2019-28150. Prospective Grant of an Exclusive Patent License: The Development of Autologous Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1) T Cell Receptor (TCR) for the Treatment of KK-LC-1 Expressing Human Cancer

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to T-Cure Biosciences, Inc. (T-Cure), located in Sherman Oaks, California.

DATES:

Only written comments and/or applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before January 14, 2020 will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Abritee Dhal, Ph.D., Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 3W610 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-9702, Telephone: [phone]; Facsimile: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Intellectual Property

U.S. Provisional Patent Application 62/327,529 entitled “Anti-KK-LC-1 T Cell Receptors” [HHS Ref. E-153-2016-0-US-01], PCT Patent Application PCT/US2017/027865 entitled “Anti-KK-LC-1 T Cell Receptors” [HHS Ref. E-153-2016-0-PCT-02], Australian Patent Application 2017258745 entitled “Anti-KK-LC-1 T Cell Receptors” [HHS Ref. E-153-2016-0-AU-03], Canadian Patent Application 3021898 entitled “Anti-KK-LC-1 T Cell Receptors” [HHS Ref. E-153-2016-0-CA-04], European Patent Application 1733120.4 entitled “Anti-KK-LC-1 T Cell Receptors” [HHS Ref. E-153-2016-0-EP-05], United States Patent Application 16/096,118, entitled “Anti-KK-LC-1 T Cell Receptors” [HHS Ref. E-153-2016-0-US-06], and U.S. and foreign patent applications claiming priority to the aforementioned applications.

The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America.

The prospective exclusive license territory may be worldwide and the field of use may be limited to:

The development, manufacture and commercialization of autologous (meaning one individual is both the donor and the recipient), peripheral blood T cell therapy products engineered by retrovirus (including lentivirus) to express T cell receptors (TCR) reactive to Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1) wherein the TCR has:

1. A single antigen specificity; and

2. a binding domain with complementary determining region (CDR) sequences of CASSLGTGGYNEQFF (beta chain) and CAGQLVYGNKLVF (alpha chain); for the treatment of KK-LC-1 expressing cancers.

This technology discloses TCRs that are specific for the cell surface domain of KK-LC-1. The TCRs can potentially be used for the treatment of triple negative breast cancer, gastric cancer, and lung cancer. In the subject situation, the TCRs can lead to the selective destruction of the cancerous cells.

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available.

License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

Dated: December 19, 2019.

Richard U. Rodriguez,

Associate Director, Technology Transfer Center, National Cancer Institute.