PLYMOUTH MEETING, Pa.,
May 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 that its next-generation Pan-COVID-19
vaccine candidate, INO-4802, induced potent neutralizing antibodies
and T cell responses against the original Wuhan strain as well as against B.1.1.7 (UK
variant), B.1.351 (South African variant) and P.1. (Brazilian
variant) in preclinical models. These results demonstrate the
potential of INOVIO's Pan-COVID-19 vaccine to induce cross-reactive
immune responses against current and emerging viral variants as
either a first-line vaccine, or potentially as a boost for
individuals previously immunized with various Wuhan-matched vaccines.
Dr. Laurent M. Humeau, INOVIO's
Chief Scientific Officer, said, "INOVIO is taking a dual-track
approach in developing a COVID-19 vaccine because we recognize the
need to support both pandemic and endemic considerations. In
addition to our work on INO-4800, which we expect to enter a global
Phase 3 trial this summer, we are also developing our
next-generation Pan-COVID-19 variant vaccine, INO-4802, which is
designed to protect against current and potentially future variants
of concern. The study data we report today confirms our two-tiered
development path is the best strategy for the short- and long-term
fight against this virus."
First-generation COVID-19 vaccines were matched against the
original Wuhan strain. These
vaccines may have reduced efficacy against emerging COVID variants.
In response, many of the next-generation vaccines under development
are matched to a single variant currently circulating. INOVIO's
Pan-COVID-19 vaccine approach is designed to provide cross-strain
protection, immune coverage, reduced susceptibility to escape
mutants, and non-restricted geographical use against both known and
potentially unknown variants. Preclinical data with INO-4802 in
multiple models revealed both broader and increased levels of
neutralizing antibodies against a panel of variants than
strain-matched vaccines. Building on this initial work, INOVIO
plans to conduct Phase 1/2 clinical trials this year with
INO-4802.
To create INOVIO's Pan-COVID-19 vaccine candidate, variant
sequences were identified over a four-month period starting in
October 2020 from multiple geographic
regions (Brazil, Canada, India, Italy,
Japan, Nigeria, South
Africa, United Kingdom, and
the United States). Mutations in
the spike sequences were aggregated for each region. The sequence
results from these regions were then further engineered to
determine a common set of overlapping mutations from emerging
variations in the COVID spike protein sequences to generate
INO-4802.
More information from this pre-clinical study can be found in
the paper entitled: "Design and immunogenicity of a
Pan-SARS-CoV-2 synthetic DNA vaccine," which has been published
as a preprint in BioRxiv prior to peer review.
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 U.S.
Department of Defense. 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® 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 ensures 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 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.
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: 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 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 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 March 31, 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.
View original
content:http://www.prnewswire.com/news-releases/inovios-pan-covid-19-vaccine-candidate-ino-4802-induces-broad-immunity-against-major-viral-variants-in-preclinical-studies-301289520.html
SOURCE INOVIO Pharmaceuticals, Inc.