[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36826-36827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15656]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Development of an
Anti-TSLPR 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 61/912,948 entitled ``Thymic Stromal Lymphopoietin
Receptor-Specific Chimeric Antigen Receptors and Methods Using Same''
[HHS Ref. E-008-2014/0-US-01], U.S. Provisional Patent Application 61/
991,697 entitled ``Thymic Stromal Lymphopoietin Receptor-Specific
Chimeric Antigen Receptors and Methods Using Same'' [HHS Ref. E-008-
2014/1-US-01], PCT Patent Application PCT/US2014/063096 entitled
``Thymic Stromal Lymphopoietin Receptor-Specific Chimeric Antigen
Receptors and Methods Using Same'' [HHS Ref. E-008-2014/2-PCT-01], and
all related continuing and foreign patents/patent applications for the
technology family, to Lentigen Technology, 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:
``The development of a TSLPR-CAR-based immunotherapy using chimeric
antigen receptors (CARs) having:
(1) The complementary determining region (CDR) sequences of either
(a) the anti-TSLPR antibody known as 2D10 or
(b) the anti-TSLPR antibody known as 3G11; and
(2) a T cell signaling domain
[[Page 36827]]
for the prophylaxis and treatment of cancer.''
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-TSLPR
(Thymic Stromal Lymphopoietin Receptor) chimeric antigen receptor (CAR)
and methods of using the CAR for the treatment of TSLPR-expressing
cancers, including B cell malignancies.
TSLPR is a cell surface antigen that is preferentially expressed on
certain types of cancer cells, particularly rare cancers of B cell
origin such as acute lymphoblastic leukemia (ALL). The anti-TSLPR CARs
of this technology contain (1) antigen recognition sequences that bind
specifically to TSLPR and (2) signaling domains that can activate the
cytotoxic functions of a T cell. The anti-TSLPR CAR can be transduced
into T cells that are harvested from a cancer patient; from there, T
cells expressing the anti-TSLPR CAR are selected, expanded and then be
reintroduced into the patient. Once the anti-TSLPR CAR-expressing T
cells are reintroduced into the patient, the T cells can selectively
bind to TSLPR-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. 2015-15656 Filed 6-25-15; 8:45 am]
BILLING CODE 4140-01-P