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]

Download as PDF 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: http://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]]

-----------------------------------------------------------------------

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