[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Page 66463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21050]


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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 T 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 Moonlight Bio, 
Inc. (``Moonlight''), headquartered in Seattle, WA.

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 12, 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. 63/492,256 
filed March 27, 2023, entitled ``T Cell Receptors Targeting Y220C or 
R175H Mutation in P53'' [HHS Reference No. E-054-2023-0-US-01].
    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 genetically engineered to express a P53 R175H-
reactive TCR claimed in the Licensed Patent Rights for the treatment of 
cancer in humans.''
    The E-054-2023 patent family is primarily directed to isolated T 
cell receptors (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.
    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: September 21, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2023-21050 Filed 9-26-23; 8:45 am]
BILLING CODE 4140-01-P