National Institute on Drug Abuse; Notice of Closed Meeting, 69866 [2014-27669]
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69866
Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices
National Institutes of Health
Prospective Grant of Exclusive
License: Development of Autologous
Tumor Infiltrating Lymphocyte
Adoptive Cells for the Treatment of
Metastatic Melanoma
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
1. U.S. Provisional Patent Application No.
61/237,889, filed August 26, 2009 entitled
‘‘Adoptive cell therapy with young T cells’’
(HHS Ref No. E–273–2009/0–US–01);
2. U.S. Patent No. 8,383,099 issued
February 26, 2013 entitled ‘‘Adoptive cell
therapy with young T cells’’ (HHS Ref No. E–
273–2009/0–US–02);
3. U.S. Patent Application No. 13/742,541
filed January 16, 2013 entitled ‘‘Adoptive cell
therapy with young T cells’’ (HHS Ref No. E–
273–2009/0–US–03);
4. U.S. Provisional Patent Application No.
61/466,200 filed March 22, 2011 entitled
‘‘Methods of growing tumor infiltrating
lymphocytes in gas-permeable containers’’
(HHS Ref No. E–114–2011/0–US–01);
5. PCT Application No. PCT/US2012/
029744 filed March 20, 2012 entitled
‘‘Methods of growing tumor infiltrating
lymphocytes in gas-permeable containers’’
(HHS Ref No. E–114–2011/0–US–01);
6. U.S. Patent Application No. 13/424,646
filed May 20, 2012 entitled ‘‘Methods of
growing tumor infiltrating lymphocytes in
gas-permeable containers’’ (HHS Ref No. E–
114–2011/0–US–01);
The patent rights in these inventions
have been assigned to 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 the Licensed Patent Rights to
develop, manufacture, distribute, sell
and use autologous tumor infiltrating
lymphocyte adoptive cell therapy
products for the treatment of metastatic
melanoma as a stand-alone therapy.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
December 24, 2014 will be considered.
20:32 Nov 21, 2014
Isolating
cells from the tumor infiltrating
lymphocytes (TIL) of a patient tumor
sample provides a suitable initial
lymphocyte culture for further in vitro
manipulations. NIH scientists have
discovered that taking the isolated cells
through one cycle of rapid expansion
(including exposure to IL–2), rather than
multiple cycles, yields lymphocyte
cultures with higher affinity and longer
persistence in patients. In addition, they
have found that through the use of gas
permeable (GP) flasks, they could obtain
large quantities of highly reactive TIL
from patient tumor samples for anticancer immunotherapy. If an adoptive T
cell transfer immunotherapy is to gain
regulatory approval and successfully
treat a wide array of patients, it will
need to be rapid, reliable, and
technically simple. One of the most
critical factors to this approach is the
generation of effective lymphocyte
cultures that will rapidly and repeatedly
attack the target cells when infused into
patients.
The prospective exclusive license
may be granted unless within thirty (30)
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.
Complete applications for a license in
the field of use 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.
SUPPLEMENTARY INFORMATION:
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 patent license to the
current licensee, Lion Biotechnologies,
Inc., which is located in Woodland
Hills, California to practice the
inventions embodied in the following
patent applications and applications
claiming priority to these applications:
SUMMARY:
VerDate Sep<11>2014
Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Whitney A. Hastings,
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) 451–7337; Facsimile: (301) 402–
0220; Email: hastingw@mail.nih.gov.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 235001
Dated: November 17, 2014.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel
Production, Analysis, and Distribution of
Cannabis and Related Materials (7793).
Date: December 2, 2014.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Lyle Furr, Scientific
Review Officer, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 4227, MSC 9550, 6001
Executive Boulevard, Bethesda, MD 20892–
9550, (301) 435–1439, lf33c.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: November 18, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–27669 Filed 11–21–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
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[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Page 69866]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27669]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; 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 contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable materials, and personal information concerning individuals
associated with the contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel Production, Analysis, and Distribution of Cannabis
and Related Materials (7793).
Date: December 2, 2014.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Lyle Furr, Scientific Review Officer, Office of
Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS,
Room 4227, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892-
9550, (301) 435-1439, lf33c.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug
Abuse and Addiction Research Programs, National Institutes of
Health, HHS)
Dated: November 18, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-27669 Filed 11-21-14; 8:45 am]
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