PLYMOUTH MEETING, Pa.,
April 30, 2020 /PRNewswire/
-- INOVIO (NASDAQ:INO) today announced it has entered into an
agreement to expand its manufacturing partnership with the German
contract manufacturer Richter-Helm BioLogics GmbH & Co. KG, to
support large-scale manufacturing of INOVIO's investigational DNA
vaccine INO-4800, which currently is in Phase 1 clinical testing in
the U.S. for COVID-19 and could potentially advance to Phase 2/3
efficacy trials this summer. The agreement is being partly funded
by an initial grant of $1.3 million
from the Coalition for Epidemic Preparedness Innovations (CEPI),
which brings CEPI's total support to date for the development of
INO-4800 to $17.2 million.
"We are grateful to CEPI for its continued generous funding and
pleased to expand our work with Richter-Helm BioLogics to support
large-scale manufacturing capacity for INO-4800," said INOVIO's
President & CEO, Dr. J. Joseph
Kim. "Richter-Helm has deep experience working with our
optimized DNA plasmids, which are the building blocks of our DNA
vaccines, and have consistently produced DNA medicines of the
highest quality under stringent GMP standards."
INOVIO has been working with Richter-Helm BioLogics, which
manufactures INOVIO's DNA medicine candidate VGX-3100, since 2014.
Currently, VGX-3100 is in Phase 3 clinical trials for the treatment
of precancerous cervical dysplasia caused by high-risk human
papillomavirus (HPV). INOVIO has established commercial-scale
plasmid production at Richter-Helm BioLogics for its DNA medicines
platform, with successful technology transfer already demonstrated
for VGX-3100 and an Advanced Therapy Medicinal Product (ATMP)
certification granted by the European Medicines Agency (EMA) in
May 2019.
"Richter-Helm BioLogics has a strong, long-standing relationship
with INOVIO and is a leading manufacturer of DNA plasmids," said
Richter-Helm BioLogics' Managing Director Dr. Kai Pohlmeyer. "We will mobilize all our
resources to ensure sufficient supply of late-stage clinical and
commercial batches of INO-4800 and contribute to the fight against
the deadly COVID-19 pandemic."
INOVIO plans to produce one million doses of INO-4800 by the end
of 2020. Additional capacity provided by Richter-Helm will
significantly expand manufacturing of this DNA vaccine candidate to
meet urgent needs in the midst of the pandemic.
"Having a trusted and proven partner with extensive experience
manufacturing INOVIO's DNA medicines is critical as we scale up our
INO-4800 production," said Robert
Juba, INOVIO's vice president of Biological Manufacturing
and Clinical Supply Management. "We look forward to continue to
work closely together in our efforts to reduce the worldwide impact
of COVID-19."
Richter-Helm Biologics is using manufacturing technology
developed by VGXI Inc., a wholly owned subsidiary of GeneOne Life
Science (KSE:011000} and INOVIO's contract manufacturer for
early-stage clinical trial supply, under a license agreement from
VGXI. Richter-Helm BioLogics will transfer and rapidly scale up the
current (400 L scale) production process for the INO-4800 DNA
plasmid from VGXI. Richter-Helm BioLogics and VGXI already share a
long-term partnership that has resulted in numerous joint projects
and project transfers followed by plasmid DNA production for
commercial supply at Richter-Helm BioLogics´ facilities, including
the technology transfer and Phase 3 manufacturing for VGX-3100.
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 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, including the planned initiation and conduct
of clinical trials, and the availability and timing of data from
those trials. 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, 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 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.