Inovio Biomedical Universal Flu Vaccines Demonstrate Broadly Protective Immune Responses Against Multiple Seasonal & Pandemic Influenza Viruses in Pre-Clinical Studies
Inovio's SynConTM Universal Flu Vaccines Provide 100% Protection in Ferrets against Death and Sickness in a Challenge Study with the Pandemic H1N1 Virus
SAN DIEGO--(BUSINESS WIRE)--Nov 20, 2009 - Inovio Biomedical Corporation (NYSE Amex:INO), a leader in DNA vaccine design, development and delivery, announced today that a combination of its synthetic consensus H1N1, H2N2, H3N2, and H5N1 influenza vaccine candidates achieved protective antibody responses against several different influenza sub-types and strains in ferrets. In addition, ferrets immunized with Inovio's SynConTM universal flu vaccine combinations were 100% protected against death and sickness in a challenge with the A/H1N1 (2009) swine-origin influenza. Dr. Niranjan Y. Sardesai, Inovio's SVP, Research and Development, presented this data at the Influenza Congress USA 2009 in Washington, DC, in a presentation titled, “Development of Universal SynCon™ DNA Vaccines for Pandemic and Seasonal Influenza.”
Inovio previously reported that its consensus H5N1 and H1N1 vaccine candidates induced protective immune responses in ferrets and other animal models against multiple strains of H5N1 (clade 1 and 2) and H1N1 viruses with pandemic potential. The studies reported here mark one of the first demonstrations of a vaccine formulation proving effective against a broad panel of influenza viruses representing seasonal and pandemic influenza strains.
Dr. J. Joseph Kim, Inovio's President and CEO, said, “Inovio is proud to be one of the first organizations to demonstrate a vaccine capable of providing protection against a broad set of unmatched influenza sub-types and strains, both seasonal and pandemic. If we can achieve similar outcomes in humans, this universal vaccine concept would have the potential to shift the current reactive paradigm of influenza vaccine design, manufacturing, and inoculation – a paradigm unrealistically challenged every year to correctly match key emerging strains, manufacture the vaccine, and inoculate people in an eight to 12 month cycle – to one that preemptively provides broader protection without having to match the minor and major changes in influenza that create new seasonal and pandemic strains. Such a shift would provide tremendous health and economic benefits worldwide.”
In these studies the researchers immunized ferrets with either a vaccine formulation targeting only H1N1 viruses (seasonal and pandemic) or a universal vaccine formulation targeting H1N1, H2N2, H3N2, and H5N1 viruses. Ferrets are considered to be the most relevant animal model for influenza vaccine development. The first test was a measurement of hemagglutination inhibition (HI) responses: blood taken from vaccinated animals was tested against different influenza strains for the level of anti-HA (e.g. H1, H2, etc.) protective antibodies in the blood serum. A measured “antibody titer” of 1:20 is generally regarded as a positive vaccine response; 1:40 is generally associated with protection against influenza in humans.
Mean HI titers for both the H1N1 and universal vaccine groups were measured to be significantly greater than 1:40 against 2009 H1N1 pandemic strains and seasonal H1N1 strains (ranging from 1:104 to 1:747). Moreover, the universal vaccine group also generated strong mean HI titers against the H3N2 strains (> 1:80). Testing of HI titers against H2N2 viruses is on-going.
Both sets of ferrets were subsequently challenged with the A/H1N1 Mexico/InDRE/4487/2009 virus. 100% of the vaccinated ferrets in both the H1N1 and universal vaccine groups survived the swine flu A/H1N1 challenge. In contrast, 75% of the animals in an unvaccinated control group died by day 10 following the challenge. The vaccinated animals were also protected from morbidity, as judged by their negligible average loss in body weight of less than 7% through the challenge period, whereas the unvaccinated animals lost as much as 17% of their body weight.
Dr. Sardesai stated in his presentation, “We continue to build an impressive and compelling set of evidence validating our universal influenza vaccine concept. This data showing broadly cross-protective antibody titers against multiple sub-types and unmatched strains of seasonal and pandemic influenza adds to our previously announced H5N1 avian flu and H1N1 pandemic flu virus data that highlighted similarly compelling protective results in mice, ferrets, and non-human primates. The consistently positive test results we are achieving with our consensus influenza vaccines are very encouraging.”
About Inovio's SynConTM Universal Influenza Vaccines
Conventional influenza vaccines can only provide protection if they substantially match the genetic makeup of the circulating virus strain(s). They have limited ability to protect against genetic shifts of the virus. As a result, a new vaccine is created each year in anticipation of the next flu season's new strain(s). If a significantly different new strain emerges, such as the current swine-origin pandemic strain, then the current vaccine will provide little or no protective capability.
Inovio is developing DNA-based influenza vaccines intended to provide broad protection against known as well as newly emerging, unknown seasonal and pandemic influenza strains. Using its SynCon™ process, Inovio's scientists designed DNA constructs representing an optimal consensus of HA, NA, and NP proteins derived from multiple strains of the sub-types H1N1, H2N2, H3N2, and H5N1. These virus sub-types have been responsible for the majority of the last century's seasonal and pandemic influenza outbreaks. Animal data is showing that Inovio's synthetically-derived consensus DNA constructs, which do not match specific influenza strains, provide protection against viruses sharing genetic roots within sub-types. By formulating a single vaccine with constructs from some or all of the key sub-types, protection may be achieved against seasonal as well as pandemic strains such as swine flu or pandemic-potential strains such as avian influenza.
About Inovio Biomedical Corporation
Inovio Biomedical is focused on the design, development, and delivery of a new generation of vaccines, called DNA vaccines, to prevent and treat cancers and infectious diseases. The company's SynCon™ technology enables the design of “universal” vaccines capable of protecting against multiple – including newly emergent, unknown – strains of pathogens such as influenza. Inovio's proprietary electroporation-based DNA vaccine delivery technology has been shown by initial human data to safely and significantly increase gene expression and immune responses. Inovio's clinical programs include HPV/cervical cancer (therapeutic) and HIV vaccines. An IND has been filed for an avian influenza vaccine. Inovio is developing its universal and avian influenza vaccines in collaboration with scientists from the University of Pennsylvania, the National Microbiology Laboratory of the Public Health Agency of Canada, and the NIH's Vaccine Research Center. Other partners and collaborators include Merck, Tripep, University of Southampton, National Cancer Institute, and HIV Vaccines Trial Network. More information is available at www.inovio.com.
This press release contains, in addition to historical information, forward-looking statements. Such statements are based on management's current estimates and expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in the forward-looking statements. Inovio is providing this information as of the date of this press release, and expressly disclaims any duty to update information contained in this press release.
Forward-looking statements in this press release include, without limitation, express and implied statements relating to Inovio's business, plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and pre-clinical and clinical studies. Actual events or results may differ from the expectations set forth herein as a result of a number of risks, uncertainties and other factors, including but not limited to: Inovio has a history of losses; all of Inovio's potential human products are in research and development phases; no revenues have been generated from the sale of any such products, nor are any such revenues expected for at least the next several years; Inovio's product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing; uncertainties inherent in clinical trials and product development programs, including but not limited to the fact that pre-clinical and clinical results may not be indicative of results achievable in other trials or for other indications, that results from one study may not necessarily be reflected or supported by the results of other similar studies, that results from an animal study may not be indicative of results achievable in human studies, that clinical testing is expensive and can take many years to complete, that the outcome of any clinical trial is uncertain and failure can occur at any time during the clinical trial process, and that Inovio's electroporation technology and DNA vaccines may fail to show the desired safety and efficacy traits in clinical trials; all product candidates that Inovio advances to clinical testing will require regulatory approval prior to commercial use, and will require significant costs for commercialization; the availability of funding; the ability to manufacture vaccine candidates; the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop; whether Inovio's proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity; and the impact of government healthcare proposals. Readers are also referred to Inovio's Annual Report on Form 10-K for the year ended December 31, 2008 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2009 filed with the Securities and Exchange Commission which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements.
Bernie Hertel, 858-410-3101
Richardson & Associates
Jeff Richardson, 805-491-8313
Posted: November 2009