PLYMOUTH MEETING, Pa. and
ALACHUA, Fla., March 24, 2020 /PRNewswire/ -- 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.
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SOURCE INOVIO Pharmaceuticals, Inc.