NEWS | Feb. 10, 2022

DOD Awards $250 Million Contract to Ology Bioservices, Inc., for Botulinum Monoclonal Antibody Advanced Development through FDA Licensure

On January 5, 2022, the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) awarded Ology Bioservices, Inc. (Ology), a wholly-owned subsidiary of Resilience, a $250 million sole source Federal Acquisition Regulation-based Indefinite Delivery/Indefinite Quantity (IDIQ) contract (W911SR22D0009). Under the contract, Ology will advance the Botulinum Monoclonal Antibody (BOT MAB) product to U.S. Food and Drug Administration (FDA) licensure as a medical countermeasure (MCM), to protect the warfighter from exposure to botulinum neurotoxin (BoNT) A and B serotypes and to subsequently procure the FDA-licensed product. 

The Centers for Disease Control and Prevention (CDC) classifies BoNT as a category ‘A’ threat – one that poses the highest risk to the public due to its extreme potency and lethality, with serotypes A/B being most likely to be engineered into a biological weapon. Through intramuscular administration, the BOT MAB MCM will prevent and reduce disease incidence or progression in adults following exposure to BoNT serotypes A/B.

“There is currently no FDA-approved MCM to act as a pretreatment against BoNT,” said Col. Ryan Eckmeier, the Joint Project Manager for CBRN Medical. “Through this contract’s success, we’ll be able to help protect the warfighter from this deadly biological warfare threat.”

The initial BOT MAB effort was a joint endeavor between the Defense Threat Reduction Agency’s Joint Science and Technology Office for Chemical and Biological Defense (JSTO-CBD) and the Joint Project Lead for Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies (JPL CBRND EB), under the Advanced Development and Manufacturing of Antibody Technologies Advanced Technology Demonstration (ATD). The JPL CBRND EB completed their efforts under the ATD in December 2019, while the JSTO-CBD and the JPM CBRN Medical awarded Ology an other transaction authority (OTA) prototype agreement in May 2020. The joint OTA effort included BOT MAB drug product regulatory, science, and technology development to prepare for entry into advanced development. 

The newly awarded IDIQ contract includes all necessary studies and manufacturing activities to further advance the BOT MAB drug product through regulatory approval for BoNT A/B exposure prophylaxis. The contract has up to 10 performance years for research, development, testing and evaluation (RDT&E) to facilitate advancement to FDA licensure, and to procure the BOT MAB MCM for the Joint Force. 

About the JPM CBRN Medical: The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. The JPM CBRN Medical facilitates the advanced development and acquisition of medical countermeasures and systems to enhance the nation’s biodefense response capability. To learn more about the JPM CBRN Medical, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND. 

About the JPEO-CBRND: The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.


 

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