[Federal Register: June 10, 2008 (Volume 73, Number 112)]
[Notices]
[Page 32719]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jn08-55]
[[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.
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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