[Federal Register Volume 86, Number 59 (Tuesday, March 30, 2021)]
[Notices]
[Pages 16603-16604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06475]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: The Development 
of Natural Killer (NK) Cell Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1) 
T Cell Receptor (TCR) Therapy for the Treatment of KK-LC-1 Expressing 
Human Cancers

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 Zelluna 
Immunotherapy (Zelluna), located in Oslo, Norway.

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 April 14, 2021 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: Abritee Dhal, Ph.D., Technology Transfer 
Manager, at Telephone: (240) 276-6154 or at Email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    U.S. Provisional Patent Application 62/327,529 entitled ``Anti-KK-
LC-1 T Cell Receptors'' [HHS Ref. E-153-2016-0-US-01], PCT Patent 
Application PCT/US2017/027865 entitled ``Anti-KK-LC-1 T Cell 
Receptors'' [HHS Ref. E-153-2016-0-PCT-02], Australian Patent 
Application 2017258745 entitled ``Anti-KK-LC-1 T Cell Receptors'' [HHS 
Ref. E-153-2016-0-AU-03], Canadian Patent Application 3021898 entitled 
``Anti-KK-LC-1 T Cell Receptors'' [HHS Ref. E-153-2016-0-CA-04], 
European Patent Application 1733120.4 entitled ``Anti-KK-LC-1 T Cell 
Receptors'' [HHS Ref. E-153-2016-0-EP-05], United States Patent 
Application 16/096,118, entitled ``Anti-KK-LC-1 T Cell Receptors'' [HHS 
Ref. E-153-2016-0-US-06], and U.S. and foreign patent applications 
claiming priority to the aforementioned applications.
    The patent rights in these inventions have been assigned and/or 
exclusively

[[Page 16604]]

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 development, manufacture and commercialization of a T-Cell 
Receptor (TCR) Therapy for the treatment of Kita-Kyushu Lung Cancer 
Antigen 1 (KK-LC-1) expressing cancers, using modified or unmodified 
natural killer (NK) cells transduced using viral vectors (including 
lentivirus or retrovirus) to express an anti-KK-LC-1 TCR wherein:
    (1) The TCR has:
    (a) A single antigen specificity; and
    (b) a binding domain with complementary determining region (CDR) 
sequences of CASSLGTGGYNEQFF (beta chain) and CAGQLVYGNKLVF (alpha 
chain); and
    (2) The modified allogeneic NK cells can be modified to express 
one or more of the following:
    (a) CD3 subunits;
    (b) CD8 co-receptor subunits;
    (c) truncated CD34 tag;
    (d) a chemokine receptor; or
    (e) IL15.

    For the sake of clarity, unmodified NK cells would mean cells that 
are modified only by the expression of the TCR without any additional 
modification.
    This technology discloses TCRs that are specific for the cell 
surface domain of KK-LC-1. KK-LC-1 is a cancer germline antigen, that 
in adults, is reported to be expressed only by germ cells and by 
certain cancers, including gastric cancer, triple-negative breast 
cancer, and non-small cell lung cancer. Currently, there for no 
effective immunotherapies for patients with these various solid tumors. 
The NK-TCRs can potentially be used for the treatment of triple 
negative breast cancer, gastric cancer, and lung cancer. In the subject 
situation, the TCRs can lead to the selective destruction of the 
cancerous cells. The development of a new therapeutic targeting KK-LC-1 
will benefit public health by providing an effective treatment for 
patients with solid tumors.
    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 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: March 11, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-06475 Filed 3-29-21; 8:45 am]
BILLING CODE 4140-01-P