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Inovio Affiliate GeneOne Files Investigational New Drug Application
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No vaccine exists for MERS virus, which has killed 40% of those infected
PLMOUTH MEETING, PA, USA I October 19, 2015 I GeneOne Life Science Inc. (KSE:011000), which partnered with Inovio Pharmaceuticals, Inc. (NASDAQ: INO) to develop Inovio’s MERS vaccine (GLS-5300), today announced the filing of an Investigational New Drug Application (IND) for GLS-5300 with the United States Food and Drug Administration. The companies expect to move the MERS vaccine into a phase I clinical trial in healthy volunteers before year end.
Middle East respiratory syndrome (MERS) is caused by a coronavirus that is related to the severe acute respiratory syndrome (SARS) virus that over 10 years ago infected over 8,000 people, with a 10% death rate. There is no vaccine or effective treatment against MERS, which spreads from human to human. Since 2012, MERS has infected over 1,500 people and killed almost 600 (40%). Recently, the largest outbreak outside of Saudi Arabia of this emergent global health concern infected 186 people with 36 fatalities in South Korea.
Earlier this year, Inovio’s MERS vaccine induced 100% protection from a live virus challenge in a preclinical study. Inovio and its collaborators evaluated its MERS vaccine in mice, camels and monkeys, or non-human primates. As published in Science Translational Medicine, the vaccine induced robust immune responses capable of preventing the virus from infecting cells in all three species. In monkeys, all vaccinated animals in the study were protected from symptoms of MERS when challenged with a live MERS virus.
Dr. J. Joseph Kim, President and CEO, said, “We are moving rapidly from achieving complete protection from MERS in monkey studies to our goals of obtaining safety data from a phase I trial and regulatory approval.”
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. Inovio holds an equity interest in GeneOne.
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 is 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, Roche, University of Pennsylvania, DARPA, GeneOne 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.
SOURCE: Inovio Pharmaceuticals
Post Views: 207
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Inovio Affiliate GeneOne Files Investigational New Drug Application
-
No vaccine exists for MERS virus, which has killed 40% of those infected
PLMOUTH MEETING, PA, USA I October 19, 2015 I GeneOne Life Science Inc. (KSE:011000), which partnered with Inovio Pharmaceuticals, Inc. (NASDAQ: INO) to develop Inovio’s MERS vaccine (GLS-5300), today announced the filing of an Investigational New Drug Application (IND) for GLS-5300 with the United States Food and Drug Administration. The companies expect to move the MERS vaccine into a phase I clinical trial in healthy volunteers before year end.
Middle East respiratory syndrome (MERS) is caused by a coronavirus that is related to the severe acute respiratory syndrome (SARS) virus that over 10 years ago infected over 8,000 people, with a 10% death rate. There is no vaccine or effective treatment against MERS, which spreads from human to human. Since 2012, MERS has infected over 1,500 people and killed almost 600 (40%). Recently, the largest outbreak outside of Saudi Arabia of this emergent global health concern infected 186 people with 36 fatalities in South Korea.
Earlier this year, Inovio’s MERS vaccine induced 100% protection from a live virus challenge in a preclinical study. Inovio and its collaborators evaluated its MERS vaccine in mice, camels and monkeys, or non-human primates. As published in Science Translational Medicine, the vaccine induced robust immune responses capable of preventing the virus from infecting cells in all three species. In monkeys, all vaccinated animals in the study were protected from symptoms of MERS when challenged with a live MERS virus.
Dr. J. Joseph Kim, President and CEO, said, “We are moving rapidly from achieving complete protection from MERS in monkey studies to our goals of obtaining safety data from a phase I trial and regulatory approval.”
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. Inovio holds an equity interest in GeneOne.
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 is 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, Roche, University of Pennsylvania, DARPA, GeneOne 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.
SOURCE: Inovio Pharmaceuticals
Post Views: 207
