PLYMOUTH MEETING, Pa.,
Sept. 8, 2020 /PRNewswire/
-- INOVIO (NASDAQ:INO), a biotechnology company focused on
bringing to market precisely designed DNA medicines to treat and
protect people from infectious diseases and cancer, today announced
that Thermo Fisher Scientific, the world leader in serving science,
has signed a letter of intent to manufacture INOVIO's DNA COVID-19
vaccine candidate INO-4800.
Thermo Fisher joins other
contract development and manufacturing organizations in INOVIO's
global manufacturing consortium, enabling INOVIO to potentially
scale commercial production of INO-4800. With its consortium of
third-party manufacturers, INOVIO plans to have 1001
million doses of INO-4800 manufactured in 2021, subject to FDA
approval of INO-4800 for use as a COVID-19 vaccine. Thermo Fisher plans to manufacture INO-4800 drug
substance as well as perform fill and finish of INO-4800 drug
product at its commercial facilities in the US. At peak capacity,
Thermo Fisher projects that it could
produce at least 100 million doses of INO-4800 annually.
"INOVIO welcomes Thermo Fisher to
our global consortium of commercial scale vaccine manufacturers and
we look forward to partnering with them on this critically
important endeavor," said Dr. J. Joseph
Kim, INOVIO's President & Chief Executive Officer.
"Thermo Fisher's global capabilities
and scale will be central to our production progress – the
organization's commitment to quality, reliable production will be
key to our ability to meet the urgent, global demand for a safe and
effective vaccine against COVID-19."
Leon Wyszkowski, President,
Commercial Operations for Thermo
Fisher's Pharma Services business, said, "INOVIO has truly
embraced the value of our end-to-end capabilities – starting with
our initial work on clinical trials through supporting their
commercial needs today. We remain extremely well-positioned to
support INOVIO on its mission to manufacture 100 million doses of
vaccine in 2021."
"INOVIO is very excited to partner with Thermo Fisher for the manufacture of DNA plasmid
drug substance and drug product," said Robert J. Juba Jr., INOVIO's Vice President of
Biological Manufacturing and Clinical Supply Management.
"Thermo Fisher provides an
end-to-end solution for manufacturing, labeling, packaging and
distribution that we believe will help us to provide hundreds of
millions of doses of INO-4800 to the US and the rest of the
world."
Thermo Fisher Scientific will join existing partners
Richter-Helm BioLogics and Ology Biosciences in INOVIO's global
manufacturing consortium. INOVIO is in active discussions with
additional manufacturers to join the consortium as INOVIO seeks to
complement its existing members with additional manufacturing
partnerships to meet global supply needs. Having multiple
manufacturers involved in the production of INO-4800 is intended to
support timely, cost-effective and scalable production of this
DNA-based vaccine. INOVIO's third-party manufacturers will produce
the patent-protected formulation for INO-4800, developed to enhance
stability of the vaccine with a favorable tolerability profile.
Importantly, INO-4800 has shown an excellent thermo-stability
profile. INOVIO's other platform DNA vaccine candidates have
demonstrated a shelf life of greater than 5 years when refrigerated
and stability for more than 30 days at 37 degrees Celsius, and more
than one year at room temperature. INOVIO's candidates also do not
need to be frozen during transport or storage, a vital factor when
implementing immunizations on a global scale. INO-4800 is
administered via INOVIO's proprietary CELLECTRA® smart
delivery device, which delivers the vaccine locally into the
patient's skin, a process that takes only a few seconds.
INOVIO is conducting a Phase 1 clinical trial of INO-4800 in
the United States and has
submitted the full trial results for the first 40 subjects for
publication in a peer-reviewed journal. The company plans to
initiate its Phase 2/3 COVID-19 vaccine trials in September,
subject to FDA clearance to proceed.
Earlier this summer, INOVIO received $71
million in funding from the U.S. Department of Defense (DoD)
to support the large-scale manufacture of the company's proprietary
CELLECTRA® 3PSP and the procurement of
CELLECTRA® 2000 devices. The DoD contract builds upon
two separate prior $5 million grants
from the Bill & Melinda Gates Foundation and the Coalition for
Epidemic Preparedness Innovations (CEPI), to accelerate the testing
of CELLECTRA® 3PSP. Initial development of this next
generation CELLECTRA® 3PSP smart device began in 2019
with $8.1 million in funding from the
medical arm of the U.S. Defense Threat Reduction Agency's Medical
CBRN Defense Consortium.
About INOVIO's Global Coalition Advancing INO-4800
INOVIO has assembled a global coalition of collaborators,
partners and funders to rapidly advance the development of
INO-4800. R&D collaborators to date include the Wistar
Institute, the University of
Pennsylvania, the University of
Texas, Fudan University and Laval
University. INOVIO has partnered with Advaccine and the
International Vaccine Institute to conduct 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 working with
a team of contract manufacturers including Thermo Fisher
Scientific, Richter-Helm BioLogics, and Ology Biosciences to
manufacture INO-4800 on a commercial scale and is seeking
additional external funding and partnerships to further scale up
manufacturing capacities to satisfy the urgent global demand for
safe and effective vaccines. To date, the Coalition for Epidemic
Preparedness Innovations (CEPI), the Bill & Melinda Gates
Foundation, and the U.S. 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 intended to protect
against the novel coronavirus SARS-CoV-2, which causes COVID-19.
INOVIO has extensive experience working with coronaviruses and was
the first company with a Phase 2 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) 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
simple-to-use CELLECTRA device provides a brief electrical pulse to
reversibly open small pores in the local skin area cells resulting
in more than a hundred-fold increase in product delivery providing
dose sparing and consistency. Once inside the cell, the DNA
plasmids instruct the cell to produce the targeted antigen. The
antigen is processed naturally in the cell and triggers a specific
T cell and antibody-mediated immune responses. Administration with
the CELLECTRA device, which takes only a few seconds, is
designed to ensure 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 are transient, and 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 consistent immune response, safety profile, and
tolerability that have been observed in clinical trials with
multiple products.
With more than 2,000 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 an
efficacious, 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)/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), 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, Roche/Genentech, Thermo Fisher Scientific, University of Pennsylvania, VGXI, 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 manufacture 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 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, our
Quarterly Report on Form 10-Q for the quarter ended June 30, 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.
1 1 mg dose equivalent
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SOURCE INOVIO Pharmaceuticals, Inc.