[Federal Register Volume 74, Number 36 (Wednesday, February 25, 2009)]
[Notices]
[Page 8558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4045]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Co-Exclusive License: Use 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 404.7(a)(1)(i), that the National Institutes of Health, Department 
of Health and Human Services, is contemplating the grant of a co-
exclusive patent license to practice the inventions embodied in U.S. 
Patent Application No. 12/296,328 entitled, ``Human IGF-I-Specific and 
IGF-I and IGF-II Cross-Reactive Human Monoclonal Antibodies'' and all 
foreign counterparts [HHS Ref. No. E-336-2005/0] to Trubion 
Pharmaceuticals, Inc., which is located in Seattle, Washington. The 
patent rights in this invention have been assigned to the United States 
of America.
    The prospective co-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 
April 27, 2009 will be considered. This notice updates the Federal 
Register Notice published in 73 FR 32719, June 10, 2008.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated co-exclusive 
license should be directed to: Whitney A. Hastings, M.S., 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; 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 ligands, IGF-I and IGF-II, are over-expressed 
by multiple tumor types. Previous studies indicate that inhibition of 
IGF-I and/or 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 discloses 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 co-exclusive license will be royalty bearing and 
will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 
404.7. The prospective co-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 co-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: February 17, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E9-4045 Filed 2-24-09; 8:45 am]
BILLING CODE 4140-01-P