SAM #HT9426-26-RFI-WS03

DHA RFI for AB023 (Xisomab 3G3 / Gruticibart) Contact Pathway Blocking Antibody

The Defense Health Agency (DHA) is seeking market information for a specialized antibody to inhibit blood clotting via the contact activation pathway. - Government Buyer: - Defense Health Agency (DHA), Contracting Activity, Fort Detrick, MD - OEMs and Vendors: - AB023 (Xisomab 3G3 / Gruticibart) is the only specified product; no other OEMs or vendors are named - Products/Services Requested: - Contact activation pathway function blocking antibody: AB023 (Xisomab 3G3 / Gruticibart) - Quantity: Up to 0.5g annually - Must inhibit Factor XI (FXI) activation in the contact pathway without increasing bleeding risk - Must bind to the 'apple 2' domain of FXI - Suitable for use in ECMO circuits, hemodialysis, catheters, and cancer-related thrombosis - Must preserve natural clotting, not block FXI activation by thrombin, and allow normal wound healing - Must be validated by clotting assays, support PK/PD testing, and demonstrate specific effects on aPTT and PT - Unique/Notable Requirements: - Product must be validated for its specific mechanism of action and safety profile - Intended for highly specialized clinical and research applications - No alternative products or generics are referenced

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.

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