[Federal Register Volume 89, Number 48 (Monday, March 11, 2024)]
[Notices]
[Page 17495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05038]


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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: Suna Gulay French, Ph.D., Technology 
Transfer Manager, NCI, Technology Transfer Center, Email: 
[email protected] or Phone: 240-276-7424.

SUPPLEMENTARY INFORMATION: 
    NIH Reference Number: E-153-2016-0.
    Title: T-Cell Immunotherapy that Targets Aggressive Epithelial 
Tumors.

Intellectual Property

US Provisional Application 62/327,529 filed April 26, 2016
PCT Application PCT/US2017/027865 filed April 17, 2017
US Patent 11,352,410 issued June 7, 2022
European Patent 3448882 issued November 24, 2021, validated in 
Switzerland, Germany, Belgium, Denmark, Spain, Finland, France, United 
Kingdom, Ireland, Italy, The Netherlands, Norway, Sweden
Australian Patent Application 2017258745 filed October 19, 2018
Canadian Patent Application 3021898 filed April 17, 2017

Technology Summery

    Metastatic cancers cause 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. Unfortunately, identification of antigens expressed solely by 
cancer cells and not normal tissues has been a major challenge for the 
development of T-cell based immunotherapies. Thus, it is essential to 
find novel target antigens differentially expressed in cancer versus 
normal tissues.
    Inventors 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 by several common and aggressive epithelial tumor 
types. Importantly, KK-LC-1 is expressed at very low levels in normal 
tissues and not in those tissues vital for survival. This expression 
profile makes KK-LC-1 an attractive target for T-cell based, anti-
cancer therapies.
    Researchers at the NCI seek licensing and/or co-development 
research collaborations for T-cell immunotherapy that targets KK-LC-1 
for use in the treatment of epithelial cancers.
    Therapeutic Area(s): Cancer.
    Competitive Advantages: Differential expression profile of KK-LC-1 
suggests that therapy with a specific KK-LC-1 TCR could be cancer-
specific and would not damage normal tissues; The repertoire of 
targetable epithelial antigens for TCR-T cell therapy is larger than 
for CAR-T cells; Increased sensitivity may improve tumor cell detection 
and killing versus CAR-T cells, due to lower epitope density required 
for activation;
    Higher avidity and lower affinity could result in each TCR-T cell 
destroying numerous antigen-presenting cancer cells; Thousands of 
cancer patients each year with otherwise untreatable disease may be 
eligible for immunotherapy with this TCR.
    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: Clinical Phase I.

    Dated: March 5, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2024-05038 Filed 3-8-24; 8:45 am]
BILLING CODE 4140-01-P