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

The National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition to Loyola University of Chicago for the modification of the A11 HERV-E TCR and T cell product to improve the therapeutic efficacy for clear cell renal cell carcinoma (ccRCC) patients. The proposed work is based on extensive preclinical and clinical research involving HERV-E, a tumor-specific antigen uniquely associated with ccRCC. • 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 ccRCC. • The proposed work includes the optimization of the TCR construct and manufacturing process 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.