Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer, 28063-28064 [2019-12707]
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Federal Register / Vol. 84, No. 116 / Monday, June 17, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Lutetium-177
Radiotherapeutics Against
Somatostatin-Receptor Expressing
Neuroendocrine Tumors
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Only written comments and/or
applications for a license which are
received by the NHLBI Office of
Technology Transfer and Development
July 2, 2019 will be considered.
DATES:
Notice.
The National Heart, Lung and
Blood Institute (NHLBI), National
Institutes of Health, Department of
SUMMARY:
khammond on DSKBBV9HB2PROD with NOTICES
Health and Human Services, is
contemplating amending an existing
license to include a exclusive patent
license to Molecular Targeting
Technologies, Inc. (MTTI); a Delaware
corporation, with its principle place of
business in West Chester, Pennsylvania,
to practice the inventions embodied in
the patent application listed in the
SUPPLEMENTARY INFORMATION section of
this notice.
NIH ref No.
Patent No. or
patent
application No.
Filing date
E–150–2016–0–US–01 ..
62/333,427 ..............
May 9, 2019 ............
E–150–2016–0–PCT–02
May 9, 2017 ............
E–150–2016–0–CN–03 ..
PCT/US2017/
031696.
201780029003X ......
E–150–2016–0–EP–04 ..
17796666.0 .............
November 12, 2018
E–150–2016–0–JP–05 ...
2018–558662 ..........
November 8, 2018 ..
E–150–2016–0–US–06 ..
16/099,488 ..............
November 7, 2018 ..
The patent rights in these inventions
have been assigned to the Government
of the United States of America. The
prospective patent license will be
granted worldwide and limited to the
extent that the above referenced patents
or patent applications cover lutetium177 radiotherapeutics for somatostatinreceptor expressing neuroendocrine
tumors.
The invention pertains to a
radiotherapeutic against neuroendocrine
tumors that express somatostatin
receptor. Radionuclide therapies
directed against tumors that express
somatostatin receptors (SSTRs) have
proven effective for the treatment of
advanced, low- to intermediate-grade
neuroendocrine tumors. The subject
radiotherapeutic covered by the subject
patent estate includes a somatostatin
(SST) peptide derivative like octreotate
(TATE), conjugated to an Evans Blue
(EB) analog, and further chelated via
DOTA to therapeutic radionuclide. The
EB analog reversibly binds to circulating
serum albumin and improves the
pharmacokinetics of SST peptide
derivatives and reduce peptide-receptor
radionuclide therapy toxicity. EB analog
conjugated to octreotate (EBDOTATATE) has been shown by the
inventors to provide reversible albumin
binding in vivo and extended half-life in
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Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
exclusive patent license should be
directed to: Michael Shmilovich, Esq.,
Senior Licensing and Patent Manager,
31 Center Drive, Room 4A29, MSC2479,
Bethesda, MD 20892–2479, phone
number 301–435–5019, or shmilovm@
mail.nih.gov.
ADDRESSES:
The
following and all continuing U.S. and
foreign patents/patent applications
thereof are the intellectual properties to
be licensed under the prospective
agreement to MTTI:
SUPPLEMENTARY INFORMATION:
Title
Chemical Conjugates of Evans Blue
diotherapy and Imaging Agents.
Chemical Conjugates of Evans Blue
diotherapy and Imaging Agents.
Chemical Conjugates of Evans Blue
diotherapy and Imaging Agents.
Chemical Conjugates of Evans Blue
diotherapy and Imaging Agents.
Chemical Conjugates of Evans Blue
diotherapy and Imaging Agents.
Chemical Conjugates of Evans Blue
diotherapy and Imaging Agents.
circulation. When EB-TATE is slowly
released into the tumor
microenvironment, tumor uptake and
internalization into SSTR positive
tumors resulted in delivery of
radioactive particles and tumor cell
killing. EB-TATE displayed significantly
more favorable pharmacokinetics than
TATE alone by achieving higher tumor
to non-tumor penetration as evidenced
by positron emission tomography.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive patent license
will be royalty bearing and may be
granted unless within fifteen (15) days
from the date of this published notice,
the NHLBI 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.
Complete applications for a license in
the prospective field of use that are
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive patent
license.
Comments and objections submitted
to this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
PO 00000
28063
Sfmt 4703
Derivatives and Their Use as RaDerivatives and Their Use as RaDerivatives and Their Use as RaDerivatives and Their Use as RaDerivatives and Their Use as RaDerivatives and Their Use as Ra-
Dated: June 3, 2019.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager,
National Heart, Lung, and Blood Institute,
Office of Technology Transfer and
Development.
[FR Doc. 2019–12708 Filed 6–14–19; 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 Tailored
Therapeutics, LLC. (‘‘Tailored’’), located
in Potomac, MD.
SUMMARY:
E:\FR\FM\17JNN1.SGM
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28064
Federal Register / Vol. 84, No. 116 / Monday, June 17, 2019 / Notices
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 2, 2019 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, 9609
Medical Center Drive, RM 1E530, MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702; Telephone: (240)-276–5484;
Facsimile: (240)-276–5504; Email:
andy.burke@nih.gov.
SUPPLEMENTARY INFORMATION:
DATES:
Intellectual Property
Group A
HLA–A3-Restricted T Cell Receptors
Against Mutated RAS
1. U.S. Provisional Patent Application
62/749,750, filed October 24, 2018 (E–
166–2018–0–US–01).
HLA Class II-Restricted T Cell Receptors
Against RAS With G12R Mutation
1. U.S. Provisional Patent Application
62/795,203, filed January 22, 2019 (E–
029–2019–0–US–01).
Group B
khammond on DSKBBV9HB2PROD with NOTICES
Methods of Producing T Cell
Populations Using Hydroxycitric Acid
and/or a Salt Thereof
1. U.S. Provisional Patent Application
62/661,941, filed April 24, 2018 (E–094–
2018–0–US–01); and
2. International Patent Application
PCT/US2019/028513, filed April 22,
2019 (E–094–2018–0–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:
Fields of Use Applying to Intellectual
Property Groups A and B
‘‘Development, manufacture and
commercialization of autologous,
peripheral blood T cell therapy products
engineered by CRISPR 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 retrovirally-engineered
peripheral blood T cell therapy products
for the treatment of human cancers.
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16:34 Jun 14, 2019
Jkt 247001
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.’’
Fields of Use Applying to Intellectual
Property Group B
‘‘Development, manufacture and
commercialization of autologous,
peripheral blood T cell therapy products
engineered by CRISPR to express T cell
receptors reactive to mutated p53, as
claimed in the Licensed Patent Rights,
for the treatment of cancer in humans.
‘‘Development, manufacture and
commercialization of autologous, tumor
infiltrating lymphocyte (TIL)-based
adoptive T cell therapy products
reactive to mutated p53, isolated as
claimed in the Licensed Patent Rights,
for the treatment of human cancers.
Specifically excluded from this field of
use are genetically engineered TIL 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.
Intellectual Property Group B is
primarily directed to methods of
preparing isolated populations of T cells
by culturing them in the presence of
hydroxycitric acid and/or a salt thereof,
and methods of treating cancer using
populations of T cells cultured in such
a manner.
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 which
establishes that the grant of the license
would not be consistent with the
PO 00000
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Fmt 4703
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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 3, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–12707 Filed 6–14–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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 on
Aging Special Emphasis Panel; High Priority
Research Networks.
Date: June 26, 2019.
Time: 12:30 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Ave,
Bethesda, MD 20892, (Telephone Conference
Call).
Contact Person: Kimberly Firth, Ph.D.,
National Institutes of Health, National
Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20892, 301–402–7702, firthkm@
mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
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]]>Agencies
[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Notices]
[Pages 28063-28064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12707]
-----------------------------------------------------------------------
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 Tailored
Therapeutics, LLC. (``Tailored''), located in Potomac, MD.
[[Page 28064]]
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 2, 2019 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, 9609 Medical Center Drive, RM
1E530, MSC 9702, Bethesda, MD 20892-9702 (for business mail),
Rockville, MD 20850-9702; Telephone: (240)-276-5484; Facsimile: (240)-
276-5504; Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
Group A
HLA-A3-Restricted T Cell Receptors Against Mutated RAS
1. U.S. Provisional Patent Application 62/749,750, filed October
24, 2018 (E-166-2018-0-US-01).
HLA Class II-Restricted T Cell Receptors Against RAS With G12R Mutation
1. U.S. Provisional Patent Application 62/795,203, filed January
22, 2019 (E-029-2019-0-US-01).
Group B
Methods of Producing T Cell Populations Using Hydroxycitric Acid and/or
a Salt Thereof
1. U.S. Provisional Patent Application 62/661,941, filed April 24,
2018 (E-094-2018-0-US-01); and
2. International Patent Application PCT/US2019/028513, filed April
22, 2019 (E-094-2018-0-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:
Fields of Use Applying to Intellectual Property Groups A and B
``Development, manufacture and commercialization of autologous,
peripheral blood T cell therapy products engineered by CRISPR 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 retrovirally-
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.''
Fields of Use Applying to Intellectual Property Group B
``Development, manufacture and commercialization of autologous,
peripheral blood T cell therapy products engineered by CRISPR to
express T cell receptors reactive to mutated p53, as claimed in the
Licensed Patent Rights, for the treatment of cancer in humans.
``Development, manufacture and commercialization of autologous,
tumor infiltrating lymphocyte (TIL)-based adoptive T cell therapy
products reactive to mutated p53, isolated as claimed in the Licensed
Patent Rights, for the treatment of human cancers. Specifically
excluded from this field of use are genetically engineered TIL 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.
Intellectual Property Group B is primarily directed to methods of
preparing isolated populations of T cells by culturing them in the
presence of hydroxycitric acid and/or a salt thereof, and methods of
treating cancer using populations of T cells cultured in such a manner.
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 which
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 3, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2019-12707 Filed 6-14-19; 8:45 am]
BILLING CODE 4140-01-P
