First Human Demonstration of Significant, Persistent Antibody Response Using Electroporation-Delivered DNA Vaccine Published in Human Gene Therapy

Inovio Biomedical & University of Southampton Collaborative Clinical Study Establishes Important Humoral Immune Response of Prostate Cancer DNA Vaccine Using Electroporation

SAN DIEGO--(BUSINESS WIRE)--Aug 5, 2009 - Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today new data representing what Inovio believes to be the first demonstration of a significantly increased and persistent level of antibody response generated by a DNA vaccine delivered using electroporation.

The results, generated in a clinical study conducted by Inovio's collaborators, the University of Southampton and The Institute of Cancer Research in the U.K., were published in the medical journal Human Gene Therapy, July 20, 2009, in a paper entitled, “DNA vaccination with electroporation induces increased antibody responses in patients with prostate cancer.” The DNA vaccine is designed to induce a strong helper T-cell response, with the aim of enhancing induction of a cytotoxic T-cell response against tumor cells. Measuring antibody (humoral) responses against the helper sequence in the vaccine may help judge the vaccine's potential performance. It may also allow predictions of vaccine performance in other settings, for example, against viral and bacterial diseases, where strong antibody responses are imperative in providing protection.

This open label phase I/II, two arm, dose escalation trial is evaluating a novel DNA vaccine based on a prostate specific membrane antigen (PSMA) fused to a tetanus toxin (DOM). The PSMA antigen is designed to induce a CD8+ T-cell response capable of killing tumor cells; the DOM element is designed to help enhance the immune response to PSMA. The study is also evaluating delivery of this DNA vaccine with and without Inovio's proprietary electroporation delivery technology. In each arm, five patients were treated at each of three dose levels. The protocol included three vaccinations at four week intervals followed by booster doses at 24 and 48 weeks.

The published data completes the reporting of antibody responses in the 30 patients vaccinated in this study. The data indicate that the use of electroporation yielded significantly enhanced antibody responses to DOM while the absence of electroporation resulted in low anti-DOM antibody responses (25-fold mean increase over baseline compared to a 1.5-fold mean increase, respectively). Importantly, the level of antibody response further increased following additional boosts of DNA vaccine delivery via electroporation at later time points. Furthermore, antibody responses persisted out to 18 months of follow-up, a significant result that would be useful in the context of a practical vaccine regimen. As reported in prior releases, this vaccine was found to be safe and well tolerated. Analyses of T-cell immune responses to the PSMA antigen are ongoing.

Dr. Christian Ottensmeier of the University of Southampton, principal investigator on the study, commented, “We are pleased to publish these data indicating a notably higher induction of antibodies to the tetanus toxoid component upon DNA vaccination with electroporation. The antibody levels appear to be in a range comparable to traditional protein-based vaccination or injection of attenuated or inactivated pathogen. With the advantageous safety profile of electroporation-delivered DNA plasmids indicated by human data to date, this data supports optimism for use of this next-generation vaccine modality as a strategy against infections and cancer.”

Dr. J. Joseph Kim, Inovio's CEO, said, “We have demonstrated in different human trials that Inovio's electroporation devices are safe and well-tolerated. This longer-duration data further validates the importance of our electroporation technology in achieving the primary goal of scientists in this field, which is to improve the immunogenicity of DNA vaccines in humans. These results bode well for our programs in development.”

The development of this DNA vaccine was supported by the UK cancer charities the Leukemia Research Fund (www.lrf.org.uk) and Cancer Research UK (www.cancerresearchuk.org), and rights to the vaccine are owned by Cancer Research Technology Limited (www.cancertechnology.com). The study was supported by Cancer Research UK funding, the Allan Willett Foundation, Inovio Biomedical Corporation, and the Experimental Cancer Medicine Centre in Southampton. The clinical study is a collaborative project between the University of Southampton (www.southampton.ac.uk) with Southampton University Hospitals NHS Trust and the Institute of Cancer Research with the Royal Marsden NHS Foundation Trust, Sutton, Surrey.

About Inovio Biomedical Corporation

Inovio Biomedical is engaged in the design, development, and delivery of a new generation of vaccines, called DNA vaccines, focused on cancers and infectious diseases. The company's SynCon™ technology enables the design of DNA-based vaccines capable of providing cross-protection against new, unmatched 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 and the National Microbiology Laboratory of the Public Health Agency of Canada. Other partners and collaborators include Merck, Tripep, University of Southampton, University of Pennsylvania, and HIV Vaccines Trial Network. Inovio's product candidates and technologies are protected by an extensive global intellectual property portfolio. More information is available at www.inovio.com.

About University of Southampton

The University of Southampton is a leading UK teaching and research institution with a global reputation for leading-edge research and scholarship. It is one of the UK's top 10 research universities, offering first-rate opportunities and facilities for study and research across a wide range of subjects in humanities, health, science and engineering. The University has over 22,000 students and 5000 staff. Its annual turnover is in the region of £325 million. www.soton.ac.uk

About The Institute of Cancer Research

The Institute of Cancer Research (ICR) is Europe's leading cancer research centre with expert scientists working on cutting-edge research. In 2009, the ICR marks its 100 years of groundbreaking research into cancer prevention, diagnosis and treatment. In December 2008, the ICR was ranked as the UK's leading academic research centre by the Times Higher Education's Table of Excellence, based on the results of the Higher Education Funding Council's Research Assessment Exercise. The ICR and its partner organization The Royal Marsden NHS Foundation Trust together represent the largest comprehensive cancer research centre in Europe. The ICR is a charity that relies on voluntary income. It is one of the world's most cost-effective major cancer research organisations with more than 95p in every £ directly supporting research. For more information visit www.icr.ac.uk.

About Cancer Research Technology

Cancer Research Technology Limited (CRT) is a specialist commercialisation and development company, which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies. CRT is wholly owned by Cancer Research UK, the largest independent funder of cancer research in the world. Further information about CRT can be found at www.cancertechnology.com.

About Cancer Research UK

Together with its partners and supporters, Cancer Research UK's vision is to beat cancer. The charity carries out world-class research to improve understanding of the disease and find out how to prevent, diagnose and treat different kinds of cancer. It ensures that its findings are used to improve the lives of all cancer patients. Cancer Research UK helps people to understand cancer, the progress that is being made and the choices each person can make. The charity works in partnership with others to achieve the greatest impact in the global fight against cancer. For further information about Cancer Research UK's work or to find out how to support the charity, please call 020 7009 8820 or visit www.cancerresearchuk.org.

About Leukaemia Research

Leukaemia Research is the only national UK charity devoted exclusively to improving treatments, finding cures and learning how to prevent leukaemia, Hodgkin's lymphoma and other lymphomas, myeloma and the related blood disorders. Leukaemia Research receives no government grants and urgently needs to raise over £100 million in the next five years to commit to new research. From basic laboratory research to clinical trials with patients, Leukaemia Research is committed to saving lives by funding high quality, carefully selected research throughout the UK. Leukaemia Research currently supports 30 Specialist Programmes in which the groups undertake long-term intensive research into relevant areas of leukaemia and the related diseases, often working closely with diagnosis and treatment; more than 200 project grants, which provides short-term funding, usually two-three years, for work on a specific problem; 25 clinical fellowships for the training of outstanding junior doctors in both the treatment and research of leukaemia and more than 20 studentships, lectureships and senior fellowships. Further information, including patient information booklets, is available from www.lrf.org.uk or on 020 7405 0101.

This press release contains certain forward-looking statements relating to our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in 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 and that results from one study may not necessarily be reflected or supported by the results of other similar 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 availability or potential availability of alternative therapies or treatments for the conditions targeted by the parties or their collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the parties and their collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide the parties 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 combined 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 companies' combined 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, our ability to maintain listing of our common stock under the rules and regulations of the NYSE Amex and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2008, our Form 10-Q for the three months ended March 31, 2009, and other regulatory filings from time to time, including our current report on Form 8-K reporting the closing of the merger transaction with VGX Pharmaceuticals, Inc. 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.

 

 

Contact: Investors:
Inovio Biomedical
Bernie Hertel, 858-410-3101
or
Media:
Richardson & Associates
Jeff Richardson, 805-491-8313

 

 

Posted: August 2009

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