[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Page 45912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16486]



[[Page 45912]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Allogeneic 
Therapy Using Chimeric Antigen Receptors Targeting GPC3

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the Patents and Patent Applications listed in 
the SUPPLEMENTARY INFORMATION section of this notice to Cytovia 
Therapeutics (``Cytovia'') located in New York, NY.

DATES: Only written comments and/or complete applications for a license 
which are received by the National Cancer Institute's Technology 
Transfer Center on or before August 14, 2020 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: David A. Lambertson, Ph.D., Senior Technology 
Transfer Manager, NCI Technology Transfer Center at Telephone: (240) 
276-5530 or Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    The following represents the intellectual property to be licensed 
under the prospective agreement:
    (A) 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 Korean 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], and United States Patent 
9,409,994 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; 
and (B) U.S. Provisional Patent Application 62/584,421 entitled 
``Chimeric Antigen Receptors Targeting Tumor Antigens'' [HHS Reference 
E-016-2018-0-US-01], PCT Patent Application PCT/US2018/059645 entitled 
``Chimeric Antigen Receptors Targeting Tumor Antigens'' [HHS Reference 
E-016-2018-0-PCT-02], Chinese Patent Application (Application number 
currently unavailable) entitled ``Chimeric Antigen Receptors Targeting 
Tumor Antigens'' [HHS Reference E-016-2018-0-CN-03], European Patent 
Application 18822526.2 entitled ``Chimeric Antigen Receptors Targeting 
Tumor Antigens'' [HHS Reference E-016-2018-0-EP-04], South Korean 
Patent Application 10-2020-7014565 entitled ``Chimeric Antigen 
Receptors Targeting Tumor Antigens'' [HHS Reference E-016-2018-0-KR-05] 
and U.S. Patent Application 16/762,459 entitled ``Chimeric Antigen 
Receptors Targeting Tumor Antigens'' [HHS Reference E-016-2018-0-US-
06], and all continuing U.S. and foreign patents/patent applications 
for the technology family.
    The patent rights in these inventions have been assigned and/or 
exclusively licensed 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 following:
    ``The development, production and commercialization of a 
monospecific anti-GPC3 chimeric antigen receptor (CAR)-based allogeneic 
immunotherapy using either (A) unmodified Natural Killer (NK) cells or 
(B) induced pluripotent stem cells (iPSC), where the NK cells or iPSC 
are transduced using a viral vector to express an anti-GPC3 CAR, and 
where the CAR has at least:
    (1) The complementary determining region (CDR) sequences of the 
anti-GPC3 antibody known as YP7 or hYP7; and
    (2) a T cell co-stimulatory domain;

for the treatment of GPC3-expressing human cancers.
    The Licensed Field of Use specifically excludes the use of 
autologous T cells or T cells that have been genetically modified to 
become allogeneic.''
    This technology discloses the development of chimeric antigen 
receptors that recognize the glypican3 (GPC3) cell surface protein. 
GPC3 is expressed on the cell surface of several solid tumors, 
including liver cancers (such as hepatocellular cancer (HCC)), certain 
ovarian cancers, and neuroblastomas. Although the FDA has approved 
certain therapies for the treatment of liver cancer, those therapies 
only provide a minimal increase in the life expectancy of patients. The 
development of a new therapeutic targeting GPC3 will benefit public 
health by providing an improved and more effective treatment for 
patients.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Cancer Institute 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.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
completed license application, will not be treated confidentially, and 
may be made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: July 23, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2020-16486 Filed 7-29-20; 8:45 am]
BILLING CODE 4140-01-P