Prospective Grant of an Exclusive License: The Development of an Anti-GPC3 Chimeric Antigen Receptor (CAR) Based on YP7 for the Treatment of Human Cancers, 31251-31252 [2016-11660]

Download as PDF Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices Dated: May 12, 2016. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. Dated: May 12, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–11661 Filed 5–17–16; 8:45 am] [FR Doc. 2016–11663 Filed 5–17–16; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Closed Meetings Prospective Grant of an Exclusive License: The Development of an AntiGPC3 Chimeric Antigen Receptor (CAR) Based on YP7 for the Treatment of Human Cancers sradovich on DSK3TPTVN1PROD with NOTICES 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 Dental and Craniofacial Research Special Emphasis Panel; NIDCR Data Analysis and Statistical Methodology PARs. Date: June 10, 2016. Time: 11:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892. Contact Person: Victor Henriquez, Ph.D., Scientific Review Officer DEA/SRB/NIDCR, 6701 Democracy Blvd., Room 668, Bethesda, MD 20892–4878, 301–451–2405, henriquv@ nidcr.nih.gov. Name of Committee: NIDCR Special Grants Review Committee. Date: June 16–17, 2016. Time: 8:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: Wyndham San Antonio Riverwalk 111 East Pecan Street, San Antonio, TX 78205 Contact Person: Marilyn Moore-Hoon, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research, 6701 Democracy Blvd., Rm. 676, Bethesda, MD 20892–4878, 301–594–4861, mooremar@nidcr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) VerDate Sep<11>2014 17:10 May 17, 2016 Jkt 238001 Public Health Service, National Institutes of Health, HHS. ACTION: Notice. AGENCY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), 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: SUMMARY: Intellectual Property 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 ‘‘Highaffinity 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 Korea 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]; United States Patent Application 14/403,896 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 Lentigen Technology, Inc. The patent rights to these inventions have been assigned to and/or PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 31251 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 YP7; and (b) a T cell signaling domain; for the prophylaxis and treatment of GPC3-expressing cancers.’’ DATES: Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before June 2, 2016 will be considered. ADDRESSEES: 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. SUPPLEMENTARY INFORMATION: 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 E:\FR\FM\18MYN1.SGM 18MYN1 31252 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 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 start-up option 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. A. Overview of Information Collection Dated: May 12, 2016. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2016–11660 Filed 5–17–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5913–N–10] 60-Day Notice of Proposed Information Collection: FHA Technology Open to Approved Lenders (TOTAL) Mortgage Scorecard Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD. ACTION: Notice. AGENCY: HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment. sradovich on DSK3TPTVN1PROD with NOTICES SUMMARY: DATES: Comments Due Date: July 18, 2016. Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB ADDRESSES: VerDate Sep<11>2014 17:10 May 17, 2016 Jkt 238001 Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410–5000; telephone 202–402–3400 (this is not a toll-free number) or email at Colette.Pollard@hud.gov for a copy of the proposed forms or other available information. Persons with hearing or speech impairments may access this number through TTY by calling the tollfree Federal Relay Service at (800) 877– 8339. FOR FURTHER INFORMATION CONTACT: Kevin Stevens, 451 7th Street SW., Washington, DC 20410; email Kevin L. Stevens@hud.gov; or telephone 202– 402–2673. This is not a toll-free number. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877–8339. SUPPLEMENTARY INFORMATION: This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A. Title of Information Collection: FHA TOTAL Mortgage Scorecard. OMB Approval Number: 2502–0556. Type of Request: Extension of a currently approved collection. Form Number: N/A. Description of the need for the information and proposed use: The regulation mandating this collection can be found in the Code of Federal Regulations at 24 CFR 203.255(b)(5). This information is necessary to assure that lenders (and automated underwriting system (AUS) vendors) are aware of their obligations regarding use of the TOTAL Mortgage Scorecard and are certifying that they will comply with all pertinent regulations. It also allows FHA to request reports from lenders regarding their use of the scorecard, that they have implemented appropriate quality control procedures for using the scorecard, and provides an appeal mechanism should FHA take an action to terminate a lender’s use of the scorecard. Respondents : Business or other for profit. Estimated Number of Respondents: 2709. Estimated Number of Responses: 100. Frequency of Response: On occasion. Average Hours per Response: .02. Total Estimated Burdens: 100. B. Solicitation of Public Comment This notice is soliciting comments from members of the public and affected PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 parties concerning the collection of information described in Section A on the following: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. HUD encourages interested parties to submit comment in response to these questions. Authority: Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35. Dated: May 12, 2016. Janet M. Golrick, Associate General Deputy Assistant Secretary for Housing Associate Deputy Federal Housing Commissioner. [FR Doc. 2016–11742 Filed 5–17–16; 8:45 am] BILLING CODE 4210–67–P DEPARTMENT OF THE INTERIOR Bureau of Land Management [16X LLUT920000 L13100000.DN0000 LXSSJ0540000 24 1A] Notice of Intent To Prepare a Master Leasing Plan, Amend the Resource Management Plans for the Price and Richfield Field Offices, and Prepare an Associated Environmental Assessment, Utah Bureau of Land Management, Interior. ACTION: Notice. AGENCY: In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) Price and Richfield Field Offices intend to prepare a Master Leasing Plan (MLP) and Resource Management Plan (RMP) amendments with a single Environmental Assessment (EA). The BLM will consider resource management plan decisions related to oil and gas leasing and post-leasing oil and gas development on approximately 525,000 acres of public land in the San Rafael Desert, located in Emery and SUMMARY: E:\FR\FM\18MYN1.SGM 18MYN1

Agencies

[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Notices]
[Pages 31251-31252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11660]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive License: The Development of an 
Anti-GPC3 Chimeric Antigen Receptor (CAR) Based on YP7 for the 
Treatment of Human Cancers

AGENCY: Public Health Service, National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 
Part 404.7(a)(1)(i), 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:
Intellectual Property
    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 Korea 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]; United States Patent 
Application 14/403,896 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 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 YP7; and (b) a T cell signaling domain; for the 
prophylaxis and treatment of GPC3-expressing cancers.''

DATES: Only written comments and/or applications for a license which 
are received by the NCI Technology Transfer Center on or before June 2, 
2016 will be considered.

ADDRESSEES: 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.

SUPPLEMENTARY INFORMATION: 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 CAR-expressing 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

[[Page 31252]]

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 start-up option 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 12, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-11660 Filed 5-17-16; 8:45 am]
 BILLING CODE 4140-01-P
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