PLYMOUTH MEETING, Pa.,
May 10, 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 positive safety, tolerability and
immunogenicity data from its placebo-controlled and blinded Phase 2
segment of its Phase 2/3 clinical trial in the U.S., called
INNOVATE (INOVIO INO-4800 Vaccine Trial
for Efficacy), evaluating INO-4800, its DNA vaccine
candidate for COVID-19. Preliminary results show in a larger
population that INO-4800 was generally safe, well-tolerated and
immunogenic in all studied age groups.
Findings from the Phase 2 Clinical Trial:
- The Phase 2 segment of the trial enrolled approximately 400
participants, 18 years of age or older, at 16 U.S. sites.
- Participants received either INO-4800 (1.0 mg or 2.0 mg dose)
or placebo at 0 and 4 weeks (randomized 3:3:1:1). Each dose was
administered by intradermal injection followed by electroporation
using INOVIO's CELLECTRA®, its proprietary smart
device.
- Safety endpoints included systemic and local administration
site reactions through 8 weeks post-dose one (or 4 weeks post-dose
2). Immunology endpoints included antigen-specific binding antibody
titers, neutralization titers, and antigen-specific
interferon-gamma (IFN-γ) cellular immune responses after two doses
of the vaccine.
- Vaccine administration was generally safe and well-tolerated.
The majority of adverse events (AEs) were Grade 1 and Grade 2 in
severity and did not appear to increase in frequency with the
second dose. The number of participants experiencing each of the
most common AEs did not differ between the two dosing groups.
- The geometric mean fold rise (GMFR) of binding and neutralizing
antibody levels were statistically significantly greater in the 2.0
mg dose group versus the 1.0 mg dose group.
- The T cell immune responses measured by the ELISpot assay were
also higher in the 2.0 mg dose group compared to the 1.0 mg dose
group.
- ClinicalTrials.gov identifier: NCT04642638
The Phase 2 segment of INNOVATE was designed to evaluate the
safety, tolerability and immunogenicity of INO-4800 in a two-dose
regimen (1.0 mg or 2.0 mg) in a three-to-one-randomization to
receive either INO-4800 or placebo for each dose to identify
optimal dose(s) for two age groups (18-50 years and 51 years and
older) for the subsequent Phase 3 efficacy evaluation. The
preliminary Phase 2 results showed that INO-4800 was safe,
well-tolerated and immunogenic in all tested age groups. The
trial was funded by the Department of Defense Joint Program
Executive Office for Chemical, Biological, Radiological and Nuclear
Defense, (JPEO-CBRND) in coordination with the Office of the
Assistant Secretary of Defense for Health Affairs (OASD(HA)) and
the Defense Health Agency. Results from the trial can be found in
the paper entitled "Safety and immunogenicity of INO-4800 DNA
vaccine against SARS-CoV-2: A Preliminary Report of a Randomized,
Blinded, Placebo-controlled, Phase 2 Clinical Trial in Adults at
High Risk of Viral Exposure," has been published as a pre-print
in MedRxiv (https://doi.org/10.1101/2021.05.07.21256652) prior
to peer review.
Dr. Laurent M. Humeau, INOVIO's
Chief Scientific Officer, said, "We thank the volunteers who are
participating in our INNOVATE Phase 2 blinded trial, as well as the
research partners, clinical teams and INOVIO employees who have
been working tirelessly to advance this important work. Our Phase 2
results validate our initial COVID-19 Phase 1 results in a larger
population, which show that INO-4800 continues to be generally
safe, well-tolerated and immunogenic in all studied age groups. The
expanded data set enabled a clear dose selection to be made with
2.0 mg as the dose for the global Phase 3 efficacy trial."
INOVIO plans to file preliminary Phase 2 results and device data
with the U.S. Food and Drug Administration (FDA). Following the
submission and FDA concurrence to proceed, the company plans to
conduct a global Phase 3 clinical trial for INO-4800. The company
recognizes the growing and unmet global demand for both initial as
well as boosting doses of COVID-19 vaccines and looks forward to
supporting the rollout of much needed additional vaccines to
prevent the spread of COVID-19 – including both current and future
variants – around the world.
About the INO-4800 "INNOVATE" Phase 2/3 Clinical
Trial
The lead Principal Investigator for the Phase 2 segment of
INNOVATE is Dr. Pablo Tebas,
Professor of Medicine at the Hospital of the University of Pennsylvania. The Phase 2 clinical
trial is designed to evaluate safety, tolerability and
immunogenicity of INO-4800 in a 2-dose regimen (1.0 mg or 2.0 mg),
in a three-to-one randomization to receive either INO-4800 or
placebo, to confirm the more appropriate dosing level for each of
three age groups (18-50 years, 51-64 years and 65 years and older)
for the subsequent Phase 3 efficacy evaluation.
The Phase 3 segment of the INNOVATE trial in the U.S. remains on
partial clinical hold until INOVIO satisfactorily resolves the
FDA's remaining questions related to the CELLECTRA® 2000
device that will be used to deliver INO-4800 into the cells of the
skin. The company plans to satisfy the remaining device questions
during the Phase 2 segment and prior to the start of the Phase 3
segment of INNOVATE. In the Phase 3 segment of the trial, INOVIO
intends to enroll men and non-pregnant women 18 years and older, to
evaluate the efficacy of the proposed dosing level(s) for each age
group based on the data from the Phase 2 evaluation. The trial will
predominately be conducted globally; participants will be enrolled
in a two-to-one randomization to receive either INO-4800 or a
placebo. The Phase 3 segment will be case-driven with the final
number of enrollees to be determined by the incidence of COVID-19
during the Phase 3 segment. The primary endpoint of the Phase 3
segment will be virologically-confirmed COVID-19 disease.
About INO-4800
INO-4800 is INOVIO's DNA vaccine candidate against SARS-CoV-2,
the novel coronavirus that causes COVID-19. INOVIO has extensive
experience working with coronaviruses and was the first company to
initiate a Phase 2a trial for INO-4700, a DNA vaccine candidate for
a related coronavirus that causes Middle East Respiratory Syndrome
(MERS).
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, safe 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 37oC 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 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.
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 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.