81_FR_61877 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

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 Range61704-61704
FR Document2016-21366

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
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly 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 Citation81 FR 61704 

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