[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54629-54630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17256]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Manufacture, 
Distribution, Sale and Use of T-Cell-Based Immunotherapies for Solid 
Tumors

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 and the National Cancer Institute, both 
institutes of the National Institutes of Health, Department of Health 
and Human Services, are 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 EnZeta Immunotherapies, Inc. of the State of Delaware.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center

[[Page 54630]]

on or before August 28, 2023 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Richard T. Girards, Jr., Esq., MBA, Senior 
Technology Transfer Manager, National Institutes of Health, NCI 
Technology Transfer Center by email ([email protected]) or phone 
(240-276-6825).

SUPPLEMENTARY INFORMATION:

Intellectual Property

E-010-2021: Enhanced Antigen Reactivity of Immune Cells Expressing a 
Mutant Non-Signaling CD3 Zeta Chain

    1. United States Provisional Patent Application No. 63/113,428, 
filed 13 November 2020 (HHS Reference No. E-010-2021-0-US-01);
    2. International Patent Application No. PCT/US2021/059109, filed 12 
November 2021 (HHS Reference No. E-010-2021-0-PCT-02);
    3. United States Patent Application No. 18/036,112, filed 09 May 
2023 (HHS Reference No. E-010-2021-0-US-02);
    4. European Patent Application No. 21824143.8, filed 30 March 2023 
(HHS Reference No. E-010-2021-0-EP-01); and
    5. 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 and patent application 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 fields of use may be limited to the following: manufacture, 
distribution, sale and use of T-cell-based immunotherapies for solid 
tumors.
    These technologies disclose, e.g., cells expressing a modified CD3 
subunit chain comprising at least one ITAM deletion. The inventive 
cells and populations thereof can be formulated into a composition, 
such as a pharmaceutical composition. Such cells and compositions 
thereof can be utilized to treat a wide variety of conditions, 
including but not limited to the indications within the scope of the 
contemplated exclusive license.
    This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
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 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 from 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: August 8, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2023-17256 Filed 8-10-23; 8:45 am]
BILLING CODE 4140-01-P