Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced positive
Phase 1 results of its collaborative vaccine study with INO-4700
(GLS-5300) against MERS (Middle East Respiratory Syndrome). Results
for INO-4700, which is being co-developed by Inovio and GeneOne
Life Science Inc. (KSE:011000), showed that the drug was
well-tolerated and demonstrated overall high levels of antibody
responses in roughly 95% of subjects, while also generating
broad-based T cell responses in nearly 90% of study participants.
The Phase 1, open-label, dose-escalation MERS
vaccine trial, in partnership with the Walter Reed Army Institute
of Research in Maryland, displayed antibody responses by ELISA in
94% of subjects at week 14 (two weeks post-third dose).
Additionally, there were no statistically significant
dose-dependent differences in antibody response rates (91%, 95%,
and 95% at doses of 0.67, 2, and 6 mg, respectively). Durable
antibody responses to INO-4700 were also maintained through 60
weeks following dosing. Dr. Joel Maslow, GeneOne’s Chief Medical
Officer, presented the data Tuesday this week in Seoul, Korea at
the WHO-IVI Joint Symposium for MERS-CoV Vaccine Development.
Dr. J. Joseph Kim, Inovio President and CEO,
said, “Inovio is utilizing our versatile immunotherapy and vaccine
platform to target and develop the most advanced preventive vaccine
for MERS, a virulent viral infection with no medical
countermeasure. This trial further demonstrates Inovio’s commitment
to fighting emerging viral threats while also continuing to
validate consistent high levels of both immune and antibody
responses across our infectious disease platform. We look forward
to continuing this development in a partnership with GeneOne and
CEPI for developing novel therapies for MERS.”
In April 2018, Inovio was awarded $56 million to
develop a MERS vaccine through Phase 2 by The Coalition for
Epidemic Preparedness Innovations (CEPI). The shared goal of Inovio
and CEPI is for the MERS vaccine to be available for stockpile as
soon as possible for emergency use. The CEPI funding also included
support for Inovio’s vaccine against the Lassa virus.
In collaboration with GeneOne Life Science,
Inovio plans to begin a Phase 1/2 study for MERS in the third
quarter of this year. The study will be conducted by GeneOne Life
Science in Korea and fully funded by a $34 million grant from the
Samsung Foundation through the International Vaccine Institute.
In preclinical testing, INO-4700 induced 100%
protection from a live virus challenge in a rhesus macaque
non-human primate study. Inovio and its collaborators evaluated its
MERS vaccine in mice, camels as well as non-human primates. As
published in Science Translational Medicine, the vaccine induced
robust immune responses 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.
About MERS
Middle East Respiratory Syndrome is caused by a
coronavirus that is related to the virus which causes severe acute
respiratory syndrome (SARS). While the SARS coronavirus
infected and caused illness in more than 8,000 people worldwide,
the disease was short-lived between 2002 and 2004 and had a case
fatality rate of about 10%. Since the MERS-CoV was first identified
in Saudi Arabia in 2012, as of May 2018 the World Health
Organization indicates that laboratory-confirmed MERS cases have
been reported for 2,220 people worldwide, with 790 deaths, for a
case fatality rate of 36%. Local occasional transmission is
still ongoing, primarily in Saudi Arabia where a hospital outbreak
occurred earlier this year. Highlighting the global concern for
MERS, in the summer of 2015 a single business person returned to
South Korea from Saudi Arabia and was the index case for a South
Korea epidemic in 17 hospitals around the country. That
epidemic was comprised of 186 confirmed cases with a 20% case
fatality rate.
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. Inovio’s proprietary platform technology,
ASPIRE, applies next-generation antigen sequencing and DNA delivery
to activate potent immune responses to targeted diseases. The
technology functions exclusively in vivo, and has been demonstrated
to consistently activate robust and fully functional T cell and
antibody responses against targeted cancers and pathogens. Inovio
is the only immunotherapy company that has reported generating T
cells whose killing capacity correlates with relevant clinical
outcomes. Inovio’s most advanced clinical program, VGX-3100, is in
Phase 3 for the treatment of HPV-related cervical pre-cancer. 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, CEPI, DARPA, GeneOne Life Science, Plumbline Life
Sciences, 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, 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, our plans and expectations regarding
partnerships and the plans of GENEOS Therapeutics, Inc. to raise
capital. 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 March 31, 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: Ben Matone, Inovio, 484-362-0076,
ben.matone@inovio.comMedia: Jeff Richardson,
Inovio, 267-440-4211, jrichardson@inovio.com
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