PLYMOUTH MEETING, Pa.,
Oct. 26, 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, cancer, and HPV-associated
diseases, today announced its Phase 1B clinical trial for INO-4500, its DNA vaccine
candidate for Lassa fever, completed full enrollment of 220
participants. This trial (LSV-002 - NCT04093076) is ongoing at
the Noguchi Memorial Institute for Medical Research in Accra, Ghana, and is the first vaccine
clinical trial for Lassa fever conducted in West Africa, where the viral illness is
endemic.
INOVIO is advancing INO-4500 with full funding from the
Coalition for Epidemic Preparedness Innovations (CEPI), a global
partnership between public, private, philanthropic, and civil
society organizations to stimulate and accelerate the development
of vaccines against emerging infectious diseases and enable access
to these vaccines for people in need during outbreaks. The company
was awarded up to US $56 million from
CEPI in 2018 under which INOVIO is advancing vaccine candidates
against Lassa fever and Middle East Respiratory Syndrome (MERS).
INOVIO and CEPI plan to establish a stockpile of these vaccines for
emergency use after Phase 2 testing, if successful. As part of
CEPI's $3.5 billion plan to reduce,
or even eradicate, the risk of epidemics and pandemics, CEPI's goal
is to get a licensed Lassa vaccine for use in endemic countries.
The forward-looking strategy also includes the aim to advance
clinical trial capacity, infrastructure, and expertise in low- and
middle-income countries.
Dr. Laurent Humeau, INOVIO's
Chief Scientific Officer, said, "Completing enrollment of LSV-002
is an important milestone for the clinical development of INO-4500,
our DNA vaccine candidate against Lassa fever. INOVIO and our
partners are committed to addressing this significant unmet public
health need, considering the prevalence of the Lassa virus, the
potential severity of Lassa fever, and the lack of any licensed
vaccines or other treatments for this disease. We are grateful to
CEPI for their support as we work with our partners to advance
INO-4500."
Dr. Humeau added, "This milestone represents another example of
the progress we are making across INOVIO's infectious disease
portfolio, including our late-stage development efforts with
INO-4800 against COVID-19 as well as advancements with INO-4700
against MERS."
Dr. Melanie Saville, Director of
Vaccine R&D at CEPI, said, "I am delighted to see the rapid
progress in enrollment for this pivotal trial to assess the safety
and immunogenicity of INOVIO's promising Lassa vaccine candidate in
Ghana. At a time when much
scientific attention is drawn towards COVID-19, it is critical that
we continue to progress research against this potentially fatal
disease which affects many countries across the West African
region. Data provided by this study will be critical for assessing
potential of the candidate to advance into late-stage clinical
trials and towards our goal, at CEPI, to get a licensed Lassa
vaccine for use in endemic countries."
Professor Dorothy Yeboah-Manu,
Director of the Noguchi Memorial Institute for Medical Research
(NMIMR) in Ghana, said, "This
achievement is another feather in our cap that goes to demonstrate
the expertise and dedication of the NMIMR in the global fight
against infectious diseases. As a leading biomedical institute in
the West African sub region and considering the public health
importance of Lassa fever in West
Africa, we are happy to be part of INO-4500 development,
indeed the fight against these emerging infections requires us to
work together and we look forward to such further
collaborations."
Professor Kwadwo Koran, the PI
for the Noguchi Memorial Institute for Medical Research site in
Ghana, said, "It has been exciting
working on this trial, a great achievement for the Institute and
the country as whole. Personally, I see this as NMIMR continuing in
the noble ideals of contributing to solutions for public health
problems in the sub region. With the successful enrollment, even
under the trying conditions engendered by the COVID-19 pandemic for
nearly two years now, the Institute and indeed the country as a
whole has demonstrated the capacity to be able to conduct
early-stage trials in support of product development for emerging
and re-emerging diseases such as Lassa Fever. It is my sincere hope
that this will be built upon not only for Lassa Fever but other
important infections that plague us."
About INOVIO's Phase 1B
Clinical Trial for INO-4500
INOVIO's Phase 1B clinical trial,
LSV-002, a randomized, blinded, placebo-controlled dose ranging
study enrolled 220 healthy adult participants between the ages of
18-50 years old, with the primary endpoints of evaluating safety
and immunogenicity profile of INO-4500 DNA vaccine candidate,
administered by intradermal (ID) injection followed by
electroporation (EP) using CELLECTRA™ 2000 device in Ghana. The dosing regimen involved two
intradermal vaccinations at 0 and 28 days with either 1.0 mg or 2.0
mg doses. In addition to providing 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 (NMIMR) 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 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. Of the survivors of
Lassa fever, about one-third have sudden-onset hearing loss, with
more than half of those cases resulting in permanent hearing loss
[Mateer et al. PLoS Negl Trop Dis (2018)].
In addition to funding INOVIO's Lassa vaccine candidate, CEPI
has therefore also created and funded the largest ever Lassa fever
study, named Enable, to provide a more accurate
assessment of the incidence of Lassa fever infections in
West Africa. The Enable
study aims to better understand the rate, location, and spread of
Lassa virus across the region.
Data from CEPI's Enable study will also guide the
location and implementation of future late-stage Lassa vaccine
efficacy trials.
Lassa virus infection in West
Africa is estimated to affect 100,000 to 300,000 people
annually, and it is responsible for 10 – 16% of hospital admissions
in some parts of Liberia and
Sierra Leone [US CDC (2019)]. The
virus is responsible for approximately 5,000 deaths annually [US
CDC (2019)]. Over the last five decades, outbreaks in Nigeria for example have worsened, with
increased frequency and geographic breadth, and during this time a
broader spread has occurred within West
Africa and possibly into West-Central Africa [Agbonlahor et
al. Am J Trop Med Hyg (2021)]. The World Health Organization (WHO)
classifies Lassa virus as one of the pathogens with epidemic
potential to be urgently addressed, thereby making the development
of safe and effective vaccines a global health priority [WHO
(2016)].
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
may be 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 or fatal in others [WHO (undated)]. The case-fatality ratio
(CFR), aka case-fatality rate, among patients hospitalized for
Lassa fever is about 15 – 20%, and, in some epidemics the
case-fatality rate has reached 50% in hospitalized patients
[Brosh-Nissimov Disaster Mil Med (2016)]. The CFR among pregnant
women is particularly high, and in pregnant women infected with
Lassa virus the fetal death rate due to spontaneous abortion rate
is estimated to be extremely high at about 95% [WHO (2017); US CDC
(2014)].
References
Agbonlahor DE, Akpede GO, Happi CT, Tomori O. 52 Years of Lassa
Fever Outbreaks in Nigeria,
1969-2020: An Epidemiologic Analysis of the Temporal and Spatial
Trends. Am J Trop Med Hyg. 2021 Aug 30:tpmd201160. doi:
10.4269/ajtmh.20-1160. Epub ahead of print. PMID: 34460421.
Brosh-Nissimov T. Lassa fever: another threat from West Africa. Disaster Mil Med. 2016 Apr
30;2:8. doi: 10.1186/s40696-016-0018-3. PMID: 28265442; PMCID:
PMC5330145
Centers for Disease Control and Prevention, United States of America. Lassa Fever. 2019.
https://www.cdc.gov/vhf/lassa/index.html [accessed Oct. 13, 2021]
Centers for Disease Control and Prevention, United States of America. Lassa Fever Fact
sheet. 2014. https://www.cdc.gov/vhf/lassa/pdf/factsheet.pdf
[accessed Oct. 13, 2021].
Mateer EJ, Huang C, Shehu NY, Paessler S. Lassa fever-induced
sensorineural hearing loss: A neglected public health and social
burden. PLoS Negl Trop Dis. 2018 Feb 22;12(2):e0006187.
World Health Organization. An R&D Blueprint for Action to
Prevent Epidemics. Plan of Action. May
2016.
World Health Organization. Health Topics -- Lassa Fever.
(undated). https://www.who.int/health-topics/lassa-fever#tab=tab_1
[Accessed Jan. 7, 2021].
World Health Organization. Lassa Fever. 2017.
https://www.who.int/news-room/fact-sheets/detail/lassa-fever
[accessed Oct. 13, 2021].
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 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 therapeutic candidate
VGX-3100 met primary and secondary endpoints for all evaluable
subjects in REVEAL 1, the first of two, Phase 3 trials for
precancerous cervical dysplasia, demonstrating ability to destroy
and clear both high-grade cervical lesions and the underlying
high-risk HPV-16/18. INOVIO is also evaluating INO-4800, a DNA
vaccine candidate against COVID-19, in a Phase 2/3 clinical trial;
the Phase 3 segment of which has received regulatory approvals to
begin in Colombia, Mexico, Brazil and Philippines. INOVIO's partners, Advaccine
Biopharmaceuticals and International Vaccine Institute, are also
evaluating INO-4800 in ongoing clinical trials in China and South
Korea, respectively.
Partners and collaborators include Advaccine, ApolloBio
Corporation, AstraZeneca, The Bill & Melinda Gates Foundation,
Coalition for Epidemic Preparedness Innovations, Defense Advanced
Research Projects Agency/Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense/Department
of Defense, HIV Vaccines Trial Network, International Vaccine
Institute, Kaneka Eurogentec, Medical CBRN Defense Consortium,
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.
For more information, visit www.inovio.com.
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 commercialize DNA medicines, our expectations regarding our
research and development programs, including the planned initiation
and conduct of pre-clinical studies and clinical trials and the
availability and timing of data from those studies and trials, 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 pre-clinical 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 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, 2020 , our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 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
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.
View original
content:https://www.prnewswire.com/news-releases/inovio-completes-enrollment-of-phase-1b-clinical-trial-for-its-dna-vaccine-candidate-against-lassa-fever-ino-4500-in-west-africa-301408429.html
SOURCE INOVIO Pharmaceuticals, Inc.