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

The contract pertains to a non-competitive modification of the A11 HERV-E TCR and T-cell product to enhance therapeutic efficacy for patients with metastatic clear cell renal cell carcinoma, conducted under the National Institutes of Health through a simplified acquisition procedure. This presolicitation, issued with solicitation number 75N98026Q00392, announces an intent to sole source the work to Loyola University of Chicago due to its exclusive possession of proprietary reagents, specialized technical expertise, and prior clinical experience with the A11 HERV-E TCR platform, eliminating the possibility of competitive procurement. The action is justified under FAR 13.106-1(b)(1), with an estimated value not exceeding the simplified acquisition threshold of $350,000, and is subject to FAR Part 13, bypassing formal evaluation factors, risk ratings, or competitive scoring. The place of performance is Bethesda, Maryland, aligning with the NIH campus, and proposals must be submitted electronically by June 3, 2026, to the contracting officer, Michael Falzone, with mandatory inclusion of a valid Unique Entity ID, Taxpayer Identification Number, and active SAM registration. The work involves refining the proprietary TCR construct and associated manufacturing processes to improve tumor regression and disease stabilization outcomes beyond prior Phase I clinical results, without explicitly citing external technical or biological standards, though adherence to cGMP, FDA 21 CFR Part 1271, and NIH clinical trial protocols is implied given the nature of clinical-grade cellular therapy. No formal delivery schedule, FOB terms, packaging requirements, or inspection criteria are specified, and while acceptance is expected to occur at the NIH site in Bethesda, no Contracting Officer’s Representative or technical representative is designated. Offerors must submit both technical and cost proposals without page or formatting limits, but no line-item pricing, CLINs, or option periods are included as this remains a presolicitation. The acquisition does not involve socioeconomic set-asides, nor are size status or socioeconomic certifications completed, though offerors are required to self-certify as small or other-than-small under the 622110 NAICS code with a $47 million size standard. No payment office, invoicing system, or accounting codes are identified beyond the agency’s procurement identifier and contracting office address.