Inovio Therapeutic Vaccine for Head & Neck and Other HPV-Related Cancers Induces Robust T-Cell Immune Response in Mice

Inovio adds synthetic vaccines for diseases caused by HPV 6 and 11 to existing Type 16 and 18 vaccines; will continue to expand products against cancer-causing HPV
 

BLUE BELL, Pa., March 5, 2012 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE AMEX: INO) announced today that its SynCon® therapeutic vaccine for human papillomavirus (HPV) types 6 and 11, which are associated with head & neck cancers and genital warts, among other conditions, induced strong antigen-specific CD8+ T cells in mice. This vaccine is complementary to Inovio's VGX-3100, a therapeutic vaccine targeting cervical dysplasias and cancers caused by HPV types 16 and 18, which is in a phase II clinical study for CIN 2/3. This positive animal data mirrors the similarly robust T-cell responses induced by VGX-3100 in earlier mice studies. These results were reported in a peer-reviewed paper titled, "Induction of robust cellular immunity against HPV6 and HPV11 in mice by DNA vaccine encoding for E6/E7 antigen," which has been published in Human Vaccines & Immunotherapeutics.

Dr. J. Joseph Kim, President and CEO, said, "Over a dozen HPV types are recognized as causing cancers and other diseases, with a significant health need and business opportunity for therapeutic vaccines to address these conditions. With the best-in-class T-cell responses generated by VGX-3100 in early human studies, our goal is to create a family of therapeutic vaccines targeting most significant diseases caused by HPV infection, including cervical cancer and dysplasia, vulvar dysplasia, head and neck cancer, and other cancers. This study demonstrates our ability to readily extend our therapeutic solutions to diseases caused by different HPV types. Importantly, our clinical experience with VGX-3100 may also help streamline the regulatory path for these related vaccines."

HPV types 6 and 11 are the major cause of recurrent respiratory papillomatosis and genital warts. They are also associated with otolaryngologic (ear, nose, and throat) malignancies, carcinoma of the lung, tonsil, larynx, and low-grade cervical lesions.

Similar to Inovio's VGX-3100, two novel engineered DNA vaccines were developed to target the antigens E6 and E7 of HPV 6 and HPV 11. After designing consensus sequences of these antigens with the purpose of providing broader cross-strain therapeutic effects, the vaccines were also modified to increase gene expression and production of the antigenic protein. These vaccines were delivered using Inovio's proprietary electroporation delivery system. Together such highly optimized SynCon® vaccines delivered using electroporation have achieved best-in-class immune responses targeting cervical dysplasia and HIV. This study revealed that robust T cell immune responses (especially the important CD8+ T cells) were generated by the HPV 6 and 11 vaccine, as measured by the standard ELISpot assay.

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.

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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.

CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101
Media: Jeff Richardson, Richardson & Associates, 805-491-8313

(Logo: http://photos.prnewswire.com/prnh/20120131/LA44118LOGO)

SOURCE Inovio Pharmaceuticals, Inc.

Web Site: http://www.inovio.com
 

Posted: March 2012

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