Assessment of Host-targeted Nanobody Therapeutics

Closed Pre-Solicitation Posted

Solicitation number
HT942626QE003
Agency
Not on record
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Frederick, Maryland 21701, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The U.S. Army Medical Research of Infectious Diseases (USAMRIID) and Defense Health Agency (DHA) laboratories are seeking capabilities assessments for host-targeted nanobody therapeutics designed to facilitate the treatment of neurotropic viral pathogens by overcoming blood-brain barrier (BBB) penetration challenges. This Request for Information (RFI) is a pre-solicitation notice intended to gather information about potential contractor capabilities rather than solicit formal proposals at this time. Key objectives include developing and refining in vitro BBB models, characterizing porcine BBB arenavirus infection models, determining nanobody transmigration mechanisms, and establishing a marmoset BBB model to evaluate therapeutic efficacy. Interested parties must submit a capabilities statement not exceeding three pages in 12-point Microsoft Office format via email to the designated points of contact, Mr. Grant A. Gratton (grant.a.gratton.civ@health.mil) or Emily O'Hara (emily.k.ohara.civ@health.mil), no later than 10:00 AM ET on Wednesday, January 21, 2026. This RFI is issued solely for information and planning purposes and does not constitute a binding solicitation, meaning responses will not be accepted as offers and responders are responsible for all associated costs.

The contract opportunity carries no small business set-aside designation and represents a five-year Indefinite Delivery/Indefinite Quantity (IDIQ) vehicle, though specific award values or budget ranges are not disclosed in the pre-solicitation notice. No incumbent contractor information or current award values have been identified in the available documentation. Contractors will be expected to deliver comprehensive technical reports, study protocols, integrated master schedules, quarterly task status reports, and final study reports demonstrating baseline transmigration efficiencies for both non-targeted and BBB-targeted nanobody therapies. The work encompasses both technical assessment activities and subject-matter expertise provision to USAMRIID, requiring specialized knowledge in virology, pharmacology, and blood-brain barrier biology. The classified NAICS code 541715 (Research and Development in Physical, Engineering, and Life Sciences) and PSC code AJ11 (General Science and Technology R&D Services) indicate this is a research and development contract focused on basic scientific investigation.

Notice text

2 versions

Update #2 · Latest ·

 Request for Information (RFI)

Title:  Assessment of Host-targeted Nanobody (USAMRIID)

Notice Type: Request for Information (RFI)

Response Date:  21 January 2026

Requiring Activity/Agency Name:  U.S. Army Medical Research of Infectious Diseases (USAMRIID) and all other Defense Health Agency (DHA) labs

RFI INSTRUCTIONS:

Interested parties are asked to respond to this RFI and submit a capabilities statement that supports the focus of this RFI.  Please review the place of performance requirements. Please submit written responses via email in Microsoft Office 2000 or 2007 format.  All responses should be complete: in 12-point font; and not to exceed 3 pages total, including graphics, tables, and appendices.

No hard copies shall be accepted. No written solicitation document is available at this time. Telephone requests will not be honored, and no bidders list shall be maintained. No inquiries regarding any potential future acquisition activities shall be entertained.

Potential offerors are requested to direct all questions via email to the Point of Contact listed below. Responses are due to the Point of Contact, Mr. Grant A. Gratton at email:  grant.a.gratton.civ@health.mil or Emily O’Hara   emily.k.ohara.civ@health.mil no later than 10:00AM ET, Wednesday, 21 January 2026.[EC1] 

DISCLAIMER:  This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any kinds of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned.

 All information received in response to this RFI will be treated as business confidential information. Submitters should properly mark their responses if the information is confidential. All information received in response to this RFI that is marked Proprietary will be handled accordingly.

1.  PURPOSE

The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to evaluate host-targeted nanobody therapeutics using established in vitro porcine blood brain barrier (BBB) models and to develop novel in vitro BBB models useful for further characterization of nanobody therapies as defined in this Statement of Objectives (SOO) except for those items specified as government furnished property and services.  The Contractor shall perform to the standards in this contract.

2.  BACKGROUND

USAMRIID works closely with other U.S. Army Medical Research and Development Command (USAMRDC) organizations, Department of War (DoW), the Interagency (including Interagency Laboratories), and private companies to accomplish its mission of protecting the Warfighter from biological threats and being prepared to investigate disease outbreaks or threats to public health.

Defense Health Agency Contracting Activity (DHACA)  and USAMRIID shall issue task orders against this proposed Indefinite Delivery/Indefinite Quantity (IDIQ). Each task order will define the deliverables for each task.  Each task order shall represent a Firm-Fixed-Price response to a DHACA issued Assessment of Host-targeted Nanobody Therapeutic request to evaluate host-targeting nanobody therapies for their ability to bind to and traffic across in vitro BBB models, and potentially other tissue model systems, and shall represent all personnel and materials required to provide a turnkey solution to the Government’s requirement as defined in the SOO.

Numerous neurotropic viral families are considered high priority pathogens to the DoW, but therapeutic development is stymied by the difficulty of trafficking into the Central Nervous System (CNS). This is mediated primarily by BBB tight junctions that prevent large molecule entry into the parenchymal space. However, the CNS has significant physiological needs in the form of energy, oxygen and other molecular components. BBB transporters, receptors and ion channels regulate this via either non-specific transcytosis, specific carrier-mediated transport (CMT) or receptor-mediated transcytosis (RMT). As part of a Defense Threat Reduction Agency (DTRA) funded effort to address these challenges, we will target various transporters expressed on the luminal side of the BBB with host-targeting nanobodies to transport molecules on a blood-to-brain directional gradient for therapeutic payload delivery. To provide multiple shots on goal, we aim to develop nanobodies against a diverse set of BBB transporters with a range of species-specificities to identify the optimal targeting strategy in the context of neurotropic viral infections. Via this IDIQ, we will contract out the in vitro BBB modeling assessment of host-targeting nanobodies and refinement of in vitro and in vivo evaluation systems that will be leveraged in outyears to down-select optimal host-targeting nanobody candidates for continued development.

3. SCOPE OF EFFORT

The Government intends to award an IDIQ contract for the assessment of host-targeting nanobody therapies (to be provided to the performer by USAMRIID) using in vitro BBB models. These services include but are not limited to the characterization of porcine BBB arenavirus infection models, determining the mechanism of nanobody transmigration across the BBB, and establishment and characterization of a marmoset BBB model. Each task order is unique in scope and will require flexibility in design, schedule, and execution, details of which will be specified for each task order.

  • The Contractor shall refine in vitro BBB models for the assessment of nanobody therapeutic transmigration in the context of viral infection. The Contractor, as subject matter experts on the in vitro BBB model and virologic assessment, shall utilize applicable technical methods to assess in vitro BBB models following infection with a pathogen of interest to characterize BBB targets for prioritization. Contractor shall deliver a comprehensive report detailing the technical methods used and the targets identified.
  • The Contractor shall utilize applicable technical methods to establish baseline transmigration efficiencies for non-targeted nanobody therapies. Contractor shall deliver a comprehensive report establishing baseline transmigration efficiencies, detailing the methods, data, and analysis used.
  • The Contractor shall utilize applicable technical methods to assess transmigration efficiencies for BBB-targeted nanobody therapies. Contractor shall deliver a comprehensive report assessing transmigration efficiencies, detailing the methods, data, and analysis used.
  • The Contractor shall utilize applicable technical methods to establish a BBB model of NHP origin, providing a species-relevant model for human BBB-targeted nanobody therapy assessment. Contractor shall deliver a validated BBB model and a detailed characterization report. Validation criteria must be pre-approved by the  Technical Representative.
  • The Contractor shall work with USAMRIID to provide subject-matter expertise on in vitro BBB models and advise on optimal targets for BBB targeting nanobody therapeutics. Contractor shall provide documented subject-matter expertise and guidance, demonstrated through meeting minutes, reports, and other documentation.

4. PLACE AND PERIOD OF PERFORMANCE (POP)

The contract shall be an IDIQ contract with a five-year ordering period for novel large surface area microparticle drug products suitable for treatment in animal models of infectious disease. A six month FAR 52.217-8 Option Period, if required, will be exercised. The place of performance will be at the contractor’s facility.

5. Administrative Tasks

The Contractor shall provide study protocol and budget; integrated master schedule; market sustainment plan; monthly IPT meetings; quarterly task status reports that describe the progress made within the period and costs incurred; spend plan; and documents inclusive of a final study report.  Each of these items must be addressed in the Offeror’s SOW.

The Government will utilize a Quality Assurance Surveillance Plan (QASP) that serves to monitor performance and to ensure that the Government is receiving the services specified in the contract and that the services meet the performance standards specified in the contract. By employing a fully developed QASP, the Government and the Contractor achieve an understanding of performance expectations and how performance will be measured against those expectations.  The QASP may be negotiated between the Government and the contractor prior to final contract award. 

USE OF TECHNICAL REFERENCE FACILITY

To the extent practical the Contractor shall utilize the technical reference facilities of the Defense Technical Information Center (DTIC) for the purpose of surveying existing knowledge and avoiding needless duplication of scientific and engineering effort and the expenditure thereby represented. The DTIC headquarters office is located at 8725 John J. Kingman Road, Fort Belvoir, VA 22060-6218. Information can also be obtained via the Internet at http://www.dtic.mil or via the toll-free number for the DTIC help desk, 1-800-225-3842. To the extent practical, all other sources, whether Government controlled, should be consulted for the same purpose.

Update #1 ·

Numerous neurotropic viral families are considered high priority pathogens to the Department of War (DOW), but the therapeutic decelopment in stymied by the difficulty of trafficking into into the Central Nervous System (CNS). This is mediated primarily by blood-brain barrier (BBB) tight junctions that prevent large molecules entry into the parenchymal space. However, the CNS has significant physiologically needs in the form of energy, oxygen and other molecular components.  See Statement of Objectives (SOO) for specific information. 

Files

File Type Posted
A02-SOO 12-31-2025.docx DOCX document

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