Inovio and Korean Partner Dose 1st Subject In Trial to Develop World’s First Vaccine to Prevent Hepatitis C Infection
September 04 2018 - 1:00AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) and GeneOne Life Science
(KSE: 011000) today announced they have dosed the first patient in
a Phase 1 study designed to evaluate a preventive vaccine against
hepatitis C infection. Recruitment has already begun in South
Korea, where GeneOne is responsible for conducting and funding this
Phase 1 trial to assess the ability of Inovio’s hepatitis C vaccine
(GLS-6150) to boost immunity in people who have been treated and
cleared of the virus. Pending study results, Inovio’s vaccine could
be employed to prevent infection and re-infection.
This jointly developed, open-label, Phase 1
study of GLS-6150 will evaluate a total of 24 persons who have a
sustained virologic response (SVR) following treatment for
Hepatitis C (n=8 per group) and an additional 8 healthy controls to
compare immune responses. Subjects will receive one of two doses of
vaccine, 1 or 2 mg, administered intra-dermally and followed by
electroporation with Cellectra-3P device. Vaccinations will occur
as a 3 dose priming series (0, 4, 12 weeks) or as a 2 dose priming
series (0, 8 weeks) and followed by a booster dose at 6 months.
Final study visit is 4 weeks following the 6 month booster
vaccination.
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “Developing the first successful vaccine against hepatitis C
virus is a highly ambitious endeavor but a truly impactful effort
for global health as well as being transformative for us
commercially. The key to a successful hepatitis C vaccine will be
its ability to activate the body’s immune system to prevent or
treat infection by a virus with multiple or ever-changing strains.
Inovio’s innovative DNA-based technology platform is uniquely
positioned to address this challenge and it has been optimizing
over the last several years in demonstrating strong in vivo immune
responses against very tough-to-treat viruses like HIV, Zika and
flu. We are very excited to launch this study with GeneOne’s
funding and execution in Korea and we look forward to the data in
2019.”
Many insurers and governments, including the
U.S., are seeking ways to control the high medical costs of
treating hepatitis C infection and frequent re-infections
especially in at-risk patient populations. Efforts to develop
a hepatitis C vaccine started more than 25 years ago when the
hepatitis C virus was first identified. Progress has been slow
because the hepatitis C virus is more variable than are the viruses
that cause hepatitis A and B. The hepatitis C virus occurs in at
least six genetically distinct forms (genotypes) with multiple
strains. About 50 subtypes have been identified to date. Inovio’s
synthetic DNA vaccines have an advantage over inactivated or
attenuated virus products since they are not limited to one
specific strain of virus. As such, they are well matched against
viruses with multiple strains and have demonstrated in clinical
trials the ability to produce broad-spectrum immune responses
against numerous strains of targeted pathogens.
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. For more information, visit
www.genels.com.
About Inovio Pharmaceuticals,
Inc.
Inovio is a late-stage biotechnology company
focused on the discovery, development, and commercialization of DNA
immunotherapies that transform the treatment of cancer and
infectious diseases. The Inovio technology platform is
designed to activate an individual’s immune system to generate a
robust, targeted T cell and antibody response against targeted
diseases. Inovio is the only immunotherapy company that has
reported generating T cells entirely in vivo in high quantity
that are fully functional and whose killing capacity correlates
with relevant clinical outcomes with a favorable safety profile.
Inovio’s most advanced clinical program, VGX-3100, is in Phase 3
for the treatment of HPV-related cervical precancer. Also in
development are Phase 2 immuno-oncology programs targeting head and
neck cancer, bladder cancer, and glioblastoma, as well as platform
development programs in hepatitis B, Zika, Ebola, MERS, and HIV.
Partners and collaborators include MedImmune, Regeneron,
Roche/Genentech, ApolloBio Corporation, The Wistar Institute,
University of Pennsylvania, the Parker Institute for Cancer
Immunotherapy, DARPA, GeneOne Life Science, Plumbline Life
Sciences, Drexel University, National Institute of Allergy and
Infectious Diseases, U.S. Army Medical Research Institute of
Infectious Diseases, NIH, HIV Vaccines Trial Network, U.S. Military
HIV Research Program and CEPI. 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, including the planned initiation
and conduct of clinical trials and the availability and timing of
data from those trials, as well as our plans and expectations
regarding the presentation of data at scientific conferences.
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, 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 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
us or our collaborators, including alternatives that may be more
efficacious or cost effective than any therapy or treatment that we
and our collaborators hope to develop, issues involving product
liability, issues involving patents and whether they or licenses to
them will provide us 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
we can finance or devote other significant resources that may be
necessary to prosecute, protect or defend them, the level of
corporate expenditures, assessments of our 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, 2017, our Quarterly Report on Form 10-Q for the
quarter ended June 30, 2018 and other regulatory filings we make
from time to time. There can be no assurance that any product
candidate in our pipeline will be successfully developed,
manufactured or commercialized, that final results of clinical
trials 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.
Forward-looking statements speak only as of the date of this
release, and we undertake no obligation to update or revise these
statements, except as may be required by law.
CONTACTS:
Investors:
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Ben Matone, Inovio,
484-362-0076, ben.matone@inovio.com |
Media: |
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Jeff Richardson,
Inovio, 267-440-4211, jrichardson@inovio.com |
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For
GeneOne: |
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Young Park, CEO: +82
10-8777-8348, park@genels.com |
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