Prospective Grant of Exclusive License: Development of Autologous Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of Metastatic Melanoma, 69866 [2014-27680]
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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.
[FR Doc. 2014–27680 Filed 11–21–14; 8:45 am]
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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
E:\FR\FM\24NON1.SGM
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]]>Agencies
[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: 2014-27680]
[[Page 69866]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
-----------------------------------------------------------------------
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 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:
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.
ADDRESSES: 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.
SUPPLEMENTARY INFORMATION: 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 anti-cancer
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.
Dated: November 17, 2014.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2014-27680 Filed 11-21-14; 8:45 am]
BILLING CODE 4140-01-P
