PLYMOUTH MEETING, Pa. and
SEOUL, South Korea, April 28, 2020 /PRNewswire/ -- INOVIO
(NASDAQ:INO) and GeneOne Life Science (KSE:011000) today announced
interim data through week 16 from a Phase 1/2a trial of DNA vaccine
INO-4700 (also called GLS-5300) for MERS coronavirus (MERS-CoV).
Vaccine recipients demonstrated strong antibody and T cell immune
responses after 2 or 3 doses with 0.6 mg of INO-4700, a DNA vaccine
that targets the MERS-CoV Spike (S) glycoprotein, delivered with
intradermal CELLECTRA® device. The vaccination regimen was
well-tolerated with no vaccine-associated severe adverse events
(SAEs). The researchers at the Wistar Institute, Seoul National University Hospital, and the International
Vaccine Institute (IVI) collaborated on this study with funding
from IVI. These results were selected for an oral presentation at
the American Society of Gene & Cell Therapy (ASGCT) Conference
to be held virtually from May 12-15,
2020.
Dr. J. Joseph Kim, INOVIO's
President & CEO, said, "The INO-4700 Phase 1/2a clinical trial
data demonstrates that our MERS DNA vaccine is able to generate
robust immune responses using INOVIO's intradermal CELLECTRA
delivery system. This exciting data provides a great foundation for
the ongoing COVID-19 vaccine advancement as it demonstrates the
power of INOVIO's delivery system and the strength of our
coronavirus experience. As we have designed our COVID-19 vaccine
INO-4800 using the same strategy as INO-4700, including the
selection of full length Spike protein as the target and the use of
intradermal CELLECTRA device, we are hopeful that the ongoing Phase
1 clinical trial with INO-4800 would generate similar clinical
immune responses and safety data as we have just reported for
INO-4700."
Overall, for those receiving 0.6 mg of INO-4700, 88%
demonstrated seroconversion after a 2 dose regimen at 0 and 8
weeks, while for those receiving a 3 dose regimen given at 0, 4 and
12 weeks, 84% seroverted after 2 doses and 100% after 3 doses, as
measured by a binding antibody assay against the full-length S
protein (ELISA). Additionally, 92% of the vaccine recipients in
both groups displayed the ability to neutralize the virus using a
neutralization assay (EMC2012-Vero neutralization). Robust T cell
responses were observed in 60% of vaccine recipients after the 2
dose regimen and 84% of those in the 3 dose group (ELISpot assay).
Interestingly, a single dose of 0.6 mg of INO-4700 intradermal
vaccination resulted in 74% binding antibody response rate and 48%
neutralization antibody response rate.
Dr. Jerome Kim, Director General
of IVI, said, "IVI is pleased to join partners in reporting these
findings as a result of our collaboration in the world's first
vaccine candidate against MERS. These and subsequent clinical
trials could pave the way for accelerated development of a DNA
vaccine against MERS."
This is the 2nd study of INO-4700 (GLS-5300) in a clinical
trial, the first being a 75-person study (MERS-001) of vaccine
administered intramuscularly and followed by electroporation at
either 0.67, 2 or 6 mg. Notably in the MERS-001 study, there was no
significant difference between dose levels and vaccine induced
immune responses were similar to those seen in recovered patients
following natural infection (Lancet Infectious Disease, 2019).
INO-4700 vaccination has previously been shown to provide 100%
protection against MERS virus disease in a pathogenic monkey
challenge model. INOVIO is planning to advance INO-4700 into a
Phase 2 clinical trial in the Middle
East with a previously announced funding of $56 million by the Coalition for Epidemic
Preparedness Innovations (CEPI).
About INOVIO's Global Coalition Advancing INO-4800
INOVIO has assembled a global coalition of collaborators,
partners and funders to rapidly advance INO-4800. R&D
collaborators to date include the Wistar Institute, the
University of Pennsylvania, Université
Laval, and the University of Texas.
INOVIO has partnered with Beijing Advaccine and the International
Vaccine Institute to advance clinical trials of INO-4800 in
China and South Korea, respectively. INOVIO is also
assessing preclinical efficacy of INO-4800 in several animal
challenge models with Public Health England (PHE) and Commonwealth
Scientific and Industrial Research Organization (CSIRO) in
Australia. INOVIO is also working
with a team of contract manufacturers including VGXI, Inc.,
Richter-Helm, and Ology Biosciences to produce one million doses of
INO-4800 by year-end and seeking additional external funding and
partnerships to scale up the manufacturing capacities to satisfy
the urgent global demand for a safe and effective vaccine. To date,
CEPI, the Bill & Melinda Gates Foundation, and the US
Department of Defense have contributed significant funding to the
advancement and manufacturing of INO-4800.
About INO-4800
INO-4800 is INOVIO's DNA vaccine candidate created to protect
against the novel coronavirus SARS-CoV-2, which causes COVID-19.
INO-4800 was designed using INOVIO's proprietary DNA medicine
platform rapidly after the publication of the genetic sequence of
the coronavirus that causes COVID-19. INOVIO has deep experience
working with coronaviruses and is the only company with a Phase 2a
vaccine for a related coronavirus that causes Middle East
Respiratory Syndrome (MERS).
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). 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 demonstrated in
clinical trials.
With more than 2,000 patients receiving INOVIO investigational
DNA medicines in more than 6,000 applications across a range of
clinical trials, INOVIO has a strong track record of rapidly
generating DNA medicine candidates to meet urgent global health
needs.
About GeneOne Life Science
GeneOne Life Science Inc. is an international developer of DNA
and RNA vaccines, nucleic acid-based therapeutics, and small
molecule therapies. GeneOne sponsored the MERS-001 and MERS-002
clinical trials against MERS-CoV and the ZIKA-001 and ZIKA-002
vaccine studies against the Zika virus. GeneOne's research group
has developed DNA vaccines and products to prevent and treat
incurable diseases as well as hematologic diseases, metabolic
diseases, and cancers. GeneOne is a recognized leader in the fight
against Emerging Infectious Diseases (EIDs) with a pipeline to
address a number of pathogenic organisms with a role in numerous
international advisory committees regarding vaccine development
against EIDs. The company is headquartered in Seoul, South Korea. VGXI, Inc., GeneOne's
wholly-owned manufacturing subsidiary, located in Texas, is the leading cGMP DNA plasmid
manufacturing facility in the world for the vaccine, cell therapy,
and gene therapy industries. VGXI has manufactured numerous DNA
vaccines against EIDs including the GLS-5300/INO-4700 and INO-4800
vaccines for MERS-CoV and COVID-19, respectively. For more
information, visit www.genels.com and www.vgxii.com.
About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a nonprofit
inter-governmental organization established in 1997 at the
initiative of the United Nations Development Programme (UNDP).
Headquartered in Seoul, South
Korea, IVI was the first international organization hosted
by Korea. IVI has 35 signatory countries and the World Health
Organization (WHO) on its treaty, including Republic of Korea,
Sweden and India as state funders.
Our mandate is to make vaccines available and accessible for the
world's most vulnerable people. We focus on infectious diseases of
global health importance such as cholera, typhoid, shigella,
salmonella, schistosomiasis, Group A Streptococcus, Hepatitis A,
HPV, TB, HIV, MERS, COVID-19, as well as antimicrobial resistance.
For more information, please visit https://www.ivi.int
About INOVIO
INOVIO is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to potentially treat and
protect people from diseases associated with HPV, cancer, and
infectious diseases. 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, currently in Phase 3 trials for
precancerous cervical dysplasia, destroyed and cleared high-risk
HPV 16 and 18 in a Phase 2b clinical
trial. High-risk HPV is responsible for 70% of cervical cancer, 91%
of anal cancer, and 69% of vulvar cancer. Also in development are
programs targeting HPV-related cancers and a rare HPV-related
disease, recurrent respiratory papillomatosis (RRP);
non-HPV-related cancers glioblastoma multiforme (GBM) and prostate
cancer; as well as externally funded infectious disease DNA vaccine
development programs in Zika, Lassa fever, Ebola, HIV, and
coronaviruses associated with MERS and COVID-19 diseases. 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)/Department of Defense (DOD), GeneOne Life
Science/VGXI, HIV Vaccines Trial Network, International Vaccine
Institute (IVI), Medical CBRN Defense Consortium (MCDC), National
Cancer Institute, National Institutes of Health, National Institute
of Allergy and Infectious Diseases, Ology Bioservices, Plumbline
Life Sciences, Regeneron, Richter-Helm, Roche/Genentech,
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
DNA medicines, our expectations regarding our research and
development programs, as well as commercialization activities,
including the planned initiation and conduct of clinical trials,
the availability and timing of data from those trials and our
commercialization strategy and tactics. Actual events or results
may differ from the expectations set forth herein as a result of a
number of factors, including uncertainties inherent in preclinical
studies, clinical trials, product development programs and
commercialization activities and outcomes, 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 vaccines, our ability to
support our pipeline of SynCon® active immunotherapy and vaccine
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, 2019, 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.