[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Page 71969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28150]



[[Page 71969]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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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: (240) 276-6154; Facsimile: (240) 276-5504; 
Email: [email protected].

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.
[FR Doc. 2019-28150 Filed 12-27-19; 8:45 am]
BILLING CODE 4140-01-P