Government Owned Invention Available for License: Selective Expansion of Engineered TCR-T Cells for Use in Adoptive Cell Immunotherapy

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services National Institutes of Health ( printed page 43649) AGENCY: National Institutes of Health, HHS. ACTION: Notice. SUMMARY: The National Cancer Institute (NCI) seeks capable licensees interested in commercializing T cell receptor (TCR)-engineered T cells expressing murine/human hybrid receptors. FOR FURTHER INFORMATION CONTACT: Inquiries related to this license opportunity should be directed to: Andrew Burke, Ph.D. at Email: burkear@mail.nih.gov or Phone: 240-276-5484. SUPPLEMENTARY INFORMATION: TCR-T therapies, particularly those targeting patient-specific neoantigens, remain a promising approach to the treatment metastatic cancers. Contemporary gene engineering techniques permit both the targeted integration of the exogenous receptor(s) and further genetic manipulation of the host cells to enhance persistence and performance following adoptive transfer ( e.g., through disruption of immune checkpoints such as ( CISH or PD1 ). However, these techniques often suffer from low transduction efficiencies and may result in the generation of infusion products with sub-optimal percentages of targeted cells. NCI scientists designed a new method that enables the selective expansion of T lymphocytes, under GMP conditions, that have been engineered to stably express a murine-human hybrid TCR. These hybrid TCRs consist of human variable regions and murine constant regions. The inventive approach uses irradiated feeder cells and an anti-mouse TCR beta c…