[Federal Register Volume 78, Number 22 (Friday, February 1, 2013)]
[Notices]
[Page 7438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02152]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of Human 
Monoclonal Antibodies Against DR4

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 an 
exclusive evaluation option license to practice the inventions embodied 
in PCT Patent Application No. PCT/US2011/040750 and foreign equivalents 
thereof entitled ``Agonistic Human Monoclonal Antibodies Against DR4'' 
(HHS Ref. No. E-158-2010/0) to Customized Biosciences, Inc., which is 
located in Pasadena, CA. The patent rights in these inventions have 
been assigned to the United States of America.
    The prospective start-up exclusive commercial license territory may 
be worldwide and the field of use may be limited to ``use of the 
Licensed Patent Rights to develop therapeutic agents for the treatment 
of lymphomas, leukemias, hepatocellular cancer, colorectal cancer, 
ovarian cancer, lung cancer, rheumatoid arthritis, systemic lupus 
erythematosus, multiple sclerosis, amyotrophic lateral sclerosis, and 
Alzheimer's disease''.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
February 19, 2013 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
evaluation option license should be directed to: Whitney A. Hastings, 
Ph.D., 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; Email: [email protected].

SUPPLEMENTARY INFORMATION: The tumor necrosis factor (TNF)-related 
apoptosis-inducing ligand (TRAIL) and its functional receptors, DR4 and 
DR5, have been recognized as promising targets for cancer treatment. 
Therapeutics targeting TRAIL and its receptors are not only effective 
in killing many types of tumors but they also synergize with 
traditional therapies, and show efficacy against tumors that are 
otherwise resistant to conventional treatments.
    The above identified patent application relates to the development 
of two human monoclonal antibodies (mAbs) that bind to death receptor 4 
(``DR4''). The two mAbs were selected from a human phage displayed Fab 
library by panning against a recombinant DR4 extracellular domain. 
Therefore the two mAbs are fully human. These antibodies could have 
considerable potential as cancer therapeutics alone or in combination 
with other drugs. Further, these antibodies could be used as a research 
tool for the study of DR4.
    The prospective start-up exclusive commercial license is being 
considered under the small business initiative launched on 1 October 
2011, and will comply with the terms and conditions of 35 U.S.C. 209 
and 37 CFR 404.7. The prospective start-up exclusive commercial 
license, may be granted unless 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 
within fifteen (15) days from the date of this published notice.
    Complete 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 start-up exclusive commercial 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: January 24, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-02152 Filed 1-31-13; 8:45 am]
BILLING CODE 4140-01-P