INOVIO Announces Positive Data from Phase 2 Segment of Clinical Trial Evaluating INO-4800, its COVID-19 DNA Vaccine
PR89430
PLYMOUTH MEETING, Pa., May 10, 2021 /PRNewswire=KYODO JBN/ --
-- INO-4800 was shown to be safe, well-tolerated and immunogenic in all
age groups
-- Phase 2 results informed INOVIO's selection of 2.0 mg dose for the
Phase 3 segment of the trial
-- Data published as a preprint in MedRxiv
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(R), 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 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 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(R) 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 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 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(R). The CELLECTRA(R) 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(R) 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.
Source - INOVIO Pharmaceuticals, Inc.
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