[Federal Register Volume 79, Number 200 (Thursday, October 16, 2014)]
[Notices]
[Page 62169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24502]



[[Page 62169]]

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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 and applications claiming priority to these applications:

    1. U.S. Provisional Patent Application No. 61/701,056 filed 
September 14, 2012 entitled ``T Cell Receptors Recognizing MCH Class 
II-Restricted Mage-A3'' (HHS Ref No. E-230-2012/0-US-01) and
    2. PCT Application No. PCT/US13/059608 filed September 13, 2013 
entitled ``T Cell Receptors Recognizing MCH Class II-Restricted 
Mage-A3'' (HHS Ref No. E-230-2012/0-PCT-02).
    3. US Provisional Patent Application no. 61/535,086 filed 
September 15 2011, entitled ``T cell receptors recognizing HLA-A1 or 
HLA-Cw7 restricted MAGE'' (HHS Ref No. E-266-2011/0-US-01).
    4. PCT Application No. PCT/US2012/054623 filed September 11 
2012, entitled ``T cell receptors recognizing HLA-A1 or HLA-Cw7 
restricted MAGE'' (HHS Ref No. E-266-2011).

    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 and 
commercialization of melanoma antigen family (MAGE) A3 and A6-specific 
T cell receptor (TCR)-based autologous peripheral blood T cell therapy 
products as set forth in the Licensed Patent Rights for the treatment 
of MAGE A3 and A6 expressing cancers.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
November 17, 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: There are twelve melanoma antigen family 
antigens (MAGE-A) designated A1-A12. Their normal function is not well 
defined, but in cancer cells they block the functions of tumor 
suppressor proteins to mediate tumor growth and spreading. The MAGE-A 
proteins are some of the most widely expressed cancer testis antigens 
expressed on human tumors. Other than non-MHC expressing germ cells of 
the testis, normal cells do not express these antigens, which make them 
ideal targets for cancer immunotherapies anticipated to generate less 
toxic side effects than conventional cancer treatments. These TCRs 
deliver a robust immune response against MAGE-A3 or A6 expressing 
cancerous cells and could prove to be a powerful approach for 
selectively attacking tumors without generating toxicity against 
healthy cells.
    The instant technology describes T cell receptors (TCRs) against 
the MAGE-A3 and A6 tumor antigens in the context of major 
histocompatibility complex (MHC) class II molecule HLA-DP-beta1*04, and 
against MAGE-A3 antigen in context of the HLA-A*0101. They comprise the 
first HLA class II restricted MAGE-A3/A6-specific TCRs developed for 
use in adoptive immunotherapy. Since approximately 80% of patients 
express the HLA-DP-beta1*04 class II HLA allele, this TCR greatly 
expands the population pool treatable with MAGE-A3/A6 TCRs to include 
the majority of patients with an amenable target expression profile. 
Cancer immunotherapy with these new HLA class II TCRs could yield a 
robust and effective CD8+ and CD4+ T cell immune response and 
selectively target MAGE-A3/A6 expressing tumors without generating 
toxicity against healthy cells. Finally, they complement TCRs that are 
restricted to MHC class I molecules such as HLA-A*01, expanding the 
population of patients beyond HLA-DP-beta1*04 MHC class II positive.
    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.
    Complete 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 evaluation option 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: October 8, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-24502 Filed 10-15-14; 8:45 am]
BILLING CODE 4140-01-P