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

INOVIO Pharmaceuticals, Inc.

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.

本プレスリリースは発表元が入力した原稿をそのまま掲載しております。また、プレスリリースへのお問い合わせは発表元に直接お願いいたします。

このプレスリリースには、報道機関向けの情報があります。

プレス会員登録を行うと、広報担当者の連絡先や、イベント・記者会見の情報など、報道機関だけに公開する情報が閲覧できるようになります。

プレスリリース受信に関するご案内

SNSでも最新のプレスリリース情報をいち早く配信中