[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Page 19211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07556]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of 5T4 
Antibodies in Human Cancer Therapeutics and Diagnostics

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 
404, that the National Cancer Institute, 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. Patents and Patent Applications to Ovensa, Inc. 
(``Ovensa'') located in Ontario, Canada.

Intellectual Property

    U.S. Provisional Patent Application No. 62/034,995 filed August 8, 
2014 entitled ``Human Monoclonal Antibodies Specific for 5T4 and 
Methods of Their Use'' [HHS Ref. No. E-158-2014/0-US-01];
    PCT Application No. PCT/US2015/044253 filed August 8, 2015 entitled 
``Human Monoclonal Antibodies Specific for 5T4 and Methods of Their 
Use'' [HHS Ref. No. E-158-2014/0-PCT-02].
    The patent rights in these inventions have been assigned to the 
government of 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 Licensed Patent 
Rights in combination with the Licensee's proprietary or exclusively 
in-licensed platforms and technologies for the treatment, prevention or 
diagnosis of cancer.''

DATES: Only written comments and/or applications for a license which 
are received by the Technology Transfer Center at the National Cancer 
Institute on or before April 19, 2016 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Rose Freel, Ph.D., Licensing and Patenting Manager, 
Technology Transfer Center, National Cancer Institute, 8490 Progress 
Drive, Riverside 5, Suite 400, Frederick, MD 21702; Telephone: (301) 
624-1257; Email: [email protected].

SUPPLEMENTARY INFORMATION: 5T4 is an antigen expressed on many 
different types of cancers, especially solid tumors. Its expression is 
limited in normal tissue, but is prevalent in malignant tumors 
throughout their development making it an attractive target for cancer 
immunotherapy. 5T4 is often found in colorectal, ovarian, and gastric 
tumors and as a result, has been used as a prognostic aid for these 
cancers. The role of 5T4 in antibody-directed immunotherapy has been 
studied using murine monoclonal antibodies (mAbs). In addition, 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. These mAbs have the potential to be cancer 
therapeutics as naked mAbs, chimeric antigen receptors (CARs) or 
antibody-drug conjugates (ADCs).
    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 
fifteen (15) days from the date of this published notice, the National 
Cancer Institute 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 404.7.
    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: March 29, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-07556 Filed 4-1-16; 8:45 am]
 BILLING CODE 4140-01-P