Ology Bioservices Inc., a biologics contract development and manufacturing organization (CDMO), has been awarded a contract to advance development of a cocktail of anti-botulinum neurotoxin monoclonal antibodies (mAb) by the Department of Defense (DOD) through the Joint Science and Technology Office of the Defense Threat Reduction Agency (DTRA) and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). The contract ceiling value is $42.6 million.
In this program, Ology Bioservices will execute a randomized, double-blinded Phase 1 dose-escalation clinical trial of a cocktail of mAb against botulinum neurotoxin serotypes A and B. In addition, the company will further refine the manufacturing process for the mAb as well as conduct nonclinical studies to support advanced development of the product. The candidate was originally developed by Xoma Corporation and later acquired by Ology Bioservices.
Ology Bioservices successfully transferred the technology and manufactured this candidate therapeutic for the DOD under a previous contract awarded in 2017.
“This contract is an important milestone for both Ology Bioservices and the DOD,” said Peter H. Khoury, Ph.D., President and Chief Executive Officer of Ology Bioservices. “Monoclonal antibodies represent an important, innovative option in medical countermeasure development, allowing the DOD to more effectively layer CBRN defense. We are excited to bring this next generation of countermeasure to the clinic.”
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 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 of experience developing and manufacturing drugs and biologics for the U.S. government, with over $1.8 billion in government contracts awarded. 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.
The Defense Threat Reduction Agency enables the Department of Defense, the United States Government, and international partners to counter and deter weapons of mass destruction (WMD) and improvised threat networks.
Countering WMD and improvised threats is a global problem that requires DTRA’s unique global presence and execution capabilities. As a Combat Support Agency, DTRA provides various forms of support to the Combatant Commands (CCMDs) and the military services with both defensive and offensive capabilities. The agency is uniquely prepared to address some of the most immediate, consequential, and non-conventional weapon threats to national security through leveraging and expanding collaboration with interagency and international partners.
As the DoD’s research and development leader focused on WMD and improvised threats, DTRA facilitates innovation through combining traditional research with unconventional means to develop and quickly field solutions to the most complex, deadly and urgent threats facing the United States and the rest of the world.
DTRA has over 2,000 uniformed military personnel and DoD civilians working on every continent except Antarctica. The agency has thousands of global engagements in more than 100 countries and in addition to multiple locations stateside and overseas, the agency has liaisons in many embassies.
About the JPEO-CBRND:
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) is the DOD 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, the JPEO-CBRND puts 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.