Prospective Grant of an Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer, 75296-75297 [2023-24229]
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75296
Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices
will be inspected before being allowed on
campus. Visitors attending a meeting on
campus or at an off-campus federal facility
will be asked to show one form of
identification (for example, a governmentissued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
(National Center for Advancing
Translational Sciences, National Institutes of
Health, HHS Assistance Listing Number
(formerly Catalog of Federal Domestic
Assistance (CFDA) numbers) No. 93.350.)
Dated: October 30, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–24224 Filed 11–1–23; 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: Mutant IDH1 Inhibitors
Useful for Treating Cancer
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Center for
Advancing Translational Sciences, 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 Platform
Pharmaceuticals, Inc. (‘‘Platform
Pharma’’), headquartered in New York,
NY.
DATES: Only written comments and/or
applications for a license which are
received by the National Center for
Advancing Translational Sciences’
Office of Strategic Alliances on or before
November 17, 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: Sury Vepa, Ph.D., J.D.,
Senior Licensing and Patenting
Manager, Office of Strategic Alliances,
Telephone: (301)–642–0460; Email:
sury.vepa@nih.gov.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
Intellectual Property
1. U.S. Provisional Patent Application No.
62/095,322 filed on 12/22/2014 which is
entitled ‘‘Mutant IDH1 Inhibitors Useful
for Treating Cancer’’ (HHS Ref. No. E–
243–2014–0–US–01);
2. International Patent Application No. PCT/
VerDate Sep<11>2014
16:32 Nov 01, 2023
Jkt 262001
US2015/067406 filed on 12/22/2015
which is entitled ‘‘Mutant IDH1
Inhibitors Useful for Treating Cancer’’
(HHS Ref. No. E–243–2014–0–PCT–02);
3. Australian Patent Application No.
2015369712 filed on 12/22/2015 which
is entitled ‘‘Mutant IDH1 Inhibitors
Useful for Treating Cancer’’ which was
issued as Patent No. 2015369712 on 8/
20/2020 (HHS Ref. No. E–243–2014–0–
AU–03);
4. Canadian Patent Application No. 2971872
filed on 12/22/2015 which is entitled
‘‘Mutant IDH1 Inhibitors Useful for
Treating Cancer’’ (HHS Ref. No. E–243–
2014–0–CA–04);
5. Chinese Patent Application No.
2015800763284 filed on 12/22/2015
which is entitled ‘‘Mutant IDH1
Inhibitors Useful for Treating Cancer’’
which was issued as Patent No.
ZL2015800763284 on 4/13/2021’’ (HHS
Ref. No. E–243–2014–0–CN–05);
6. European Patent Application No.
15823901.2 filed on 12/22/2015 which is
entitled ‘‘Mutant IDH1 Inhibitors Useful
for Treating Cancer’’ which issued as
Patent No. 3237385 on 11/24/2021 and
validated in Germany, Spain, France,
Great Britain, and Italy (HHS Ref. No. E–
243–2014–0–EP–06);
7. Japanese Patent Application No.
2017534314 filed on 6/22/2017 which is
entitled ‘‘Mutant IDH1 Inhibitors Useful
for Treating Cancer’’ which was issued
as Patent No. 6901394 on 6/21/2021
(HHS Ref. No. E–243–2014–0–JP–07);
8. U.S. Patent Application No. 15/538,570
filed on 12/12/2015 which is entitled
‘‘Mutant IDH1 Inhibitors Useful for
Treating Cancer’’ which issued as Patent
No. 10,703,746 on 7/7/2020 (HHS Ref.
No. E–243–2014–0–US–08);
9. U.S. Provisional Patent Application No.
62/353,298 filed on 6/22/2016 which is
entitled ‘‘Mutant IDH1 Inhibitors Useful
for Treating Cancer’’ (HHS Ref. No. E–
189–2016–0–US–01);
10. International Patent Application No.
PCT/US2017/038549 filed on 6/21/2017
which is entitled ‘‘Mutant IDH1
Inhibitors Useful for Treating Cancer’’
(HHS Ref. No. E–189–2016–0–PCT–02);
11. Australian Patent Application No.
2017281088 filed on 6/21/2017 which is
entitled ‘‘Mutant IDH1 Inhibitors Useful
for Treating Cancer’’ which was issued
as Patent No. 2017281088 on 9/9/2021
(HHS Ref. No. E–189–2016–0–AU–04);
12. Canadian Patent Application No. 3028999
filed on 6/21/2017 which is entitled
‘‘Mutant IDH1 Inhibitors Useful for
Treating Cancer’’ (HHS Ref. No. E–189–
2016–0–CA–05);
13. Chinese Patent Application No.
2017800514100 filed on 6/21/2017
which is entitled ‘‘Mutant IDH1
Inhibitors Useful for Treating Cancer’’
which was issued as Patent No.
201780051410.0 on 9/20/2022 (HHS Ref.
No. E–189–2016–0–CN–06);
14. European Patent Application No.
17735296.0 filed on 6/21/2017 which is
entitled ‘‘Mutant IDH1 Inhibitors Useful
for Treating Cancer’’ which issued as
Patent No. 3475276 on 3/31/2021 and
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
validated in Germany, Spain, France,
Great Britain, and Italy (HHS Ref. No. E–
189–2016–0–EP–07);
15. Japanese Patent Application No. 2018–
567108 filed on 6/21/2017 which is
entitled ‘‘Mutant IDH1 Inhibitors Useful
for Treating Cancer’’ which was issued
as Patent No. 6987798 on 12/3/
2021(HHS Ref. No. E–189–2016–0–JP–
08); and
16. U.S. Patent Application No. 16/312,206
filed on 12/20/2018 which is entitled
‘‘Mutant IDH1 Inhibitors Useful for
Treating Cancer’’ which was issued as
Patent No. 10,836,759 on 11/17/2020
(HHS Ref. No. E–189–2016–0–US–03).
The patent rights in these inventions
have been either assigned and/or
exclusively licensed to the government
of the United States of America and the
University of North Carolina at Chapel
Hill.
The prospective exclusive license
territory may be worldwide, and the
field of use may be limited to the
following:
‘‘Use of mutant isocitrate
dehydrogenase 1 (mIDH1) inhibitors, as
claimed in the licensed patent rights, for
the treatment of cancers (such as acute
myeloid leukemia, glioma,
cholangiocarcinoma, glioblastoma
multiforme (GBM) and other solid
tumors) and rare diseases.’’
The inventions relate to a series of
novel compounds that potently and
selectively inhibit mIDH1. These
compounds reduce 2–HG levels in cell
lines in vitro as well as in human cancer
cells grown in mouse xenografts in vivo.
These compounds show greater than
250-fold selectivity for the mutant
enzyme over the wild-type, show
favorable in vitro stability (in mouse,
rat, dog and human hepatocyte exposure
studies), are AMES negative, and exhibit
no significant metabolic CYP liabilities.
These compounds possess very
favorable in vivo rodent
pharmacokinetics and bioavailability
and are well tolerated in rodents, even
when dosed at high levels.
Thus, the compounds of the subject
inventions can be used individually or
in combination to develop new
therapies to treat diseases which result
from mutant IDH1 activity. The diseases
caused by mutant IDH1 activity include
cancer (e.g., acute myeloid leukemia,
glioma, cholangiocarcinoma and
potentially other solid tumors) and
selected rare diseases, such as Ollier
Disease.
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
E:\FR\FM\02NON1.SGM
02NON1
Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices
Center for Advancing Translational
Sciences 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.
Joni L. Rutter,
Director, Office of the Director, National
Center for Advancing Translational Sciences.
[FR Doc. 2023–24229 Filed 11–1–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
khammond on DSKJM1Z7X2PROD with NOTICES
National Eye Institute; Notice of
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory Eye
Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend as well
as those who need special assistance,
such as sign language interpretation or
other reasonable accommodations, must
notify the Contact Person listed below
in advance of the meeting. The open
session will be videocast and can be
accessed from the NIH Videocasting and
Podcasting website (https://
videocast.nih.gov/watch=52746).
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/or contract proposals 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 and/or proposals, the
disclosure of which would constitute a
VerDate Sep<11>2014
16:32 Nov 01, 2023
Jkt 262001
clearly unwarranted invasion of
personal privacy.
Name of Committee: National Advisory
Eye Council.
Date: February 16, 2024.
Open: 8:00 a.m. to 3:00 p.m.
Agenda: Presentation of the NEI Director’s
report, discussion of NEI programs, and
concept clearances.
Place: National Eye Institute, 1st Floor,
Room A/B/C, 6700B Rockledge Drive,
Bethesda, MD 20892.
Closed: 3:15 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Eye Institute, 1st Floor,
Room A/B/C, 6700B Rockledge Drive,
Bethesda, MD 20892.
Contact Person: Kathleen C. Anderson,
Ph.D. Director, Division of Extramural
Activities 6700B Rockledge Drive, Room
3440 Bethesda, MD 20892 (301) 451–2020
kanders1@nei.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the contact person listed
above before the meeting or within 15 days
after the meeting. The statement should
include the name, address, telephone number
and when applicable, the business or
professional affiliation of the interested
person.
In the interest of security, NIH has
procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors attending a meeting on
campus or at an off-campus federal facility
will be asked to show one form of
identification (for example, a governmentissued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.nei.nih.gov/about/advisory-committees/
national-advisory-eye-council-naec, where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
Dated: October 27, 2023.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–24133 Filed 11–1–23; 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 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
75297
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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 Advisory
Council on Aging National Advisory Council
on Aging.
Date: September 18–19, 2024.
Closed: September 18, 2024, 3:00 p.m. to
5:00 p.m.
Agenda: To review and evaluate review of
Applications.
Place: National Institutes of Health Natcher
Building 45 Natcher Drive Bethesda, MD
20892.
Open: September 19, 2024, 9:00 a.m. to
1:10 p.m.
Agenda: Call to Order and Director’s Status
Report; Staff Introduction; Future Meeting
Dates, Consideration of Minutes from Last
Meeting; Task Force on Minority Aging
Research; Working Group on Program and
NOFO Concept Clearances; A Word from
Retiring Members, Dr. Manly and Weir;
Program Highlights; Council Speaker, Dr.
Matthew Gillman, M.D., SM.; Meeting
Adjourned.
Place: National Institutes of Health,
Natcher Building 45, Natcher Drive,
Bethesda, MD 20892.
Contact Person: Kenneth Santora, Director,
Office of Extramural Activities, National
Institute on Aging, National Institutes of
Health, Gateway Building, 7201 Wisconsin
Avenue, Bethesda, MD 20814, (301) 496–
9322, ksantora@nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.nia.nih.gov/about/naca, where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: October 27, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–24134 Filed 11–1–23; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\02NON1.SGM
02NON1
]]>Agencies
[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Pages 75296-75297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24229]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Mutant IDH1
Inhibitors Useful for Treating Cancer
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Center for Advancing Translational Sciences, 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 Platform Pharmaceuticals, Inc. (``Platform Pharma''),
headquartered in New York, NY.
DATES: Only written comments and/or applications for a license which
are received by the National Center for Advancing Translational
Sciences' Office of Strategic Alliances on or before November 17, 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: Sury Vepa, Ph.D., J.D., Senior Licensing and
Patenting Manager, Office of Strategic Alliances, Telephone: (301)-642-
0460; Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. U.S. Provisional Patent Application No. 62/095,322 filed on 12/
22/2014 which is entitled ``Mutant IDH1 Inhibitors Useful for
Treating Cancer'' (HHS Ref. No. E-243-2014-0-US-01);
2. International Patent Application No. PCT/US2015/067406 filed on
12/22/2015 which is entitled ``Mutant IDH1 Inhibitors Useful for
Treating Cancer'' (HHS Ref. No. E-243-2014-0-PCT-02);
3. Australian Patent Application No. 2015369712 filed on 12/22/2015
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating
Cancer'' which was issued as Patent No. 2015369712 on 8/20/2020 (HHS
Ref. No. E-243-2014-0-AU-03);
4. Canadian Patent Application No. 2971872 filed on 12/22/2015 which
is entitled ``Mutant IDH1 Inhibitors Useful for Treating Cancer''
(HHS Ref. No. E-243-2014-0-CA-04);
5. Chinese Patent Application No. 2015800763284 filed on 12/22/2015
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating
Cancer'' which was issued as Patent No. ZL2015800763284 on 4/13/
2021'' (HHS Ref. No. E-243-2014-0-CN-05);
6. European Patent Application No. 15823901.2 filed on 12/22/2015
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating
Cancer'' which issued as Patent No. 3237385 on 11/24/2021 and
validated in Germany, Spain, France, Great Britain, and Italy (HHS
Ref. No. E-243-2014-0-EP-06);
7. Japanese Patent Application No. 2017534314 filed on 6/22/2017
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating
Cancer'' which was issued as Patent No. 6901394 on 6/21/2021 (HHS
Ref. No. E-243-2014-0-JP-07);
8. U.S. Patent Application No. 15/538,570 filed on 12/12/2015 which
is entitled ``Mutant IDH1 Inhibitors Useful for Treating Cancer''
which issued as Patent No. 10,703,746 on 7/7/2020 (HHS Ref. No. E-
243-2014-0-US-08);
9. U.S. Provisional Patent Application No. 62/353,298 filed on 6/22/
2016 which is entitled ``Mutant IDH1 Inhibitors Useful for Treating
Cancer'' (HHS Ref. No. E-189-2016-0-US-01);
10. International Patent Application No. PCT/US2017/038549 filed on
6/21/2017 which is entitled ``Mutant IDH1 Inhibitors Useful for
Treating Cancer'' (HHS Ref. No. E-189-2016-0-PCT-02);
11. Australian Patent Application No. 2017281088 filed on 6/21/2017
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating
Cancer'' which was issued as Patent No. 2017281088 on 9/9/2021 (HHS
Ref. No. E-189-2016-0-AU-04);
12. Canadian Patent Application No. 3028999 filed on 6/21/2017 which
is entitled ``Mutant IDH1 Inhibitors Useful for Treating Cancer''
(HHS Ref. No. E-189-2016-0-CA-05);
13. Chinese Patent Application No. 2017800514100 filed on 6/21/2017
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating
Cancer'' which was issued as Patent No. 201780051410.0 on 9/20/2022
(HHS Ref. No. E-189-2016-0-CN-06);
14. European Patent Application No. 17735296.0 filed on 6/21/2017
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating
Cancer'' which issued as Patent No. 3475276 on 3/31/2021 and
validated in Germany, Spain, France, Great Britain, and Italy (HHS
Ref. No. E-189-2016-0-EP-07);
15. Japanese Patent Application No. 2018-567108 filed on 6/21/2017
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating
Cancer'' which was issued as Patent No. 6987798 on 12/3/2021(HHS
Ref. No. E-189-2016-0-JP-08); and
16. U.S. Patent Application No. 16/312,206 filed on 12/20/2018 which
is entitled ``Mutant IDH1 Inhibitors Useful for Treating Cancer''
which was issued as Patent No. 10,836,759 on 11/17/2020 (HHS Ref.
No. E-189-2016-0-US-03).
The patent rights in these inventions have been either assigned
and/or exclusively licensed to the government of the United States of
America and the University of North Carolina at Chapel Hill.
The prospective exclusive license territory may be worldwide, and
the field of use may be limited to the following:
``Use of mutant isocitrate dehydrogenase 1 (mIDH1) inhibitors, as
claimed in the licensed patent rights, for the treatment of cancers
(such as acute myeloid leukemia, glioma, cholangiocarcinoma,
glioblastoma multiforme (GBM) and other solid tumors) and rare
diseases.''
The inventions relate to a series of novel compounds that potently
and selectively inhibit mIDH1. These compounds reduce 2-HG levels in
cell lines in vitro as well as in human cancer cells grown in mouse
xenografts in vivo.
These compounds show greater than 250-fold selectivity for the
mutant enzyme over the wild-type, show favorable in vitro stability (in
mouse, rat, dog and human hepatocyte exposure studies), are AMES
negative, and exhibit no significant metabolic CYP liabilities. These
compounds possess very favorable in vivo rodent pharmacokinetics and
bioavailability and are well tolerated in rodents, even when dosed at
high levels.
Thus, the compounds of the subject inventions can be used
individually or in combination to develop new therapies to treat
diseases which result from mutant IDH1 activity. The diseases caused by
mutant IDH1 activity include cancer (e.g., acute myeloid leukemia,
glioma, cholangiocarcinoma and potentially other solid tumors) and
selected rare diseases, such as Ollier Disease.
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
[[Page 75297]]
Center for Advancing Translational Sciences 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.
Joni L. Rutter,
Director, Office of the Director, National Center for Advancing
Translational Sciences.
[FR Doc. 2023-24229 Filed 11-1-23; 8:45 am]
BILLING CODE 4140-01-P
