[Federal Register Volume 73, Number 112 (Tuesday, June 10, 2008)]
[Notices]
[Page 32719]
From the Federal Register Online via the Government Publishing 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.

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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: [email protected].

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