Inovio Pharmaceuticals' HIV DNA Vaccine/Electroporation Delivery Technology Selected for NIH-Sponsored U.S. Army Human Clinical Trial
Phase I Study of PENNVAX(TM)-G /MVA-CMDR Will Assess Safety and Immune Responses in HIV-Uninfected Volunteers at Five Sites on Three Continents
BLUE BELL, Pa., Sep 28, 2010 (BUSINESS WIRE) --
Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that a Phase I study, called RV262, recently began to evaluate a combination DNA prime/MVA vector boost regimen that was developed to protect against diverse subtypes of HIV-1 prevalent in North America, Europe, Africa, and South America.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), is sponsoring the study, which will enroll 92 total participants and is designed to assess safety and immune responses. The study is being conducted by the U.S. Military HIV Research Program (MHRP) through its clinical research network in the US, East Africa and Thailand.
This clinical trial was designed to test a unique prime-boost preventive HIV vaccination strategy aimed at global coverage. The prime is a plasmid DNA vaccine, PENNVAX(TM)-G, and the boost is a virus vector vaccine, Modified Vaccinia Ankara-Chiang Mai Double Recombinant (MVA-CMDR). Together, the vaccines are designed to deliver a diverse mixture of antigens for HIV-1 subtypes A, B, C, D and E.
Colonel Nelson Michael, Director of MHRP and the Division of Retrovirology at the Walter Reed Army Institute of Research, said: "We are very excited about the launch of this important clinical trial exploring the role of newer prime-boost HIV vaccine approaches building on the success of the RV 144 Thai prime-boost trial. The role of electroporation as a method of delivery of the priming DNA vaccine will be an especially critical factor to assess in this initial phase I safety and immunogenicity trial."
Dr. J. Joseph Kim, President and CEO of Inovio, said: "We are pleased that our PENNVAXTM-G DNA vaccine candidate was selected as an integral component of this novel approach to HIV prevention. Given the recently announced exceptional immune responses generated by another Inovio DNA vaccine candidate delivered using our proprietary electroporation technology, we are optimistic that we can achieve new advancements against HIV as well."
Dr. Mary Marovich, Chief of the Department of Vaccine Research and Development at MHRP and the Protocol Chair for the study, said: "We hypothesize that this vaccine regimen, which has subtype-mismatched inserts, will facilitate the emergence of subdominant epitopes and increase the overall breadth of the immune response."
Taken separately, DNA based and MVA based strategies have been shown to be safe and immunogenic in pre-clinical and clinical trials. Researchers hope they can enhance immune responses by using this prime-boost strategy. Another distinguishing feature of this study is the use of different HIV antigens during the priming (A,B,C,D) and boosting (A/E), which is being studied as a means to increase the breadth of the immune response.
The DNA vaccine was designed in Prof. David B. Weiner's laboratory at the University of Pennsylvania and licensed by Inovio Pharmaceuticals for further clinical product development. The boost vaccine component, based on Modified Vaccinia Ankara (MVA), is a modified version of the smallpox vaccine that has been used safely and effectively to eradicate that disease worldwide. Researchers at MHRP and NIAID developed the boost.
Historically, DNA vaccine potency has been constrained by the inability to deliver enough DNA into cells, which express the antigens coded by the DNA. To address this, researchers will also test two intramuscular delivery methods for the DNA prime (PENNVAXTM-G) to compare their effects on immune response. The two products that will be tested in this study are the Biojector(R) 2000 and the CELLECTRA(R) EP (electroporation) device.
The Biojector(R) is a needle-free injection system that has FDA clearance for delivering vaccines and other injected medications. The CELLECTRA(R) EP system is an intramuscular electroporation device currently being evaluated in clinical trials as an alternative vaccine delivery system to increase immune responses above those elicited by standard needle and syringe injections. Electroporation involves the application of controlled, millisecond electrical pulses to cells to enhance their uptake of the vaccine.
Once the vaccine combination has been assessed as safe and acceptable in twelve HIV-uninfected participants in the U.S., the study will begin at four MHRP sites: Kericho, Kenya; Kampala, Uganda; Mbeya, Tanzania; and Bangkok, Thailand. Twenty healthy, HIV-uninfected participants will be enrolled at each of these sites for a total of 80 international participants.
This clinical trial is a collaboration that includes Bioject Medical Technologies Inc., Inovio Pharmaceuticals, Inc., Henry M. Jackson Foundation for the Advancement of Military Medicine, NIAID and the U.S. Army/MHRP.
About Inovio's PENNVAX(TM)-G and CELLECTRA(R) EP Electroporation System
PENNVAX(TM)-G is a SynCon(TM) multi-subtype optimized plasmid DNA vaccine. Using a synthetically derived consensus of env and gag antigens of HIV-1 subtypes A, B, C, D, this novel vaccine aims to provide broader protection against the constantly emerging new strains of this challenging disease. Inovio's electroporation systems have been shown to increase cellular uptake of a vaccine by a 1000 times or more and have been shown to be safe and well-tolerated in multiple human studies. An Inovio SynCon(TM)DNA vaccine (against cervical cancer), delivered using the CELLECTRA(R) EP device, recently achieved significant antibody and T-cell immune responses, which are both thought to be important in controlling HIV infection and transmission.
The U.S. Military HIV Research Program (MHRP)--centered at Walter Reed Army Institute of Research (WRAIR) and part of the US Medical Research and Materiel Command--conducts research to develop an effective HIV vaccine and integrates prevention, treatment, diagnosis and monitoring as part of an international effort to protect troops and reduce the risk of HIV infection worldwide. MHRP has developed five state-of-the-art international research sites in the U.S., Africa and Asia. The program collaborates on HIV prevention care and treatment services, funded by the President's Emergency Plan for AIDS Relief (PEPFAR), with African militaries and in the communities where it conducts research.
In 2009, MHRP announced results of an Army-sponsored clinical trial in Thailand that demonstrated for the first time a modest ability to protect against HIV infection, reducing the number of infections by 31.2 percent. MHRP researchers are now working with scientists around the world, with the support of NIAID, to dissect the trial results to inform basic research and design future clinical trials to translate this scientific milestone into a deployable vaccine. For more information, visit www.hivresearch.org.
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(TM) 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, 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.
SOURCE: Inovio Pharmaceuticals, Inc.