[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Notices]
[Pages 31246-31247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11659]


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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.

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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