National Institute on Minority Health and Health Disparities; Notice of Closed Meeting, 22553-22554 [2017-09786]
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Federal Register / Vol. 82, No. 93 / Tuesday, May 16, 2017 / Notices
Health, 6701 Rockledge Drive, Room 6194,
MSC 7804, Bethesda, MD 20892, 301–594–
7945, smileyja@csr.nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Arthritis, Connective Tissue and Skin Study
Section.
Date: June 12–13, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Long Beach and Executive
Center, 701 West Ocean Boulevard, Long
Beach, CA 90831.
Contact Person: Alexey Belkin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4102,
Bethesda, MD 20817, 301–435–1786,
alexey.belkin@nih.gov.
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
Clinical Research and Field Studies of
Infectious Diseases Study Section.
Date: June 12–13, 2017.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Cambria Hotel and Suites, 1 Helen
Heneghan Way, Rockville, MD 20850.
Contact Person: Soheyla Saadi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3211,
MSC 7808, Bethesda, MD 20892, 301–435–
0903, saadisoh@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: May 10, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–09780 Filed 5–15–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Invention;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Licensing information may be obtained
by emailing the indicated licensing
contact at the National Heart, Lung, and
Blood, Office of Technology Transfer
and Development Office of Technology
Transfer, 31 Center Drive Room 4A29,
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16:42 May 15, 2017
Jkt 241001
MSC 2479, Bethesda, MD 20892–2479;
telephone: 301–402–5579. A signed
Confidential Disclosure Agreement may
be required to receive any unpublished
information.
SUPPLEMENTARY INFORMATION: The
following inventions are available for
licensing in accordance with 35 U.S.C.
209 and 37 CFR part 404 to achieve
expeditious commercialization of
results of federally-funded research and
development. Technology description
follows.
Efficient mRNA-Based Genetic
Engineering of Human NK Cells With
High-Affinity CD16 and CCR7
Description of Technology: A highly
efficient method to genetically modify
natural killer (NK) cells to induce
expression of high affinity CD16 (HA–
CD16) through mRNA electroporation,
to potentiate NK cell-mediated
antibody-dependent cellular
cytotoxicity (ADCC). ADCC is mediated
by CD16+ NK cells following adoptive
NK cell transfer, but most humans
express CD16 which has a relatively low
affinity for IgG1 antibodies. However, a
single nucleotide polymorphism (SNP
rs396991) in the CD16 gene, resulting in
an amino acid substitution at position
158 (F158V), is associated with
substantially higher affinity and
superior NK cell-mediated ADCC than
those with the 158F genotype. This HA–
CD16–158V polymorphism has also
been linked to enhanced ADCC capacity
in vivo. The nearly 100% efficiency of
our method resulted in: (a) Sustained
surface expression of transgenes at high
levels for up to 4 days without
compromising NK cell cytotoxicity and
viability; and (b) augmented ADCC
against Daratumumab coated multiple
myeloma cells by ex vivo expanded NK
cells electroporated with mRNA coding
for HA–CD16. This system is GMP
compliant and has been used previously
in FDA approved clinical trials.
Potential Commercial Applications:
Infusion of a large number of highly
cytotoxic autologous ex vivo expanded
NK cells expressing high-affinity CD16
into patients, to induce a more profound
anti-malignancy response to specific
monoclonal antibodies, including:
multiple myeloma (Daratumumab);
lymphoma (Rituximab); breast cancer
(Trastuzumab); and colon cancer
(Cetuximab).
Development Stage: Early-stage; In
vitro data available.
Inventors: Richard W. Childs and
Mattias Carlsten (NHLBI).
Publications:
(1) Carlsten M, Levy E, Karambelkar
A, Li L, Reger R, Berg M, Peshwa MV
and Childs RW (2016) Efficient mRNA-
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22553
Based Genetic Engineering of Human
NK Cells with High-Affinity CD16 and
CCR7 Augments Rituximab-Induced
ADCC against Lymphoma and Targets
NK Cell Migration toward the Lymph
Node-Associated Chemokine CCL19.
Front. Immunol. 7:105. doi: 10.3389/
fimmu.2016.00105.
(2) Carlsten M and Childs RW (2015)
Genetic manipulation of NK cells for
cancer immunotherapy: techniques and
clinical implications. Front. Immunol.
6:266. doi: 10.3389/fimmu.2015.00266.
Intellectual Property: NIH Reference
No. E–036–2015/0,1—US Application
No. 62/079,975, filed 14 Nov 2014; and
PCT Application No. PCT/US2015/
060646, filed 13 Nov 2015.
Licensing Contact: Cristina
Thalhammer-Reyero, Ph.D., M.B.A.;
301–435–4507; thalhamc@mail.nih.gov.
Dated: May 4, 2017.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager,
Office of Technology Transfer and
Development, National Heart, Lung, and
Blood Institute.
[FR Doc. 2017–09791 Filed 5–15–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Minority Health
and Health Disparities; Notice of
Closed Meeting
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 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 materials,
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
Minority Health and Health Disparities,
Special Emphasis Panel; NIH Support for
Conferences and Scientific Meeting—DRI
(01).
Date: June 19, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Gateway Plaza, 533J, 7201 Wisconsin
Avenue, Suite 533, Bethesda, MD 20814
(Teleconference).
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22554
Federal Register / Vol. 82, No. 93 / Tuesday, May 16, 2017 / Notices
Contact Person: Deborah Ismond, Ph.D.,
Scientific Review Officer, Division of
Scientific Programs, National Institute on
Minority Health, and Health Disparities,
National Institutes of Health, 7201 Wisconsin
Ave., Suite 525, Bethesda, MD 20814, (301)
594–2704, ismonddr@mail.nih.gov/.
Dated: May 10, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–09786 Filed 5–15–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Invention;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government.
FOR FURTHER INFORMATION CONTACT:
Licensing information may be obtained
by emailing the indicated licensing
contact at the National Heart, Lung, and
Blood, Office of Technology Transfer
and Development Office of Technology
Transfer, 31 Center Drive Room 4A29,
MSC 2479, Bethesda, MD 20892–2479;
telephone: 301–402–5579. A signed
Confidential Disclosure Agreement may
be required to receive any unpublished
information.
SUPPLEMENTARY INFORMATION: The
following inventions are available for
licensing in accordance with 35 U.S.C.
209 and 37 CFR part 404 to achieve
expeditious commercialization of
results of federally-funded research and
development. Technology description
follows.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
T-Cells Transduced With HLA A11
Restricted CT–RCC HERV–E Reactive
TCR To Treat Patients With ccRCC
Description of Technology: We
isolated an allogeneic T cell clone from
a clear cell renal cell carcinoma (ccRCC)
HLA–A11 patient who showed
prolonged tumor regression after an
allogeneic transplant. This clone was
found to have tumor specific
cytotoxicity, killing patient’s tumor cells
in vitro. We found that antigen
recognized by this clone is an HLA–A11
restricted peptide (named CT–RCC–1)
and it is encoded by a novel human
endogenous retrovirus-E (named CT–
RCC HERV–E) whose expression was
discovered to be restricted to ccRCC, but
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not observed in normal tissues or other
tumor types. We observed that more
than 80% of ccRCC tumors express CT–
RCC HERV–E provirus, which makes it
an ideal target for T cell based
immunotherapy. We have sequenced
and cloned the genes for a T cell
receptor (TCR) that specifically
recognizes an HLA–A11 restricted CT–
RCC–1 antigen. We then created a
retroviral vector encoding this TCR as
well as a truncated CD34 protein lacking
the intracellular domain, which can be
used to facilitate the isolation of T-cells
transduced with this TCR. Phase I/II
clinical trials are currently being
planned in patients with metastatic
ccRCC using normal patient’s T-cells
transduced with this vector.
Potential Commercial Applications:
The vector can be used to transduce and
expand normal T cells from HLA–A11
patients with metastatic ccRCC with the
TCR recognizing HLA–A11-restricted
CT–RCC HERV–E antigen that
specifically expressed on clear cell type
of kidney cancer. The transduced
cytotoxic T cells can then be
administered to subjects to treat or
inhibit metastatic kidney cancer. Kidney
cancer is responsible for approximately
12,000 deaths every year in the United
States alone. As with most cancer, when
detected at early stages, surgical
intervention is highly effective. Despite
progress in treating kidney cancer with
IL–2 and inhibitors of immune
checkpoints, metastatic ccRCC is
generally lethal, with mean survival
being less than a year. Patients with
melanoma and other malignancies can
now benefit from adoptive T cell
transfer. One of the limitations of this
approach for metastatic kidney cancer is
a lack of identified tumor restricted
antigens for this tumor. We show that
the CT–RCC HERV–E is expressed in
most ccRCC tumors but not in normal
tissues which makes the antigens
encoded by this provirus ideal targets
for T cell-based immunotherapy of
ccRCC.
Development Stage: Early-stage; In
vitro data available.
Inventors: Richard W. Childs and
Elena Cherkasova (NHLBI), Michael
Nishimura (Loyola University Chicago).
Publications:
1. Takahashi Y. et al. 2008. Regression
of kidney cancer following allogeneic
stem-cell transplantation associated
with T-cells recognizing a HERV–E
antigen. J. Clin. Invest. 118:1099–109.
2. Cherkasova E. et al. 2011.
Inactivation of the von Hippel-Lindau
tumor suppressor leads to selective
expression of a human endogenous
retrovirus in kidney cancer. Oncogene
30:4697–706.
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3. Cherkasova E. et al. 2013.
Endogenous retroviruses as targets for
antitumor immunity in renal cell cancer
and other tumors. Front. Oncol. 3:243–
247.
4. Cherkasova E. et al. 2016. Detection
of a HERV–E envelope with selective
expression in clear cell kidney cancer.
Cancer Res. 76:2177–2185.
Intellectual Property: NIH Reference
No. E–120–2016/0—US Application No.
62/357,265, filed June 30, 2016.
Licensing Contact: Cristina
Thalhammer-Reyero, Ph.D., M.B.A.;
301–435–4507; thalhamc@mail.nih.gov.
Dated: May 2, 2017.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager,
Office of Technology Transfer and
Development, National Heart, Lung, and
Blood Institute.
[FR Doc. 2017–09792 Filed 5–15–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
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 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 of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; AMSC
Review Conflict Meeting.
Date: June 8, 2017.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: 6701 Democracy Boulevard,
Conference Room 803, Bethesda, MD 20892.
Contact Person: Yin Liu, Ph.D., M.D.,
Scientific Review Officer, Scientific Review
Branch, NIH/National Institute of Arthritis,
Musculoskeletal and Skin Diseases, 6701
Democracy Boulevard, Suite 824, Bethesda,
MD 20892, 301–451–4838, yin.liu@.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
E:\FR\FM\16MYN1.SGM
16MYN1
Agencies
[Federal Register Volume 82, Number 93 (Tuesday, May 16, 2017)]
[Notices]
[Pages 22553-22554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09786]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Minority Health and Health Disparities;
Notice of Closed Meeting
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
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 materials, 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 Minority Health and
Health Disparities, Special Emphasis Panel; NIH Support for
Conferences and Scientific Meeting--DRI (01).
Date: June 19, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Gateway Plaza, 533J, 7201
Wisconsin Avenue, Suite 533, Bethesda, MD 20814 (Teleconference).
[[Page 22554]]
Contact Person: Deborah Ismond, Ph.D., Scientific Review
Officer, Division of Scientific Programs, National Institute on
Minority Health, and Health Disparities, National Institutes of
Health, 7201 Wisconsin Ave., Suite 525, Bethesda, MD 20814, (301)
594-2704, ismonddr@mail.nih.gov/.
Dated: May 10, 2017.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-09786 Filed 5-15-17; 8:45 am]
BILLING CODE 4140-01-P