[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Notices]
[Page 54817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19549]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Development of T 
Cell Receptors (TCRs) Targeting the KRAS G12D Mutation for the 
Treatment of Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Cancer Institute, National Institutes of 
Health, Department of Health and Human Services, is contemplating the 
grant of an exclusive patent license to Kite Pharma, Inc. (``Kite'') 
located in Santa Monica, CA to practice the inventions embodied in the 
following patent applications:

Intellectual Property

    United States Provisional Patent Application No. 62/084,654, filed 
November 26, 2014, entitled ``Anti-mutated KRAS T Cell Receptors'' [HHS 
Reference No. E-028-2015/0-US-01]; and
    PCT Application No. PCT/US2015/062269 filed November 24, 2015 
entitled ``Anti-mutated KRAS T Cell Receptors'' [HHS Reference No. E-
028-2015/1-PCT-01].
    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 development, manufacture and commercialization of retrovirally-
engineered mutated KRAS TCR-based autologous peripheral blood T cell 
therapy products as set forth in the Licensed Patent Rights for the 
treatment of human cancers.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute on or before September 1, 
2016 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Andrew Burke, Ph.D., Licensing and Patenting Manager, 
Technology Transfer Center, National Cancer Institute, 9609 Medical 
Center Drive, MSC 9702, Rockville, MD 20852; Telephone: (240) 276-5484; 
Email [email protected].

SUPPLEMENTARY INFORMATION: The present invention describes an isolated 
T cell receptor (TCR) which recognizes the G12D mutation of the Kristen 
rat sarcoma viral oncogene homolog (KRAS) protein within the context of 
major histocompatibility complex HLA-A11 presentation.
    KRAS is an oncogene with a well-characterized role in the formation 
of several human cancers, including: Pancreatic, colorectal and lung. 
Certain mutations, such as the substitution of aspartic acid or valine 
for glycine at codon 12 (termed G12D and G12V, respectively), occur at 
relatively high frequency and may represent amenable targets for 
immunotherapies. Due to the restricted expression of KRAS G12D in pre-
cancerous and malignant cells, engineered T cell therapies based on the 
present invention may be useful for the treatment of select cancers.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 
404. The prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the NCI 
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 in an appropriate field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive license. Comments 
and objections submitted to this notice will not be made available for 
public inspection and, to the extent permitted by law, will not be 
released under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: August 8, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-19549 Filed 8-16-16; 8:45 am]
 BILLING CODE 4140-01-P