Inovio and Partners Initiate Phase 1/2a Clinical Trial To Further Advance Its Vaccine Against Deadly MERS Infection
September 18 2017 - 8:00AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that the
Korean Ministry of Food and Drug Safety approved the initiation of
a study to evaluate GLS-5300, Inovio’s vaccine against the MERS
virus (Middle East Respiratory Syndrome), in a phase 1/2a trial.
The trial will be conducted in South Korea by Inovio’s MERS
development partner, GeneOne Life Science (KSE:011000). The
International Vaccine Institute (IVI) is fully funding this trial
utilizing a $34 million grant Samsung Foundation committed to IVI
in 2015 to support the development of a MERS vaccine.
This phase 1/2a study represents the second
clinical trial for GLS-5300, which remains the first and only MERS
vaccine being tested in humans. The first phase 1 MERS study
is being successfully completed at the Walter Reed Army Institute
of Research in Maryland. In this study, after a three dose
vaccine regimen with GLS-5300 delivered intramuscularly, high
levels of binding antibodies were measured (ELISA) in 92% (57 of
62) of evaluated subjects. Significant antigen-specific cytotoxic
T-lymphocyte (CTL) responses were also observed. Importantly, all
but one evaluated vaccinated subject or 98% (61 of 62) generated an
antibody and/or T cell response against the MERS vaccine.
Generation of MERS antigen-specific antibody and T cell responses
is believed to be important for generating immediate and
long-lasting protection against the disease. The vaccine was well
tolerated and no significant safety concerns were noted.
The new phase 1/2a trial in Korea will assess
the responses of GLS-5300 delivered intradermally. In preclinical
challenge studies, GLS-5300 protected 100% of vaccinated rhesus
macaques from a lethal MERS virus challenge.
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “Korea was devastated by a MERS outbreak two years ago and
now looks to Inovio to produce an approved product for emergency
use in Korea. Our DNA-based vaccines, which can be rapidly designed
and manufactured, are well matched to meet public health challenges
such as this. With financial support from IVI and Samsung,
Inovio and GeneOne are expanding GLS-5300 vaccine development in
Korea, executing our vision to generate additional immune data to
support the potential approval of GLS-5300 in Korea. Our
Korean study is also notable because it will utilize our
intradermal vaccine delivery device which has demonstrated in other
infectious disease trials (HIV, Ebola & Zika) to elicit very
high immune responses at a much lower dose.”
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 more than 2,000 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. MERS causes a rapidly
progressive respiratory illness that may require intensive care
treatment and mechanical ventilation in many patients.
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 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, Regeneron, Genentech, The Wistar Institute, University
of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life
Sciences, ApolloBio Corporation, 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, including GLS-5300, 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, and the
sufficiency of 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, the
development of Inovio’s dMAb products, 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 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, 2016, our Form 10-Q for the
period ended June 30, 2017, and other regulatory filings we make
from time to time. There can be no assurance that any product
candidate in Inovio's 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. In addition,
the forward-looking statements included in this press release
represent Inovio’s views as of the date hereof. Inovio anticipates
that subsequent events and developments may cause its views to
change. However, while Inovio may elect to update these
forward-looking statements at some point in the future, the company
specifically disclaims any obligation to do so, except as may be
required by law. These forward-looking statements should not be
relied upon as representing Inovio’s views as of any date
subsequent to the date of this release.
CONTACTS:
Investors/Media: Jeff Richardson, Inovio Pharmaceuticals,
267-440-4211, jrichardson@inovio.com
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Sep 2023 to Sep 2024