Prospective Grant of Exclusive License: Use of the Licensed Patent Rights To Develop Fully Human and/or Humanized Monoclonal Antibodies Against IGF-I and/or IGF-II for the Treatment of Human Cancers, 32719 [E8-12925]
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Federal Register / Vol. 73, No. 112 / Tuesday, June 10, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Use of the Licensed Patent
Rights To Develop Fully Human and/or
Humanized Monoclonal Antibodies
Against IGF–I and/or IGF–II for the
Treatment of Human Cancers
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
dwashington3 on PRODPC61 with NOTICES
AGENCY:
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7(a)(1)(i), 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 U.S. Patent
Applications to Systems Medicine, Inc.,
which is located in Tucson, Arizona.
1. PCT Patent Application No. PCT/
US2006/031814 entitled ‘‘Human
Monoclonal Antibodies that Specifically
Bind IGF–II’’ [HHS Ref. Nos. E–217–
2005/0, 1, and 2]; and
2. PCT Application Serial No. PCT/
US2007/66180 entitled ‘‘Human IGF–ISpecific and IGF–I and IGF–II CrossReactive Human Monoclonal
Antibodies’’ [HHS Ref. No. E–336–2005/
0].
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 antibodies and their method of
use in the Licensed Patent Rights for the
treatment of human cancers
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
August 11, 2008 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 Hastings, PhD,
Technology Licensing Specialist, 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; E-mail:
hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The type 1
insulin-like growth factor (IGF) receptor
(IGF1R) is over-expressed by many
tumors and mediates proliferation,
motility, and protection from apoptosis.
Agents that inhibit IGF1R expression or
VerDate Aug<31>2005
15:35 Jun 09, 2008
Jkt 211001
function can potentially block tumor
growth and metastasis. Its major ligand,
IGF–II, is over-expressed by multiple
tumor types. Previous studies indicate
that inhibition of IGF–II binding to its
cognizant receptor negatively modulates
signal transduction through the IGF
pathway and concomitant cell growth.
Therefore, use of humanized or fully
human antibodies against IGFs
represents a valid approach to inhibit
tumor growth.
The above identified patent
applications relate to the identification
of multiple, novel fully human
monoclonal antibodies that are specific
for IGF–II and do not cross-react with
IGF–1 or insulin and identification and
characterization of three (3) novel fully
human monoclonal antibodies
designated m705, m706, and m708,
which are specific for insulin-like
growth factor (IGF)–I. Two (2) of the
three (3) antibodies, m705 and m706 are
specific for IGF–I and do not cross react
with IGF–II and insulin while, m708
cross reacts with IGF–II.
These antibodies can be used to
prevent binding of IGF–I to its
concomitant receptor IGFIR,
consequently, modulating diseases such
as cancer. Additional embodiments
describe methods for treating various
human diseases associated with
aberrant cell growth and motility
including breast, prostate, and leukemia
carcinomas. Thus, these novel
antibodies may provide a therapeutic
intervention for multiple carcinomas
without the negative side effects
associated with insulin inhibition.
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 sixty (60) 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 404.7.
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.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
32719
Dated: May 30, 2008.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–12925 Filed 6–9–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, Office of
Biotechnology Activities; Recombinant
DNA Research: Action Under the NIH
Guidelines for Research Involving
Recombinant DNA Molecules (NIH
Guidelines)
National Institutes of Health
(NIH), DHHS.
ACTION: Notice of a final action under
the NIH Guidelines and notice of
additions to Appendix D of the NIH
Guidelines.
AGENCY:
SUMMARY: Proposal to conduct research
involving the deliberate transfer of a
drug resistance trait to a microorganism
that causes disease in humans has been
reviewed by the Recombinant DNA
Advisory Committee (RAC) and
approved by the NIH Director.
DATES: The final action is effective April
7, 2008.
FOR FURTHER INFORMATION CONTACT:
Background documentation and
additional information can be obtained
from the Office of Biotechnology
Activities (OBA), National Institutes of
Health, 6705 Rockledge Drive, Suite
750, MSC 7985, Bethesda, Maryland
20892–7985; e-mail at oba@od.nih.gov,
or telephone at 301–496–9838. The
NIH/OBA Web site is located at:
https://www4.od.nih.gov/oba/.
SUPPLEMENTARY INFORMATION: This final
action allows Dr. David Walker,
University of Texas Medical Branch at
Galveston to deliberately introduce a
gene encoding chloramphenicol
resistance into Rickettsia conorii. This
approval is specific to Dr. Walker. His
research with these resistant organisms
may only occur under the conditions
outlined below. It should be noted that
any work involving the introduction of
chloramphenicol resistance into R.
conorii by other investigators would
need to be reviewed by the RAC and
specifically approved by the NIH
Director.
Background Information and
Response to Comments: On July 24,
2007, background on the proposed
action and information on how to
submit public comment, was published
E:\FR\FM\10JNN1.SGM
10JNN1
Agencies
[Federal Register Volume 73, Number 112 (Tuesday, June 10, 2008)]
[Notices]
[Page 32719]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12925]
[[Page 32719]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Use of the Licensed
Patent Rights To Develop Fully Human and/or Humanized Monoclonal
Antibodies Against IGF-I and/or IGF-II for the Treatment of Human
Cancers
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 part 404.7(a)(1)(i), 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 U.S. Patent Applications to Systems Medicine, Inc., which is
located in Tucson, Arizona.
1. PCT Patent Application No. PCT/US2006/031814 entitled ``Human
Monoclonal Antibodies that Specifically Bind IGF-II'' [HHS Ref. Nos. E-
217-2005/0, 1, and 2]; and
2. PCT Application Serial No. PCT/US2007/66180 entitled ``Human
IGF-I-Specific and IGF-I and IGF-II Cross-Reactive Human Monoclonal
Antibodies'' [HHS Ref. No. E-336-2005/0].
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 antibodies and their
method of use in the Licensed Patent Rights for the treatment of human
cancers
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
August 11, 2008 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 Hastings, PhD, Technology
Licensing Specialist, 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; E-
mail: hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The type 1 insulin-like growth factor (IGF)
receptor (IGF1R) is over-expressed by many tumors and mediates
proliferation, motility, and protection from apoptosis. Agents that
inhibit IGF1R expression or function can potentially block tumor growth
and metastasis. Its major ligand, IGF-II, is over-expressed by multiple
tumor types. Previous studies indicate that inhibition of IGF-II
binding to its cognizant receptor negatively modulates signal
transduction through the IGF pathway and concomitant cell growth.
Therefore, use of humanized or fully human antibodies against IGFs
represents a valid approach to inhibit tumor growth.
The above identified patent applications relate to the
identification of multiple, novel fully human monoclonal antibodies
that are specific for IGF-II and do not cross-react with IGF-1 or
insulin and identification and characterization of three (3) novel
fully human monoclonal antibodies designated m705, m706, and m708,
which are specific for insulin-like growth factor (IGF)-I. Two (2) of
the three (3) antibodies, m705 and m706 are specific for IGF-I and do
not cross react with IGF-II and insulin while, m708 cross reacts with
IGF-II.
These antibodies can be used to prevent binding of IGF-I to its
concomitant receptor IGFIR, consequently, modulating diseases such as
cancer. Additional embodiments describe methods for treating various
human diseases associated with aberrant cell growth and motility
including breast, prostate, and leukemia carcinomas. Thus, these novel
antibodies may provide a therapeutic intervention for multiple
carcinomas without the negative side effects associated with insulin
inhibition.
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
sixty (60) 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 404.7.
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: May 30, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-12925 Filed 6-9-08; 8:45 am]
BILLING CODE 4140-01-P