National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 36934 [2016-13500]

Download as PDF mstockstill on DSK3G9T082PROD with NOTICES 36934 Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices Monoclonal Antibodies Specific for Glypican-3 And Use Thereof’’ [HHS Ref. E–130–2011/0–CN–03], European Patent 2699603 entitled ‘‘Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof’’ [HHS Ref. E–130–2011/0– EP–04], and validated in France, Germany and the United Kingdom, United States Patent 9,206,257 entitled ‘‘Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof’’ [HHS Ref. E–130–2011/0–US– 05], United States Patent Application 14/837,903 entitled ‘‘Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof’’ [HHS Ref. E–130–2011/0–US–06], European Patent Application 15188264.4 entitled ‘‘Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof’’ [HHS Ref. E–130–2011/0–EP– 07], United States Patent Application 15/090,873 entitled ‘‘Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof’’ [HHS Ref. E–130–2011/0–US–12], Chinese Patent Application 201610290837.3 entitled ‘‘Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof’’ [HHS Ref. E–130–2011/0–CN– 13], European Patent Application 16166924.7 entitled ‘‘Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof’’ [HHS Ref. E–130–2011/0–EP–14], and all continuing U.S. and foreign patents/ patent applications for the technology family, to Lentigen Technology, Inc. The patent rights to these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be the United States, Australia, Canada, the European Union, Russia, China, Hong Kong, Japan, Taiwan, South Korea and Singapore, and the field of use may be limited to: ‘‘The development of a glypican-3 (GPC3) chimeric antigen receptor (CAR)based immunotherapy using autologous (meaning one individual is both the donor and the recipient) primary human lymphocytes (T cells or NK cells) transfected with a lentiviral or retroviral vector, wherein the vector expresses a CAR having (1) a single antigen specificity and (2) comprising at least: (a) The complementary determining region (CDR) sequences of the anti-GPC3 antibody known as HN3; and (b) a T cell signaling domain; for the prophylaxis and treatment of GPC3-expressing cancers.’’ Only written comments and/or applications for a license which are received by the NCI Technology DATES: VerDate Sep<11>2014 18:59 Jun 07, 2016 Jkt 238001 Transfer Center on or before June 23, 2016 will be considered. not be released under the Freedom of Information Act, 5 U.S.C. 552. Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: David A. Lambertson, Ph.D., Senior Licensing and Patenting Manager, National Cancer Institute, 9609 Medical Center Drive, Rm. 1–E530 MSC9702, Rockville, MD 20850–9702, Email: david.lambertson@nih.gov. Dated: June 3, 2016. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. ADDRESSES: This invention concerns an anti-GPC3 (Glypican-3) chimeric antigen receptor (CAR) and methods of using the CAR for the treatment of GPC3-expressing cancers. GPC3 is a cell surface antigen that is preferentially expressed on certain types of cancer cells, particularly liver cancers such as hepatocellular carcinoma (HCC). The anti-GPC3 CARs of this technology contain (1) antigen recognition sequences that bind specifically to GPC3 and (2) signaling domains that can activate the cytotoxic functions of a T cell. The anti-GPC3 CAR can be transduced into T cells that are harvested from a donor, followed by (a) selection and expansion of the T cells expressing the anti-GPC3 CAR, and (b) reintroduction of the T cells into the patient. Once the anti-GPC3 CARexpressing T cells are reintroduced into the patient, the T cells can selectively bind to GPC3-expressing cancer cells through its antigen recognition sequences, thereby activating the T cell through its signaling domains to selectively kill the cancer cells. Through this mechanism of action, the selectivity of the a CAR allows the T cells to kill cancer cells while leaving healthy, essential cells unharmed. This can result in an effective therapeutic strategy with fewer side effects due to less non-specific killing of cells. 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 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 404.7 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 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 [FR Doc. 2016–13530 Filed 6–7–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTARY INFORMATION: PO 00000 Frm 00075 Fmt 4703 Sfmt 9990 National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting 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. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI Clinical Trial Pilot Studies (R34). Date: June 27, 2016. Time: 8:30 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Chang Sook Kim, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7188, Bethesda, MD 20892–7924, 301–435– 0287, carolko@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS). Dated: June 2, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–13500 Filed 6–7–16; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\08JNN1.SGM 08JNN1

Agencies

[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Notices]
[Page 36934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13500]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute; Notice of Closed 
Meeting

    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.

    Name of Committee: National Heart, Lung, and Blood Institute 
Special Emphasis Panel; NHLBI Clinical Trial Pilot Studies (R34).
    Date: June 27, 2016.
    Time: 8:30 a.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, 
MD 20814.
    Contact Person: Chang Sook Kim, Ph.D., Scientific Review 
Officer, Office of Scientific Review/DERA, National Heart, Lung, and 
Blood Institute, 6701 Rockledge Drive, Room 7188, Bethesda, MD 
20892-7924, 301-435-0287, carolko@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.233, 
National Center for Sleep Disorders Research; 93.837, Heart and 
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, 
Blood Diseases and Resources Research, National Institutes of 
Health, HHS).

    Dated: June 2, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-13500 Filed 6-7-16; 8:45 am]
 BILLING CODE 4140-01-P
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