Inovio Pharmaceuticals Partners with GeneOne Life Science for MERS Immunotherapy Clinical Development
Lethal Middle East Respiratory Syndrome Kills 40% of Those Infected; Human-to-Human Transmission of the Virus has Occurred in South Korea
PLYMOUTH MEETING, Pa., May 27, 2015 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (Nasdaq:INO) announced it will advance its DNA vaccine for MERS (Middle East Respiratory Syndrome) into a phase I clinical trial in healthy volunteers in a collaboration with GeneOne Life Science Inc. (KSE: 011000), an international DNA vaccine developer and manufacturer in which Inovio holds an equity interest. MERS is a respiratory disease caused by a coronavirus, which is related to the severe acute respiratory syndrome (SARS) virus. Currently, MERS carries a 40% death rate; there is no vaccine or effective treatment for this virus.
Inovio and GeneOne will conduct a phase I trial to evaluate the safety, tolerability and immunogenicity of Inovio's DNA-based MERS vaccine. The companies are currently conducting pre-IND activities and plan to start the clinical study before year end. GeneOne will conduct and fund the clinical study in return for milestone-based co-ownership of the immunotherapy. Upon successful completion of the study, the companies plan to jointly seek additional third party support and resources to further develop and commercialize this product.
In preclinical tests, INO-4500 showed robust and durable immune responses. Animals vaccinated with INO-4500 generated strong neutralizing antibodies and robust CD8+ T cells to MERS antigens. These findings are vital given the importance of neutralizing antibodies in preventing infection and the role T cells play in clearing infection by killing cells that harbor the virus.
MERS was first identified in humans in 2012. By the end of May 2015, health ministries reported that 23 countries had a combined 1,142 cases of MERS and 465 deaths, almost all in four Middle Eastern countries. This month, South Korean health officials confirmed the country's fifth confirmed case of MERS, with the four latest cases found in people who had been in contact with the first patient after he returned from the Middle East.
Inovio's MERS vaccine was designed using Inovio's SynCon® technology to provide broad protective antibody and T-cell responses against multiple strains of MERS virus. Inovio's SynCon® technology has the ability to activate immune responses against multiple disease-specific antigens and elicit broad protection against diverse unmatched strains of pathogens in humans. These DNA-based immunotherapy products have shown a favorable safety profile in clinical studies to date.
Dr. J. Joseph Kim , President and CEO, said, "Inovio has again utilized its SynCon platform to generate a synthetic DNA immunotherapy candidate, INO-4500, that shows promise for providing an effective shield or treatment where there is none. What's most impressive about our candidate vaccine is that it is designed with the goal to universally protect against multiple and newly emergent strains of MERS. In light of the rapid spread of the recent Ebola outbreak, we want to be proactive in assessing the immunogenicity and safety of our MERS immunotherapy and be prepared to advance this product against this deadly virus in a timely manner."
About GeneOne Life Science
GeneOne Life Science Inc. is an international DNA vaccine developer and leading contract manufacturer of DNA plasmid based agents for pre-clinical and clinical trials for global companies and institutions. It researches and develops DNA vaccines to prevent and treat incurable diseases in South Korea and internationally. The company is headquartered in Seoul, South Korea. VGXI, Inc., GeneOne's wholly-owned manufacturing subsidiary located in Texas is the largest pure-play cGMP DNA plasmid manufacturing facility in the world.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy 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 Roche, MedImmune, University of Pennsylvania, DARPA, Gene One Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. 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, 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, including safety and efficacy for VGX-3100, 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, our ability to support our broad pipeline of SynCon® active immune therapy and vaccine products, our ability to advance our portfolio of immune-oncology products independently, including INO-5150, and to commence a phase I clinical trial for INO-5150 in the first half of 2015, 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, our ability to enter into partnerships in conjunction with our research and development programs, 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, 2014, our Form 10-Q for the quarter ended March 31, 2015, 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.
CONTACT: Inovio: Investors: Bernie Hertel, Inovio Pharmaceuticals 858-410-3101, [email protected] Media: Jeff Richardson, Inovio Pharmaceuticals 267-440-4211, [email protected]