Notice: Prospective Grant of Exclusive License: Development of T Cell 
Receptors and Chimeric Antigen Receptors Into Therapeutics for Adoptive 
Transfer in Humans To Treat Cancer

Federal Register: Volume 77, Number 15 (Tuesday, January 24, 2012)
                  Page 3482

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR404.7(a)(1)(i), that the National Institutes of Health, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive patent license, subject to existing non-exclusive licenses 
and current non-exclusive license applications under consideration, to 
practice the inventions embodied in U.S. Provisional Patent Application 
No. 61/405,668 and PCT Patent Application No. PCT/US2011/057272 and 
foreign equivalents thereof entitled ``Anti-MAGE-A3 T cell receptors 
and related materials and methods of use'' (HHS Ref. No. E-236-2010/0); 
U.S. Provisional Patent Application No. 61/384,931 and PCT Patent 
Application No. PCT/US2011/051537 and foreign equivalents thereof 
entitled ``Anti-SSX-2 T cell receptors and related materials and 
methods of use'' (HHS Ref. No. E-269-2010/0); U.S. Provisional Patent 
Application No. 61/473,409 entitled ``Anti-epidermal growth factor 
receptor variant III chimeric antigen receptors and use of same for the 
treatment of cancer'' (HHS Ref. No. E-148-2011/0); and U.S. Provisional 
Patent Application No. 61/535,086 entitled ``T cell receptors 
recognizing HLA-A1- or HLA-Cw7-restricted MAGE-A'' (E-266-2011/0) to 
Kite Pharma, Inc., which is located in Los Angeles, California. The 
patent rights in these inventions have been assigned to the United 
States of America.
    Other than license applications submitted as objections to this 
Notice of Intent to Grant an Exclusive License, no further license 
applications will be considered for the exclusive field of use set 
forth below if Kite Pharma, Inc. is granted an exclusive license 
pursuant to this Notice of Intent to Grant an Exclusive License. The 
prospective exclusive license territory may be worldwide and the field 
of use may be limited to the treatment of cancers, which may include 
brain cancer, breast cancer, colorectal cancer, esophageal cancer, 
gastric cancer, head and neck cancer, liver cancer, lung cancer, 
melanoma, multiple myeloma, ovarian cancer, prostate cancer, sarcoma, 
and urothelial cancer, as claimed in the Licensed Patent Rights.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
February 23, 2012 will be considered, in addition to the current non-
exclusive applications under consideration, for the prospective license 
territory and field of use to be granted under the contemplated 
exclusive patent license.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Samuel E. Bish, 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) 435-5282; Facsimile: (301) 402-0220; Email: 
bishse@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The technologies describe T cells engineered 
to express MAGE-A3, MAGE-A12, or SSX-2 T cell receptors (TCRs) or 
EGFRvIII chimeric antigen (CARs) and methods of using these engineered 
T cells to treat and/or prevent cancer. These technologies include the 
TCR and CAR amino acid sequences, the nucleic acid sequences that 
encode these compositions, vectors to express the TCRs and CARs, host 
cells and populations of host cells, such as T cells, that express the 
compositions, antibodies to the TCRs and CARs, pharmaceutical 
compositions, and associated methods of detecting, preventing, and 
treating diseases, such as cancer, with these TCRs and CARs. TCRs and 
CARs are proteins that recognize antigens, such as cancer antigens, and 
activate the cells expressing these compositions to destroy the 
antigen-expressing cell. TCRs consist of two domains, one variable 
domain that recognizes the antigen and one constant region that helps 
the TCR anchor to the membrane and transmit recognition signals by 
interacting with other proteins. CARs are hybrid proteins consisting of 
a portion of an antibody that recognizes an antigen fused to protein 
domains that signal to activate the CAR-expressing cell. Therapies 
utilizing these technologies involve isolating a cancer patient's own T 
cells to be engineered with the TCR and/or CAR that recognize the tumor 
antigen(s) expressed on that specific patient's cancer cell. 
Afterwards, the engineered T cells from the patient are adoptively 
transferred back into the patient to mediate tumor regression. 
Personalized adoptive cell transfer therapies developed from these 
technologies could yield innovative therapeutics for any cancers that 
express the antigens recognized by these TCRs and CARs.
    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 404.7. 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 404.7.
    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: January 18, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-1383 Filed 1-23-12; 8:45 am]
BILLING CODE 4140-01-P