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[Federal Register Volume 89, Number 238 (Wednesday, December 11, 2024)]
[Notices]
[Page 99888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29076]

[[Page 99888]]

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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 for the Treatment of Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute (NCI), 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 StraightLine 
Bio, Inc. located in Princeton, New Jersey.

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 December 26, 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 Technology Transfer Center at Telephone; (240)-276-5530, 
Email: [email protected].

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:
    Development, manufacture and commercialization of autologous T cell 
therapy products that are genetically engineered via retroviral-
mediated gene transfer or CRISPR-based gene transfer or transposon-
mediated gene transfer to express a T cell receptor (TCR) targeting 
human Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1) restricted to HLA-
A*01, as claimed in the Licensed Patent Rights, for the treatment of 
KK-LC-1 positive cancers and premalignant conditions in humans.
    For the avoidance of doubt, specifically excluded from the Field of 
Use are:
    1. Development, manufacture, and commercialization of Natural 
Killer cell therapy products engineered via viral vectors (including 
lentivirus or retrovirus) to express the TCR(s) claimed in the Licensed 
Patent Rights; and
    2. Development, manufacture and commercialization of a combination 
therapy for the treatment of KK-LC-1 positive human cancers that do not 
have the HLA-A*01 genotype, wherein the treatment comprises as a step: 
Modification of the patient's tumor to express the HLA-A*01 restriction 
element.
    This technology discloses isolated T cell receptors (TCR) reactive 
to the 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.

    Date: December 6, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2024-29076 Filed 12-10-24; 8:45 am]
BILLING CODE 4140-01-P
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