Prospective Grant of an Exclusive Patent License: Development and Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies, 328-329 [2019-28356]
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Federal Register / Vol. 85, No. 2 / Friday, January 3, 2020 / Notices
• Development of therapeutics against
severe RSV infection
• Diagnostic biomarker
Competitive Advantages:
• Enhance the innate immune response
to respiratory infection
• Improve clinical trial outcome in
patients with TLR8 mediated RSV
infection
Development Stage:
• Early stage
• In vitro data available
Inventors: Michael Resnick (NIEHS),
Daniel Menendez (NIEHS), Steven
Kleeberger (NIEHS), and Fernando
Polack (Infant Foundation).
Intellectual Property: HHS Reference
No. E–072–2019–0; US Application No.
62/881,656.
Licensing Contact: Vidita Choudhry,
Ph.D.; 301–594–4095; vidita.choudhry@
nih.gov. This notice is made in
accordance with 35 U.S.C. 209 and 37
CFR part 404.
Dated: December 26, 2019.
Vidita Choudhry,
Technology Development Specialist, National
Heart, Lung, and Blood Institute, Office of
Technology Transfer and Development.
[FR Doc. 2019–28358 Filed 1–2–20; 8:45 am]
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Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Helen Huang, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH, Bethesda, MD 20817,
301–435–8380, helen.huang@nih.gov.
Name of Committee: National Institute of
Child Health and Human Development Initial
Review Group; Function, Integration, and
Rehabilitation Sciences Subcommittee.
Date: February 26, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Helen Huang, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH, Bethesda, MD 20817,
301–435–8380, helen.huang@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: December 27, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–28359 Filed 1–2–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 27, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–28357 Filed 1–2–20; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSKJLSW7X2PROD with NOTICES
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Ileana Hancu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5116,
Bethesda, MD 20817, 301–402–3911,
ileana.hancu@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Secondary Analyses of Existing Datasets in
Heart, Lung and Blood Diseases and Sleep
Disorders.
Date: January 28, 2020.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Heidi B. Friedman, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1012A,
MSC 7770, Bethesda, MD 20892, 301–379–
5632, hfriedman@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)
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Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meetings
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Center for Scientific Review; Notice of
Closed Meetings
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
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.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
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: National Institute of
Child Health and Human Development Initial
Review Group; Reproduction, Andrology,
and Gynecology Subcommittee.
Date: February 21, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Early Phase
Clinical Trials in Imaging and Image-Guided
Interventions (R01 Clinical Trial Required).
Date: January 28, 2020.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
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Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of CD19/CD22
Chimeric Antigen Receptor (CAR)
Therapies for the Treatment of B-Cell
Malignancies
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 CJ Healthcare,
(‘‘CJ’’), located in Seoul, Republic of
Korea.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
SUMMARY:
E:\FR\FM\03JAN1.SGM
03JAN1
329
Federal Register / Vol. 85, No. 2 / Friday, January 3, 2020 / Notices
Institute’s Technology Transfer Center
on or before January 21, 2020 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: Jim Knabb, Senior
Technology Transfer Manager, NCI
Technology Transfer Center, 9609
Medical Center Drive, RM 1E530, MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702; Telephone: (240) 276–7856;
Facsimile: (240) 276–5504; Email:
jim.knabb@nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectual Property
E–016–2015: Chimeric Antigen Receptor
Targeting Both CD19 and CD22
1. US Provisional Patent Application
62/135,442, filed March 19, 2015
(E–106–2015–0–US–01);
2. International Patent Application PCT/
US2016/023055, filed March 18,
2016 (E–106–2015/0–PCT–02)
3. US Patent Application No.: 15/
559,485, filed September 19, 2017
(E–E–106–2015/0–US–03)
E–017–2017: CD19/CD22 Bicistronic
CAR Targeting Human B-Cell
Malignancies
1. US Provisional Patent Application
62/506,268, filed May 15, 2017 (E–
017–2017–0–US–01);
2. International Patent Application PCT/
US2018/032,809, filed May 15,
2018 (E–017–2017/0–PCT–02)
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
fields of use may be limited to the
following:
Treatment of B cell malignancies using
autologously-derived, lentiviral vector
transduced, T cells expressing chimeric
antigen receptor(s) (CAR) dual specific for
CD19 and CD22, utilizing the anti-CD19
antigen binding domain of the FM63
antibody and the anti-CD22 antigen binding
domain of the M971 antibody
Dated: December 20, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–28356 Filed 1–2–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–7011–N–60]
30-Day Notice of Proposed Information
Collection: Survey of Market
Absorption of New Multifamily Units
(SOMA); OMB #2528–0013
This technology discloses CAR
therapies that target both CD19 and
jbell on DSKJLSW7X2PROD with NOTICES
CD22 by utilizing the anti-CD19 binder
known as FM63 and the anti-CD22
binder known as M971. CD19 and CD22
are each expressed on the surface of B
cells in B cell malignancies and are
hallmark examples of antigen targeting
in CAR-T therapies, with CD19-targeting
CAR-T therapies being the first FDA
approved CAR-T, and CD22-targeting
CAR-T showing early promise in
clinical trials for ALL and NHL.
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
Freedom of Information Act, 5 U.S.C.
552.
Office of the Chief Information
Officer, HUD.
AGENCY:
ACTION:
Notice.
HUD is seeking approval from
the Office of Management and Budget
(OMB) for the information collection
described below. In accordance with the
Paperwork Reduction Act, HUD is
requesting comment from all interested
parties on the proposed collection of
information. The purpose of this notice
is to allow for 30 days of public
comment.
SUMMARY:
DATES:
Comments Due Date: February 3,
2020.
Interested persons are
invited to submit comments regarding
this proposal. Comments should refer to
the proposal by name and/or OMB
Control Number and should be sent to:
HUD Desk Officer, Office of
Management and Budget, New
Executive Office Building, Washington,
DC 20503; fax: 202–395–5806, Email:
OIRA Submission@omb.eop.gov.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Anna P. Guido, Reports Management
Officer, QMAC, Department of Housing
and Urban Development, 451 7th Street
SW, Washington, DC 20410; email Anna
P. Guido at Anna.P.Guido@hud.gov or
telephone 202–402–5535. This is not a
toll-free number. Person with hearing or
speech impairments may access this
number through TTY by calling the tollfree Federal Relay Service at (800) 877–
8339. Copies of available documents
submitted to OMB may be obtained
from Ms. Guido.
This
notice informs the public that HUD is
seeking approval from OMB for the
information collection described in
Section A.
The Federal Register notice that
solicited public comment on the
information collection for a period of 60
days was published on Friday,
November 8, 2019 at 84 FR 60404.
SUPPLEMENTARY INFORMATION:
A. Overview of Information Collection
Title of Information Collection:
Survey of Market Absorption of New
Multifamily Units (SOMA).
OMB Approval Number: 2528–0013.
Type of Request: Revision.
Information
collection
Number of
respondents
Frequency
of response
Responses
per annum
Burden hour
per response
Annual
burden hours
Hourly
cost per
response
Annual cost
SOMA ...........................
12,000.00
4.00
48,000.00
* .125
6,000.00
$36.75
$220,500.00
* (30 minutes’ total divided by 4 interviews).
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]]>Agencies
[Federal Register Volume 85, Number 2 (Friday, January 3, 2020)]
[Notices]
[Pages 328-329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28356]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR)
Therapies for the Treatment of B-Cell Malignancies
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 CJ Healthcare,
(``CJ''), located in Seoul, Republic of Korea.
DATES: Only written comments and/or applications for a license which
are received by the National Cancer
[[Page 329]]
Institute's Technology Transfer Center on or before January 21, 2020
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: Jim Knabb, Senior Technology Transfer Manager,
NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530,
MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD
20850-9702; Telephone: (240) 276-7856; Facsimile: (240) 276-5504;
Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
E-016-2015: Chimeric Antigen Receptor Targeting Both CD19 and CD22
1. US Provisional Patent Application 62/135,442, filed March 19, 2015
(E-106-2015-0-US-01);
2. International Patent Application PCT/US2016/023055, filed March 18,
2016 (E-106-2015/0-PCT-02)
3. US Patent Application No.: 15/559,485, filed September 19, 2017 (E-
E-106-2015/0-US-03)
E-017-2017: CD19/CD22 Bicistronic CAR Targeting Human B-Cell
Malignancies
1. US Provisional Patent Application 62/506,268, filed May 15, 2017 (E-
017-2017-0-US-01);
2. International Patent Application PCT/US2018/032,809, filed May 15,
2018 (E-017-2017/0-PCT-02)
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 fields of use may be limited to the following:
Treatment of B cell malignancies using autologously-derived,
lentiviral vector transduced, T cells expressing chimeric antigen
receptor(s) (CAR) dual specific for CD19 and CD22, utilizing the
anti-CD19 antigen binding domain of the FM63 antibody and the anti-
CD22 antigen binding domain of the M971 antibody
This technology discloses CAR therapies that target both CD19 and
CD22 by utilizing the anti-CD19 binder known as FM63 and the anti-CD22
binder known as M971. CD19 and CD22 are each expressed on the surface
of B cells in B cell malignancies and are hallmark examples of antigen
targeting in CAR-T therapies, with CD19-targeting CAR-T therapies being
the first FDA approved CAR-T, and CD22-targeting CAR-T showing early
promise in clinical trials for ALL and NHL.
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 Freedom of Information Act, 5
U.S.C. 552.
Dated: December 20, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2019-28356 Filed 1-2-20; 8:45 am]
BILLING CODE 4140-01-P
