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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, HHS.

# ACTION:

Notice.

# 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:                         *suna.gulay@nih.gov.*                         A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to this invention.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;                          ( print 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