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)

Page Range		61704-61704
FR Document		2016-21366

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 Issue 173 (Wednesday, September 7, 2016)

[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: david.lambertson@nih.gov.

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

61704 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices

SUMMARY: Indian Health Service (IHS) SUMMARY: This notice, in accordance recipient of the T cell are different
has entered into a contract with the with 35 U.S.C. 209 and 37 CFR part 404, individuals) T cell, and the resulting
National Academy of Public that the National Institutes of Health, anti-CD19 CAR-expressing genome-
Administration (the Academy) to assist Department of Health and Human edited allogeneic T cell will be
in the development of a five-year Services, is contemplating the grant of introduced into a cancer patient to
strategic plan. Funding for this project an exclusive patent license to practice exhibit a therapeutic effect. CD19 is a
was provided by Congress in the 2016 the inventions embodied in the cell surface antigen that is preferentially
Consolidated Appropriations Act, following Patents and Patent expressed on certain types of cancer
which directs IHS to develop the plan Applications and all continuing U.S. cells, particularly cancers of B cell
in consultation with urban Indians and and foreign patents/patent applications origin such as Non-Hodgkin’s Leukemia
the Academy. to Sangamo BioSciences, Inc. located in (NHL), acute lymphoblastic leukemia
As part of this project, the Academy Richmond, California, USA: (ALL) and chronic lymphocytic
project team is in the process of leukemia (CLL). The anti-CD19 CARs of
conducting extensive outreach to IHS/ Intellectual Property this technology contain (1) antigen
Office of Urban Indian Health Programs U.S. Provisional Patent Application recognition sequences that bind
(OUIHP) leadership and employees, as 62/006,313, filed 2 June 2014 and specifically to CD19 and (2) signaling
well as conferring with urban Indian entitled ‘‘Chimeric Antigen Receptors domains that can activate the cytotoxic
organizations and other key external Targeting CD–19’’ [HHS Ref. E–042– functions of a T cell. The anti-CD19
stakeholder groups. The final product 2014/0–US–01]; and PCT Patent CAR can be integrated into genome-
will be a strategic plan to guide the Application PCT/US2015/033473, filed edited allogeneic T cells; from there,
work of the headquarters office of 1 June 2015 and entitled ‘‘Chimeric genome-edited allogeneic T cells
OUIHP, area urban coordinators, and Antigen Receptors Targeting CD–19’’ expressing the anti-CD19 CAR are
urban Indian organizations participating [HHS Ref. E–042–2014/0–PCT–02]. selected, expanded and then introduced
in IHS programs. The strategic plan will The patent rights in these inventions into a patient. Once the anti-CD19 CAR-
be completed by the end of December have been assigned and/or exclusively expressing genome-edited allogeneic T
2016. licensed to the Government of the cells are introduced into the patient, the
IHS is requesting input on the United States of America. T cells can selectively bind to CD19-
strategic planning process, the strengths The prospective exclusive license expressing cancer cells through its
and weaknesses of OUIHP, and the territory may be worldwide and the antigen recognition sequences, thereby
opportunities and threats facing the field of use may be limited to the use activating the T cell through its
program. Comments will be used to help of Licensed Patent Rights for the signaling domains to selectively kill the
develop the mission, goals, objectives, following: ‘‘The integration of a cancer cells. Through this mechanism of
and strategies to be included in the monospecific anti-CD19 chimeric action, the selectivity of the a CAR
strategic plan. antigen receptor (CAR) into genome- allows the T cells to kill cancer cells
DATES: Submit your input to the edited, allogeneic T cells (where the while leaving healthy, essential cells
Academy no later than September 16, donor and recipient are different), unharmed. This can result in an
2016. All comments submitted to the where the monospecific CAR has at effective therapeutic strategy with fewer
Academy are not for attribution. least: (a) The complementary side effects due to less non-specific
Written Comments: Send input by determining region (CDR) sequences of killing of cells.
email to UIOconfer@napawash.org with the anti-CD19 47G4 antibody; and (b) a The prospective exclusive license will
the subject line: UIHP Strategic Plan. T cell signaling domain, for the be royalty bearing and will comply with
FOR FURTHER INFORMATION CONTACT: prophylaxis and treatment of CD19- the terms and conditions of 35 U.S.C.
Pamela Haze, Project Director, National positive malignancies.’’ 209 and 37 CFR part 404.7. The
Academy of Public Administration, DATES: Only written comments and/or prospective exclusive license may be
1600 K St. NW., Suite 400, Washington, applications for a license which are granted unless within fifteen (15) days
DC 20006, (201) 204–3682. received by the NIH Office of from the date of this published notice,
Technology Transfer on or before the NIH receives written evidence and
Dated: August 26, 2016.
September 22, 2016 will be considered. argument that establishes that the grant
Elizabeth A. Fowler, of the license would not be consistent
ADDRESSES: Requests for copies of the
Deputy Director for Management Operations, with the requirements of 35 U.S.C. 209
Indian Health Service. patent application, inquiries, comments,
and other materials relating to the and 37 CFR part 404.7.
[FR Doc. 2016–21485 Filed 9–6–16; 8:45 am] Complete applications for a license in
contemplated exclusive license should
BILLING CODE 4165–16–P
be directed to: David A. Lambertson, the prospective field of use that are filed
Ph.D., Senior Licensing and Patenting in response to this notice will be treated
Manager, National Cancer Institute, as objections to the grant of the
DEPARTMENT OF HEALTH AND contemplated Exclusive Patent License
HUMAN SERVICES 9609 Medical Center Drive, Rm. 1–E530
MSC9702, Rockville, MD 20850–9702, Agreement. Comments and objections
Email: david.lambertson@nih.gov. submitted to this notice will not be
National Institutes of Health made available for public inspection
SUPPLEMENTARY INFORMATION: This
Prospective Grant of Exclusive Patent and, to the extent permitted by law, will
invention concerns an anti-CD19
License: The Development of an Anti- not be released under the Freedom of
chimeric antigen receptor (CAR) and
mstockstill on DSK3G9T082PROD with NOTICES

CD19 Chimeric Antigen Receptor Information Act, 5 U.S.C. 552.
methods of using the CAR for the
(CAR) for the Treatment of Human treatment of CD19-expressing cancers, Dated: August 31, 2016.
Cancers including B cell malignancies. With Richard U. Rodriguez,
regard to the proposed license, the CAR Associate Director, Technology Transfer
AGENCY: National Institutes of Health,
covered by the invention will be Center, National Cancer Institute.
HHS.
integrated into a genome-edited [FR Doc. 2016–21366 Filed 9–6–16; 8:45 am]
ACTION: Notice.
allogeneic (where the donor and BILLING CODE 4140–01–P

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Document Created: 2016-09-07 11:50:22
Document Modified: 2016-09-07 11:50:22

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
FR Citation		81 FR 61704

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 SERVICESNational Institutes of Health

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health