Modification to the A11 HERV-E TCR and T cell product to improve the therapeutic efficacy for ccRCC patients.
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Institutes of Health (NIH), under the Department of Health and Human Services, has issued a Notice of Intent to Sole Source for a modification to the A11 HERV-E TCR and T cell product. This procurement aims to improve the therapeutic efficacy of this product for patients with clear cell renal cell carcinoma (ccRCC). NIH intends to award this contract non-competitively to Loyola University of Chicago. Interested parties capable of fulfilling this requirement must submit their capabilities by June 3, 2026, at 9:00 AM Eastern Time.
Scope of Work
The requirement involves modifying the A11 HERV-E TCR and T cell product. This work builds upon existing research and a Phase I clinical trial, focusing on optimizing the T-cell receptor (TCR) gene transfer technologies to enhance treatment for ccRCC patients.
Justification for Non-Competition
Loyola University of Chicago is identified as the sole source possessing the unique scientific expertise, proprietary knowledge, prior developmental experience, and access to necessary reagents, cell lines, and manufacturing methodologies specific to the A11 HERV-E TCR platform. Awarding to any other source would lead to unacceptable delays and substantial duplication of cost, as no other vendor is known to possess the required technical capability or prior experience.
Contract & Timeline
- Type: Presolicitation / Notice of Intent to Sole Source
- NAICS: 622110 (Other Professional Services), Size Standard $47.0M
- Acquisition Method: FAR Part 13 (Simplified Acquisition Procedures)
- Estimated Value: Not expected to exceed the Simplified Acquisition Threshold ($350,000)
- Set-Aside: N/A
- Response Due: June 3, 2026, 9:00 AM Eastern Time
- Published: May 19, 2026
- Place of Performance: Bethesda, MD
Submission & Response
This is not a request for competitive proposals. However, interested parties who believe they can meet the requirements may submit a response. Submissions must include: sufficient information to establish bona-fide capabilities, a technical proposal, a cost-price proposal, the proposed period of performance, Unique Entity ID (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must have an active registration in SAM. Responses should be submitted electronically to Michael Falzone (michael.falzone@nih.gov). Fax responses will not be accepted. The government will use responses to determine if a competitive procurement is feasible.