Contact Activation Pathway Function Blocking Antibody AB023view on SAM.gov

Request for Information Notice HT9426-26-RFI-WS03 for Contact Activation Pathway Function Blocking Antibody AB023 This is a REQUEST FOR INFORMATION (RFI) ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this RFI must be in writing. The purpose of this RFI announcement is to conduct market research to make appropriate acquisition decisions and to gain knowledge of potential qualified offerors interested and capable of providing the contact activation pathway function blocking antibody AB023 described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area of expertise and experience to compete for the acquisition. The Defense Health Agency (DHA), Defense Health Agency Contracting Activity (DHACA), 808 Schreider Street, Fort Detrick, MD 21702, is seeking potential qualified offerors to provide contact activation pathway function blocking antibody AB023: Coagulation Factor XI (FXI) Inhibitor AB023 (Xisomab 3G3 / Gruticibart) Shall target specific blood clotting factors without increasing the risk of bleeding Shall 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 Shall be designed for use in Extracorporeal Membrane Oxygenation (ECMO) circuits, hemodialysis, catheters, and cancer-related thrombosis Shall preserve natural clotting (hemostasis) Shall not block the activation of FXI by thrombin Shall not block the conversion of Factor IX by activated Factor XI (FXIa), which allows it to preserve the necessary hemostatic function of FXI activation by thrombin required for normal wound healing Shall provide a maximum of 0.5g of AB023 each year 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 Shall cause a dose-dependent prolongation of the activated partial thromboplastin time (aPTT), measures how long it takes for blood to clot Shall not affect Prothrombin Time (PT), a blood test that measures how many seconds it takes for blood to clot Shall be effective at preventing platelet-rich thrombus growth and fibrin accumulation in vascular thrombosis models Shall be validated by using clotting assays to ensure stability, dose and potency The Government is not obligated to, nor will it, pay for or reimburse any costs associated with responding to this RFI. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if an…