PLYMOUTH MEETING, Pa. and
OSLO, Norway, May 21, 2019 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NASDAQ: INO), together with CEPI, today
announced it has dosed subjects in a Phase 1, first-in-human
clinical trial to evaluate INO-4500, its DNA candidate vaccine to
prevent infection from the Lassa virus. Inovio plans to enroll
approximately 60 volunteers in this placebo controlled, blinded,
dose escalation study evaluating INO-4500 for safety, tolerability
and immune responses. This Inovio trial represents the first Lassa
candidate vaccine to enter the clinic. This Inovio-sponsored trial,
as well as its INO-4500 program, is fully funded through a global
partnership with CEPI – the Coalition for Epidemic Preparedness
Innovations.
Melanie Saville, Director of
Vaccine Development at CEPI, said, "This is an important
development in our work to accelerate the development of vaccines
against emerging infectious diseases. With marked increases in the
number of cases documented in Nigeria over the last two years and outbreaks
occurring annually, Lassa fever remains a serious public health
threat across West Africa. We
welcome Inovio's work and progress which could pave the way to
reducing the great suffering caused by this disease."
Dr. J. Joseph Kim, Inovio's
President and CEO, said, "Inovio's class-leading synthetic nucleic
vaccines delivered intradermally with its proprietary
CELLECTRA® efficacy enhancing systems are well suited to
rapidly produce countermeasures against emerging viral threats
potentially protecting large populations from a pandemic. Inovio
has rapidly advanced several global health candidate vaccines,
including those against HIV, Ebola, MERS, and Zika, and has
reported above 90% immune response rates from multiple clinical
studies. We join our partner CEPI in the shared quest to bring new
vaccines to medicine and save lives."
In a previously published paper, Inovio reported that its DNA
candidate vaccine against Lassa fever provided 100% protection in
non-human primates challenged with a lethal dose of the virus in a
pre-clinical study funded by a $3.5
million grant from the National Institute of Allergy and
Infectious Diseases (NIAID). Lassa fever is an acute viral illness
that occurs in West Africa and can
cause recurrent large outbreaks with high case fatality rates in
the region. There is no licensed vaccine or approved treatment for
Lassa fever.
Leveraging results of this study, Inovio expects to advance its
Lassa candidate vaccine into a Phase 2 field trial in endemic
countries of West Africa later in
2019/2020. With satisfactory Phase 2 data, CEPI in cooperation with
local regulatory authorities and the WHO, may stockpile the Inovio
vaccine for future use throughout the region. For more information
on this study.
Last year, Inovio received a $56
million grant from CEPI under which Inovio will develop
vaccine candidates through Phase 2 against Lassa fever and MERS
(Middle East Respiratory Syndrome.) The shared goal of Inovio and
CEPI is for a Lassa vaccine to be available as soon as possible for
emergency use as a stockpile post-Phase 2 testing.
Inovio's synthetic nucleic acid platform of immunotherapies and
vaccines deliver optimized synthetic antigen genes into cells with
CELLECTRA® immune enhancing systems, where they are
translated into protein antigens that activate an individual's
immune system to generate robust targeted T cell and antibody
responses. Inovio's immunotherapies function exclusively in
vivo, and have generated an antigen-specific immune response
against targeted diseases in all clinical trials to date.
About Lassa Fever
Lassa fever, also known as Lassa hemorrhagic fever, is an acute
viral disease which occurs mostly in West
Africa. The disease can cause a range of outcomes including
fever, vomiting, and swelling of the face, pain in the chest, back
and abdomen, bleeding of various parts of the body including the
eyes and nose -- and death. This infection is spread through
contact with infected rodents. Person to person transmission
is also possible, via bodily fluids, albeit less common.
Lassa virus infection in West
Africa is estimated to affect 300,000 people annually,
resulting in approximately 5,000 deaths, as disease and infection
surveillance has been poor. Because of difficulties in
diagnosing Lassa fever and the remoteness in many areas that the
disease occurs in, the numbers of reported cases and deaths are
very likely significantly lower than the true numbers of cases and
deaths. Though the majority (about 80%) of Lassa
virus-infected persons are asymptomatic or have mild symptoms, the
infection can be quite serious to fatal in others. There are
no licensed vaccines or treatments specifically for Lassa. The
case-fatality among patients hospitalized for Lassa fever is about
15% to 20%, and in some epidemics case-fatality has reached 50% in
hospitalized patients -- e.g. in the 2015-2016 Nigeria portion of the West Africa outbreak. Of the survivors of
Lassa fever, about one-third have sudden-onset hearing loss. In
Nigeria, an unprecedented outbreak
has been underway this year, with more cases recorded and reported
in the first two months than in any previous full year there.
From January 1 to December 31, 2018,
a total 633 confirmed and 20 probable cases were reported to the
Nigeria Centre for Disease Control with 171 deaths among confirmed
cases and 20 in probable cases, yielding a 27% case-fatality rate
in confirmed cases.
About CEPI
CEPI is an innovative partnership between public, private,
philanthropic, and civil organisations launched in Davos in 2017 to develop vaccines to stop
future epidemics. CEPI has received multi-year funding from
Norway, Germany, Japan, Canada, Australia, and the Bill & Melinda Gates
Foundation, and Wellcome. CEPI has also received single-year
investments from the government of Belgium and the United Kingdom. The European Commission
foresees substantial financial contributions to support relevant
projects through EC mechanisms. CEPI has reached over US$ 750 million of its $1
billion funding target. Since its launch in January 2017, CEPI has announced three calls for
proposals. The first call was for candidate vaccines against Lassa
virus, Middle East Respiratory Syndrome coronavirus (MERS-CoV), and
Nipah virus. The second call was for the development of platforms
that can be used for rapid vaccine development against unknown
pathogens. The third call is for candidate vaccines against Rift
Valley fever and Chikungunya viruses. To date, CEPI has committed
to investing up to $350 million in 12
vaccine candidates (five against Lassa virus, four against
MERS-CoV, three against Nipah virus) and three vaccine platforms to
develop vaccines against Disease X. Learn more at CEPI.net.
Follow us at @CEPIvaccines.
About Inovio Pharmaceuticals Inc.
Inovio is an innovative biotechnology company focused on the
discovery, development, and commercialization of its synthetic
nucleic technology targeted against cancers and infectious
diseases. Inovio's proprietary technology platform applies antigen
sequencing and 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'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 HPV-related cancers, bladder cancer, and
glioblastoma, as well as platform development programs in hepatitis
B, Zika, Ebola, MERS, and HIV. Partners and collaborators include
AstraZeneca, Regeneron, Roche/Genentech, ApolloBio Corporation,
GeneOne Life Science, The Bill & Melinda Gates Foundation,
Coalition for Epidemic Preparedness Innovations, Defense Advanced
Research Projects Agency, National Institutes of Health, National
Institute of Allergy and Infectious Diseases, National Cancer
Institute, HIV Vaccines Trial Network, Walter Reed Army Institute
of Research, The Wistar Institute, and the University of Pennsylvania. For more information,
visit www.inovio.com.
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
DNA-based immunotherapies, 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. 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 immunotherapies, 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, 2018, our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 and other filings we
make from time to time with the Securities and Exchange Commission.
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 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:
Inovio:
Investors:
Ben Matone, 484-362-0076,
ben.matone@inovio.com
Media:
Jeff Richardson, 267-440-4211,
jrichardson@inovio.com
CEPI:
Rachel Grant: +44(0)7891249190,
Rachel.Grant@cepi.net
Jodie Rogers: +44(0)7917030828,
Jodie.Rogers@cepi.net
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SOURCE Inovio Pharmaceuticals, Inc.