Notice of Intent to Sole Source.pdf

Synopsis No. 75N98026Q00392

Hospital and Laboratory Support Division Office of Logistics and Operations (OLAO) Office of Acquisition and Logistics Management (OALM)

Title: Modification to the A11 HERV-E TCR and T cell product to improve the therapeutic efficacy for ccRCC patients.

Presolicitation

SYNOPSIS

General Information

Document Type: Presolicitation Synopsis Number: 75N98026Q00392 Posted Date: May 19, 2026 Original Response Date: June 3, 2026 Current Response Date: June 3, 2026 Set Aside: N/A NAICS Code: 622110

Contracting Office Address

National Institutes of Health (NIH), Office of the Director (OD) Office of Logistics and Operations (OLAO) Office of Acquisition and Logistics Management (OALM) Hospital and Laboratory Support Division 6701 Rockledge Drive Bethesda, MD 20817

Description

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL

OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to:

Loyola University of Chicago 2160 S 1st Ave.

Maywood, IL 60153

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 622110 with a Size Standard $47.0M.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-99-1, July 16, 2018. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($350,000).

STATUTORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6- Competition Requirements.

GENERAL INFORMATION

1. Title: Modification to the A11 HERV-E TCR and T cell product to improve the therapeutic efficacy for ccRCC patients.

Background Information: The proposed contractor possesses unique and specialized expertise in the development and clinical application of T-cell receptor (TCR) gene transfer technologies for the treatment of clear cell renal cell carcinoma (ccRCC). The proposed work is based on extensive preclinical and clinical research involving HERV-E, a tumor-specific antigen uniquely associated with ccRCC.

Previous clinical studies demonstrated that patients with metastatic ccRCC treated with allogeneic stem cell transplantation developed T cells capable of recognizing a peptide derived from HERV- E, a defective endogenous retrovirus integrated within the human genome. Although HERV-E is typically transcriptionally silent, mutations in the VHL oncogene — a primary driver of ccRCC — result in transcriptional activation of HERV-E. Because HERV-E expression is regulated through the VHL/HIF-2α pathway, it represents a shared tumor-specific antigen and a highly promising target for kidney cancer immunotherapy.

The proposed contractor was the first organization to successfully demonstrate that the specificity of human T cells could be redirected through engineering with TCR genes and subsequently developed the HLA-A11-restricted, HERV-E-reactive TCR (A11 HERV-E TCR) that is the subject of this project. In addition, the proposed contractor developed and maintains the proprietary reagents, constructs, characterization data, manufacturing methods, and technical know-how necessary to support the continued optimization of this cellular therapy platform.

The proposed contractor also generated the specialized materials and supporting technical data required for the first-in-human Phase I clinical trial conducted at the NIH Clinical Center evaluating A11 HERV-E TCR-transduced T cells in patients with metastatic ccRCC. While the trial demonstrated evidence of tumor regression and disease stabilization, additional optimization of the TCR construct and manufacturing process is required to improve therapeutic efficacy.

Loyola University of Chicago is the only known source with the unique combination of scientific expertise, proprietary knowledge, prior developmental experience, and access to the specific reagents, cell lines, vector constructs, and manufacturing methodologies required to perform the proposed work without unacceptable delays or substantial duplication of cost. No other vendor is known to possess the requisite technical capability or prior experience with the A11 HERV-E TCR platform necessary to successfully continue and expand this highly specialized research effort.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by June 3, 2026 at 9:00 AM Eastern time and must reference solicitation number 75N98026Q00392. Responses may be submitted electronically to Mr.

Michael Falzone, Contracting Officer at Michael.falzone@nih.gov. Fax responses will not be accepted.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.”

http://www.sam.gov/