81 FR 36934 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 110 (June 8, 2016)

Page Range		36934-36934
FR Document		2016-13500

Federal Register, Volume 81 Issue 110 (Wednesday, June 8, 2016)

[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Notices]
[Page 36934]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13500]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute; Notice of Closed 
Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of the following 
meeting.
    The meeting will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Heart, Lung, and Blood Institute 
Special Emphasis Panel; NHLBI Clinical Trial Pilot Studies (R34).
    Date: June 27, 2016.
    Time: 8:30 a.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, 
MD 20814.
    Contact Person: Chang Sook Kim, Ph.D., Scientific Review 
Officer, Office of Scientific Review/DERA, National Heart, Lung, and 
Blood Institute, 6701 Rockledge Drive, Room 7188, Bethesda, MD 
20892-7924, 301-435-0287, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.233, 
National Center for Sleep Disorders Research; 93.837, Heart and 
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, 
Blood Diseases and Resources Research, National Institutes of 
Health, HHS).

    Dated: June 2, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-13500 Filed 6-7-16; 8:45 am]
 BILLING CODE 4140-01-P

36934 Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices

Monoclonal Antibodies Specific for Transfer Center on or before June 23, not be released under the Freedom of
Glypican-3 And Use Thereof’’ [HHS Ref. 2016 will be considered. Information Act, 5 U.S.C. 552.
E–130–2011/0–CN–03], European Patent ADDRESSES: Requests for copies of the Dated: June 3, 2016.
2699603 entitled ‘‘Human Monoclonal patent application, inquiries, comments,
Antibodies Specific for Glypican-3 And Richard U. Rodriguez,
and other materials relating to the Associate Director, Technology Transfer
Use Thereof’’ [HHS Ref. E–130–2011/0– contemplated exclusive license should
EP–04], and validated in France, Center, National Cancer Institute.
be directed to: David A. Lambertson, [FR Doc. 2016–13530 Filed 6–7–16; 8:45 am]
Germany and the United Kingdom, Ph.D., Senior Licensing and Patenting
United States Patent 9,206,257 entitled Manager, National Cancer Institute, BILLING CODE 4140–01–P
‘‘Human Monoclonal Antibodies 9609 Medical Center Drive, Rm. 1–E530
Specific for Glypican-3 And Use MSC9702, Rockville, MD 20850–9702,
Thereof’’ [HHS Ref. E–130–2011/0–US– DEPARTMENT OF HEALTH AND
Email: david.lambertson@nih.gov.
05], United States Patent Application HUMAN SERVICES
14/837,903 entitled ‘‘Human SUPPLEMENTARY INFORMATION: This
Monoclonal Antibodies Specific for invention concerns an anti-GPC3 National Institutes of Health
Glypican-3 And Use Thereof’’ [HHS Ref. (Glypican-3) chimeric antigen receptor
E–130–2011/0–US–06], European Patent (CAR) and methods of using the CAR for National Heart, Lung, and Blood
Application 15188264.4 entitled the treatment of GPC3-expressing Institute; Notice of Closed Meeting
‘‘Human Monoclonal Antibodies cancers. GPC3 is a cell surface antigen
Specific for Glypican-3 And Use that is preferentially expressed on Pursuant to section 10(d) of the
Thereof’’ [HHS Ref. E–130–2011/0–EP– certain types of cancer cells, particularly Federal Advisory Committee Act, as
07], United States Patent Application liver cancers such as hepatocellular amended (5 U.S.C. App.), notice is
15/090,873 entitled ‘‘Human carcinoma (HCC). The anti-GPC3 CARs hereby given of the following meeting.
Monoclonal Antibodies Specific for of this technology contain (1) antigen The meeting will be closed to the
Glypican-3 And Use Thereof’’ [HHS Ref. recognition sequences that bind public in accordance with the
E–130–2011/0–US–12], Chinese Patent specifically to GPC3 and (2) signaling provisions set forth in sections
Application 201610290837.3 entitled domains that can activate the cytotoxic 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
‘‘Human Monoclonal Antibodies functions of a T cell. The anti-GPC3
as amended. The grant applications and
Specific for Glypican-3 And Use CAR can be transduced into T cells that
the discussions could disclose
Thereof’’ [HHS Ref. E–130–2011/0–CN– are harvested from a donor, followed by
(a) selection and expansion of the T confidential trade secrets or commercial
13], European Patent Application property such as patentable material,
16166924.7 entitled ‘‘Human cells expressing the anti-GPC3 CAR, and
(b) reintroduction of the T cells into the and personal information concerning
Monoclonal Antibodies Specific for
patient. Once the anti-GPC3 CAR- individuals associated with the grant
Glypican-3 And Use Thereof’’ [HHS Ref.
expressing T cells are reintroduced into applications, the disclosure of which
E–130–2011/0–EP–14], and all
continuing U.S. and foreign patents/ the patient, the T cells can selectively would constitute a clearly unwarranted
patent applications for the technology bind to GPC3-expressing cancer cells invasion of personal privacy.
family, to Lentigen Technology, Inc. through its antigen recognition Name of Committee: National Heart, Lung,
sequences, thereby activating the T cell and Blood Institute Special Emphasis Panel;
The patent rights to these inventions
through its signaling domains to NHLBI Clinical Trial Pilot Studies (R34).
have been assigned to and/or
selectively kill the cancer cells. Through Date: June 27, 2016.
exclusively licensed to the Government
this mechanism of action, the selectivity Time: 8:30 a.m. to 4:00 p.m.
of the United States of America.
of the a CAR allows the T cells to kill Agenda: To review and evaluate grant
The prospective exclusive licensed cancer cells while leaving healthy, applications.
territory may be the United States, essential cells unharmed. This can Place: Residence Inn Bethesda, 7335
Australia, Canada, the European Union, result in an effective therapeutic Wisconsin Avenue, Bethesda, MD 20814.
Russia, China, Hong Kong, Japan, strategy with fewer side effects due to Contact Person: Chang Sook Kim, Ph.D.,
Taiwan, South Korea and Singapore, less non-specific killing of cells. Scientific Review Officer, Office of Scientific
and the field of use may be limited to: Review/DERA, National Heart, Lung, and
The prospective exclusive license will
‘‘The development of a glypican-3 Blood Institute, 6701 Rockledge Drive, Room
be royalty bearing and will comply with
(GPC3) chimeric antigen receptor (CAR)- 7188, Bethesda, MD 20892–7924, 301–435–
the terms and conditions of 35 U.S.C.
based immunotherapy using autologous 0287, carolko@mail.nih.gov.
209 and 37 CFR part 404.7. The
(meaning one individual is both the (Catalogue of Federal Domestic Assistance
prospective exclusive license may be
donor and the recipient) primary human Program Nos. 93.233, National Center for
granted unless the NIH receives written
lymphocytes (T cells or NK cells) Sleep Disorders Research; 93.837, Heart and
evidence and argument that establishes
transfected with a lentiviral or retroviral Vascular Diseases Research; 93.838, Lung
that the grant of the license would not
vector, wherein the vector expresses a Diseases Research; 93.839, Blood Diseases
be consistent with the requirements of
CAR having (1) a single antigen and Resources Research, National Institutes
35 U.S.C. 209 and 37 CFR part 404.7
specificity and (2) comprising at least: of Health, HHS).
within fifteen (15) days from the date of
(a) The complementary determining
this published notice. Dated: June 2, 2016.
region (CDR) sequences of the anti-GPC3
Complete applications for a license in
mstockstill on DSK3G9T082PROD with NOTICES

antibody known as HN3; and (b) a T cell Michelle Trout,
signaling domain; for the prophylaxis the field of use filed in response to this Program Analyst, Office of Federal Advisory
and treatment of GPC3-expressing notice will be treated as objections to Committee Policy.
cancers.’’ the grant of the contemplated exclusive [FR Doc. 2016–13500 Filed 6–7–16; 8:45 am]
license. Comments and objections
BILLING CODE 4140–01–P
DATES: Only written comments and/or submitted to this notice will not be
applications for a license which are made available for public inspection
received by the NCI Technology and, to the extent permitted by law, will

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Document Created: 2016-06-08 03:10:24
Document Modified: 2016-06-08 03:10:24

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
Dates		June 27, 2016.
FR Citation		81 FR 36934

81 FR 36934 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 110 (June 8, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health