[Federal Register Volume 87, Number 249 (Thursday, December 29, 2022)]
[Notices]
[Pages 80190-80191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28357]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of Engineered Cell Therapies for the Treatment of 
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 Affini-T 
Therapeutics, Inc. (``Affini-T''), headquartered in Watertown, MA.

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 13, 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: Andrew Burke, Ph.D., Senior Technology Transfer 
Manager, NCI Technology Transfer Center, Telephone: (240)-276-5484; 
Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    1. United States Provisional Patent Application No. 63/185,805 
filed May 7, 2021, entitled ``T Cell Receptors Recognizing C135Y, R175H 
or M237I Mutation in P53'' [HHS Reference No. E-101-2021-0-US-01]; and
    2. PCT Application No. PCT/US2022/028066 filed May 6, 2022, 
entitled ``T Cell Receptors Recognizing C135Y, R175H or M237I Mutation 
in P53'' [HHS Reference No. E-101-2021-0-PCT-02].
    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 T or Natural 
Killer cell therapy products genetically engineered to express the P53 
R175H-reactive T cell receptor claimed in the Licensed Patent Rights 
for the treatment of cancer in humans.''
    E-101-2021 patent family is primarily directed to isolated TCRs 
reactive to certain mutated forms of tumor protein 53 (TP53 or P53), 
within the context of several human leukocyte antigens. P53 is the 
archetypal tumor suppressor gene and the most frequently mutated gene 
in cancer. Contemporary estimates suggest that >50% of all tumors carry 
mutations in P53. Because of its prevalence in cancer and its 
restricted expression to precancerous and cancerous cells, this antigen 
may be targeted on mutant P53-expressing tumors with minimal normal 
tissue toxicity.

[[Page 80191]]

    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 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: December 22, 2022.
Richard U. Rodriguez,
Associate Director,Technology Transfer Center,National Cancer 
Institute.
[FR Doc. 2022-28357 Filed 12-28-22; 8:45 am]
BILLING CODE 4140-01-P