Contact Activation Pathway Function Blocking Antibody AB023
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The Defense Health Agency is conducting a Request for Information (RFI) to gather market intelligence and identify qualified sources for the supply of the contact activation pathway function blocking antibody AB023, also known as Xisomab 3G3 or Gruticibart. This antibody is designed to inhibit Coagulation Factor XI (FXI) by targeting the "apple 2" domain, preventing its activation by activated factor XII (FXIIa) in the contact pathway, which is implicated in clot formation on artificial surfaces. The antibody is intended for use in medical applications such as Extracorporeal Membrane Oxygenation (ECMO) circuits, hemodialysis, catheters, and cancer-associated thrombosis. It is designed to preserve natural clotting processes by not interfering with FXI activation by thrombin or the conversion of Factor IX by activated FXI, thus maintaining normal hemostasis required for wound healing. The Government anticipates procuring up to 0.5 grams of AB023 annually and requires pharmacokinetic and pharmacodynamic testing to assess its concentration over time, biochemical impacts, clotting time effects, and ability to prevent thrombus growth and fibrin accumulation in vascular thrombosis models. Stability, dosage, and potency validations must be conducted using clotting assays. Although this announcement does not represent a solicitation or obligation to award a contract, interested parties with relevant expertise must submit technical information by June 18, 2026. All responders must be registered in the System for Award Management (SAM). The associated NAICS code is 541714, reflecting research and development in biotechnology. The point of contact is based at the Defense Health Agency in Fort Detrick, Maryland, with the place of performance listed in Texas.
General Info
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Place of Performance
DWG, TX, 78234, USASet-Aside
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Full Description
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 any solicitation is issued. No subcontracting opportunity is anticipated. The North American Classification System (NAICS) code for this acquisition is 541714 – Research and Development in Biotechnology (except Nanobiotechnology); (Small Business Size Standard 1,000 employees).
Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM) at www.sam.gov and complete online representations and certification in SAM.
All interested parties shall submit information by email to: william.a.shortall.civ@health.mil, and justin.h.pickett.civ@health.mil to be received no later than 18 June 2026, at 10:00ET.