80 FR 36828 - Prospective Grant of Exclusive 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 80, Issue 123 (June 26, 2015)

This is 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 license to practice the inventions embodied in U.S. Provisional Patent Application 62/006,313 entitled ``Chimeric Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014/0-US-01], and all related continuing and foreign patents/patent applications for the technology family, to Kite Pharma, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be worldwide, and the field of use may be limited to: ``All prophylactic and therapeutic uses for CD19-associated diseases, states and conditions in humans.''

[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36828-36829]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15657]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive 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.

-----------------------------------------------------------------------

SUMMARY: This is 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 license 
to practice the inventions embodied in U.S. Provisional Patent 
Application 62/006,313 entitled ``Chimeric Antigen Receptors Targeting 
CD-19'' [HHS Ref. E-042-2014/0-US-01], and all related continuing and 
foreign patents/patent applications for the technology family, to Kite 
Pharma, Inc. The patent rights in these inventions have been assigned 
to and/or exclusively licensed to the Government of the United States 
of America.
    The prospective exclusive licensed territory may be worldwide, and 
the field of use may be limited to: ``All prophylactic and therapeutic 
uses for

[[Page 36829]]

CD19-associated diseases, states and conditions in humans.''

DATES: Only applications for a license which are received by the NIH 
Office of Technology Transfer on or before July 27, 2015 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, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 
402-0220; 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.
    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 transduced 
into T cells that are harvested from a cancer patient; from there, T 
cells expressing the anti-CD19 CAR are selected, expanded and then be 
reintroduced into the patient. Once the anti-CD19 CAR-expressing T 
cells are reintroduced 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. The prospective exclusive license may be granted unless 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 within thirty (30) days from the date of 
this published notice.
    Complete applications for a license in an appropriate field of use 
that are 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: June 22, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-15657 Filed 6-25-15; 8:45 am]
 BILLING CODE 4140-01-P