81 FR 61704 - Prospective Grant of Exclusive Patent License: The Development of an Anti-CD19 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancers

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 173 (September 7, 2016)

This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that 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 following Patents and Patent Applications and all continuing U.S. and foreign patents/ patent applications to Sangamo BioSciences, Inc. located in Richmond, California, USA:

[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Page 61704]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21366]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: The Development of 
an Anti-CD19 Chimeric Antigen Receptor (CAR) for the Treatment of Human 
Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 
404, that 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 following Patents 
and Patent Applications and all continuing U.S. and foreign patents/
patent applications to Sangamo BioSciences, Inc. located in Richmond, 
California, USA:

Intellectual Property

    U.S. Provisional Patent Application 62/006,313, filed 2 June 2014 
and entitled ``Chimeric Antigen Receptors Targeting CD-19'' [HHS Ref. 
E-042-2014/0-US-01]; and PCT Patent Application PCT/US2015/033473, 
filed 1 June 2015 and entitled ``Chimeric Antigen Receptors Targeting 
CD-19'' [HHS Ref. E-042-2014/0-PCT-02].
    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 use of Licensed Patent Rights 
for the following: ``The integration of a monospecific anti-CD19 
chimeric antigen receptor (CAR) into genome-edited, allogeneic T cells 
(where the donor and recipient are different), where the monospecific 
CAR has at least: (a) The complementary determining region (CDR) 
sequences of the anti-CD19 47G4 antibody; and (b) a T cell signaling 
domain, for the prophylaxis and treatment of CD19-positive 
malignancies.''

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
September 22, 2016 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: David A. Lambertson, Ph.D., Senior 
Licensing and Patenting Manager, National Cancer Institute, 9609 
Medical Center Drive, Rm. 1-E530 MSC9702, Rockville, MD 20850-9702, 
Email: [email protected].

SUPPLEMENTARY INFORMATION: This invention concerns an anti-CD19 
chimeric antigen receptor (CAR) and methods of using the CAR for the 
treatment of CD19-expressing cancers, including B cell malignancies. 
With regard to the proposed license, the CAR covered by the invention 
will be integrated into a genome-edited allogeneic (where the donor and 
recipient of the T cell are different individuals) T cell, and the 
resulting anti-CD19 CAR-expressing genome-edited allogeneic T cell will 
be introduced into a cancer patient to exhibit a therapeutic effect. 
CD19 is a cell surface antigen that is preferentially expressed on 
certain types of cancer cells, particularly cancers of B cell origin 
such as Non-Hodgkin's Leukemia (NHL), acute lymphoblastic leukemia 
(ALL) and chronic lymphocytic leukemia (CLL). The anti-CD19 CARs of 
this technology contain (1) antigen recognition sequences that bind 
specifically to CD19 and (2) signaling domains that can activate the 
cytotoxic functions of a T cell. The anti-CD19 CAR can be integrated 
into genome-edited allogeneic T cells; from there, genome-edited 
allogeneic T cells expressing the anti-CD19 CAR are selected, expanded 
and then introduced into a patient. Once the anti-CD19 CAR-expressing 
genome-edited allogeneic T cells are introduced into the patient, the T 
cells can selectively bind to CD19-expressing cancer cells through its 
antigen recognition sequences, thereby activating the T cell through 
its signaling domains to selectively kill the cancer cells. Through 
this mechanism of action, the selectivity of the a CAR allows the T 
cells to kill cancer cells while leaving healthy, essential cells 
unharmed. This can result in an effective therapeutic strategy with 
fewer side effects due to less non-specific killing of cells.
    The prospective 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 
fifteen (15) 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 404.7.
    Complete applications for a license in the prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Patent License Agreement. 
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: August 31, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-21366 Filed 9-6-16; 8:45 am]
 BILLING CODE 4140-01-P