BLUE BELL, Pa., March 26, 2012 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSEAMEX: INO) announced today that the United States Patent and Trademark Office granted U.S. Patent No. 8,133,723, covering Inovio's SynCon® universal vaccine related to H1N1 influenza. The patent granted to the Trustees of The University of Pennsylvania has been licensed exclusively to Inovio under its existing license agreement with the university. The patent includes claims that cover the synthetic consensus H1 antigen and DNA constructs and vaccines that include this antigen, including universal influenza vaccine INO-3510. This patent also covers methods of treating a patient using the SynCon® universal influenza vaccine.
Dr. J. Joseph Kim, Inovio's president and CEO, said: "This patent is significant for Inovio. It validates the patentable novelty of our SynCon® technology and vaccines created using this technology. We have filed for additional patents to protect our broad emerging portfolio of SynCon vaccine products against multiple diseases. Furthermore, this issued patent covers an important component of our universal influenza vaccine, which is in clinical development. Inovio's universal flu vaccine is designed to protect against many if not all strains within multiple selected subtypes--most importantly against the perpetually emerging new strains for which there has never been truly preemptive protection."
Inovio researchers have previously shown that its H1N1 influenza SynCon® vaccine provided 100% protection of animals challenged with the 2009 swine origin H1N1 virus and, separately, the H1N1 virus that caused the 1918 Spanish flu that killed over 40 million people. Additional animal studies have also shown that the vaccination generated protective HAI titers against other important H1N1 strains. The first H1N1 human data from Inovio's phase I study of VGX-3510, which consists of SynCon constructs against H1N1 and H5N1, is expected in Q2 2012.
More recently, human clinical study data from Inovio's H5N1 vaccine, designed using the same SynCon® technology, demonstrated that the vaccine generated high levels of antigen-specific binding antibodies and exhibited a four-fold or greater rise in geometric mean titers (GMT) in the HAI assay (ranging from 1:20 to 1:80 HAI titers) against six different H5N1 virus strains. A four-fold rise in HAI titers, compared to pre-vaccination, is considered an important indicator of immune activation. An HAI titer of 1:20 is generally regarded as a positive vaccine response; 1:40 or higher is generally associated with protection against influenza in humans. These results also demonstrate the potential to provide universal protection against unmatched, changing strains of influenza. Final H5N1 immune response data from Inovio's phase I study of VGX-3400X is expected in early Q2 2012.
Inovio's INO-3510 Vaccine
INO-3510 is a synthetically created, prophylactic DNA vaccine based on multiple influenza strains within multiple influenza subtypes. The vaccine combines SynCon® vaccine constructs for two important Type A subtypes, H1N1 and H5N1. Rather than specifically matching a single targeted influenza strain within a subtype, like today's conventional influenza vaccines, these constructs are based on a genetic consensus of multiple existing strains within the selected subtype. Thus "universality" is achieved within and across selected subtypes. The vaccine is expected to generate interim Phase I clinical data in Q2 2012.
The challenge of current influenza vaccines is that their protective capability is substantially limited to protecting against the specific influenza strains targeted in any given year – the circulating strains must match the vaccine strains in order for the vaccine to provide protection. Annually, influenza vaccines typically consist of three strains (two Type A, one Type B) estimated to be the primary strains of concern for the upcoming flu season. However, if the chosen strains subsequently mutate, the vaccine may not provide protection against these newly emergent strains in the next flu season. While Type B strains do not evolve as quickly, Type A strains typically change from season to season. By encompassing multiple strains, VGX-3150 circumvents the traditional vaccine model and may potentially protect against changing strains within the targeted subtypes across many seasons.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon® vaccines are designed to provide universal cross-strain protection against known as well as newly emergent unmatched strains of pathogens such as influenza. These synthetic vaccines, in combination with Inovio's proprietary electroporation delivery, have been shown in humans to generate best-in-class immune responses with a favorable safety profile. Inovio's clinical programs include Phase II studies for cervical dysplasia, leukemia and hepatitis C virus and Phase I studies for influenza and HIV. Partners and collaborators include the University of Pennsylvania, Merck, ChronTech, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, US Dept. of Homeland Security 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, 2011, 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.