vaccines in collaboration with scientists from the University of Pennsylvania. Other partners and collaborators include Merck, National Cancer Institute, U.S. Military HIV Research Program, HIV Vaccines Trial Network, National Microbiology Laboratory of the Public Health Agency of Canada, 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 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, our ability to successfully integrate Inovio and VGX Pharmaceuticals, 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, 2009, our Form 10-Q for the six months ended June 30, 2010, 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.