The Department of Defense this week announced a notable contract award related to the field of chemical, biological, radiological and nuclear (CBRN) defense or life science research of interest for potential applications in biodefense:
Dynport Vaccine Company, LLC, a CSC company, was awarded a $156,621,207.00 cost-reimbursement type contract action for the Development and FDA Licensure of a Bioscavenger Prophylactic.
The countermeasure will increase the likelihood that a Warfighter will maintain operational effectiveness following nerve agent exposure, specifically a drug or biologic intended for use prior to an exposure to nerve agent. It is anticipated that the countermeasure shall decrease incapacitation and death associated with nerve agent poisoning. Specifically, when administered prior to nerve agent exposure, the countermeasure should prevent injury by binding and sequestering or degrading nerve agent in the circulatory system before it can reach the nervous system.
The award was issued by Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division.
The U.S. Army has been researching naturally occurring human enzyme called butyrylcholinesterase for their potential as a chemical agent countermeasure. Nicknamed “BioScavenger,” the enzyme works by capturing the nerve agent as it enters the body, before it can reach its physiological target and negating the danger.
In 2005, the U.S. Department of Defense (DoD) Chemical Biological Medical Systems – Medical Identification and Treatment Systems (CMBS-MITS), building on the work of Army scientists, awarded a contract to DynPort for further advance development of human plasma-derived BioScavenger as a pre-exposure therapeutic, or prophylactic, against chemical nerve agents.
Under this funding effort, DynPort led a collaborative effort with Baxter International, Inc., a leader in the development and manufacturing of plasma-derived therapeutics. Baxter completed process development and manufacturing of a candidate therapeutic to be used in a Phase 1 clinical trial conducted by Dynport. Baxter developed, manufactured, characterized and preclinically tested the candidate protein used in the trial, and served as the Sponsor. Both CBMS-MITS scientists and Baxter personnel were an integral part of the BioScavenger team from the beginning, and worked in concert with DynPort to address program challenges.
The BioScavenger clinical trial material was manufactured using Baxter’s proprietary commercial plasma fractionation process. Phase 1 clinical trials, or “first-in-human” trials of BioScavenger were conducted, testing both intravenous (IV) and intramuscular (IM) routes of administration. While IV administration provides the more rapid response typically needed for post-exposure treatment, IM administration lends itself more readily to the possibility of self-administration, as might be necessary in a combat setting.
Read more at the CSC: Successful Partnership Tests Chemical Defense Countermeasures