Prospective Grant of Exclusive Patent License: Lutetium-177 Radiotherapeutics Against Somatostatin-Receptor Expressing Neuroendocrine Tumors, 28063 [2019-12708]
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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
VerDate Sep<11>2014
16:34 Jun 14, 2019
Jkt 247001
November 9, 2018 ..
Frm 00064
Fmt 4703
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
17JNN1
]]>Agencies
[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Notices]
[Page 28063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12708]
[[Page 28063]]
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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: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National
Institutes of Health, Department of 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.
DATES: 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.
ADDRESSES: 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 [email protected].
SUPPLEMENTARY INFORMATION: 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:
----------------------------------------------------------------------------------------------------------------
Patent No. or patent
NIH ref No. application No. Filing date Title
----------------------------------------------------------------------------------------------------------------
E-150-2016-0-US-01............... 62/333,427.................. May 9, 2019................. Chemical
Conjugates of
Evans Blue
Derivatives and
Their Use as
Radiotherapy and
Imaging Agents.
E-150-2016-0-PCT-02.............. PCT/US2017/031696........... May 9, 2017................. Chemical
Conjugates of
Evans Blue
Derivatives and
Their Use as
Radiotherapy and
Imaging Agents.
E-150-2016-0-CN-03............... 201780029003X............... November 9, 2018............ Chemical
Conjugates of
Evans Blue
Derivatives and
Their Use as
Radiotherapy and
Imaging Agents.
E-150-2016-0-EP-04............... 17796666.0.................. November 12, 2018........... Chemical
Conjugates of
Evans Blue
Derivatives and
Their Use as
Radiotherapy and
Imaging Agents.
E-150-2016-0-JP-05............... 2018-558662................. November 8, 2018............ Chemical
Conjugates of
Evans Blue
Derivatives and
Their Use as
Radiotherapy and
Imaging Agents.
E-150-2016-0-US-06............... 16/099,488.................. November 7, 2018............ Chemical
Conjugates of
Evans Blue
Derivatives and
Their Use as
Radiotherapy and
Imaging Agents.
----------------------------------------------------------------------------------------------------------------
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 lutetium-177
radiotherapeutics for somatostatin-receptor 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 (EB-DOTATATE) has been shown by the inventors to provide
reversible albumin binding in vivo and extended half-life in
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.
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
