PLYMOUTH MEETING, Pa.,
April 15, 2021 /PRNewswire/
-- INOVIO (NASDAQ:INO), a biotechnology company focused on
rapidly bringing to market precisely designed DNA medicines to
treat and protect people from infectious diseases, and cancer,
today announced the results of a study focusing on the human immune
responses induced by INOVIO's DNA vaccine candidate for COVID-19,
INO-4800, against variants of concern. The results showed that
INO-4800 induced a robust T cell response against all spike protein
variants tested, which the company believes will be key in
providing protection against SARS-CoV-2 variants, in addition to
providing similar levels of neutralizing activity against both the
UK and Brazilian variants as those against the original strain. The
study, entitled "INO-4800 DNA Vaccine Induces Neutralizing
Antibodies and T cell Activity Against Global SARS-CoV-2 Variants,"
has been submitted for peer review and can be viewed at
https://www.biorxiv.org/content/10.1101/2021.04.14.439719v1.
Dr. J. Joseph Kim, INOVIO's
President & CEO, said, "These results are consistent with our
expectation that INO-4800, which was found to be well-tolerated and
able to produce a balanced immune response in our Phase 1 trial, is
able to generate both neutralizing antibodies and robust T cell
responses – both of which will be essential to protect against the
emerging variants of concern."
Regarding INO-4800 development Dr. Kim said, "We will report
Phase 2 results in 2Q, and, with FDA concurrence, expect to move
into Phase 3 in the second quarter of this year. Our COVID
vaccine's projected safety profile, its stability at room
temperature for more than a year, and likely ability to safely
boost numerous times positions INOVIO's COVID-19 vaccine as an
important factor in addressing the virus in its pandemic and
endemic states."
In the study, clinical samples were collected at varying
timepoints post-immunization from subjects in INOVIO's Phase 1
US-based INO-4800 clinical trial. Antibodies capable of
neutralizing activity were measured against the spike protein
variants tested, including B.1.1.7 (UK variant), B.1.351 (South
African variant) and P.1. (Brazilian variant). The study showed the
T cell responses induced by INO-4800 vaccination were fully
maintained against the UK, South African and Brazilian variants
when compared to the T cell responses to the original Wuhan strain. The neutralization levels of
INO-4800 against South Africa and
UK variants were reduced to the levels similar to the previous
reports of mRNA or viral vector vaccines. Furthermore, despite
recent reports showing a reduction in neutralizing activity against
the Brazilian variant by the mRNA or viral vector vaccines,
INO-4800 generated robust neutralizing antibodies at levels against
Brazilian variant which were comparable to those against the
Wuhan strain. Taken together with
the data showing the maintenance of T cell activity, the results
reported in this study provide a comprehensive overview of
cross-reactive cellular and humoral immune responses against
SARS-CoV-2 variants for INO-4800 vaccinated individuals that may be
important for protection against variant strains of SARS-CoV-2.
Collectively, the studies showcase how the combination of robust
T cell responses in conjunction with neutralizing antibody
responses provide an important defense against both emerging and
potential future viral variants, exhibiting broad protection
against the virus and less impacted by the mutational changes a
virus may undergo.
About INO-4800
INO-4800 is INOVIO's DNA vaccine candidate against SARS-CoV-2,
the novel coronavirus that causes COVID-19. Composed of an
optimized DNA plasmid, INO-4800 is delivered directly into cells in
the body via a proprietary smart device to produce a robust and
tolerable immune response. INO-4800 is the only nucleic-acid based
vaccine that is stable at room temperature for more than a year, at
37o 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 – all of which are important
considerations when preparing for mass immunizations.
About INOVIO's DNA Medicines Platform
INOVIO has 15 DNA medicine clinical programs currently in
development focused on infectious diseases, cancer and
HPV-associated diseases. 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® 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 nucleic acid
approaches, such as mRNA. Once inside the cell, the DNA plasmids
enable the cell to produce the targeted antigen, which is processed
naturally in the cell and triggers the desired T cell and
antibody-mediated immune responses. 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 cold storage or 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 met primary and secondary endpoints for all
evaluable subjects in REVEAL 1, in 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 and 18. INOVIO is also evaluating
INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2
clinical trial in the U.S., as well as Phase 2 trials in
China and South Korea. 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.
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
DNA medicines and in particular our clinical work relating to
INO-4800 and its potential effectiveness against SARS-CoV-2
variants, our expectations regarding our research and development
programs, including the planned initiation and conduct of
preclinical 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 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, 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.