Prospective Grant of Exclusive License: Development of 5T4 Antibodies in Human Cancer Therapeutics and Diagnostics, 19211 [2016-07556]

Download as PDF Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices Dated: March 29, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–07484 Filed 4–1–16; 8:45 am] BILLING CODE 4140–01–P 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: rose.freel@nih.gov. 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 antibodydirected 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. 19211 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings SUPPLEMENTARY INFORMATION: 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. 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. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: 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: VerDate Sep<11>2014 19:03 Apr 01, 2016 Jkt 238001 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 PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; AIDS and Related Research NAED Conflicts. Date: April 5, 2016. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Robert Freund, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892, 301–435– 1050, freundr@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR16–028: HIV/AIDS Vaccine Scholars Program. Date: April 7, 2016. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Barna Dey, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3184, Bethesda, MD 20892, 301–451–2796, bdey@ mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Multidisciplinary Studies on HIV and Aging. Date: April 8, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\04APN1.SGM 04APN1

Agencies

[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.

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

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: rose.freel@nih.gov.

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

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