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

# AGENCY:

National Institutes of Health, HHS.

# ACTION:

Notice.

# SUMMARY:

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

# FOR FURTHER INFORMATION CONTACT:

                        Inquiries related to this licensing opportunity should be directed to: Andrew Burke Ph.D., Technology Transfer Manager, NCI, Technology Transfer Center, email:                         *burkear@mail.nih.gov*                         or phone: (240) 276-5484.                    

# SUPPLEMENTARY INFORMATION:

*NIH Reference Number:*                     E-251-2023-0.                

*Title:*                     T Cell Receptors Targeting EGFR L858R mutation on HLA-A*11:01 +                     Tumors.                

                    Tumor-specific mutated proteins can create neoepitopes, mutation-derived antigens that distinguish tumor cells from healthy cells, which are attractive targets for adoptive cell therapies. However, the process of precisely identifying the neoepitopes to target is complex and challenging. One method to identify such neoepitopes is Mass Spectrometry (MS) when used in conjunction with elution of peptides bound to a specific Human Leukocyte Antigen (HLA) allele. Using MS in this                           ( print page 15211)                        context can demonstrate which oncogene derived neoepitopes are presented by common HLA alleles, and can provide the data necessary to rapidly develop TCRs against the desired antigens.                

Using the MS approach, inventors at the National Cancer Institute (NCI) have identified neoepitopes derived from a mutated isoform of Epithelial Growth Factor Receptor (EGFR) presented by HLA A*11:01 across multiple biological replicates. From this MS data, the inventors were able to successfully isolate murine TCRs that specifically recognize HLA A*11:01 restricted neoepitopes targeting EGFR L858R. According to various cancer genome databases, EGFR L858R is highly prevalent in lung adenocarcinoma, non-small cell lung carcinoma, and non-squamous non-small cell lung carcinoma, making this driver mutation an excellent target to develop off-the-shelf cellular therapies. The clinical potential of these TCRs has not been explored.

*Therapeutic Area(s):*                     Cancer.                

Research uses include: TCRs may be used as positive controls to identify HLA-A*11:01 EGFR L858R reactive T cells from different sources such as patients or animal models; TCRs recognize the common EGFR L858R driver mutation in the context of HLA-A*11:01; EGFR; the prevalence of EGFR L858R substitutions, relative to the overall EGFR mutation population, ranges from 27.7% to 41.1% in non-small cell lung cancer patients; HLA-A*11:01 allele frequency is particularly high (up to 60%) in Asian and Oceanian populations. This research has validated the effectiveness of using mass spectrometry to detect amino acid sequences on specific HLA complexes.

Achieving expeditious commercialization of federally funded research and development is consistent with the goals of the Bayh-Dole Act, codified as 35 U.S.C. 200-212 and 37 CFR 404.4.

*Development Stage:*                     Research Tool.                

Dated: February 26, 2024.

Richard U. Rodriguez,

Associate Director, Technology Transfer Center, National Cancer Institute.

[FR Doc. 2024-04251 Filed 2-29-24; 8:45 am]

BILLING CODE 4140-01-P