81 FR 31246 - Prospective Grant of an Exclusive License: The Development of an Anti-GPC3 Chimeric Antigen Receptor (CAR) Based on HN3 for the Treatment of Human Cancers
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 96 (May 18, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 96 (May 18, 2016)
| Page Range | 31246-31247 | |
| FR Document | 2016-11659 |
[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)] [Notices] [Pages 31246-31247] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11659] ----------------------------------------------------------------------- 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 HN3 for the Treatment of Human Cancers AGENCY: National Institutes of Health, Public Health Service, Department of Health and Human Services. 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 HN3; and (b) a T cell signaling domain; for the prophylaxis and treatment of GPC3-expressing cancers.'' [[Page 31247]] 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. 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, National Cancer Institute, 9609 Medical Center Drive, Rm 1-E530 MSC9702, Rockville, MD 20850-9702, Email: [email protected]. 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 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. 2016-11659 Filed 5-17-16; 8:45 am] BILLING CODE 4140-01-P
![31246 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
OIRA_submission@omb.eop.gov or by This program will further support Likely Respondents: The respondents
fax to 202–395–5806. integrated rural health networks that are recipients of the Rural Network
FOR FURTHER INFORMATION CONTACT: To can partner with local community Allied Health Training Program grant
request a copy of the clearance requests colleges and other accredited funding.
submitted to OMB for review, email the educational institutions (such as Burden Statement: Burden in this
HRSA Information Collection Clearance vocational and technical colleges) to context means the time expended by
Officer at paperwork@hrsa.gov or call develop formal clinical training persons to generate, maintain, retain,
(301) 443–1984. programs. disclose or provide the information
SUPPLEMENTARY INFORMATION: Need and Proposed Use of the requested. This includes the time
Information Collection Request Title: Information: For this program, needed to review instructions; to
Rural Network Allied Health Training performance measures were drafted to develop, acquire, install and utilize
Program Performance Improvement provide data to the program and to technology and systems for the purpose
Measurement System (PIMS) enable HRSA to provide aggregate of collecting, validating and verifying
program data required by Congress information, processing and
OMB No.: 0906–xxxx—NEW.
Abstract: The Rural Network Allied under the Government Performance and maintaining information, and disclosing
Health Training Program will support Results Act of 1993. These measures and providing information; to train
the development of formal, mature rural cover the principal topic areas of personnel and to be able to respond to
health networks that focus on activities interest to the Federal Office of Rural a collection of information; to search
that achieve efficiencies, expand access Health Policy (FORHP), including: (a) data sources; to complete and review
to, coordinate and improve the quality Access to care; (b) population the collection of information; and to
of essential health care services, and demographics; (c) staffing; (d) transmit or otherwise disclose the
strengthen the rural health care system consortium/network; (e) sustainability; information. The total annual burden
as a whole. This purpose will be and (f) project specific domains. Several hours estimated for this ICR are
achieved through the recruitment, measures will be used for this program. summarized in the table below.
clinical training, and retention of allied All measures will speak to FORHP’s Total Estimated Annualized Burden
health professionals. progress toward meeting the goals. Hours:
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Rural Network Allied Health Training Program Perform-
ance Measures ................................................................. 10 1 10 6.55 65.5
Total .............................................................................. 10 ........................ 10 ........................ 65.5
Jason E. Bennett, Intellectual Property: U.S. Provisional E–136–2012/0–US–07]; and all
Director, Division of the Executive Secretariat. Patent Application 61/654,232 entitled continuing U.S. and foreign patents/
[FR Doc. 2016–11672 Filed 5–17–16; 8:45 am] ‘‘High-affinity Monoclonal Antibodies patent applications for the technology
BILLING CODE 4165–15–P To Glypican-3 And Use Thereof’’ [HHS family, to Lentigen Technology, Inc.
Ref. E–136–2012/0–US–01]; PCT Patent The patent rights to these inventions
Application PCT/US2013/043633 have been assigned to and/or
DEPARTMENT OF HEALTH AND entitled ‘‘High-affinity Monoclonal exclusively licensed to the Government
HUMAN SERVICES Antibodies To Glypican-3 And Use of the United States of America.
Thereof’’ [HHS Ref. E–136–2012/0– The prospective exclusive licensed
National Institutes of Health PCT–02]; Chinese Patent Application territory may be the United States,
201380039993.7 entitled ‘‘High-affinity Australia, Canada, the European Union,
Prospective Grant of an Exclusive Monoclonal Antibodies To Glypican-3 Russia, China, Hong Kong, Japan,
License: The Development of an Anti- And Use Thereof’’ [HHS Ref. E–136– Taiwan, South Korea and Singapore,
GPC3 Chimeric Antigen Receptor 2012/0–CN–03]; Japanese Patent and the field of use may be limited to:
(CAR) Based on HN3 for the Treatment Application 2015–515243 entitled ‘‘The development of a glypican-3
of Human Cancers ‘‘High-affinity Monoclonal Antibodies (GPC3) chimeric antigen receptor (CAR)-
To Glypican-3 And Use Thereof’’ [HHS based immunotherapy using autologous
AGENCY: National Institutes of Health,
Ref. E–136–2012/0–JP–04]; South Korea (meaning one individual is both the
Public Health Service, Department of
Patent Application 10–2014–7037046 donor and the recipient) primary human
Health and Human Services.
entitled ‘‘High-affinity Monoclonal lymphocytes (T cells or NK cells)
ACTION: Notice. Antibodies To Glypican-3 And Use transfected with a lentiviral or retroviral
Thereof’’ [HHS Ref. E–136–2012/0–KR– vector, wherein the vector expresses a
SUMMARY: This notice, in accordance 05]; Singapore Patent Application CAR having (1) a single antigen
sradovich on DSK3TPTVN1PROD with NOTICES
with 35 U.S.C. 209(c)(1) and 37 CFR 11201407972R entitled ‘‘High-affinity specificity and (2) comprising at least:
Part 404.7(a)(1)(i), that the National Monoclonal Antibodies To Glypican-3 (a) the complementary determining
Institutes of Health, Department of And Use Thereof’’ [HHS Ref. E–136– region (CDR) sequences of the anti-GPC3
Health and Human Services, is 2012/0–SG–06]; United States Patent antibody known as HN3; and (b) a T cell
contemplating the grant of an exclusive Application 14/403,896 entitled ‘‘High- signaling domain; for the prophylaxis
license to practice the inventions affinity Monoclonal Antibodies To and treatment of GPC3-expressing
embodied in: Glypican-3 And Use Thereof’’ [HHS Ref. cancers.’’
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![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31247
DATES: Only written comments and/or within fifteen (15) days from the date of Regulatory Affairs, OIRA_submission@
applications for a license which are this published notice. omb.eop.gov or by fax to 202–395–6974,
received by the NCI Technology Complete applications for a license in Attention: NIH Desk Officer.
Transfer Center on or before June 2, the field of use filed in response to this Comment Due Date: Comments
2016 will be considered. notice will be treated as objections to regarding this information collection are
ADDRESSES: Requests for copies of the the grant of the contemplated exclusive best assured of having their full effect if
patent application, inquiries, comments, start-up option license. Comments and received within 30 days of the date of
and other materials relating to the objections submitted to this notice will this publication.
contemplated exclusive license should not be made available for public
inspection and, to the extent permitted FOR FURTHER INFORMATION CONTACT: To
be directed to: David A. Lambertson,
by law, will not be released under the obtain a copy of the data collection
Ph.D., Senior Licensing and Patenting
Freedom of Information Act, 5 U.S.C. plans and instruments, or request more
Manager, National Cancer Institute,
552. information on the proposed project,
9609 Medical Center Drive, Rm 1–E530
contact: Goli Samimi, Program Director,
MSC9702, Rockville, MD 20850–9702, Dated: May 12, 2016.
Breast and Gynecologic Cancer Research
Email: david.lambertson@nih.gov. Richard U. Rodriguez, Group, Division of Cancer Prevention.
SUPPLEMENTARY INFORMATION: This Associate Director, Technology Transfer 9609 Medical Center Drive, MSC 9783,
invention concerns an anti-GPC3 Center, National Cancer Institute.
Bethesda, MD 20892, or call non-toll-
(Glypican-3) chimeric antigen receptor [FR Doc. 2016–11659 Filed 5–17–16; 8:45 am] free number (240) 276–6582, or Email
(CAR) and methods of using the CAR for BILLING CODE 4140–01–P your request, including your address to:
the treatment of GPC3-expressing goli.samimi@nih.gov. Formal requests
cancers. GPC3 is a cell surface antigen for additional plans and instruments
that is preferentially expressed on DEPARTMENT OF HEALTH AND must be requested in writing.
certain types of cancer cells, particularly HUMAN SERVICES
liver cancers such as hepatocellular Proposed Collection: Survey to assess
carcinoma (HCC). The anti-GPC3 CARs National Institutes of Health the feasibility of establishing a
of this technology contain (1) antigen gynecologic specimen bank (NCI), 0925–
Submission for OMB Review; 30-Day NEW, National Cancer Institute (NCI),
recognition sequences that bind
Comment Request; Survey To Assess National Institutes of Health (NIH).
specifically to GPC3 and (2) signaling
the Feasibility of Establishing a Need and Use of Information
domains that can activate the cytotoxic
Gynecologic Specimen Bank (NCI) Collection: The National Cancer
functions of a T cell. The anti-GPC3
CAR can be transduced into T cells that SUMMARY: Under the provisions of Institute is assessing the feasibility of
are harvested from a donor, followed by Section 3507(a)(1)(D) of the Paperwork developing a tissue bank that would
(a) selection and expansion of the T Reduction Act of 1995, the National include tube and ovary tissues from
cells expressing the anti-GPC3 CAR, and Cancer Institute, the National Institutes women undergoing surgery for benign
(b) reintroduction of the T cells into the of Health, has submitted to the Office of conditions, risk reduction and early
patient. Once the anti-GPC3 CAR- Management and Budget (OMB) a stage cancer. Collecting tissues from
expressing T cells are reintroduced into request for review and approval of the tubes and ovaries containing clinically
the patient, the T cells can selectively information collection listed below. unsuspected precursors or early stage
bind to GPC3-expressing cancer cells This proposed information collection cancer is challenging, especially among
through its antigen recognition was previously published in the Federal women that are not at increased genetic
sequences, thereby activating the T cell Register on March 8, 2016 page 12111 risk. However, given that many
through its signaling domains to and allowed 60 days for public pathology laboratories have enhanced
selectively kill the cancer cells. Through comment. No comments were received. their processing protocols for
this mechanism of action, the selectivity The purpose of this notice is to allow an gynecologic surgical specimens
of the a CAR allows the T cells to kill additional 30 days for public comment. removed for benign indications, it may
cancer cells while leaving healthy, The National Cancer Institute (NCI), be possible to develop a tissue resource.
essential cells unharmed. This can National Institutes of Health, may not Accordingly, we are requesting
result in an effective therapeutic conduct or sponsor, and the respondent information via a survey about the
strategy with fewer side effects due to is not required to respond to, an volume of samples that are accessioned
less non-specific killing of cells. information collection that has been at different pathology laboratories, and
The prospective exclusive license will extended, revised, or implemented on or the methods used to process these
be royalty bearing and will comply with after October 1, 1995, unless it displays samples. These data would provide
the terms and conditions of 35 U.S.C. a currently valid OMB control number. information necessary to assess the
209 and 37 CFR part 404.7. The Direct Comments to OMB: Written feasibility of establishing a tissue bank
prospective exclusive license may be comments and/or suggestions regarding for research and provide insights into
granted unless the NIH receives written the item(s) contained in this notice, the best design of a pilot study.
evidence and argument that establishes especially regarding the estimated OMB approval is requested for 1 year.
that the grant of the license would not public burden and associated response There are no costs to respondents other
be consistent with the requirements of time, should be directed to the: Office than their time. The total estimated
35 U.S.C. 209 and 37 CFR part 404.7 of Management and Budget, Office of annualized burden hours are 42 hours.
sradovich on DSK3TPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Frequency of Time per
Number of
Category of respondent Form name response per response Burden hours
respondents respondent (in hours)
Lab Managers ................................... Survey .............................................. 250 1 10/60 42
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Document Created: 2016-05-18 00:06:06
Document Modified: 2016-05-18 00:06:06
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 81 FR 31246 |
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