PLYMOUTH MEETING, Pa.,
Feb. 23, 2021 /PRNewswire/ -- INOVIO
(NASDAQ:INO), a biotechnology company focused on bringing to market
precisely designed DNA medicines to treat and protect people from
infectious diseases and cancer, today announced the first
participant was dosed in a Phase 1B
clinical trial for INO-4500, its DNA vaccine candidate for Lassa
fever, in Ghana. The Phase
1B clinical trial (LSV-002), ongoing
at the Noguchi Memorial Institute for Medical Research in
Accra, Ghana, is the first vaccine
clinical trial for Lassa fever to be conducted in West Africa, where the infection is endemic.
INO-4500 is also the first vaccine candidate for Lassa fever to
enter human trials.
INOVIO is advancing INO-4500 with full funding from the
Coalition for Epidemic Preparedness Innovations (CEPI), a global
partnership that leverages funding from public, private,
philanthropic, and civil society organizations to support research
projects to develop vaccines against emerging infectious diseases.
INOVIO previously received a $56
million grant from CEPI in 2018, under which the company is
developing vaccine candidates for Lassa fever and Middle East
Respiratory Syndrome (MERS). INOVIO and CEPI are committed to
making a vaccine available as soon as possible for emergency use as
a stockpile product post-Phase 2 testing.
Dr. J. Joseph Kim, President and
CEO of INOVIO, said, "We have observed that INO-4500 vaccination
generates robust antibody and T cell immune responses in a Phase 1
clinical trial conducted in the U.S., and this continued
advancement of INO-4500 into Phase 1B
trial is another important step in a fight against Lassa
fever. This trial also represents a significant advancement within
INOVIO's infectious disease portfolio and further validates the
company's DNA medicines platform and proprietary CELLECTRA®
delivery device."
Dr. Kim added, "This is the same device being used to deliver
our DNA vaccine candidate, INO-4800, in the Phase 2 segment of our
INNOVATE Phase 2/3 COVID-19 trial. We are grateful to CEPI for the
continued support and confidence in our vaccine programs – and we
look forward to advancing INO-4500 as a vaccine candidate against
Lassa fever."
Dr Melanie Saville, Director of
Vaccine R&D at CEPI, said, "We are delighted to see our partner
INOVIO launch the first-ever Lassa vaccine trial on the African
continent, with today's announcement marking an important milestone
in the fight against this deadly hemorrhagic fever. With the
emerging infectious disease remaining a serious public health
threat across West Africa,
including Ghana, it is crucial
that populations can participate in vaccine trials to ensure
sufficient data is generated so that they can be confidently rolled
out in outbreak-prone areas in the future, dependent on safety and
immunogenicity testing. Together, this work plays into broader
research efforts led by CEPI to minimize the threat of the disease,
including the launch of the largest-ever Lassa fever epidemiology
research program launched in West
Africa late last year."
Professor Kwadwo A. Koram,
Principal Investigator of the clinical trial and head of Noguchi
Medical Center, said, "I see this as a great opportunity to
use the resources of the Institute for the benefit not only of the
country but the sub-region at large. We are grateful to the
sponsor, INOVIO Pharmaceuticals, and hope that this will be only
the beginning of a long and fruitful collaboration in the fight
against infectious diseases."
About INOVIO's Phase 1B
Clinical Trial for INO-4500
INOVIO's Phase 1B clinical trial,
LSV-002, will enroll approximately 220 adult participants who are
18-50 years old, with the primary endpoints of evaluating safety
and immunogenicity in an African population. The dosing regimen
involves two vaccinations at 0 and 28 days with either 1.0 mg or
2.0 mg dosing levels. In addition to providing valuable insights on
the INO-4500 safety and immunogenicity profile, this trial will
inform dose selection for subsequent Phase 2 studies in
West Africa.
Since its establishment in 1979, the Noguchi Memorial Institute
for Medical Research ("The Institute") has gained global
recognition as a leading biomedical research institute in
Africa, building capacity for
prevention and control of endemic diseases, as well as emerging and
re-emerging diseases, in Ghana and
the West African sub-region. The Institute has been a leader
in developing effective diagnosis capabilities and clinical
research for the treatment and protection against HIV/AIDS, H1N1
Pandemic Flu, Lassa fever, Yellow fever, Ebola virus disease, and
malaria. The lead clinical Principal Investigator for LSV-002 is
Professor Dr. Kwadwo A. Koram, an
expert and specialist in tropical medicines and epidemiologist with
more than 20 years of research experience, including malaria
vaccines.
About Lassa Fever
Lassa fever is an animal-borne, acute hemorrhagic viral illness
primarily observed in parts of West
Africa. Infection is spread through contact with infected
rodents, as well as person-to-person transmission via bodily fluids
(primarily in health care settings). 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. Lassa virus
infection in West Africa is
estimated to affect 100,000 to 300,000 people annually and is
responsible for 10-16% of hospital admissions in the region. The
virus is responsible for approximately 5,000 deaths annually.
Because of difficulties in diagnosing Lassa fever, the lack of
standardized surveillance assays, and the remote nature of many of
the areas in West Africa where
outbreaks typically occur, the numbers of reported cases and deaths
are very likely significantly lower than the actual 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. The
case-fatality among patients hospitalized for Lassa fever is about
15-20% and, in some epidemics, case-fatality has reached 50% in
hospitalized patients. There are no licensed vaccines or treatments
specifically for Lassa fever.
About INOVIO's DNA Medicines Platform
INOVIO has 15 DNA medicine clinical programs currently in
development focused on HPV-associated diseases, cancer, and
infectious diseases, including coronaviruses associated with MERS
and COVID-19 diseases being developed under grants from the
Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S.
Department of Defense. DNA medicines are composed of optimized DNA
plasmids, which are small circles of double-stranded DNA that are
synthesized or reorganized by a computer sequencing technology and
designed to produce a specific immune response in the body.
INOVIO's DNA medicines deliver optimized plasmids directly into
cells intramuscularly or intradermally using INOVIO's proprietary
hand-held smart device called CELLECTRA®. The
CELLECTRA® device uses a brief electrical pulse to
reversibly open small pores in the cell to allow the plasmids to
enter, overcoming a key limitation of other DNA and other nucleic
acid approaches, such as mRNA. Once inside the cell, the DNA
plasmids enable the cell to produce the targeted antigen. The
antigen is processed naturally in the cell and triggers the desired
T cell and antibody mediated immune responses. Administration with
the CELLECTRA® device ensures that the DNA medicine is
efficiently delivered directly into the body's cells, where it can
go to work to drive an immune response. INOVIO's DNA medicines do
not interfere with or change in any way an individual's own DNA.
The advantages of INOVIO's DNA medicine platform are how fast DNA
medicines can be designed and manufactured; the stability of the
products, which do not require freezing in storage and transport;
and the robust immune response, safety profile, and tolerability
that have been observed in clinical trials.
With more than 3,000 patients receiving INOVIO investigational
DNA medicines in more than 7,000 applications across a range of
clinical trials, INOVIO has a strong track record of rapidly
generating DNA medicine candidates with potential to meet urgent
global health needs.
About INOVIO
INOVIO is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to treat and protect people
from infectious diseases, cancer, and diseases associated with HPV.
INOVIO is the first and only company to have clinically
demonstrated that a DNA medicine can be delivered directly into
cells in the body via a proprietary smart device to produce a
robust and tolerable immune response. Specifically, INOVIO's lead
candidate VGX-3100, currently in Phase 3 trials for precancerous
cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18
in a Phase 2b clinical trial.
High-risk HPV is responsible for 70% of cervical cancer, 91% of
anal cancer, and 69% of vulvar cancer. Also in development are
programs targeting HPV-related cancers and a rare HPV-related
disease, recurrent respiratory papillomatosis (RRP);
non-HPV-related cancers glioblastoma multiforme (GBM) and prostate
cancer; as well as externally funded infectious disease DNA vaccine
development programs in Zika, Lassa fever, Ebola, HIV, and
coronaviruses associated with MERS and COVID-19 diseases. Partners
and collaborators include Advaccine, ApolloBio Corporation,
AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for
Epidemic Preparedness Innovations (CEPI), Defense Advanced Research
Projects Agency (DARPA)/Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND)/Department of Defense (DoD), HIV Vaccines Trial
Network, International Vaccine Institute (IVI), Kaneka Eurogentec,
Medical CBRN Defense Consortium (MCDC), National Cancer Institute,
National Institutes of Health, National Institute of Allergy and
Infectious Diseases, Ology Bioservices, the Parker Institute for
Cancer Immunotherapy, Plumbline Life Sciences, Regeneron,
Richter-Helm BioLogics, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army
Institute of Research, and The Wistar Institute. INOVIO also is a
proud recipient of 2020 Women on Boards "W" designation recognizing
companies with more than 20% women on their board of directors. For
more information, visit www.inovio.com.
About CEPI
CEPI is an innovative partnership between public, private,
philanthropic, and civil organizations, launched at Davos in 2017, to develop vaccines to stop
future epidemics. CEPI has moved with great urgency and in
coordination with WHO in response to the emergence of COVID-19.
CEPI has initiated 11 partnerships to develop vaccines against the
novel coronavirus. The programs will leverage rapid response
platforms already supported by CEPI as well as new partnerships.
The aim is to advance COVID-19 vaccine candidates into clinical
testing as quickly as possible.
Before the emergence of COVID-19 CEPI's priority diseases
included Ebola virus, Lassa virus, Middle East Respiratory Syndrome
coronavirus, Nipah virus, Rift Valley fever and Chikungunya virus.
CEPI also invested in platform technologies that can be used for
rapid vaccine and immunoprophylactic development against unknown
pathogens (Disease X). Follow our news page for
the latest updates. Follow us
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CONTACTS:
Media: Jeff Richardson,
267-440-4211, jrichardson@inovio.com
Investors: Ben Matone, 484-362-0076,
ben.matone@inovio.com
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
and manufacture DNA medicines, our expectations regarding our
research and development programs, and our ability to successfully
manufacture and produce large quantities of our product candidates
if they receive regulatory approval. Actual events or results may
differ from the expectations set forth herein as a result of a
number of factors, including uncertainties inherent in preclinical
studies, clinical trials, product development programs and
commercialization activities and outcomes, our ability to secure
sufficient manufacturing capacity to mass produce our product
candidates, 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 medicines, our ability to support our pipeline of DNA
medicine 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, 2019, our Quarterly Report on Form
10-Q for the quarter ended September 30,
2020 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.
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SOURCE INOVIO Pharmaceuticals, Inc.