ALACHUA, Fla.–(BUSINESS WIRE)–Ology Bioservices Inc. (Ology Bio), a biologics contract development and manufacturing organization (CDMO), announced today that it has begun dosing volunteers in a Phase 1 clinical trial with ADM03820, a cocktail of anti-SARS-CoV-2 monoclonal antibodies. This trial is part of a Department of Defense (DOD) award to manufacture and test anti-COVID-19 monoclonal antibodies. The study will randomize a total of 40 healthy subjects between the ages of 18-55 to receive either an intramuscular injection or intravenous infusion of either ADM03820 or placebo at two clinical sites.
“As both vaccines and monoclonal antibodies are important in the strategy for reducing the continued spread and related morbidity and mortality of COVID-19, Ology Bio is excited for this product to be entering the clinical trial phase”
“As both vaccines and monoclonal antibodies are important in the strategy for reducing the continued spread and related morbidity and mortality of COVID-19, Ology Bio is excited for this product to be entering the clinical trial phase,” said Peter H. Khoury, Ph.D., President and Chief Executive Officer of Ology Bio.
About Ology Bioservices Inc.
Ology Bio 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 Bio has more than 20 years’ experience developing and manufacturing drugs and biologics for the U.S. government, with more than $1.8 billion in government contracts awarded. The team at Ology Bio 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 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.]
Ology Bioservices Inc.
Robert V. House, Ph.D.
Senior VP, Government Contracts
Surgence Communications Strategies
Wendy Crites Wacker, APR, CPRC