[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Notices]
[Pages 16347-16348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06412]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of T Cell 
Receptors for Adoptive Transfer in Humans to Treat 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 
404, that the National Institutes of Health, Department of Health and 
Human Services, is contemplating the grant of an exclusive patent 
license to Kite Pharma, Inc., which is located in Los Angeles, 
California to practice the inventions embodied in the following patent 
applications:

1. U.S. Provisional Patent Application No. 61/650,020 filed May 22, 
2012 entitled ``Murine anti-NY-ESO-1 T cell receptors'' (HHS Ref No. E-
105-2012/0-US-01) and
2. PCT Application No. PCT/US13/042162 filed May 22, 2013 entitled 
``Murine anti-NY-ESO-1 T cell receptors'' (HHS Ref No. E-105-2012/0-
PCT-02)

    The patent rights in these inventions have been assigned to 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, distribution, sale, and use of the 
compositions and methods set forth in the Licensed Patent Rights using 
genetically engineered autologous T lymphocytes derived from the 
peripheral blood of humans for the treatment of NY-ESO-1-expressing 
cancers.

[[Page 16348]]


DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
April 24, 2014 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Whitney A. Hastings, Ph.D., Licensing 
and Patenting Manager, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 451-7337; Facsimile: (301) 402-0220; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: The instant technology describes a T cell 
receptor (TCR) derived from mouse T cells (i.e. murine TCR) that can be 
expressed in human T cells to recognize the cancer testis antigen 
(CTA), NY-ESO-1, with high specificity. This anti-NY-ESO-1 TCR has 
murine variable regions that recognize the NY-ESO-1 epitope and murine 
constant regions. The inventors performed in vitro studies comparing 
this murine NY-ESO-1 TCR with a previously developed human NY-ESO-1 TCR 
counterpart, which yielded promising clinical outcomes in patients with 
a variety of cancers. The murine TCR functioned similarly to the human 
counterpart in their ability to recognize and react to NY-ESO-1 tumor 
targets.
    NY-ESO-1 is a CTA, which is expressed only on tumor cells and 
germline cells of the testis and placenta. CTAs are ideal targets for 
developing cancer immunotherapeutics, such as anti-CTA TCRs, because 
these TCRs are expected to target cancer cells without harming normal 
tissues and thereby minimize the harsh side effects associated with 
other types of cancer treatment. NY-ESO-1 is expressed on a wide 
variety of cancers, including but not limited to breast, lung, 
prostate, thyroid, and ovarian cancers, melanoma, and synovial 
sarcomas. Thus, this technology should be applicable in adoptive cell 
transfer therapies for many types of cancer.
    The prospective exclusive license, subject to current non-exclusive 
license applications under consideration and any further license 
applications received as objections to this Notice of Intent to Grant 
an 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 thirty (30) 
days from the date of this published notice, the NIH 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.
    Any additional applications for a license in the field of use 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: March 20, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-06412 Filed 3-24-14; 8:45 am]
BILLING CODE 4140-01-P