Inovio Pharmaceuticals Partners with GeneOne Life Science for MERS Immunotherapy Clinical Development
May 27 2015 - 01:00AM
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, bhertel@inovio.com
Media:
Jeff Richardson, Inovio Pharmaceuticals
267-440-4211, jrichardson@inovio.com
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