[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Pages 60406-60407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27416]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: The Development 
of an Anti-CD30 Chimeric Antigen Receptor (CAR) for the Treatment of 
Human Cancer

AGENCY: National Institutes of Health

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 Kite Pharma, 
Inc. (``Kite'') located in Santa Monica, CA.

DATES: Only written comments and/or complete applications for a license 
which are received by the National Cancer Institute's Technology 
Transfer Center on or before January 4, 2018 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: David A. Lambertson, Ph.D., Senior Technology 
Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center 
Drive, RM 1E530, MSC 9702, Bethesda, MD 20892-9702 (for business mail), 
Rockville, MD 20850-9702; Telephone: (240)-276-5530; Facsimile: (240)-
276-5504; Email: [email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    United States Provisional Patent Application No. 62/241,896, filed 
15 October 2015 and entitled ``Anti-CD30 Chimeric Antigen Receptors'' 
[HHS Reference No. E-016-2018/0-US-01]; PCT Patent Application PCT/
US2016/056262, filed 10 October 2016 and entitled ``Anti-CD30 Chimeric 
Antigen Receptors'' [HHS Reference No. E-016-2018/0-PCT-02]; 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 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:

    ``The development of a CD30 chimeric antigen receptor (CAR)-
based

[[Page 60407]]

immunotherapy using autologous (meaning one individual is both the 
donor and the recipient) T cells transfected with a retroviral 
vector (including lentiviral vectors), wherein the vector expresses 
a CAR having:
    (1) a single antigen specificity; and
    (2) comprising at least:
    (a) the complementary determining region (CDR) sequences of the 
anti-CD30 antibody known as 5F11; and
    (b) a T cell signaling domain;

for the prophylaxis and treatment of CD30-expressing human 
cancers.''

    This technology discloses the development of chimeric antigen 
receptors that recognize the CD30 protein (also known as tumor necrosis 
factor receptor superfamily member 8 (TNFRSF8)). CD30 is expressed on 
the cell surface of several rare forms of cancer, including Hodgkin 
lymphoma (HL), Non-Hodgkin's Lymphoma (NHL), diffuse large B cell 
lymphoma (DLBCL), peripheral T cell lymphoma not otherwise specified 
(PTCL-NOS), anaplastic large cell lymphoma (ALCL), and 
angioimmunoblastic T cell lymphoma (AITL). The development of a new 
therapeutic targeting CD30 will benefit public health by offering up a 
treatment for these rare cancers in instances when conventional first 
line therapies are ineffective.
    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 
completed 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: December 8, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-27416 Filed 12-19-17; 8:45 am]
 BILLING CODE 4140-01-P