[Federal Register Volume 88, Number 247 (Wednesday, December 27, 2023)]
[Notices]
[Pages 89461-89462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government Owned Inventions

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is directed to a T cell receptor 
(TCR) that specifically targets the Kita-Kyushu Lung Cancer Antigen 1 
(KK-LC-1). This TCR may be used to develop novel immunotherapies 
against several common and aggressive epithelial cancers. It may also 
be possible to use portions of the KK-LC-1 TCR in chimeric proteins for 
cancer therapy and/or for antigen detection assays. This technology was 
discovered and is being developed by the National Cancer Institute 
(NCI). The NCI is currently seeking a licensee and/or collaborator to 
further develop this technology.

FOR FURTHER INFORMATION CONTACT: Inquiries related to this licensing 
and collaboration opportunity should be directed to: Suna Gulay French, 
Technology Transfer Manager, NCI Technology Transfer Center, 9609 
Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for 
business mail), Rockville, MD 20850-9702; Telephone: (240) 276-5530; 
Facsimile: (240) 276-5504; Email: <a href="/cdn-cgi/l/email-protection#f784829996d990829b968eb7999e9fd9909881"><span class="__cf_email__" data-cfemail="e794928986c980928b869ea7898e8fc9808891">[email protected]</span></a>. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished information related to this invention.

SUPPLEMENTARY INFORMATION: The following patent applications are 
available for licensing and/or collaboration under a Cooperative 
Research and Development Agreement (CRADA):
    1. U.S. Provisional Application No. 62/327,529;

[[Page 89462]]

    2. PCT Application No. PCT/US17/027865;
    3. U.S. Patent No. 11,352,410;
    4. Australia Patent Application No. 2017258745;
    5. Canada Patent Application No. 3021898; and
    6. European Patent No. 17733120.4, validated in Switzerland, 
Germany, Belgium, Denmark, Spain, Finland, France, United Kingdom, 
Ireland, Italy, The Netherlands, Norway, Sweden.
    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.

Background and Description of Technology

    Metastatic cancers are the cause of up to 90% of cancer deaths, yet 
few treatment options exist for patients with metastatic disease. 
Adoptive transfer of T cells that express tumor-reactive T-cell 
receptors (TCRs) has been shown to mediate regression of metastatic 
cancers in some patients. However, identification of antigens that are 
expressed solely by cancer cells and not normal tissues has been a 
major challenge for the development of TCR-based immunotherapies. 
Researchers at the National Cancer Institute (NCI) have developed a TCR 
that specifically targets the Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-
1) 52-60 epitope. KK-LC-1 antigen (encoded by the CT83 gene) is highly 
expressed in several common and aggressive epithelial tumor types. 
Importantly, KK-LC-1 is expressed at very low levels in normal tissues 
and is not expressed in life-essential tissues. This expression profile 
makes KK-LC-1 an attractive target for TCR-based anti-cancer therapies. 
This TCR may be used to genetically modify peripheral blood lymphocytes 
from eligible patients. After expansion, these genetically modified 
lymphocytes can be used to treat patients. This technology is currently 
being evaluated in clinical trials at the NCI and at Rutgers Cancer 
Institute of New Jersey.

Potential Commercial Applications

    T cell receptor (TCR)-based immunotherapies and/or therapeutic 
products against several common and aggressive epithelial tumor types.

Competitive Advantages

--This TCR has been preclinically validated and is currently being 
evaluated in the clinic;
--Differential expression profile of KK-LC-1 in cancers versus normal 
tissues suggests that therapy with a specific KK-LC-1 TCR would be 
cancer-specific and would not damage life-essential tissues;
--Thousands of cancer patients each year with otherwise untreatable 
disease may be eligible for treatment with this TCR.

Development Stage

    Clinical development.

    Dated: December 20, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2023-28481 Filed 12-26-23; 8:45 am]
BILLING CODE 4140-01-P


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