PLYMOUTH MEETING, Pa.,
Nov. 30, 2021 /PRNewswire/ -- INOVIO
(NASDAQ:INO), a biotechnology company focused on bringing to market
precisely designed DNA medicines to help protect people from
infectious diseases and treat cancer and HPV-associated diseases,
today announced the company is rapidly moving to evaluate its
COVID-19 DNA vaccine candidates INO-4800 and INO-4802 against the
emerging B.1.1.529 (Omicron) variant of concern. Concurrently,
INOVIO has initiated pre-clinical development of an
Omicron-specific DNA vaccine candidate and will progress if
needed.
The Omicron variant of SARS-CoV-2 is the latest variant to
emerge, following previous variants of concern (VOCs), Alpha, Beta,
Gamma and Delta. Notably, INO-4800 has maintained T cell responses
against these previously identified VOCs as well as the ability to
generate binding and neutralizing antibodies against them.
Generally, T cell immune responses are less likely to be evaded by
multiple mutations, and the ability to generate a strong T cell
response is likely to play a crucial role in reducing mortality and
the severity of symptoms in those infected. More specifically,
Omicron mutations at the T cell level is predicted to be only 2%,
supporting that majority of the T cell epitopes induced by T cell
generating vaccines such as INO-4800 will likely remain capable of
targeting this variant. INOVIO plans to test clinical samples from
our INO-4800 vaccine candidate as well as our Pan-COVID-19 vaccine
candidate INO-4802 against the Omicron variant to assess the
generation of immune responses, with data expected in the coming
weeks.
Dr. J. Joseph Kim, INOVIO's
President and CEO, said, "INOVIO is moving rapidly to test its
COVID-19 vaccine candidates against the emerging Omicron variant.
Both INO-4800, our lead candidate vaccine currently in Phase 3
testing) and INO-4802, our Pan-COVID-19 vaccine candidate, have
maintained T cell responses and generated neutralizing antibodies
against previous SARS-CoV-2 VOCs. In particular, we believe that
INO-4800's ability to generate durable T cell responses, which
could be resilient to changes in the SARS-CoV-2 virus, positions
INO-4800 as a potentially important tool in the U.S. and
international arsenal against both current and future
variants."
Since late 2020, INOVIO has been advancing a comprehensive
strategy to address both existing and new VOCs.
To address the Omicron variant, INOVIO is:
1) Rapidly assessing INO-4800 samples from clinical
trial participants against the Omicron variant using lab-based
read-outs. INOVIO has generated clinical data demonstrating that
immune responses following vaccination with INO-4800 are reactive
to the Alpha, Beta, Gamma and Delta VOCs. INOVIO is working rapidly
to assess the immune responses against the Omicron variant; data
are expected in the coming weeks.
2) Testing INO-4802, a Pan-COVID-19 vaccine
candidate, against Omicron. INOVIO has been proactively developing
INO-4802 as a second-generation Pan-COVID 19 vaccine to potentially
address future variants. Published preclinical data with INO-4802
in multiple animal models revealed both broader and increased
levels of neutralizing antibodies against a panel of variants over
strain-matched vaccines. INOVIO will analyze the preclinical
samples from INO-4802 to assess the immune responses against the
Omicron variant and anticipates data in the coming weeks.
INO-4800 is undergoing Phase 3 evaluations as a 2-dose regimen.
However, given its tolerability and immunologic profile to date, as
well as lack of an anti-vector response, INO-4800 may also serve as
a heterologous booster independent of the primary vaccination
regimen. INO-4800 is composed of a precisely designed DNA plasmid
that is administered intradermally followed by electroporation
using a proprietary smart device, which delivers the DNA plasmid
directly into cells in the dermis of the skin and is intended to
produce a well-tolerated immune response. INO-4800 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. The ability to distribute INO-4800, and to license to
global manufacturers, without the burden and expense of frozen
cold-chain logistics, indicate the suitability of this DNA vaccine
for international deployment at scale.
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 vaccine candidate 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 vaccine
candidate against COVID-19, in a Phase 2/3 clinical trial; the
Phase 3 segment of which has received regulatory authorizations to
proceed in Colombia, Mexico, Brazil, Philippines, India, Thailand, and the
United States. 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, our
ability to successfully manufacture and produce large quantities of
our product candidates if they receive regulatory approval and
planned collaborations with third parties. 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 September 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.
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SOURCE INOVIO Pharmaceuticals, Inc.