[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