Notice2025-23691

Prospective Grant of an Exclusive Patent License: Enhanced Tumor Reactivity of T Cells Lacking SIT1, LAX1, or TRAT1

Primary source

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Published
December 23, 2025

Issuing agencies

Health and Human Services DepartmentNational Institutes of Health

Abstract

The Eunice Kennedy Shriver National Institute of Child Health and Human Development, an institute of the National Institutes of Health, United States Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice to EnZeta Immunotherapies, Inc., a company located in Coral Gables, FL.

Full Text

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<title>Federal Register, Volume 90 Issue 244 (Tuesday, December 23, 2025)</title>
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[Federal Register Volume 90, Number 244 (Tuesday, December 23, 2025)]
[Notices]
[Pages 60111-60112]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23691]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Enhanced Tumor 
Reactivity of T Cells Lacking SIT1, LAX1, or TRAT1

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The Eunice Kennedy Shriver National Institute of Child Health 
and Human Development, an institute of the National Institutes of 
Health, United States Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the patent applications listed in the 
Supplementary Information section of this notice to EnZeta 
Immunotherapies, Inc., a company located in Coral Gables, FL.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center, representing the Eunice Kennedy Shriver National Institute of 
Child Health and Human Development, on or before January 7, 2026 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: Geoffrey E. Ravilious, Ph.D., NCI Technology 
Transfer Center, Telephone: 240-276-6391; Email: 
<a href="/cdn-cgi/l/email-protection#f196949e9797839488df839087989d989e8482b19f9899df969e87"><span class="__cf_email__" data-cfemail="5a3d3f353c3c283f2374283b2c333633352f291a343332743d352c">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Intellectual Property

    1. United States Provisional Patent Application No. 63/625,354 
filed January 26, 2024, and entitled ``ENHANCED TUMOR REACTIVITY OF T 
CELLS LACKING SIT1, LAX1, OR TRAT1'' [HHS Reference No. E-004-2024-0-
US-01];
    2. International Patent Application No. PCT/US2025/013054 filed 
January 24, 2025, and entitled ``ENHANCED TUMOR REACTIVITY OF T CELLS 
LACKING SIT1, LAX1, OR TRAT1'' [HHS Reference No. E-004-2024-0-PC-01]; 
and
    3. any and all other U.S. and ex-U.S. patents and patent 
applications claiming priority to any one of the foregoing, now or in 
the future.
    The patent rights in these inventions have been assigned 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:
    ``The use of the Licensed Patent Rights to develop, manufacture, 
distribute, sell and use T-cell-based therapeutics for the treatment of 
solid tumors, high-grade dysplasia and pre-neoplastic conditions.''

[[Page 60112]]

    This technology describes modified T cell therapeutics that have 
reduced expression of one or a combination of transmembrane adaptor 
proteins SIT1, LAX1 and TRAT1. T cell-based therapeutics such as ex 
vivo expanded tumor infiltrating lymphocytes (TIL) and chimeric antigen 
receptor T-cells (CAR-T) have clinical utility against a limited number 
of solid tumor types, most notably, melanoma. However, to date, 
efficacy in patients has been limited due to several factors. The 
subject invention potentially addresses the limited efficacy of T cell 
therapeutics by reducing expression of SIT1, LAX1 and/or TRAT1 which 
leads to enhanced T cell cytotoxic activity against tumor 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, representing the Eunice Kennedy Shriver National 
Institute of Child Health and Human Development, 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.
    Complete applications for a license that are timely filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive patent license. 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 18, 2025.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2025-23691 Filed 12-22-25; 8:45 am]
BILLING CODE 4140-01-P


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Indexed from Federal Register on December 23, 2025.

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