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 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.”
- 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.”
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.
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.
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.