Prospective Grant of an Exclusive Patent License: Development and Commercialization of Logic-Gated Chimeric Antigen Receptor (CAR) Therapies for the Treatment of Cluster of Differentiation 33 (CD33) Expressing Cancers, 28966-28967 [2020-10303]
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Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
that the Secretary may adjust the terms
of appointees who are initially
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the Pandemic and All-Hazards
Preparedness and Advancing Innovation
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renewal date will have a term length
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members rotate out or resign using the
same procedures as the initial selection
process.
Robert P. Kadlec,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2020–10323 Filed 5–13–20; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Mono-Specific
Chimeric Antigen Receptor (CAR)
Therapies for the Treatment of Cluster
of Differentiation 33 (CD33) Expressing
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 Vor Biopharma
Inc. (‘‘Vor’’), located in Cambridge, MA.
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 June 15, 2020 will be
considered.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
Requests for copies of the
patent applications, inquiries, and
ADDRESSES:
VerDate Sep<11>2014
18:29 May 13, 2020
Jkt 250001
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–097–2018–0: Anti-CD33 Chimeric
Antigen Receptors for Treatment of
Human Acute Myeloid Leukemia
1. U.S. Provisional Patent Application
62/643,015, filed March 14, 2018
(E–097–2018–0–US–01);
2. International Patent Application PCT/
US2019/022,309, filed March 14,
2019 (E–097–2018–0–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:
An exclusive license to:
The development of a chimeric
antigen receptor (CAR) therapy monospecific for CD33 for the prophylaxis or
treatment of CD33-expressing
hematological malignancies wherein the
CAR is comprised of the CD33-binding
domain referenced as Hu195 or hP67.6,
is delivered via lentiviral transduction,
and the T cells are:
1. Derived autologously (meaning
cells derived from one individual who
is both the donor and the recipient) in
the first-line or relapsed/refractory
setting, or
2. derived allogeneically (meaning
cells derived from a matched healthy
donor), in the post-transplant setting.
This technology discloses a CAR
therapy that targets CD33 by utilizing
the anti-CD33 binder known as Hu195
or hP67.6 for the treatment of
hematological malignancies. CD33 is a
validated immunotherapeutic target that
is expressed on the surface of the vast
majority of acute myelogenous leukemia
(AML) blasts and cells in chronic
myeloid leukemia-blast crisis (CML–
BC).
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 thirty (30) days from the date of
this published Notice, the National
Cancer Institute receives written
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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: May 7, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2020–10304 Filed 5–13–20; 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: Development and
Commercialization of Logic-Gated
Chimeric Antigen Receptor (CAR)
Therapies for the Treatment of Cluster
of Differentiation 33 (CD33) Expressing
Cancers
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 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 June 15, 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
SUMMARY:
E:\FR\FM\14MYN1.SGM
14MYN1
Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
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:
jbell on DSKJLSW7X2PROD with NOTICES
Intellectual Property
E–097–2018–0: Anti-CD33 Chimeric
Antigen Receptors for Treatment of
Human Acute Myeloid Leukemia
1. U.S. Provisional Patent Application
62/643,015, filed March 14, 2018 (E–
097–2018–0–US–01);
2. International Patent Application
PCT/US2019/022,309, filed March 14,
2019 (E–097–2018–0–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:
An exclusive license to:
1. The development of a CD33specific logic-gated CAR-based
immunotherapy using autologous
human T cells transduced with
lentiviral vectors, wherein the viral
transduction leads to the expression of
a CAR that targets CD33 (comprised of
the CD33-binding domain referenced as
Hu195 or hP67.6 in the invention as
well as an intracellular signaling
domain), for the prophylaxis or
treatment of CD33-expressing cancers.
For clarity, ‘‘CD33-specific logic-gated
CAR-based immunotherapy’’ means
therapies where the CAR-expressing T
cells recognize CD33 and are engineered
to respond to one or more additional
antigens (but not necessarily all of the
signals).
2. The development of a CD33specific logic-gated CAR-based
immunotherapy using allogeneic human
NK cells transduced with lentiviral
vectors, wherein the viral transduction
leads to the expression of a CAR that
targets CD33 (comprised of the CD33binding domain referenced as Hu195 or
hP67.6 in the invention as well as an
intracellular signaling domain), for the
prophylaxis or treatment of CD33expressing cancers. For clarity, ‘‘CD33specific logic-gated CAR-based
immunotherapy’’ means therapies
where the CAR-expressing NK cells
recognize CD33 and are engineered to
respond to one or more additional
antigens (but not necessarily all of the
signals).
This technology discloses a CAR
therapy that targets CD33 by utilizing
the anti-CD33 binder known as Hu195
VerDate Sep<11>2014
18:29 May 13, 2020
Jkt 250001
or hP67.6 for the treatment of
hematological malignancies. CD33 is a
validated immunotherapeutic target that
is expressed on the surface of the vast
majority of acute myelogenous leukemia
(AML) blasts and cells in chronic
myeloid leukemia-blast crisis (CML–
BC).
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 thirty (30) 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: May 7, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2020–10303 Filed 5–13–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act. To request a
copy of these documents, call or email
the SAMHSA Reports Clearance Officer
on (240) 276–0361 or carlos.graham@
samhsa.hhs.gov.
PO 00000
Frm 00041
Fmt 4703
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28967
Project: Projects for Assistance in
Transition from Homelessness (PATH)
Program Annual Report (OMB No.
0930–0205)—Revision
The Center for Mental Health Services
awards grants each fiscal year to each of
the states, the District of Columbia, the
Commonwealth of Puerto Rico, the
Virgin Islands, Guam, American Samoa,
and the Commonwealth of the Northern
Mariana Islands from allotments
authorized under the PATH program
established by Public Law 101–645, 42
U.S.C. 290cc-21 et seq., the Stewart B.
McKinney Homeless Assistance
Amendments Act of 1990 (section 521 et
seq. of the Public Health Service (PHS)
Act) and the 21st Century Cures Act
(114–255 Pub. L). Section 522 of the
PHS Act and the 21st Century Cures Act
requires that the grantee states and
territories must expend their payments
under the Act solely for making grants
to political subdivisions of the state, and
to nonprofit private entities (including
community-based veterans’
organizations and other community
organizations) for the purpose of
providing services specified in the Act.
Available funding is allotted in
accordance with the formula provision
of section 524 of the PHS Act.
This submission is for a revision of
the current approval of the annual
grantee reporting requirements. Section
528 of the PHS Act and the 21st Century
Cures Act specify that not later than
January 31 of each fiscal year, a funded
entity will prepare and submit a report
in such form and containing such
information as is determined necessary
for securing a record and description of
the purposes for which amounts
received under section 521 were
expended during the preceding fiscal
year and of the recipients of such
amounts and determining whether such
amounts were expended in accordance
with statutory provisions.
The proposed changes to the PATH
2020 Annual Report are as follows:
1. HMIS Data Standards updates
When needed, field response options
and questions have been updated to
align with the most recent version of the
HMIS Data Standards.
Effective October 1, 2019, the HMIS
Data Standards have been further
updated. The changes in the HMIS Data
Standards are reflected in this version of
the PATH Annual Report Manual, and
include:
—Updates to response categories for
Living Situation
—Addition of an ‘‘Unable to Locate
Client’’ response option to PATH
Status
E:\FR\FM\14MYN1.SGM
14MYN1
]]>Agencies
[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28966-28967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10303]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of Logic-Gated Chimeric Antigen Receptor (CAR)
Therapies for the Treatment of Cluster of Differentiation 33 (CD33)
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 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 June 15, 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
[[Page 28967]]
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-097-2018-0: Anti-CD33 Chimeric Antigen Receptors for Treatment of
Human Acute Myeloid Leukemia
1. U.S. Provisional Patent Application 62/643,015, filed March 14,
2018 (E-097-2018-0-US-01);
2. International Patent Application PCT/US2019/022,309, filed March
14, 2019 (E-097-2018-0-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:
An exclusive license to:
1. The development of a CD33-specific logic-gated CAR-based
immunotherapy using autologous human T cells transduced with lentiviral
vectors, wherein the viral transduction leads to the expression of a
CAR that targets CD33 (comprised of the CD33-binding domain referenced
as Hu195 or hP67.6 in the invention as well as an intracellular
signaling domain), for the prophylaxis or treatment of CD33-expressing
cancers. For clarity, ``CD33-specific logic-gated CAR-based
immunotherapy'' means therapies where the CAR-expressing T cells
recognize CD33 and are engineered to respond to one or more additional
antigens (but not necessarily all of the signals).
2. The development of a CD33-specific logic-gated CAR-based
immunotherapy using allogeneic human NK cells transduced with
lentiviral vectors, wherein the viral transduction leads to the
expression of a CAR that targets CD33 (comprised of the CD33-binding
domain referenced as Hu195 or hP67.6 in the invention as well as an
intracellular signaling domain), for the prophylaxis or treatment of
CD33-expressing cancers. For clarity, ``CD33-specific logic-gated CAR-
based immunotherapy'' means therapies where the CAR-expressing NK cells
recognize CD33 and are engineered to respond to one or more additional
antigens (but not necessarily all of the signals).
This technology discloses a CAR therapy that targets CD33 by
utilizing the anti-CD33 binder known as Hu195 or hP67.6 for the
treatment of hematological malignancies. CD33 is a validated
immunotherapeutic target that is expressed on the surface of the vast
majority of acute myelogenous leukemia (AML) blasts and cells in
chronic myeloid leukemia-blast crisis (CML-BC).
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
thirty (30) 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: May 7, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2020-10303 Filed 5-13-20; 8:45 am]
BILLING CODE 4140-01-P
