Prospective Grant of an Exclusive Patent License: Development and Commercialization of Engineered T Cell Therapies for the Treatment of Cancer, 66463 [2023-21050]
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Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Notices
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VerDate Sep<11>2014
18:44 Sep 26, 2023
Jkt 259001
Dated: September 21, 2023.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2023–20980 Filed 9–26–23; 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 Engineered T
Cell Therapies for the Treatment of
Cancer
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 Moonlight Bio,
Inc. (‘‘Moonlight’’), headquartered in
Seattle, WA.
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 12, 2023 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
1. United States Provisional Patent
Application No. 63/492,256 filed March
27, 2023, entitled ‘‘T Cell Receptors
Targeting Y220C or R175H Mutation in
P53’’ [HHS Reference No. E–054–2023–
0–US–01].
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 autologous T cell
therapy products genetically engineered
PO 00000
Frm 00103
Fmt 4703
Sfmt 4703
66463
to express a P53 R175H-reactive TCR
claimed in the Licensed Patent Rights
for the treatment of cancer in humans.’’
The E–054–2023 patent family is
primarily directed to isolated T cell
receptors (TCRs) reactive to certain
mutated forms of tumor protein 53
(TP53 or P53), within the context of
several human leukocyte antigens. P53
is the archetypal tumor suppressor gene
and the most frequently mutated gene in
cancer. Contemporary estimates suggest
that >50% of all tumors carry mutations
in P53. Because of its prevalence in
cancer and its restricted expression to
precancerous and cancerous cells, this
antigen may be targeted on mutant P53expressing tumors with minimal normal
tissue toxicity.
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: September 21, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2023–21050 Filed 9–26–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 1009 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
E:\FR\FM\27SEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Page 66463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21050]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of Engineered T Cell Therapies for the Treatment of
Cancer
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 Moonlight Bio,
Inc. (``Moonlight''), headquartered in Seattle, WA.
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 12, 2023 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: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. United States Provisional Patent Application No. 63/492,256
filed March 27, 2023, entitled ``T Cell Receptors Targeting Y220C or
R175H Mutation in P53'' [HHS Reference No. E-054-2023-0-US-01].
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 autologous T
cell therapy products genetically engineered to express a P53 R175H-
reactive TCR claimed in the Licensed Patent Rights for the treatment of
cancer in humans.''
The E-054-2023 patent family is primarily directed to isolated T
cell receptors (TCRs) reactive to certain mutated forms of tumor
protein 53 (TP53 or P53), within the context of several human leukocyte
antigens. P53 is the archetypal tumor suppressor gene and the most
frequently mutated gene in cancer. Contemporary estimates suggest that
>50% of all tumors carry mutations in P53. Because of its prevalence in
cancer and its restricted expression to precancerous and cancerous
cells, this antigen may be targeted on mutant P53-expressing tumors
with minimal normal tissue toxicity.
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: September 21, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2023-21050 Filed 9-26-23; 8:45 am]
BILLING CODE 4140-01-P
