Inovio Initiates H1N1 Universal Influenza Vaccine Clinical Trial Targeting Over-65 Population, Which Represents 90% of Flu Deaths Clinical Study of SynCon® Influenza Vaccine Alone and With Seasonal H1N1 Vaccine Will Measure Universal Antibody Responses and T-Cell Responses, Which May be Vital to Fighting Influenza in Elderly
BLUE BELL, Pa., July 10, 2012 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that the first patients have been treated in a clinical trial evaluating immune responses in elderly adults immunized with Inovio's H1N1 SynCon® universal influenza vaccine. This phase I study will evaluate the ability of Inovio's SynCon® vaccine alone as well as in combination with the 2012 seasonal influenza vaccine to generate: protective levels of immune responses; antigen-specific antibody immune responses against unmatched influenza strains; and T-cell immune responses that may be helpful in fighting influenza.
The population most susceptible to influenza, those over 65 years of age, represent about 90% of annual influenza deaths in the US. Older people's immune systems typically mount weaker immune responses to vaccines. There is consequently a need for new vaccine technology able to stimulate a broader immune response that is capable of protecting against influenza strains not specifically matched to the strain(s) represented in the vaccine.
The phase I open label study will take place at the University of Manitoba in Winnipeg, Canada, funded in part by a grant from the Canadian Institute of Health Research. In the trial, 50 healthy elderly patients will be divided into three groups: One group of 20 subjects will receive a 2 dose regimen of Inovio's H1N1 SynCon® flu vaccine delivered using Inovio's proprietary CELLECTRA® intradermal electroporation device; a second group of 20 subjects will receive one dose of Inovio's SynCon® vaccine delivered using electroporation followed by a dose of the 2012 trivalent seasonal flu vaccine 24 weeks later; a third group of 10 subjects will receive a placebo delivered by electroporation followed by a dose of the seasonal flu vaccine 24 weeks later. The study will assess the tolerability, safety, and the immune responses of the different vaccination regimens. See the detailed clinical study protocol.
Dr. Gary P. Kobinger, Chief, Special Pathogens Program, National Microbiology Laboratory, Public Health Agency of Canada, and a principal investigator of his study, said, "There have been limited new vaccine innovations with the potential to better protect the elderly against influenza. We are pleased to conduct this trial to evaluate this potential breakthrough influenza vaccine technology."
Dr. J. Joseph Kim, Inovio's President and CEO, said, "We recently reported protective levels of immune responses against six unmatched strains of influenza in our H5N1 clinical study and expect data in the third quarter from our second influenza study, which includes an H1N1 component and is being tested in a population less vulnerable to influenza. Having achieved best-in-class T-cell responses against other diseases, we will also assess T-cell generation against influenza, which is widely believed to be an important avenue to increasing protection for the highly at-risk 65-plus population."
With the vulnerability of elderly in mind, this clinical study will assess the ability to generally induce stronger antibody responses; provide universal cross-strain protection; and stimulate a part of the immune system not triggered by conventional influenza vaccines, the cellular immune response that generates CD8+ killer T-cells.
About SynCon® Influenza Vaccines and this Clinical Trial Design
The strategy to combine an influenza DNA vaccine prime with a conventional seasonal vaccine boost is based on the idea that combining the different modalities of Inovio's SynCon® flu vaccine's ability to generate cross-protective antibody and T-cell responses with the conventional seasonal flu vaccine in a prime-boost regimen could generate a stronger and broader antibody response in the elderly.
Inovio's SynCon® influenza vaccine approach provides "universality" within and across subtypes. Individual SynCon® DNA vaccine "constructs" are designed to provide broad cross-strain protection against existing and potential new strains of influenza within key branches (clades) of subtypes of greatest concern to humans, including H1N1, H3N2 and Type B as well as H5N1. Inovio combines multiple DNA constructs into a universal influenza vaccine potentially able to provide broad protection against the targeted subtypes. Such preemptive protection against new strains could be particularly important to the elderly.
T-cells are widely recognized as playing a vital role in clearing cells of infections including influenza. Current influenza vaccines, however, are unable to strongly induce this facet of the immune system, missing a vital opportunity to better protect the elderlyin particular. Inovio's SynCon DNA vaccines are capable of stimulating T-cell responses on par with live viruses and better than other non-live virus vaccine technologies. When antibodies fail to prevent an influenza infection, T-cells are responsible for clearing the infected cells. Inducing a more robust T-cell response could be instrumental to better protection of the elderly against influenza.
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, our Form 10-Q for the quarter ended March 31, 2012, 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.
SOURCE Inovio Pharmaceuticals, Inc.