PLYMOUTH MEETING, Pa.,
Oct. 12, 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 the online preprint publication in
MedRxiv of Phase 1 clinical data on homologous boosting of
its COVID-19 DNA vaccine candidate, INO-4800.
The paper, titled "SARS-CoV-2 DNA Vaccine INO-4800 Induces
Durable Immune Responses Capable of Being Boosted in a Phase 1
Open-Label Trial," found that among the full Phase 1 cohort of 120
participants – of which 82.5%, or 99 participants, received a
booster (or third) dose – INO-4800 produced robust immune responses
and was well-tolerated as both a two-dose series and as a
homologous booster dose in all adults, including participants 65
years of age and older. Of note, a durable antibody response was
observed six months following the second dose, and a homologous
booster dose administered 6 to 10.5 months following the second
dose also significantly increased antibody and T cell responses.
INO-4800 was well-tolerated, with no treatment-related serious
adverse events reported. Most adverse events were mild in severity
and did not increase in frequency with age and subsequent
dosing.
Dr. J. Joseph Kim, President and
CEO of INOVIO, said, "We are pleased to share the clinical data on
the homologous boosting of INO-4800, as well as for our full Phase
1 cohort. As much of the world's population remains unvaccinated
and susceptible to COVID-19, there remains an urgent need for
additional safe and effective vaccines that are affordable,
scalable and can be distributed to countries where the
infrastructure may not be supportive of ultra-cold chain transport
and storage. We believe that INO-4800, if approved, will be well
suited to support the continued fight against COVID-19 – both as a
primary vaccination and as a booster. We look forward to
contributing to the international public health knowledge base via
our global Phase 3 clinical trial."
The detailed trial write-up can be found
at: medRxiv.org - the preprint server for Health Sciences.
The newly reported results are consistent with previously
shared data from the Phase 2 segment of INOVIO's INNOVATE
clinical trial. Advancing in its efforts in the fight against
COVID-19, INOVIO, with partner Advaccine, recently
announced that it has received regulatory authorization from
Mexico, Brazil, Colombia, and the
Philippines to proceed with the global Phase 3 segment of
INNOVATE.
INOVIO also announced in August that it had received the
authorization from China to
proceed with two Advaccine-sponsored clinical trials investigating
the safety, tolerability, and immunogenicity of heterologous boost
combinations with INO-4800 and an inactivated COVID vaccine.
About INO-4800
INOVIO's DNA vaccine candidate against SARS-CoV-2, INO-4800, is
composed of a precisely designed DNA plasmid that is injected
intradermally followed by electroporation using a proprietary smart
device, which delivers the DNA plasmid directly into cells in the
body and is intended to produce a well-tolerated immune response.
As one of the only nucleic-acid based vaccines that is stable at
room temperature for more than a year, at 37°C for more than a
month, has a five-year projected shelf life at normal refrigeration
temperature and does not need to be frozen during transport or
storage, INO-4800 is anticipated to be well-positioned for first-in
line usage as well as for boosting.
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 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 efficacy
segment of which has received regulatory approvals to begin in
Mexico, Brazil, Colombia, and the
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 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.