Prospective Grant of an Exclusive Patent License: The Development of Siglec-6-Specific Chimeric Antigen Receptor (CAR) for the Treatment Acute Myeloid Leukemia (AML), Chronic Lymphocytic Leukemia (CLL), and Other Forms of Acute and Chronic B- and T-Cell Leukemia and Lymphoma, 68466-68467 [2019-27002]
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lotter on DSKBCFDHB2PROD with NOTICES
68466
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
Place: Gaithersburg Marriott
Washingtonian Center, 9751 Washington
Blvd., Gaithersburg, MD 20878.
Contact Person: Anita T. Tandle, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W248,
Bethesda, MD 20892, 240–276–5085,
tandlea@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Program Project (P01) Review III.
Date: February 6–7, 2020.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, Montgomery County
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852.
Contact Person: Jennifer C. Schiltz, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, National Institutes
of Health, Rockville, MD 20850, 240–276–
5864, jennifer.schiltz@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP 7: NCI
Clinical and Translational R21 and Omnibus
R03.
Date: February 12–13, 2020.
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Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Robert Stephen Coyne,
Ph.D., Scientific Review Officer, National
Cancer Institute, NIH, Division of Extramural
Activities, Special Review Branch, 9609
Medical Center Drive, Room 7W236,
Rockville, MD 20850, 240–276–5120,
coyners@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–3: NCI
Clinical and Translational R21 and Omnibus
R03.
Date: February 13–14, 2020.
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Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, Montgomery County
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852.
Contact Person: Hasan Siddiqui, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, Room 7W240, Rockville, MD
20850, 240–276–5122, hasan.siddiqui@
nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; TEP–1:
SBIR Contract Review.
Date: February 19–20, 2020.
Time: 6:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Marriott Bethesda North Hotel &
Conference Center, 5701 Marinelli Road,
Rockville, MD 20850.
Contact Person: Nadeem Khan, Ph.D.,
Scientific Review Officer, Research
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Technology and Contract Review Branch,
Division of Extramural Activities, 9609
Medical Center Drive, Room 7W260, National
Cancer Institute, NIH, Bethesda, MD 20892–
9745, 240–276–5856, nadeem.khan@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Research Specialist Award R50.
Date: February 27–28, 2020.
Time: 5:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Zhiqiang Zou, M.D., Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, 7W242, Bethesda, MD 20892,
240–276–6372, zouzhiq@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Transition
to Independence SEP.
Date: March 10, 2020.
Time: 10:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W602, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Delia Tang, M.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W602,
Bethesda, MD 20892, 240–276–6456, tangd@
mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Quantitative Imaging Methods and Resources
(UG3/UH3, U24).
Date: March 13, 2020.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
6W030, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Saejeong J. Kim, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, Room 7W640, Rockville, MD
20850, 240–276–7684, saejeong.kim@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; HIVAssociated Malignancy Research.
Date: March 26–27, 2020.
Time: 5:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marriott Bethesda North Hotel &
Conference Center, 5701 Marinelli Road,
Rockville, MD 20852.
Contact Person: Nadeem Khan, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, 9609
Medical Center Drive, Room 7W260, National
Cancer Institute, NIH, Bethesda, MD 20892–
9745, 240–276–5856, nadeem.khan@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
PO 00000
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93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: December 10, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–27003 Filed 12–13–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: The Development of
Siglec-6-Specific Chimeric Antigen
Receptor (CAR) for the Treatment
Acute Myeloid Leukemia (AML),
Chronic Lymphocytic Leukemia (CLL),
and Other Forms of Acute and Chronic
B- and T-Cell Leukemia and
Lymphoma
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 T–CURX GmbH
(T–CURX), located in Wu¨rzburg,
Germany.
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 December 31, 2019 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: Abritee Dhal, Ph.D.,
Technology Transfer Manager, NCI
Technology Transfer Center, 9609
Medical Center Drive, RM 3W610, MSC
9702, Bethesda, MD 20892–9702, (for
business mail), Rockville, MD 20850–
9702, Telephone: (240) 276–6154;
Facsimile: (240) 276–5504; Email:
abritee.dhal@nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Intellectual Property
U.S. Provisional Patent Application
61/178,688 entitled ‘‘A Panel Of Fully
E:\FR\FM\16DEN1.SGM
16DEN1
lotter on DSKBCFDHB2PROD with NOTICES
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
Human Monoclonal Antibodies To The
Same Epitope Of An Unknown Cell
Surface Antigen Expressed In B-cell
Lymphocytic Leukemia (B–CLL)’’ [HHS
Ref. E–163–2009–0–US–01], PCT Patent
Application PCT/US2010/034491
entitled ‘‘B-cell Surface Reactive
Antibodies’’ [HHS Ref. E–163–2009–0–
PCT–02], and United States Patent
8,877,199, entitled ‘‘B-cell Surface
Reactive Antibodies’’ [HHS Ref. E–163–
2009–0–US–03].
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 development, production, and
commercialization of a Siglec-6-specific
chimeric antigen receptor (CAR) based
immunotherapy using autologous
(meaning one individual is both the
donor and recipient) T cells modified by
virus-free Sleeping Beauty (SB)-based
gene transposition compromising of at
least:
a. A single antigen specificity; and
b. comprising at least:
i. The complementary determining
region (CDR) sequences of the Siglec-6
antibody known as JML–1, and
ii. a CD3z activation module and
either a CD28 or a 4–1BB co-stimulation
moiety.
for the treatment of acute myeloid
leukemia (AML), chronic lymphocytic
leukemia (CLL), and other forms of
acute and chronic B- and T-cell
leukemia and lymphoma.
The licensed field of use excludes any
(a) non-specified immunoconjugates,
including, but not limited to, antibody
drug conjugates and immunotoxins and
(b) unconjugated antibodies.
This technology discloses monoclonal
antibodies that are specific for the cell
surface domain of Siglec-6. The
antibodies can potentially be used for
the treatment of acute myeloid leukemia
(AML), chronic lymphocytic leukemia
(CLL), and other forms of acute and
chronic B-and T-cell leukemia and
lymphoma cells. In the subject situation,
the antibodies can be used in a CAR,
leading to the selective destruction of
the cancerous cells.
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
VerDate Sep<11>2014
19:21 Dec 13, 2019
Jkt 250001
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 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: December 5, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–27002 Filed 12–13–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
meetings of the Council of Councils.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The open
session will be videocast and can be
accessed from the NIH Videocasting and
Podcasting website (https://
videocast.nih.gov).
A portion of the meetings 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: Council of Councils.
Open: January 24, 2020.
Time: 8:15 a.m. to 12:10 p.m.
PO 00000
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68467
Agenda: Call to Order and Introductions;
Announcements and Updates; Scientific
Talks; NIH Program Updates.
Place: National Institutes of Health, John E.
Porter Neuroscience Research Center,
Building 35A, Rooms 620/630, 35 Convent
Drive, Bethesda, MD 20892.
Closed: January 24, 2020.
Time: 12:10 p.m. to 1:10 p.m.
Agenda: Review of Grant Applications.
Place: National Institutes of Health, John E.
Porter Neuroscience Research Center,
Building 35A, Rooms 620/630, 35 Convent
Drive, Bethesda, MD 20892.
Open: January 24, 2020.
Time: 1:10 p.m. to 4:00 p.m.
Agenda: Scientific Talks and NIH Program
Updates.
Place: National Institutes of Health, John E.
Porter Neuroscience Research Center,
Building 35A, Rooms 620/630, 35 Convent
Drive, Bethesda, MD 20892.
Contact Person: Franziska Grieder, D.V.M.,
Ph.D., Executive Secretary, Council of
Councils Director, Office of Research
Infrastructure Programs, Division of Program
Coordination, Planning, and Strategic
Initiatives, Office of the Director, NIH, 6701
Democracy Boulevard, Room 948, Bethesda,
MD 20892, GriederF@mail.nih.gov, 301–435–
0744.
Name of Committee: Council of Councils.
Open: May 15, 2020.
Time: 8:15 a.m. to 12:00 p.m.
Agenda: Call to Order and Introductions;
Announcements and Updates; Scientific
Talks; NIH Program Updates.
Place: National Institutes of Health, 6001
Executive Boulevard, Neuroscience Center,
Room C, E, Bethesda, MD 20892.
Closed: May 15, 2020.
Time: 12:00 p.m. to 1:00 p.m.
Agenda: Review of Grant Applications.
Place: National Institutes of Health, 6001
Executive Boulevard, Neuroscience Center,
Room C, E, Bethesda, MD 20892.
Open: May 15, 2020.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: Scientific Talks and NIH Program
Updates.
Place: National Institutes of Health, 6001
Executive Boulevard, Neuroscience Center,
Room C, E, Bethesda, MD 20892.
Contact Person: Franziska Grieder, D.V.M.,
Ph.D., Executive Secretary, Council of
Councils Director, Office of Research
Infrastructure Programs, Division of Program
Coordination, Planning, and Strategic
Initiatives, Office of the Director, NIH, 6701
Democracy Boulevard, Room 948, Bethesda,
MD 20892, GriederF@mail.nih.gov, 301–435–
0744.
Name of Committee: Council of Councils.
Open: September 11, 2020.
Time: 8:15 a.m. to 12:00 p.m.
Agenda: Call to Order and Introductions;
Announcements and Updates; Scientific
Talks; NIH Program Updates.
Place: National Institutes of Health,
Natcher Building, Building 45, Room D, C1/
C2 and G1/G2, 45 Center Drive, Bethesda,
MD 20892.
Closed: September 11, 2020.
Time: 12:00 p.m. to 1:00 p.m.
Agenda: Review of Grant Applications.
Place: National Institutes of Health,
Natcher Building, Building 45, Room D, C1/
E:\FR\FM\16DEN1.SGM
16DEN1
]]>Agencies
[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68466-68467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27002]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: The Development
of Siglec-6-Specific Chimeric Antigen Receptor (CAR) for the Treatment
Acute Myeloid Leukemia (AML), Chronic Lymphocytic Leukemia (CLL), and
Other Forms of Acute and Chronic B- and T-Cell Leukemia and Lymphoma
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 T-CURX GmbH (T-
CURX), located in W[uuml]rzburg, Germany.
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 December 31, 2019 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: Abritee Dhal, Ph.D., Technology Transfer
Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM
3W610, MSC 9702, Bethesda, MD 20892-9702, (for business mail),
Rockville, MD 20850-9702, Telephone: (240) 276-6154; Facsimile: (240)
276-5504; Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
U.S. Provisional Patent Application 61/178,688 entitled ``A Panel
Of Fully
[[Page 68467]]
Human Monoclonal Antibodies To The Same Epitope Of An Unknown Cell
Surface Antigen Expressed In B-cell Lymphocytic Leukemia (B-CLL)'' [HHS
Ref. E-163-2009-0-US-01], PCT Patent Application PCT/US2010/034491
entitled ``B-cell Surface Reactive Antibodies'' [HHS Ref. E-163-2009-0-
PCT-02], and United States Patent 8,877,199, entitled ``B-cell Surface
Reactive Antibodies'' [HHS Ref. E-163-2009-0-US-03].
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 development, production, and commercialization of a Siglec-6-
specific chimeric antigen receptor (CAR) based immunotherapy using
autologous (meaning one individual is both the donor and recipient) T
cells modified by virus-free Sleeping Beauty (SB)-based gene
transposition compromising of at least:
a. A single antigen specificity; and
b. comprising at least:
i. The complementary determining region (CDR) sequences of the
Siglec-6 antibody known as JML-1, and
ii. a CD3[zeta] activation module and either a CD28 or a 4-1BB co-
stimulation moiety.
for the treatment of acute myeloid leukemia (AML), chronic lymphocytic
leukemia (CLL), and other forms of acute and chronic B- and T-cell
leukemia and lymphoma.
The licensed field of use excludes any (a) non-specified
immunoconjugates, including, but not limited to, antibody drug
conjugates and immunotoxins and (b) unconjugated antibodies.
This technology discloses monoclonal antibodies that are specific
for the cell surface domain of Siglec-6. The antibodies can potentially
be used for the treatment of acute myeloid leukemia (AML), chronic
lymphocytic leukemia (CLL), and other forms of acute and chronic B-and
T-cell leukemia and lymphoma cells. In the subject situation, the
antibodies can be used in a CAR, leading to the selective destruction
of the cancerous cells.
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 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: December 5, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2019-27002 Filed 12-13-19; 8:45 am]
BILLING CODE 4140-01-P
