[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36828-36829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15657]
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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.
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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