PLYMOUTH MEETING, Pa.,
June 30, 2020 /PRNewswire/
-- INOVIO (NASDAQ:INO), a biotechnology company focused on
rapidly bringing to market precisely designed DNA medicines to
protect and treat people from infectious diseases and cancer, today
announced positive interim clinical data of INO-4800, its vaccine
candidate against novel coronavirus (SARS-CoV-2), from the first
two Phase 1 clinical trial cohorts. In addition, INO-4800 has been
selected to participate in a non-human primate (NHP) challenge
study as part of the U.S. government's Operation Warp Speed, a new
national program aiming to provide substantial quantities of safe,
effective vaccine for Americans by January
2021. Furthermore, INOVIO has expanded its Phase 1 trial to
add older participants in additional cohorts and plans to initiate
a Phase 2/3 efficacy trial this summer upon regulatory
concurrence.
Dr. J. Joseph Kim, President and
CEO of INOVIO, said, "INOVIO would like to thank all of the trial
participants and the investigator staff who have made this trial
possible. We are very encouraged by the positive interim safety and
preliminary cellular and humoral immune response results to date as
well as the inclusion of INO-4800 in Operation Warp Speed. We are
also pleased that INO-4800 vaccination abrogated viral replication
in the lungs of mice challenged with SARS-CoV-2. We look
forward to urgently advancing INO-4800, as it is the only
nucleic-acid based vaccine that is stable at room temperature for
more than a year and does not require to be frozen in transport or
for years of storage, which are important factors when implementing
mass immunizations to battle the current pandemic."
The Phase 1 clinical trial of INO-4800 initially enrolled 40
healthy adult volunteers 18 to 50 years of age at two U.S. sites
with funding from the Coalition for Epidemic Preparedness
Innovations (CEPI). The participants were enrolled into 1.0 mg and
2.0 mg dose cohorts; each participant received two doses of
INO-4800 four weeks apart. Each dose was administered by
intradermal injection using INOVIO's
CELLECTRA® 2000 device. An independent Data Safety
Monitoring Board reviewed the safety data. INO-4800 was generally
safe and well-tolerated in all participants in both cohorts through
week 8; all ten reported adverse events (AEs) were grade 1 in
severity, and most were local injection site redness. There were no
reported serious adverse events (SAEs).
Multiple immunology assays including those for humoral and
cellular immune responses are being conducted for both 1.0 mg and
2.0 mg dose cohorts after two doses at week 6. Analyses to date
have shown that 94% (34 out of 36 total trial participants)
demonstrated overall immunological response rates based on
preliminary data assessing humoral (binding and neutralizing) and T
cell immune responses. One participant in the 1.0 mg dose cohort
and two participants in the 2.0 mg dose cohort were excluded in the
immune analyses as they tested positive for COVID-19 immune
responses at study entry, indicating prior infection. One
participant in the 2.0 mg dose cohort discontinued the study for
reasons unrelated to safety or tolerability. INOVIO plans to
publish the full data set in a peer-reviewed medical journal.
One key feature of INOVIO's DNA vaccines is the ability to
generate balanced antibody and T cell immune responses, which in
the case of SARS-CoV-2 infection could be important in the
development of potential COVID-19 vaccines. In this regard, recent
scientific reports have highlighted that SARS-CoV-2-specific T
cells found in convalescent patients have been positively
implicated in controlling the severity of their COVID-19 disease
(Grifoni et al, Cell 2020) while other studies have shown
that a significant proportion (33% to 40%) of convalescent
individuals in their reports had neutralizing antibody below
detectable levels (Robbiani et al, Nature 2020 and Payne et
al, MMWR 2020).
In addition to positive interim Phase 1 data, INO-4800 has been
shown to protect mice in SARS-CoV-2 viral challenge studies, where
vaccination with INO-4800 prevented viral replication in the lungs
of animals challenged with SARS-CoV-2. Moreover, INO-4800 is
currently being tested in a ferret challenge model as well as in
NHP challenge studies as part of Operation Warp Speed.
"While the pathophysiologic profile of SARS-CoV-2 is not
completely understood, research and clinical studies suggest that
both T cell and antibody immune responses will be important for
protection in both mild and serious infections. Leveraging our
previous expertise in MERS with INO-4700, where we demonstrated
significant antibody and cellular responses, the breadth and
profile of the responses observed to date with INO-4800 targeting
SARS-CoV-2 provide a promising read towards further development and
addressing the existing public health threat," said Dr.
Kate Broderick, Senior Vice
President of R&D at INOVIO.
As previously announced, INOVIO received $71 million funding from the U.S. Department of
Defense to support the large-scale manufacture of the company's
proprietary CELLECTRA® 3PSP smart device and the
procurement of CELLECTRA® 2000 devices. INO-4800
development has also been supported by generous funding from CEPI
and the Bill & Melinda Gates Foundation.
About INO-4800
INO-4800 is INOVIO's DNA vaccine candidate being developed to
protect against the novel coronavirus SARS-CoV-2, which causes
COVID-19. INO-4800 was designed rapidly using INOVIO's proprietary
DNA medicine platform after the publication of the genetic sequence
of the coronavirus that causes COVID-19. INOVIO has extensive
experience working with coronaviruses and is the only company with
a Phase 2 vaccine for a related coronavirus that causes Middle East
Respiratory Syndrome (MERS).
INO-4800 is the only nucleic-acid based vaccine that is stable
at room temperature for more than a year and does not require to be
frozen in transport or storage, which are important factors when
implementing mass immunizations.
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 DoD.
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 intradermally or intramuscularly 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 is
designed to ensure 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
demonstrated in clinical trials.
With more than 2,000 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), GeneOne Life
Science/VGXI, HIV Vaccines Trial Network, International Vaccine
Institute (IVI), 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, Roche/Genentech, 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.
CONTACTS:
|
|
Media:
|
Jeff Richardson,
267-440-4211, jrichardson@inovio.com
|
Investors:
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Ben Matone,
484-362-0076, ben.matone@inovio.com
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This press release contains certain forward-looking
statements relating to our business, including our plans to develop
DNA medicines, our expectations regarding our research and
development programs, including the availability and timing of data
from the company's ongoing Phase 1 clinical trial of INO-4800 and
the company's plans and ability to outsource manufacturing of its
delivery devices to contract manufacturers. 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, 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, our ability to secure
adequate third-party manufacturing resources for the production of
our product candidates, including the transfer of necessary
processes, 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 March 31,
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.