Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer, 36872 [2020-13137]
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Federal Register / Vol. 85, No. 118 / Thursday, June 18, 2020 / Notices
estimated annualized burden hours are
68.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Form name
Type of respondent
Initial Request ...................................
State Government ............................
Federal Government ........................
State Government ............................
Federal Government ........................
70
60
20
10
1
1
1
1
30/60
30/60
5/60
5/60
35
30
2
1
...........................................................
........................
160
........................
68
Annual Update ..................................
Totals .........................................
Dated: June 15, 2020.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
Intellectual Property
[FR Doc. 2020–13139 Filed 6–17–20; 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 Cell Therapies
for 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 Ziopharm
Oncology, Inc. (‘‘Ziopharm’’),
headquartered in Boston, MA.
SUMMARY:
Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before July 6, 2020 will be
considered.
DATES:
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 or Email:
andy.burke@nih.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:40 Jun 17, 2020
Jkt 250001
Group A
E–031–2020: HLA Class I-Restricted T
Cell Receptors Against RAS with
G12D Mutation
1. U.S. Provisional Patent Application
62/975,544, filed February 12, 2020
(E–031–2020–0–US–01).
E–074–2020: HLA Class I-Restricted T
Cell Receptors Against RAS with
G12V Mutation
1. U.S. Provisional Patent Application
62/976,655, filed February 14, 2020
(E–074–2020–0–US–01).
E–088–2020: HLA Class II-Restricted T
Cell Receptors Against RAS with
G12V Mutation
1. U.S. Provisional Patent Application
62/981,856, filed February 26, 2020
(E–088–2020–0–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
fields of use may be limited to the
following:
Fields of Use Applying to Intellectual
Property Group A
‘‘Development, manufacture and
commercialization of autologous,
peripheral blood T cell therapy products
engineered by transposon-mediated
gene transfer to express T cell receptors
reactive to mutated KRAS, as claimed in
the Licensed Patent Rights, for the
treatment of human cancers.
Specifically excluded from this field of
use are, a) retrovirally-engineered
peripheral blood T cell therapy products
for the treatment of human cancers, and
b) CRISPR-engineered peripheral blood
T cell therapy products for the treatment
of human cancers.
Development, manufacture and
commercialization of companion
diagnostics approved or cleared by the
FDA or equivalent foreign regulatory
agency for Licensee-proprietary T cell
therapy products.’’
PO 00000
Frm 00045
Fmt 4703
Sfmt 9990
Intellectual Property Group A is
primarily directed to isolated T cell
receptors (TCRs) reactive to mutated
Kirsten rat sarcoma viral oncogene
homolog (KRAS), within the context of
several human leukocyte antigens
(HLAs). Mutated KRAS, which plays a
well-defined driver role in oncogenesis,
is expressed by a variety of human
cancers, including: Pancreatic, lung,
endometrial, ovarian and prostate. Due
to its restricted expression in
precancerous and cancerous cells, this
antigen may be targeted on mutant
KRAS-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: June 10, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2020–13137 Filed 6–17–20; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\18JNN1.SGM
18JNN1
]]>Agencies
[Federal Register Volume 85, Number 118 (Thursday, June 18, 2020)]
[Notices]
[Page 36872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13137]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of Cell Therapies for 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 Ziopharm
Oncology, Inc. (``Ziopharm''), headquartered in Boston, 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 July 6, 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: Andrew Burke, Ph.D., Senior Technology Transfer
Manager, NCI Technology Transfer Center, Telephone: (240)-276-5484 or
Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
Group A
E-031-2020: HLA Class I-Restricted T Cell Receptors Against RAS with
G12D Mutation
1. U.S. Provisional Patent Application 62/975,544, filed February
12, 2020 (E-031-2020-0-US-01).
E-074-2020: HLA Class I-Restricted T Cell Receptors Against RAS with
G12V Mutation
1. U.S. Provisional Patent Application 62/976,655, filed February
14, 2020 (E-074-2020-0-US-01).
E-088-2020: HLA Class II-Restricted T Cell Receptors Against RAS with
G12V Mutation
1. U.S. Provisional Patent Application 62/981,856, filed February
26, 2020 (E-088-2020-0-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 fields of use may be limited to the following:
Fields of Use Applying to Intellectual Property Group A
``Development, manufacture and commercialization of autologous,
peripheral blood T cell therapy products engineered by transposon-
mediated gene transfer to express T cell receptors reactive to mutated
KRAS, as claimed in the Licensed Patent Rights, for the treatment of
human cancers. Specifically excluded from this field of use are, a)
retrovirally-engineered peripheral blood T cell therapy products for
the treatment of human cancers, and b) CRISPR-engineered peripheral
blood T cell therapy products for the treatment of human cancers.
Development, manufacture and commercialization of companion
diagnostics approved or cleared by the FDA or equivalent foreign
regulatory agency for Licensee-proprietary T cell therapy products.''
Intellectual Property Group A is primarily directed to isolated T
cell receptors (TCRs) reactive to mutated Kirsten rat sarcoma viral
oncogene homolog (KRAS), within the context of several human leukocyte
antigens (HLAs). Mutated KRAS, which plays a well-defined driver role
in oncogenesis, is expressed by a variety of human cancers, including:
Pancreatic, lung, endometrial, ovarian and prostate. Due to its
restricted expression in precancerous and cancerous cells, this antigen
may be targeted on mutant KRAS-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: June 10, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2020-13137 Filed 6-17-20; 8:45 am]
BILLING CODE 4140-01-P
