[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Pages 15220-15221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06488]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Commercial License Agreement: 
Development of 5T4 Antibody-Drug Conjugates for the Treatment of Human 
Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an start-up exclusive 
commercial license to practice the inventions embodied in U.S. Patent 
Application No. 62/034,995 entitled ``Human Monoclonal Antibodies 
Specific for 5T4 and Methods of Their Use'' filed August 8, 20014 [HHS 
Ref. E-158-2014/0-US-01] and all related continuing and foreign 
patents/patent applications for the technology family to Concortis, 
Inc. The patent rights in these inventions have been assigned to the 
Government of 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 the development of 5T4 antibody drug conjugate 
therapeutics for the treatment of human cancers using Concortis' 
proprietary conjugation technologies.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
April 7, 2015 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments, and other materials relating to the contemplated exclusive 
evaluation option license should be directed to: Whitney Hastings, 
Ph.D., Senior 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: 5T4 is an antigen expressed in a number of

[[Page 15221]]

carcinomas. Its expression is limited in normal tissue, but is 
prevalent in malignant tumors throughout their development. This 
confined expression makes it an attractive target for cancer 
immunotherapy. 5T4 is often found in colorectal, ovarian, and gastric 
tumors and thus has been used as a prognostic aid for these cancers. In 
addition, its role in antibody-directed immunotherapy for delivering 
response modifiers to tumors has been studied using murine monoclonal 
antibodies (mAbs) and the cancer vaccine TroVax (currently in clinical 
trials for multiple solid tumors) targets 5T4. The present invention 
describes the identification and characterization of two fully human 
mAbs (m1001 and m1002) that bind to 5T4. Since the mAbs are fully 
human, they could have less immunogenicity and better safety profiles 
than the existing mouse and humanized antibodies.
    The prospective start-up exclusive commercial license is being 
considered under the small business initiative launched on October 1, 
2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 
37 CFR part 404. The prospective start-up exclusive commercial license 
may be granted unless within fifteen (15) 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 part 404.
    Any additional, properly filed, and 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 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: March 17, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-06488 Filed 3-20-15; 8:45 am]
 BILLING CODE 4140-01-P