[Federal Register Volume 89, Number 194 (Monday, October 7, 2024)]
[Notices]
[Pages 81089-81090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23029]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Anti-KK-LC-1 T 
Cell Receptors

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 Calabasas, 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 October 22, 2024 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: Suna Gulay French, Ph.D., Technology Transfer 
Manager, NCI

[[Page 81090]]

Technology Transfer Center, 9609 Medical Center Drive, RM 3W-204, MSC 
9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-
9702; Telephone: (240)-276-5530; Email: <a href="/cdn-cgi/l/email-protection#7102041f105f16041d1008311f18195f161e07"><span class="__cf_email__" data-cfemail="4132342f206f26342d2038012f28296f262e37">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Intellectual Property

    1. United States Provisional Patent Application No. 62/327,529, 
filed April 26, 2016 and entitled ``Anti-KK-LC-1 T Cell Receptors'' 
[HHS Reference No. E-153-2016-0-US-01];
    2. PCT Patent Application No. PCT/US2017/027865, filed April 17, 
2017 and entitled ``Anti-KK-LC-1 T Cell Receptors'' [HHS Reference No. 
E-153-2016-0-PCT-02];
    3. Australian Patent No. 2017258745, issued July 14, 2022 and 
entitled ``Anti-KK-LC-1 T Cell Receptors'' [HHS Reference No. E-153-
2016-0-AU-03];
    4. Canadian Patent Application No. 3021898, filed April 17, 2017 
and entitled ``Anti-KK-LC-1 T Cell Receptors'' [HHS Reference No. E-
153-2016-0-CA-04];
    5. European Patent No. 3448882, issued November 24, 2021 and 
entitled ``Anti-KK-LC-1 T Cell Receptors'' [HHS Reference No. E-153-
2016-0-EP-05];
    a. Validated in the following jurisdictions: CH, DE, BE, DK, ES, 
FI, FR, GB, IE, IT, NL, NO and SE.
    6. U.S. Patent No. 11,352,410, issued June 7, 2022 and entitled 
``Anti-KK-LC-1 T Cell Receptors'' [HHS Reference No. E-153-2016-0-US-
06].
    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 following:
    ``1. Development, manufacture, and commercialization of autologous 
T cell therapy products, including T cells with stem-like properties, 
engineered via retrovirus-mediated gene transfer to express T cell 
receptors reactive to Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1), as 
claimed in the Licensed Patent Rights; such products to be developed 
for treatment of patients carrying HLA-A*01:01 histocompatibility 
haplotype, and diagnosed with a cancer expressing KK-LC-1 protein 
(``KK-LC-1 Targeting TCR-T Products'').
    2. Development, manufacture, and commercialization of a combination 
therapy for the treatment of KK-LC-1 expressing human cancers, 
independent of their HLA phenotype, wherein the treatment comprises:
    a. Modification of the patient's tumor using Licensee's proprietary 
technology to express the HLA-A*01:01 restriction element, and
    b. Treatment with the KK-LC-1 Targeting TCR-T Products.
    For the avoidance of doubt, specifically excluded from these Fields 
of Use are Natural Killer cell therapy products engineered via viral 
vectors (including lentivirus or retrovirus) to express the TCR(s) 
claimed in the Licensed Patent Rights.''
    This technology discloses isolated T cell receptors (TCR) reactive 
to the Kita-Kyushu lung cancer antigen 1 (KK-LC-1) within the context 
of human leukocyte antigen (HLA) A*01:01. KK-LC-1 is expressed by 
various epithelial cancers including carcinomas of the bladder, cervix, 
stomach, breast, lung, and pancreas. Due to its minimal expression in 
normal tissues, this antigen may be targeted on KK-LC-1-expressing 
tumors with minimal normal tissue toxicity.
    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: October 1, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2024-23029 Filed 10-4-24; 8:45 am]
BILLING CODE 4140-01-P


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