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Ology Bioservices, Inovio Partner To Manufacture COVID-19 DNA Vaccine With $11.9 Million Department of Defense Grant

March 24, 2020

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.

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