Prospective Grant of Exclusive Patent License: The Development of Monospecific and Bispecific Antibodies to GPC3 for the Treatment of Human Liver Cancers, 23013-23014 [2017-10154]

Download as PDF Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices Dated: May 11, 2017. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2017–10153 Filed 5–18–17; 8:45 am] Prospective Grant of Exclusive Patent License: The Development of Monospecific and Bispecific Antibodies to GPC3 for the Treatment of Human Liver Cancers National Institutes of Health BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: ACTION: National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting asabaliauskas on DSK3SPTVN1PROD with NOTICES Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; NIAAA Fellowship Review. Date: July 21, 2017. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, Terrace Level Conference Room, 5635 Fishers Lane, Bethesda, M.D 20892 Contact Person: Richard A. Rippe, Ph.D., Scientific Review Officer , Extramural Project Review Branch, Office of Extramural Activities, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Room 2109, Rockville, MD 20852, 301–443– 8599, rippera@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards., National Institutes of Health, HHS) Dated: May 15, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–10113 Filed 5–18–17; 8:45 am] BILLING CODE 4140–01–P 19:15 May 18, 2017 Jkt 241001 Notice. The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to AbPro, located in Woburn, Massachusetts, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice. DATES: Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before June 5, 2017 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: David A. Lambertson, Ph.D., Senior Licensing and Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892– 9702 (for business mail), Rockville, MD 20850–9702, Telephone: (240)–276– 6467; Email: david.lambertson@nih.gov. SUPPLEMENTARY INFORMATION: The following represents the intellectual property to be licensed under the prospective agreement: U.S. Provisional Patent Application 61/654,232 entitled ‘‘High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. E–136–2012/0–US–01], PCT Patent Application PCT/US2013/043633 entitled ‘‘High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. E–136–2012/0– PCT–02], Chinese Patent Application 201380039993.7 entitled ‘‘High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. E–136– 2012/0–CN–03], Japanese Patent Application 2015–515243 entitled ‘‘High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. E–136–2012/0–JP–04], South Korean Patent Application 10–2014– 7037046 entitled ‘‘High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. E–136– 2012/0–KR–05], Singapore Patent Application 11201407972R entitled SUMMARY: 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 meeting. The meeting 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. VerDate Sep<11>2014 National Institutes of Health, HHS. National Institutes of Health PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 23013 ‘‘High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. E–136–2012/0–SG–06], and United States Patent 9,409,994 entitled ‘‘Highaffinity Monoclonal Antibodies To Glypican-3 And Use Thereof’’ [HHS Ref. E–136–2012/0–US–07], and all continuing U.S. and foreign patents/ patent applications for the technology family, to AbPro. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. With respect to persons who have an obligation to assign their right, title and interest to the Government of the United States of America, the patent rights in these inventions have been assigned to the Government of the United States of America. The prospective Exclusive Patent License territory may be worldwide for the following field of use: The use of the YP7, YP8 and YP9.1 antiGPC3 monoclonal antibodies as monospecific or bispecific antibodies for the treatment of liver cancer. The licensed field of use excludes any non-specified immunoconjugates, including, but not limited to, chimeric antigen receptors (CARs) and variants thereof, Immunotoxins, and antibody-drug conjugates (ADCs). The present inventions to be licensed concern monoclonal antibodies that are specific for the cell surface domain of GPC3: YP6, YP7, YP8, YP9 and YP9.1. These antibodies can potentially be used for the treatment of GPC3expressing cancers such as HCC. By binding to and blocking GPC3 function, these antibodies can inhibit the growth of HCC cells, thereby decreasing the ability of tumors to grow and metastasize. Alternatively, the antibodies can be used to induce antibody-dependent anti-tumor activity by selectively killing cells which overexpress GPC3 while leaving healthy, normal cells unscathed. Finally, a secondary antibody capable of recruiting T cells to the tumor can be attached to the antibodies, thereby allowing for the localization of T cells or NK cells only to those cells which express GPC3, similarly leading to the selective killing of the cancer cells. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Exclusive Patent License will be royalty bearing and 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. E:\FR\FM\19MYN1.SGM 19MYN1 23014 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent 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 11, 2017. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2017–10154 Filed 5–18–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Manufacturing and Testing of PVSRIPO in the Treatment of Solid, Non-lymphoid Tumors Expressing Poliovirus Receptor CD155 AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Istari Oncology Incorporated located in North Carolina, U.S.A. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before June 5, 2017 will be considered. SUMMARY: Requests for copies of the patent application, inquiries, and comments relating to the contemplated Exclusive Commercialization Patent License should be directed to: Lauren Nguyen-Antczak, Ph.D., J.D., Senior Licensing and Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850– 9702, Telephone: (240) 276–5530; Facsimile: (240) 276–5504, Email: lauren.nguyen-antczak@nih.gov. SUPPLEMENTARY INFORMATION: asabaliauskas on DSK3SPTVN1PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 Intellectual Property United States Provisional Patent Application No. 62/173,777, filed June 10, 2015 and entitled ‘‘Processes for Production and Purification of Nucleic Acid Containing Compositions’’ [HHS Reference No. E–267–2014/0–US–01]; PCT Patent Application PCT/US2016/ 036888, filed E–267–2014/0–PCT–02 and entitled ‘‘Processes for Production and Purification of Nucleic Acid Containing Compositions’’ [HHS Reference No. E–267–2014/0–PCT–02]; United States Provisional Patent Application No. 62/199,663, filed July 31, 2015 and entitled ‘‘Methods of Analyzing Virus-Derived Therapeutics’’ [HHS Reference No. E–240–2015/0–US– 01]; PCT Patent Application PCT/US2016/ 044788, filed July 29, 2016 and entitled ‘‘Methods of Analyzing Virus-Derived Therapeutics’’ [HHS Reference No. E– 240–2015/1–PCT–01]; and U.S. and foreign patent applications claiming priority to the aforementioned applications. The patent rights in these inventions have been assigned and/or exclusively licensed 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 Licensed Patent Rights for the following: ‘‘Manufacturing and Testing of PVSRIPO in the Treatment of Solid, Non-lymphoid Tumors expressing Poliovirus Receptor CD155, wherein PVSRIPO is genetically recombinant, non-pathogenic poliovirus:rhinovirus chimera that consists of the genome of the live attenuated poliovirus serotype 1 (SABIN) vaccine (PV1S) with its cognate IRES element replaced with that of HRV2.’’ The E–267–2014 technology discloses improved methods for large scale production of highly purified, therapeutic grade, oncolytic polioviruses. Invention processes provide industrial scale, and cGMP compliant manufacturing of PVSRIPO. The E–240–2015 technology discloses improved methods for detecting genetic micro-heterogeneity in manufactured batches of RNA virus-derived therapeutics, such as PVSRIPO. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and 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 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Commercialization Patent License Agreement. 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 12, 2017. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2017–10155 Filed 5–18–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Dr. Dianca Finch, 240–669–5503; dianca.finch@nih.gov. Licensing information and copies of the patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD, 20852; tel. 301–496–2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. SUMMARY: Products for Treatment and Prevention of Ebola Zaire Disease Description of Technology Scientists at the NIAID Vaccine Research Center have developed human E:\FR\FM\19MYN1.SGM 19MYN1

Agencies

[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23013-23014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: The Development of 
Monospecific and Bispecific Antibodies to GPC3 for the Treatment of 
Human Liver Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Cancer Institute, National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
an Exclusive Patent License to AbPro, located in Woburn, Massachusetts, 
to practice the inventions embodied in the patent applications listed 
in the SUPPLEMENTARY INFORMATION section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NCI Technology Transfer Center on or before June 5, 
2017 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: David A. Lambertson, Ph.D., Senior Licensing and 
Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center 
Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), 
Rockville, MD 20850-9702, Telephone: (240)-276-6467; Email: 
david.lambertson@nih.gov.

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement: U.S. 
Provisional Patent Application 61/654,232 entitled ``High-affinity 
Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-
2012/0-US-01], PCT Patent Application PCT/US2013/043633 entitled 
``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' 
[HHS Ref. E-136-2012/0-PCT-02], Chinese Patent Application 
201380039993.7 entitled ``High-affinity Monoclonal Antibodies To 
Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-CN-03], Japanese 
Patent Application 2015-515243 entitled ``High-affinity Monoclonal 
Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-JP-
04], South Korean Patent Application 10-2014-7037046 entitled ``High-
affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS 
Ref. E-136-2012/0-KR-05], Singapore Patent Application 11201407972R 
entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use 
Thereof'' [HHS Ref. E-136-2012/0-SG-06], and United States Patent 
9,409,994 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 
And Use Thereof'' [HHS Ref. E-136-2012/0-US-07], and all continuing 
U.S. and foreign patents/patent applications for the technology family, 
to AbPro. The patent rights in these inventions have been assigned to 
and/or exclusively licensed to the Government of the United States of 
America.
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, the patent rights in these inventions have been assigned to 
the Government of the United States of America.
    The prospective Exclusive Patent License territory may be worldwide 
for the following field of use:

    The use of the YP7, YP8 and YP9.1 anti-GPC3 monoclonal 
antibodies as monospecific or bispecific antibodies for the 
treatment of liver cancer. The licensed field of use excludes any 
non-specified immunoconjugates, including, but not limited to, 
chimeric antigen receptors (CARs) and variants thereof, 
Immunotoxins, and antibody-drug conjugates (ADCs).

    The present inventions to be licensed concern monoclonal antibodies 
that are specific for the cell surface domain of GPC3: YP6, YP7, YP8, 
YP9 and YP9.1. These antibodies can potentially be used for the 
treatment of GPC3-expressing cancers such as HCC. By binding to and 
blocking GPC3 function, these antibodies can inhibit the growth of HCC 
cells, thereby decreasing the ability of tumors to grow and 
metastasize. Alternatively, the antibodies can be used to induce 
antibody-dependent anti-tumor activity by selectively killing cells 
which overexpress GPC3 while leaving healthy, normal cells unscathed. 
Finally, a secondary antibody capable of recruiting T cells to the 
tumor can be attached to the antibodies, thereby allowing for the 
localization of T cells or NK cells only to those cells which express 
GPC3, similarly leading to the selective killing of the cancer cells.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Exclusive Patent License will be royalty 
bearing and 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.

[[Page 23014]]

    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated Exclusive Patent 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 11, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-10154 Filed 5-18-17; 8:45 am]
 BILLING CODE 4140-01-P

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