Prospective Grant of Exclusive License: Development of Human Monoclonal Antibodies Against DR4, 7438 [2013-02152]
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7438
Federal Register / Vol. 78, No. 22 / Friday, February 1, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average time
per response
(in hours)
Annual burden
hours
Type of respondents
Instrument
Clinical Trials .....................................
Initial Registration .............................
Amendment ......................................
Accrual Updates ...............................
5,500
5,500
5,500
1
4
4
2
1
15/60
11,000
22,000
5,500
Total ...........................................
...........................................................
16,500
........................
........................
38,500
Dated: January 25, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Cancer Institute (NCI), National Institutes of
Health (NIH).
[FR Doc. 2013–02123 Filed 1–31–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of Human
Monoclonal Antibodies Against DR4
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
evaluation option license to practice the
inventions embodied in PCT Patent
Application No. PCT/US2011/040750
and foreign equivalents thereof entitled
‘‘Agonistic Human Monoclonal
Antibodies Against DR4’’ (HHS Ref. No.
E–158–2010/0) to Customized
Biosciences, Inc., which is located in
Pasadena, CA. The patent rights in these
inventions have been assigned to the
United States of America.
The prospective start-up exclusive
commercial license territory may be
worldwide and the field of use may be
limited to ‘‘use of the Licensed Patent
Rights to develop therapeutic agents for
the treatment of lymphomas, leukemias,
hepatocellular cancer, colorectal cancer,
ovarian cancer, lung cancer, rheumatoid
arthritis, systemic lupus erythematosus,
multiple sclerosis, amyotrophic lateral
sclerosis, and Alzheimer’s disease’’.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
February 19, 2013 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:26 Jan 31, 2013
Jkt 229001
and other materials relating to the
contemplated exclusive evaluation
option license should be directed to:
Whitney A. Hastings, Ph.D., 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: The tumor
necrosis factor (TNF)-related apoptosisinducing ligand (TRAIL) and its
functional receptors, DR4 and DR5, have
been recognized as promising targets for
cancer treatment. Therapeutics targeting
TRAIL and its receptors are not only
effective in killing many types of tumors
but they also synergize with traditional
therapies, and show efficacy against
tumors that are otherwise resistant to
conventional treatments.
The above identified patent
application relates to the development
of two human monoclonal antibodies
(mAbs) that bind to death receptor 4
(‘‘DR4’’). The two mAbs were selected
from a human phage displayed Fab
library by panning against a
recombinant DR4 extracellular domain.
Therefore the two mAbs are fully
human. These antibodies could have
considerable potential as cancer
therapeutics alone or in combination
with other drugs. Further, these
antibodies could be used as a research
tool for the study of DR4.
The prospective start-up exclusive
commercial license is being considered
under the small business initiative
launched on 1 October 2011, and will
comply with the terms and conditions
of 35 U.S.C. 209 and 37 CFR 404.7. The
prospective start-up exclusive
commercial license, may be granted
unless 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 404.7 within
fifteen (15) days from the date of this
published notice.
Complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
the grant of the contemplated start-up
exclusive commercial 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: January 24, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–02152 Filed 1–31–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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 meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel, RFA Panel:
Studies in Neonatal Resuscitation.
Date: February 27–28, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Gary Hunnicutt, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6164,
MSC 7892, Bethesda, MD 20892, 301–435–
0229, gary.hunnicutt@nih.gov.
E:\FR\FM\01FEN1.SGM
01FEN1
]]>Agencies
[Federal Register Volume 78, Number 22 (Friday, February 1, 2013)]
[Notices]
[Page 7438]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02152]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Development of Human
Monoclonal Antibodies Against DR4
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR 404.7(a)(1)(i), that the National Institutes of Health, Department
of Health and Human Services, is contemplating the grant of an
exclusive evaluation option license to practice the inventions embodied
in PCT Patent Application No. PCT/US2011/040750 and foreign equivalents
thereof entitled ``Agonistic Human Monoclonal Antibodies Against DR4''
(HHS Ref. No. E-158-2010/0) to Customized Biosciences, Inc., which is
located in Pasadena, CA. The patent rights in these inventions have
been assigned to the United States of America.
The prospective start-up exclusive commercial license territory may
be worldwide and the field of use may be limited to ``use of the
Licensed Patent Rights to develop therapeutic agents for the treatment
of lymphomas, leukemias, hepatocellular cancer, colorectal cancer,
ovarian cancer, lung cancer, rheumatoid arthritis, systemic lupus
erythematosus, multiple sclerosis, amyotrophic lateral sclerosis, and
Alzheimer's disease''.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
February 19, 2013 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
evaluation option license should be directed to: Whitney A. Hastings,
Ph.D., 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: The tumor necrosis factor (TNF)-related
apoptosis-inducing ligand (TRAIL) and its functional receptors, DR4 and
DR5, have been recognized as promising targets for cancer treatment.
Therapeutics targeting TRAIL and its receptors are not only effective
in killing many types of tumors but they also synergize with
traditional therapies, and show efficacy against tumors that are
otherwise resistant to conventional treatments.
The above identified patent application relates to the development
of two human monoclonal antibodies (mAbs) that bind to death receptor 4
(``DR4''). The two mAbs were selected from a human phage displayed Fab
library by panning against a recombinant DR4 extracellular domain.
Therefore the two mAbs are fully human. These antibodies could have
considerable potential as cancer therapeutics alone or in combination
with other drugs. Further, these antibodies could be used as a research
tool for the study of DR4.
The prospective start-up exclusive commercial license is being
considered under the small business initiative launched on 1 October
2011, and will comply with the terms and conditions of 35 U.S.C. 209
and 37 CFR 404.7. The prospective start-up exclusive commercial
license, may be granted unless 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 404.7
within fifteen (15) days from the date of this published notice.
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 start-up exclusive commercial 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: January 24, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-02152 Filed 1-31-13; 8:45 am]
BILLING CODE 4140-01-P
