[Federal Register Volume 89, Number 42 (Friday, March 1, 2024)]
[Notices]
[Pages 15210-15211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government Owned Inventions Available for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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: 
[email protected] 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

[[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