Notice2023-28481
Government Owned Inventions
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 27, 2023
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 247 (Wednesday, December 27, 2023)</title>
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[Federal Register Volume 88, Number 247 (Wednesday, December 27, 2023)]
[Notices]
[Pages 89461-89462]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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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