Inovio MERS Vaccine Development to be Expanded with Funding from International Vaccine Institute

Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that the International Vaccine Institute (IVI) will provide new funding and support to further advance GLS-5300, Inovio’s vaccine to prevent Middle East Respiratory Syndrome (MERS) virus infection. Inovio is co-developing this vaccine with GeneOne Life Science. IVI will add technical, laboratory and financial support for GLS-5300 clinical trials in Korea.
Inovio, GeneOne and its academic collaborators have evaluated GLS-5300 in mice, rhesus macaques and camels. As published in Science Translational Medicine, the vaccine induced robust immune responses in all three species. GLS-5300 has been specifically able to induce 100% protection from a live virus challenge in a rhesus macaque non-human primate study. The results of the non-human primate study supported the conduct of the first phase I clinical trial of 75 healthy volunteers in collaboration with the Walter Reed Army Institute of Research.Dr. J. Joseph Kim, Inovio’s President & CEO and a member of the Board of Trustees of IVI, said, “This collaborative funding is part of a 41 billion Won (USD $34 million) grant publicly pledged in 2015 from the Samsung Foundation to IVI to support the development of a MERS vaccine for emergency use in Korea and internationally. The goal of this funding is to expand clinical testing of GLS-5300 toward emergency use authorization by the Korean government as well as authorities of other countries.”“Inovio’s GLS-5300 remains the only vaccine for MERS in clinical testing. With this support from IVI, Inovio, GeneOne, and our other collaborators can expand GLS-5300 vaccine development in Korea and the US. Our phase I MERS trial in the U.S. is fully enrolled with 75 subjects dosed. We intend to report interim data in early 2017 and publish the full data set in peer reviewed journals. We already published positive non-human primate protection results. After obtaining human safety and immunogenicity data, we may be in position to secure additional external funding as well as approach regulators next year to discuss the path to approval via the “Animal Rule,” Dr. Kim said.Despite the continuing threat of MERS outbreaks, there are no licensed vaccines or treatments for MERS. Since the virus was first identified in Saudi Arabia in 2012, the World Health Organization reports almost 1,900 MERS infections and nearly 700 deaths worldwide. Twenty seven countries have reported cases, including Korea where an outbreak in the summer of 2015 resulted in 186 cases and 38 deaths. While a SARS epidemic in 2003 killed 10% of those infected, MERS has killed about 36% of people who contracted this communicable virus.
About IVI
The International Vaccine Institute (IVI) is the world’s only international organization devoted exclusively to developing and introducing new and improved vaccines to protect the world’s poorest people, especially children in developing countries. Established in 1997, IVI operates as an independent international organization under a treaty signed by 35 countries and the World Health Organization. The Institute conducts research in more than 20 countries of Asia, Africa and Latin America on vaccines against enteric and diarrheal infections, Japanese encephalitis, MERS, and dengue fever, and develops new and improved vaccines at its headquarters in Seoul, Republic of Korea. For more information, please visit https://www.ivi.int.
About GeneOne Life Science, Inc.
GeneOne is an international company focused on finding gene-based solutions to clinical disease. GeneOne is at the forefront of DNA vaccine and DNA-based therapeutic development. GeneOne is currently spearheading clinical trials of vaccines for the Zika virus, MERS-CoV, Ebola and other infectious diseases. GeneOne has a rich pipeline of products targeting multiple cancers and diseases of man. GeneOne’s wholly-owned subsidiary VGXI, Inc. (www.vgxii.com) has 15 years of experience in the manufacture of DNA plasmid vaccines and therapeutics and has the distinction of making vaccines for Zika, MERS, and Ebola for use in human clinical trials. GeneOne is headquartered in Seoul, South Korea. For more information, visit www.genels.com.
About Inovio Pharmaceuticals, Inc.
Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit 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, our expectations regarding our research and development programs 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 the MERS vaccine GLS-5300, 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, our ability to support our broad pipeline of SynCon® active immunotherapy and vaccine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, 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, 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, 2015, our Form 10-Q for the quarter ended September 30, 2016, 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, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com