Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting, 55626 [2021-21855]
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55626
Federal Register / Vol. 86, No. 191 / Wednesday, October 6, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of T Cell Therapies
for Mesothelin-Expressing Cancers
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.
jspears on DSK121TN23PROD with NOTICES1
Name of Committee: National Institute of
Child Health and Human Development Initial
Review Group; Pediatrics Study Section.
Date: October 7, 2021.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, National Institutes of Health,
6710B Rockledge Drive, Room 2137B,
Bethesda, MD 20892 (Video Assisted
Meeting).
Contact Person: Joanna Kubler-Kielb,
Ph.D., Scientific Review Officer, Scientific
Review Branch, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, National Institutes of
Health, 6710B Rockledge Drive, Room 2137B,
Bethesda, MD 20892, (301) 435–6916, kielbj@
mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.865, Research for Mothers
and Children, National Institutes of Health,
HHS)
Dated: October 1, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–21855 Filed 10–5–21; 8:45 am]
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AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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 Ares
Immunotherapy, Inc. (‘‘Ares’’), a
Delaware corporation.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before October 21, 2021 will be
considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Andrew Burke, Ph.D.,
Senior Technology Transfer Manager,
NCI Technology Transfer Center,
Telephone: (240)-276–5484; Email:
andy.burke@nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Intellectual Property
E–078–2012: Anti-Mesothelin Chimeric
Antigen Receptors
1. United States Provisional Patent
Application No. 61/614,612 filed March
23, 2012 (NCI Reference E–078–2012–0–
US–01);
2. PCT Patent Application No. PCT/
US2013/028980 filed March 5, 2013
(NCI Reference E–078–2012–0–PCT–02);
3. Australian Patent No. 2013235726
issued August 3, 2017 (NCI Reference
E–078–2012–0–AU–03);
4. Canadian Patent No. 2,868,121
issued June 1, 2021 (NCI Reference E–
078–2012–0–CA–04);
5. European Patent No. 2828290
issued August 15, 2018 (NCI Reference
E–078–2012–0–EP–05);
a. Validated in: FR, DE and UK
6. United States Patent No. 9,359,447
issued June 7, 2016 (NCI Reference E–
078–2012–0–US–06);
7. European Patent No. 3421489
issued May 5, 2021 (NCI Reference E–
078–2012–0–EP–07); and
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
a. Validated in: FR, DE and UK
8. Canadian Patent Application No.
3,116,051 filed April 23, 2021 (NCI
Reference E–078–2012–0–CA–11).
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:
‘‘Development, manufacture and
commercialization of T cell therapy
products engineered to express the
chimeric antigen receptor(s) claimed in
the Licensed Patent Rights for the
treatment of mesothelin-expressing
cancers in humans.’’
The E–078–2012 invention family
discloses certain chimeric antigen
receptors (CARs) targeting mesothelin.
CARs are synthetic proteins comprised
of extracellular antigen binding domains
and intracellular signaling domains
designed to activate the cytolytic
functions of CAR-expressing T cells
upon antigen recognition.
Mesothelin is a cell surface protein.
Its expression is primarily restricted to
mesothelial cells of the pleura,
peritoneum, and pericardium; however,
research has demonstrated that several
cancers, including malignant
mesothelioma, pancreatic, ovarian and
lung adenocarcinoma, also express
mesothelin under certain circumstances.
Due to its limited expression in normal
tissues, CARs targeting mesothelin may
be useful in the development of T cell
therapy products for the treatment of
select cancers.
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 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 from these license
applications will be made only as
required and upon a request under the
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[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Page 55626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21855]
[[Page 55626]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and
Human Development; 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 of Child Health and Human
Development Initial Review Group; Pediatrics Study Section.
Date: October 7, 2021.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Eunice Kennedy Shriver National Institute of Child Health
and Human Development, National Institutes of Health, 6710B
Rockledge Drive, Room 2137B, Bethesda, MD 20892 (Video Assisted
Meeting).
Contact Person: Joanna Kubler-Kielb, Ph.D., Scientific Review
Officer, Scientific Review Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human Development, National Institutes
of Health, 6710B Rockledge Drive, Room 2137B, Bethesda, MD 20892,
(301) 435-6916, [email protected].
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.865,
Research for Mothers and Children, National Institutes of Health,
HHS)
Dated: October 1, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-21855 Filed 10-5-21; 8:45 am]
BILLING CODE 4140-01-P
