National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting, 61960 [2020-21672]
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61960
Federal Register / Vol. 85, No. 191 / Thursday, October 1, 2020 / Notices
Monoclonal Antibodies To Glypican-3
And Use Thereof’’ [HHS Ref. E–136–
2012–0–SG–06], 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
201880073043.9 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
chimeric antigen receptor (CAR)-based
immunotherapy for the prophylaxis and
treatment of GPC3-expressing human
cancers using unmodified, allogeneic
NK cells transduced with a viral vector
that expresses a CAR and a gene circuit
regulating the expression of one or more
armoring payloads, wherein:
(1) The CAR includes:
a. A single antigen specificity
comprising at least the complementary
determining region (CDR) sequences of
the anti-GPC3 antibody known as YP7,
and
b. an intracellular signaling domain;
(2) the gene circuit includes either (a)
a synthetic transcription factor that is
stabilized or activated by a small
molecule drug or environmental signal,
or (b) a synthetic promoter element that
is responsive to a small molecule drug
or environmental signal; and
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(3) the armored payload is selected
from:
a. An immune-stimulating cytokine,
b. a chemokine,
c. a growth factor,
d. a co-activation molecule, and
e. a tumor microenvironment
modulator.
The Licensed Field of Use specifically
excludes the use of autologous T cells
or T cells that have been genetically
modified to become allogeneic. For
clarity ‘‘allogeneic’’ means the cells are
from a donor that is not the recipient
and the term ‘‘unmodified’’ means that
no genetic engineering with genome
editing tools is performed.’’
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: September 23, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
BILLING CODE 4140–01–P
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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 Neurosciences
Special Review Panel.
Date: November 4, 2020.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neurosciences Center Building, 6700B
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Beata Buzas, Ph.D.,
Scientific Review Officer, Extramural Project
Review, Branch Office of Extramural
Activities, National Institute on Alcohol
Abuse and Alcoholism, 6700B Rockledge
Drive, Room 2116, MSC 6902, Bethesda, MD
20817, (301) 443–0800, bbuzas@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; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards, National
Institutes of Health, HHS)
Dated: September 25, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–21672 Filed 9–30–20; 8:45 am]
[FR Doc. 2020–21714 Filed 9–30–20; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 85, Number 191 (Thursday, October 1, 2020)]
[Notices]
[Page 61960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21672]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of
Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting 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 Neurosciences Special
Review Panel.
Date: November 4, 2020.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neurosciences Center
Building, 6700B Rockledge Drive, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Beata Buzas, Ph.D., Scientific Review Officer,
Extramural Project Review, Branch Office of Extramural Activities,
National Institute on Alcohol Abuse and Alcoholism, 6700B Rockledge
Drive, Room 2116, MSC 6902, Bethesda, MD 20817, (301) 443-0800,
[email protected].
(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; 93.273, Alcohol Research Programs; 93.891,
Alcohol Research Center Grants; 93.701, ARRA Related Biomedical
Research and Research Support Awards, National Institutes of Health,
HHS)
Dated: September 25, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-21672 Filed 9-30-20; 8:45 am]
BILLING CODE 4140-01-P
