National Institute of General Medical Sciences; Notice of Closed Meetings, 36827-36828 [2015-15659]

Download as PDF tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices for the prophylaxis and treatment of cancer.’’ DATES: Only applications for a license which are received by the NIH Office of Technology Transfer on or before July 27, 2015 will be considered. ADDRESSES: 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, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–4632; Facsimile: (301) 402– 0220; Email: lambertsond@mail.nih.gov. SUPPLEMENTARY INFORMATION: This invention concerns an anti-TSLPR (Thymic Stromal Lymphopoietin Receptor) chimeric antigen receptor (CAR) and methods of using the CAR for the treatment of TSLPR-expressing cancers, including B cell malignancies. TSLPR is a cell surface antigen that is preferentially expressed on certain types of cancer cells, particularly rare cancers of B cell origin such as acute lymphoblastic leukemia (ALL). The anti-TSLPR CARs of this technology contain (1) antigen recognition sequences that bind specifically to TSLPR and (2) signaling domains that can activate the cytotoxic functions of a T cell. The anti-TSLPR CAR can be transduced into T cells that are harvested from a cancer patient; from there, T cells expressing the anti-TSLPR CAR are selected, expanded and then be reintroduced into the patient. Once the anti-TSLPR CAR-expressing T cells are reintroduced into the patient, the T cells can selectively bind to TSLPRexpressing 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. 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 within thirty (30) days from the date of this published notice. VerDate Sep<11>2014 18:15 Jun 25, 2015 Jkt 235001 Complete applications for a license in an appropriate field of use that are 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: June 22, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015–15656 Filed 6–25–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 36827 Place: NIAAA, NIH, 5635 Fishers Lane, Room CR2098, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Ranga Srinivas, Ph.D., Chief, Extramural Project Review Branch, National Institute on Alcohol Abuse and Alcoholism, NIH, 5635 Fishers Lane, Room 2085, Rockville, MD 20852, (301) 451–2067, srinivar@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; 92.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Supports Awards, National Institutes of Health, HHS) Dated: June 22, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–15658 Filed 6–25–15; 8:45 am] National Institutes of Health BILLING CODE 4140–01–P National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings DEPARTMENT OF HEALTH AND HUMAN SERVICES 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: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; NIAAA Review of Member Conflict Applications (AA2). Date: July 24, 2015. Time: 1:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: NIAAA, NIH, 5635 Fishers Lane, Room CR2098, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Ranga Srinivas, Ph.D., Chief, Extramural Project Review Branch, National Institute on Alcohol Abuse and Alcoholism, NIH, 5635 Fishers Lane, Room 2085, Rockville, MD 20852, (301) 451–2067, srinivar@mail.nih.gov. Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; NIAAA Neuroscience Member Conflict Applications. Date: July 29, 2015. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meetings 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: National Institute of General Medical Sciences Special Emphasis Panel; Medical Scientist Training Program Grants. Date: July 14, 2015. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, 45 Center Drive, Room 3An.12, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Rebecca H. Johnson, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3An.18C, Bethesda, MD 20892, 301–594–2771, johnsonrh@ nigms.nih.gov. Name of Committee: National Institute of General Medical Sciences Special Emphasis E:\FR\FM\26JNN1.SGM 26JNN1 36828 Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices Panel Review of R25 Research Training Grant Applications. Date: July 17, 2015. Time: 8:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Courtyard by Marriott Chevy Chase, 5520 Wisconsin Avenue, Chevy Chase, MD 20815 Contact Person: Lisa A. Dunbar, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3An.12F, Bethesda, MD 20892, 301–594–2849, dunbarl@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives, National Institutes of Health, HHS) Dated: June 22, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–15659 Filed 6–25–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive License Agreement: Development of Bispecific and Multi-Specific Fusion Proteins for the Treatment of ROR1 Expressing Human Cancers AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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 exclusive license agreement to practice the inventions embodied in US Provisional Application No. 61/418,550 entitled, ‘‘Chimeric rabbit/human ROR1 antibodies’’ filed December 1, 2010 [HHS Ref. E–039–2011/0–US–01]; PCT Application No. PCT/US2011/062670 entitled, ‘‘Chimeric rabbit/human ROR1 antibodies’’ filed November 30, 2011 [HHS Ref. E–039–2011/0–PCT–02]; Australian Patent Application No. 2011336650 entitled, ‘‘Chimeric rabbit/ human ROR1 antibodies’’ filed November 30, 2011 [HHS Ref. E–039– 2011/0–AU–03]; Canadian Patent Application No. 2818992 entitled, ‘‘Chimeric rabbit/human ROR1 antibodies’’ filed November 30, 2011 tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:15 Jun 25, 2015 Jkt 235001 [HHS Ref. E–039–2011/0–CA–04]; European Patent Application No. 11791733.6 entitled, ‘‘Chimeric rabbit/ human ROR1 antibodies’’ filed November 30, 2011 [HHS Ref. E–039– 2011/0–EP–05]; and U.S. Patent Application No. 13/990,977 entitled, ‘‘Chimeric rabbit/human ROR1 antibodies’’ filed May 31, 2013 [HHS Ref. E–039–2011/0–US–06] and all related continuing and foreign patents/ patent applications for the technology family to Emergent BioSolutions. 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 to develop, make, have made, sell, have sold, import and export bi-specific and multi-specific fusion proteins that are capable of eliciting redirected T-cell cytotoxicity for the treatment of human receptor tyrosine kinase-like orphan receptor 1 (ROR1) expressing cancers, wherein said fusion proteins comprise one or more single-chain variable fragment (scFv) ROR1 binding domains from the anti-ROR1 antibodies designated as R11 or R12, one or more of Licensee’s proprietary scFv CD3 binding domains, and optionally a fragment crystallizable (Fc) domain. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before July 27, 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: Jennifer Wong, M.S., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 4633; Facsimile: (301) 402–0220; Email: wongje@od.nih.gov. SUPPLEMENTARY INFORMATION: Tyrosine kinase-like orphan receptor 1 (ROR1) is a signature cell surface antigen for B-cell malignancies, most notably, B-cell chronic lymphocytic leukemia (B–CLL) and mantle cell lymphoma (MCL) cells, two incurable diseases. The investigators have developed a portfolio of chimeric anti-ROR1 monoclonal antibodies that selectively target ROR1 malignant B-cells but not normal Bcells. These antibodies may be linked to chemical drugs or biological toxins thus providing targeted cytotoxic delivery to malignant B-cells while sparing normal PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 cells. Moreover, as these antibodies selectively target ROR1, they can also be used to diagnose B-cell malignancies. The prospective exclusive license will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The exclusive license may be granted unless within thirty (30) 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 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: June 22, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015–15655 Filed 6–25–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: The Development of an AntiCD19 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancers AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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 exclusive license to practice the inventions embodied in U.S. Provisional Patent Application 62/006,313 entitled ‘‘Chimeric Antigen Receptors Targeting CD–19’’ [HHS Ref. E–042–2014/0–US– 01], and all related continuing and foreign patents/patent applications for the technology family, to Kite Pharma, Inc. The patent rights in 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 worldwide, and the field of use may be limited to: ‘‘All prophylactic and therapeutic uses for SUMMARY: E:\FR\FM\26JNN1.SGM 26JNN1

Agencies

[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36827-36828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15659]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of General Medical Sciences; Notice of Closed 
Meetings

    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: National Institute of General Medical 
Sciences Special Emphasis Panel; Medical Scientist Training Program 
Grants.
    Date: July 14, 2015.
    Time: 1:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Natcher Building, 45 
Center Drive, Room 3An.12, Bethesda, MD 20892, (Telephone Conference 
Call).
    Contact Person: Rebecca H. Johnson, Ph.D., Scientific Review 
Officer, Office of Scientific Review, National Institute of General 
Medical Sciences, National Institutes of Health, 45 Center Drive, 
Room 3An.18C, Bethesda, MD 20892, 301-594-2771, 
johnsonrh@nigms.nih.gov.

    Name of Committee: National Institute of General Medical 
Sciences Special Emphasis

[[Page 36828]]

Panel Review of R25 Research Training Grant Applications.
    Date: July 17, 2015.
    Time: 8:30 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Courtyard by Marriott Chevy Chase, 5520 Wisconsin Avenue, 
Chevy Chase, MD 20815
    Contact Person: Lisa A. Dunbar, Ph.D., Scientific Review 
Officer, Office of Scientific Review, National Institute of General 
Medical Sciences, National Institutes of Health, 45 Center Drive, 
Room 3An.12F, Bethesda, MD 20892, 301-594-2849, 
dunbarl@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.375, 
Minority Biomedical Research Support; 93.821, Cell Biology and 
Biophysics Research; 93.859, Pharmacology, Physiology, and 
Biological Chemistry Research; 93.862, Genetics and Developmental 
Biology Research; 93.88, Minority Access to Research Careers; 93.96, 
Special Minority Initiatives, National Institutes of Health, HHS)

    Dated: June 22, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-15659 Filed 6-25-15; 8:45 am]
BILLING CODE 4140-01-P

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