Contact Activation Pathway Function Blocking Antibody AB023

The Defense Health Agency (DHA) is seeking potential qualified offerors to provide the contact activation pathway function blocking antibody AB023, also known as Coagulation Factor XI (FXI) Inhibitor AB023. The antibody should target specific blood clotting factors without increasing the risk of bleeding and should be designed for use in Extracorporeal Membrane Oxygenation (ECMO) circuits, hemodialysis, catheters, and cancer-related thrombosis. The contractor shall conduct pharmacokinetics (PK) testing and pharmacodynamics (PD) analyses on the biochemical, physiological, and molecular effects of the drug. The Government is not obligated to pay for or reimburse any costs associated with responding to this RFI. Some key requirements include: • The antibody should bind to the "apple 2" domain of FXI, inhibiting its activation by activated factor XII (FXIIa) in the "contact pathway" which drives clot formation in artificial surfaces. • The antibody should preserve natural clotting (hemostasis) and not block the activation of FXI by thrombin. • The contractor shall provide a maximum of 0.5g of AB023 each year. • The contractor shall conduct pharmacokinetics (PK) testing to determine its concentration over time and pharmacodynamics (PD) analyses on the biochemical, physiological, and molecular effects of the drug.