Ology Bioservices, Inovio Partner To Manufacture COVID-19 DNA Vaccine With $11.9 Million Department of Defense Grant
PR83402
PLYMOUTH MEETING, Pennsylvania and ALACHUA, Florida, March 24, 2020 /PRNewswire=KYODO JBN/ -
Ology Bioservices Inc., a biologics contract development and manufacturing
organization (CDMO), and Inovio Pharmaceuticals Inc., (NASDAQ: INO) developing
DNA medicines for infectious diseases and cancer, announced today that the
Department of Defense (DOD) has awarded Ology Bioservices with a contract
valued at $11.9 million to work with Inovio on DNA technology transfer to
rapidly manufacture DNA vaccines. This work is supported by the Office of the
Assistant Secretary of Defense for Health Affairs with funding from the Defense
Health Agency.
Under this program, Ology Bioservices will work with Inovio Pharmaceuticals to
manufacture Inovio's DNA vaccine (INO-4800) for prevention of infection with
the COVID-19 virus. The aim of the program is to rapidly and efficiently
deliver the vaccine to the Department of Defense for upcoming clinical trials.
Peter H. Khoury, Ph.D., President and Chief Executive Officer of Ology
Bioservices, noted "We are excited to be working with the Department of Defense
and Inovio to rapidly respond to this crisis. The Advanced Development and
Manufacturing Facility operated by Ology Bioservices was designed to respond to
just such emergencies as we are now experiencing, and we are proud to be part
of this effort to protect the U.S. warfighter and the nation."
J. Joseph Kim, Ph.D., Inovio's President and CEO, said, "Along with advancing
INO-4800 through clinical studies as rapidly as possible, Inovio's goal is to
scale up the manufacturing of this vaccine for future studies and for potential
emergency use, if appropriate. Powered by the U.S. Department of Defense
support, Inovio is pleased to partner with Ology to enable rapid response
manufacture of INO-4800 especially for the nation's warfighters and other
military personnel. This DOD-funded partnership is a testament to the
importance and strength of public-private partnerships in meeting the
challenges the world faces with the COVID-19 outbreak. This partnership
increases Inovio's manufacturing capabilities for our COVID vaccine and
establishes an additional DNA vaccine manufacturing facility to protect the
U.S. military against current and future disease outbreaks."
"Given the current global health crisis, prophylaxis/vaccine development is
critical to defend against the coronavirus disease 2019," said Douglas Bryce,
Joint Program Executive Officer for Chemical, Biological, Radiological and
Nuclear Defense. "We need several approaches to ensure we have a quick
solution, and the medical countermeasures Advanced Development and
Manufacturing Facility is poised to contribute to the race for a vaccine in
coordination with our interagency partners like Health and Human Services,
along with our partners in industry and academia."
Matthew Hepburn, M.D., Joint Project Lead CBRN Defense Enabling
Biotechnologies, stated, "We are sincerely optimistic about the partnership
between Inovio and Ology Bioservices, in order to make doses of a vaccine that
could potentially protect our military personnel. It is urgently needed."
About Ology Bioservices Inc.
Ology Bioservices is a privately held, full-service Contract Development
Manufacturing Organization (CDMO) serving both government and commercial
clients, specializing in biologic drug substance manufacturing, from early
stage through commercial product. The company has 183,000 square feet of
manufacturing, process development and QA/QC space in its state-of-the-art,
Department of Defense Advanced Development and Manufacturing Facility in
Florida. The company's infrastructure provides unique services to its clients,
including full regulatory support from preclinical through licensure, clinical
trial operational support and bioanalytical testing, as well as CGMP
manufacturing up to Biosafety Level 3 (BSL3). Ology Bioservices has more than
20 years' experience developing and manufacturing drugs and biologics for the
U.S. Government, with nearly $1B in government contracts awarded to date. The
team at Ology Bioservices has decades of experience manufacturing, developing
and licensing vaccines and protein/antibody therapeutics. For more information,
visit the company's website at www.ologybio.com.
About Inovio Pharmaceuticals
Inovio is a biotechnology company focused on rapidly bringing to market
precisely designed DNA medicines to treat, cure, 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, demonstrated it 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, 90% 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 MERS and COVID-19. Partners and collaborators
include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates
Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense
Advanced Research Projects Agency, GeneOne Life Science, HIV Vaccines Trial
Network, Medical CBRN Defense Consortium (MCDC), National Cancer Institute,
National Institutes of Health, National Institute of Allergy and Infectious
Diseases, Plumbline Life Sciences, Regeneron, 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.
About the JPEO-CBRND
The Joint Program Executive Office for Chemical, Biological, Radiological and
Nuclear Defense is the Joint Service's lead for development, acquisition,
fielding and life-cycle support of chemical, biological, radiological and
nuclear defense equipment and medical countermeasures. As an effective
acquisition program, we put capable and supportable systems in the hands of the
service members and first responders, when and where it is needed, at an
affordable price. Our vision is a resilient Joint Force enabled to fight and
win unencumbered by a chemical, biological, radiological, or nuclear
environment; championed by innovative and state-of-the-art solutions. JPEO
Enabling Biotechnologies (EB) is an organization established for the purpose of
providing medical solutions, during a crisis, against future threats.
[The information contained in this press release does not necessarily reflect
the position or the policy of the U.S. government and no official endorsement
should be inferred.]
CONTACTS
Inovio Pharmaceuticals
Media: Jeff Richardson,
267-440-4211, jrichardson@inovio.com
Investors: Ben Matone,
484-362-0076, ben.matone@inovio.com
Ology Bioservices Inc.
Robert V. House, Ph.D.
Senior VP, Government Contracts
301-276-7851
robert.house@ologybio.com
or
Rx Communications Group, LLC
Melody A. Carey, 917-322-2571
President and Chief Executive Officer
mcarey@rxir.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.
SOURCE: INOVIO Pharmaceuticals, Inc.
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