Prospective Grant of an Exclusive/Co-Exclusive Patent License: Development and Commercialization of Next Generation Chimeric Antigen Receptor (CAR) Therapies for the Treatment of FMS-Like tyrosine kinase 3 (FLT3) Expressing Cancers, 13305-13306 [2019-06575]
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Federal Register / Vol. 84, No. 65 / Thursday, April 4, 2019 / Notices
Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
grant of an Exclusive/Co-Exclusive
Patent License to practice the inventions
embodied in the Patents and Patent
Applications listed in the
Supplementary Information section of
this Notice to Senti Bio (‘‘Senti’’),
located in South San Francisco, CA.
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 April 19, 2019 will be
considered.
[FR Doc. 2019–06549 Filed 4–3–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Charter Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Frederick
National Laboratory Advisory
Committee to the National Cancer
Institute was renewed for an additional
two-year period on March 30, 2019.
It is determined that the Frederick
National Laboratory Advisory
Committee to the National Cancer
Institute is in the public interest in
connection with the performance of
duties imposed on the National Cancer
Institute and National Institutes of
Health by law, and that these duties can
best be performed through the advice
and counsel of this group.
Inquiries may be directed to Claire
Harris, Acting Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or harriscl@nih.gov.
Dated: April 1, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–06569 Filed 4–3–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive/CoExclusive Patent License:
Development and Commercialization
of Next Generation Chimeric Antigen
Receptor (CAR) Therapies for the
Treatment of FMS-Like tyrosine kinase
3 (FLT3) Expressing Cancers
jbell on DSK30RV082PROD with NOTICES
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
SUMMARY:
VerDate Sep<11>2014
17:25 Apr 03, 2019
Jkt 247001
Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive/Co-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:
ADDRESSES:
Intellectual Property
E–133–2016: FLT3-Specific Chimeric
Antigen Receptors and Methods Using
Same
1. US Provisional Patent Application
62/342,394, filed May 27, 2016 (E–133–
2016–0–US–01);
2. International Patent Application
PCT/US2017/034,691, filed May 26,
2017 (E–133–2016–0–PCT–02)
3. EP Patent Application
No.:17729627.4, filed December 11,
2018 (E–133–2016/0–EP–03)
4. US Patent Application No.: 16/
304,552, filed November 26, 2018 (E–
133–2016/0–US–05
5. Australia Patent Application No.:
2017271606, filed November 13, 2018
(E–133–2016/0–AU–06)
6. Canadian Patent Application No.:
3025516, filed November 23, 2018 (E–
133–2016/0–CA–07)
7. Japan Patent Application No.:
2018–561669, filed November 22, 2018
(E–133–2016/0–JP–08)
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/coexclusive license territory may be
worldwide, and the fields of use may be
limited to the following:
An exclusive license to: ‘‘the
development of a universal/split
chimeric antigen receptor (CAR)-based
immunotherapy using autologous or
allogeneic human lymphocytes (T cells
or NK cells) transduced with lentiviral
vectors, for the prophylaxis or treatment
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
13305
of cancers expressing FMS-like tyrosine
kinase 3 (FLT3; also known as CD135),
wherein the CAR construct binds to the
FLT3-binding domain referenced as
NC7 in the invention, but NC7 is not
included in the CAR construct.
Specifically excluded from the field of
use for this exclusive license are FLT3specific CAR -based immunotherapies
wherein the CAR construct comprises
the FLT3-binding domain referenced as
NC7 in the invention as well as an
intracellular signaling domain.’’ The
proposed territory is worldwide.
A co-exclusive license to: ‘‘the
development of a multi-specific FLT3
CAR-based immunotherapy using
autologous or allogeneic human
lymphocytes (T cells or NK cells)
transduced with lentiviral vectors,
wherein the viral transduction leads to
the expression of a CAR that targets
FLT3 (comprised of the FLT3-binding
domain referenced as NC7 in the
invention as well as an intracellular
signaling domain), for the prophylaxis
or treatment of FLT3-expressing
cancers.’’ The proposed territory is
worldwide.
A co-exclusive license to: ‘‘the
development of a FLT3-specific
Regulated/Switch/Logic-Gated CARbased immunotherapy using autologous
or allogeneic human lymphocytes (T
cells or NK cells) transduced with
lentiviral vectors, wherein the viral
transduction leads to the expression of
a CAR that targets FLT3 (comprised of
the FLT3-binding domain referenced as
NC7 in the invention as well as an
intracellular signaling domain), for the
prophylaxis or treatment of FLT3expressing cancers.’’ The proposed
territory is worldwide.
This technology discloses a CAR
therapy that targets FLT3 by utilizing
the anti-FLT3 binder known as NC7.
FLT3 (CD135) is a cytokine receptor
expressed on hematopoietic progenitor
cells and is one of the most frequently
mutated genes in acute myeloid
leukemia (AML) and infant acute
lymphoblastic leukemia (ALL). FLT3
mutation leads to increased cell surface
expression and therefore on leukemic
cells, which makes it an attractive
candidate for cellular therapies such as
CAR–T.
This Notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive/co-exclusive
license will be royalty bearing, and the
prospective exclusive/co-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
E:\FR\FM\04APN1.SGM
04APN1
13306
Federal Register / Vol. 84, No. 65 / Thursday, April 4, 2019 / Notices
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: March 28, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–06575 Filed 4–3–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Scientific Information
Reporting System (SIRS) (National
Institute of General Medical Sciences)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institute of General Medical
Sciences (NIGMS), will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
DATES: Comments regarding this
information collection are best assured
SUMMARY:
collection system whose purpose is to
obtain supplemental information to the
annual Research Performance Progress
Report (RPPR) submitted by grantees of
the Institutional Development Award
(IDeA) Program and the Native
American Research Centers for Health
(NARCH) Program. The SIRS will
collect program-specific data not
requested in the RPPR data collection
system. The IDeA Program is a
congressionally mandated, long-term
interventional program administered by
NIGMS aimed at developing and/or
enhancing the biomedical research
competitiveness of States and
Jurisdictions that lag in NIH funding.
The NARCH Program is an interagency
initiative that provides support to
American Indian and Alaska Native
(AI/AN) tribes and organizations for
conducting research in their
communities in order to address health
disparities, and to develop a cadre of
competitive AI/AN scientists and health
professionals. The data collected by
SIRS will provide valuable information
for the following purposes: (1)
Evaluation of progress by individual
grantees towards achieving granteedesignated and program-specified goals
and objectives, (2) evaluation of the
overall program for effectiveness,
efficiency, and impact in building
biomedical research capacity and
capability, and (3) analysis of outcome
measures to determine need for
refinements and/or adjustments of
different program features including but
not limited to initiatives and eligibility
criteria. Data collected from SIRS will
be used for various regular or ad hoc
reporting requests from interested
stakeholders that include members of
Congress, state and local officials, other
federal agencies, professional societies,
media, and other parties.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
744.
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Dr. Ming Lei, Director, Division
for Research Capacity Building NIGMS,
NIH, 45 Center Drive, Room 2AS44C,
MSC–6200, Bethesda, Maryland 20892
or call non-toll-free number (301) 827–
5323 or Email your request, including
your address to: leim@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: Scientific
Information Reporting System (SIRS),
0925–0735, Expiration Date 3/31/2019,
REINSTATEMENT WITHOUT
CHANGE, National Institute of General
Medical Sciences (NIGMS), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The SIRS is an online data
ESTIMATED ANNUALIZED BURDEN HOURS
jbell on DSK30RV082PROD with NOTICES
Form name
SIRS
SIRS
SIRS
SIRS
SIRS
SIRS
...........................
...........................
...........................
...........................
...........................
...........................
Total ....................
VerDate Sep<11>2014
Number of
respondents
Type of respondent
Principal
Principal
Principal
Principal
Principal
Principal
Average time
per response
(in hours)
Total annual
burden hours
COBRE Phase I ................
COBRE Phase II ...............
COBRE Phase III ..............
INBRE ................................
IDeA–CTR .........................
NARCH ..............................
54
34
54
24
11
17
1
1
1
1
1
1
3.5
3.5
3.5
5.5
3.5
4.5
189
119
189
132
38.5
76.5
..................................................................................
194
194
........................
744
19:40 Apr 03, 2019
Investigators,
Investigators,
Investigators,
Investigators,
Investigators,
Investigators,
Number of
responses per
respondent
Jkt 247001
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
E:\FR\FM\04APN1.SGM
04APN1
]]>Agencies
[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13305-13306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06575]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive/Co-Exclusive Patent License:
Development and Commercialization of Next Generation Chimeric Antigen
Receptor (CAR) Therapies for the Treatment of FMS-Like tyrosine kinase
3 (FLT3) Expressing Cancers
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/Co-Exclusive Patent License to
practice the inventions embodied in the Patents and Patent Applications
listed in the Supplementary Information section of this Notice to Senti
Bio (``Senti''), located in South San Francisco, CA.
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 April 19, 2019 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated Exclusive/Co-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-133-2016: FLT3-Specific Chimeric Antigen Receptors and Methods Using
Same
1. US Provisional Patent Application 62/342,394, filed May 27, 2016
(E-133-2016-0-US-01);
2. International Patent Application PCT/US2017/034,691, filed May
26, 2017 (E-133-2016-0-PCT-02)
3. EP Patent Application No.:17729627.4, filed December 11, 2018
(E-133-2016/0-EP-03)
4. US Patent Application No.: 16/304,552, filed November 26, 2018
(E-133-2016/0-US-05
5. Australia Patent Application No.: 2017271606, filed November 13,
2018 (E-133-2016/0-AU-06)
6. Canadian Patent Application No.: 3025516, filed November 23,
2018 (E-133-2016/0-CA-07)
7. Japan Patent Application No.: 2018-561669, filed November 22,
2018 (E-133-2016/0-JP-08)
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/co-exclusive license territory may be
worldwide, and the fields of use may be limited to the following:
An exclusive license to: ``the development of a universal/split
chimeric antigen receptor (CAR)-based immunotherapy using autologous or
allogeneic human lymphocytes (T cells or NK cells) transduced with
lentiviral vectors, for the prophylaxis or treatment of cancers
expressing FMS-like tyrosine kinase 3 (FLT3; also known as CD135),
wherein the CAR construct binds to the FLT3-binding domain referenced
as NC7 in the invention, but NC7 is not included in the CAR construct.
Specifically excluded from the field of use for this exclusive license
are FLT3-specific CAR -based immunotherapies wherein the CAR construct
comprises the FLT3-binding domain referenced as NC7 in the invention as
well as an intracellular signaling domain.'' The proposed territory is
worldwide.
A co-exclusive license to: ``the development of a multi-specific
FLT3 CAR-based immunotherapy using autologous or allogeneic human
lymphocytes (T cells or NK cells) transduced with lentiviral vectors,
wherein the viral transduction leads to the expression of a CAR that
targets FLT3 (comprised of the FLT3-binding domain referenced as NC7 in
the invention as well as an intracellular signaling domain), for the
prophylaxis or treatment of FLT3-expressing cancers.'' The proposed
territory is worldwide.
A co-exclusive license to: ``the development of a FLT3-specific
Regulated/Switch/Logic-Gated CAR-based immunotherapy using autologous
or allogeneic human lymphocytes (T cells or NK cells) transduced with
lentiviral vectors, wherein the viral transduction leads to the
expression of a CAR that targets FLT3 (comprised of the FLT3-binding
domain referenced as NC7 in the invention as well as an intracellular
signaling domain), for the prophylaxis or treatment of FLT3-expressing
cancers.'' The proposed territory is worldwide.
This technology discloses a CAR therapy that targets FLT3 by
utilizing the anti-FLT3 binder known as NC7. FLT3 (CD135) is a cytokine
receptor expressed on hematopoietic progenitor cells and is one of the
most frequently mutated genes in acute myeloid leukemia (AML) and
infant acute lymphoblastic leukemia (ALL). FLT3 mutation leads to
increased cell surface expression and therefore on leukemic cells,
which makes it an attractive candidate for cellular therapies such as
CAR-T.
This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive/co-exclusive license will be
royalty bearing, and the prospective exclusive/co-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
[[Page 13306]]
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: March 28, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2019-06575 Filed 4-3-19; 8:45 am]
BILLING CODE 4140-01-P
