Inovio Pharmaceuticals, Inc. (NASDAQ:INO) and CEPI – the Coalition
for Epidemic Preparedness Innovations – today announced a
partnership under which Inovio will develop vaccine candidates
against Lassa fever and Middle East Respiratory Syndrome (MERS).
CEPI will fund up to $56,000,000 to support
Inovio’s pre-clinical and clinical advancement through Phase 2
of INO-4500, its Lassa fever vaccine, and INO-4700, its MERS
vaccine. The shared goal of Inovio and CEPI is for the Lassa
and MERS vaccines to be available as soon as possible for emergency
use.
This is the second company agreement CEPI has
signed since its launch in 2017. These partnerships represent an
innovative approach to funding vaccine development, unlocking
research and development potential so that vaccines are ready for
efficacy studies during an outbreak. The agreement will enable
funding for Inovio’s development efforts over a five-year period.
The partnership agreement also includes options, not counted in the
total above, to establish investigational stockpiles of both
vaccines.
Lassa fever is a disease endemic to West Africa
associated with annual outbreaks. An ongoing outbreak in Nigeria
has, according to figures from the Nigerian Centre for Disease
Control, resulted in over 400 confirmed cases and over 100 deaths
from January 1, 2018 through April 8, 20181. MERS, first identified
in 2012, causes a severe respiratory illness and has been
associated with a number of outbreaks in Saudi Arabia and
neighboring countries.
Individuals acquiring these diseases in the
regions of origin occasionally travel to other locations, becoming
ill in areas outside the endemic regions. In 2015 an individual
with MERS returned to South Korea from the Middle East. This
resulted in an outbreak that resulted in 186 confirmed cases and 38
deaths. The outbreak affected 24 hospitals, led to the temporary
closure of more than 2,000 schools, and had a significant impact on
the South Korean economy.
Richard Hatchett, CEO of CEPI, said, “Epidemics
don’t respect borders; they destroy lives and devastate economies
and we need to move swiftly to prepare for them. Partnering with
Inovio is a considerable move forward for CEPI’s vaccine portfolio
and developing a global insurance policy against these
diseases.”
CEPI’s funding will support development up to
the end of Phase 2, providing clinical safety and immunological
data, and the establishment of investigational stockpiles that will
be ready for clinical efficacy trial testing during outbreaks.
CEPI’s portfolio of investments will provide
additional benefits to the wider vaccine community through the
development of assays, reference standards and associated knowledge
that may accelerate the development of other vaccines and medical
counter measures against Lassa fever and MERS.
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “The Inovio/CEPI partnership demonstrates the confidence of
both organizations in Inovio’s DNA vaccine platform to rapidly
produce countermeasures against emerging viral threats potentially
protecting large populations from a pandemic. A key
demonstration of such capabilities was that Inovio was the first
organization to develop, manufacture and report positive human data
from a Zika vaccine in less than seven months – when traditional
vaccines take several years to reach this point. We look forward to
addressing the global health challenges of emerging infectious
diseases.”
Inovio will develop these DNA vaccines employing
its ASPIRE™ (Antigen SPecific Immune REsponses) platform. This
platform delivers optimized synthetic antigenic genes into cells,
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.
The CEPI partnership builds upon Inovio’s
clinical and preclinical advancements for MERS and Lassa fever
vaccines. Results from a first-in-human Phase 1 study for its MERS
vaccine found high levels of binding antibodies 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. Inovio’s
Lassa vaccine data also holds much promise2. In a study funded by a
$3.5 million grant from the National Institute of Allergy and
Infectious Diseases (NIAID), Inovio previously published that its
DNA vaccine against Lassa fever provided 100% protection for
non-human primates challenged with a lethal dose of the virus3.
Inovio is advancing MERS and Lassa vaccines with
the support of its collaborators: The Wistar Institute, Laval
University, the NIH’s Rocky Mountain Laboratories, U.S. Army
Medical Research Institute of Infectious Diseases (USAMRIID),
VGXI/GeneOne Life Science and the International Vaccine
Institute.
About MERS
Middle East Respiratory Syndrome is caused by
the MERS-Corona virus, part of the same family of viruses that
causes the common cold and SARS (Severe Acute Respiratory
Syndrome). It is transmitted from animals to humans and can be
further transmitted by person to person contact. Symptoms include
severe acute respiratory illness with fever, cough and shortness of
breath as well as gastrointestinal symptoms, which can lead to
death.
About Lassa Fever
Lassa fever is also known as Lassa hemorrhagic
fever. The Lassa virus is transferred to humans from animals, most
commonly by the Mastomys rodent. The virus can spread from person
to person via bodily fluids and causes a range of symptoms
including vomiting, swelling of the face, bleeding, and pain in the
chest, back and abdomen.
About CEPI
CEPI is an innovative partnership between
public, private, philanthropic and civil organizations founded in
Davos in 2017.
To date, CEPI has received multi-year funding
from Norway, Germany, Japan, the Bill & Melinda Gates
Foundation and Wellcome. CEPI has also received single-year
investments from the governments of Australia, Belgium, and
Canada. It has reached $630 million of its target $1 billion
funding target. The European Commission has announced a
contribution in kind of €250 million that will support relevant
projects through EC mechanisms.
Since its launch in January 2017, CEPI has
announced two Calls for Proposals. The first was for candidate
vaccines against MERS-COV, Nipah and Lassa viruses. The second was
for the development of platforms that can be used for rapid vaccine
development against unknown pathogens.
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 CD8+ 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 clinical stage
product pipeline, including candidates in Phase 3 and Phase 2.
Partners and collaborators include MedImmune, Regeneron, Genentech,
The Wistar Institute, University of Pennsylvania, the Parker
Institute for Cancer Immunotherapy, 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, 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 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, 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.
Forward-looking statements speak only as of the date of this
release, and Inovio undertakes no obligation to update or revise
these statements, except as may be required by law.
1 http://ncdc.gov.ng/diseases/sitreps/?cat=5&name=An update
of Lassa fever outbreak in Nigeria
2
http://ir.inovio.com/news-and-media/news/press-release-details/2017/Inovio-Reports-New-Positive-Clinical-Data-on-Vaccine-Advances--in-the-Fight-Against-Emerging-Infectious-Diseases/default.aspx
3
http://ir.inovio.com/news-and-media/news/press-release-details/2015/Inovio-Pharmaceuticals-DNA-Vaccine-Protects-100-Against-Deadly-MERS-Virus-in-Non-Human-Primates/default.aspx
Contacts
For CEPIRachel GrantPhone:
+44(0)7891249190Email: Rachel.Grant@cepi.net
For InovioInvestors:
Ben MatonePhone:
484-362-0076Email: ben.matone@inovio.com
Media:Jeff RichardsonPhone: 267-440-4211Email:
jrichardson@inovio.com
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Jun 2024 to Jul 2024
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Jul 2023 to Jul 2024