Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer, 25295 [2017-11241]
Download as PDF
Federal Register / Vol. 82, No. 104 / Thursday, June 1, 2017 / Notices
Contact Person: Shalanda A. Bynum, MPH,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3206,
Bethesda, MD 20892, 301–755–4355,
bynumsa@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: May 26, 2017.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–11349 Filed 5–31–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dehydrogenase 1 (mIDH1) inhibitors for
the Treatment of Human Cancers.
Category: Routine.
Action Needed By: There is no
specific date that this needs to be
approved by, but the sooner the
document is approved, the sooner NIH
can make a potential therapeutic
available to the public.
Summary: Administration of an
inhibitor of mIDH1 can potentially treat
cancers resulting from or characterized
by the presence of mIDH1. Industrial
partners are being sought for licensing
and to help further develop this
technology for use in humans. There are
currently few effective therapeutics to
treat resulting from aberrant activity of
mIDH1, such as acute myeloid
leukemia.
Justification: Although there is no
specific date requirement, rapid
approval is requested in order to make
a potential therapeutic available to the
public quickly.
SUPPLEMENTARY INFORMATION:
National Institutes of Health
Intellectual Property
Prospective Grant of Exclusive Patent
License: Mutant IDH1 Inhibitors Useful
for Treating Cancer
1. International Application No. PCT/US15/
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), and
2. U.S. Provisional Application No. 62/
353298 filed on 06/22/2016 which is
entitled ‘‘Mutant IDH1 Inhibitors Useful
for Treating Cancer’’ (HHS Ref. No. E–
189–2016/0–US–01)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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
Patent Applications listed in the
Summary Information section of this
notice to GeneXion Oncology, Inc.,
located 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 on or
before July 3, 2017 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
exclusive license should be directed to:
Sury Vepa, Ph.D., J.D., Senior Licensing
and Patenting Manager, National Center
for Advancing Translational Sciences,
NIH, 9800 Medical Center Drive,
Rockville, MD 20850, Phone: 301–217–
9197, Fax: 301–217–5736, or email
sury.vepa@nih.gov. A signed
Confidential Disclosure Agreement may
be required to receive copies of the
patent applications.
Licensing Availability: The
Development of mutant Isocitrate
mstockstill on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:32 May 31, 2017
Jkt 241001
The patent rights in these inventions
have been 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 use of
Licensed Patent Rights for the following:
‘‘Therapeutics for cancers in humans
which result from or characterized by
the presence of mutant IDH1.’’
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.
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
25295
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 thirty (30) days from the date of
this published notice, the National
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.
Complete applications for a license in
the prospective field of use that are filed
in response to this notice will be treated
as objections to the grant of the
contemplated Exclusive Patent License
Agreement. 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: May 25, 2017.
Pamela McInnes,
Deputy Director, Office of the Director,
National Center for Advancing Translational
Sciences.
[FR Doc. 2017–11241 Filed 5–31–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings 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.
E:\FR\FM\01JNN1.SGM
01JNN1
Agencies
[Federal Register Volume 82, Number 104 (Thursday, June 1, 2017)]
[Notices]
[Page 25295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11241]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Mutant IDH1
Inhibitors Useful for Treating Cancer
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 Patent Applications
listed in the Summary Information section of this notice to GeneXion
Oncology, Inc., located 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 on or before July 3, 2017 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated exclusive license should be
directed to: Sury Vepa, Ph.D., J.D., Senior Licensing and Patenting
Manager, National Center for Advancing Translational Sciences, NIH,
9800 Medical Center Drive, Rockville, MD 20850, Phone: 301-217-9197,
Fax: 301-217-5736, or email sury.vepa@nih.gov. A signed Confidential
Disclosure Agreement may be required to receive copies of the patent
applications.
Licensing Availability: The Development of mutant Isocitrate
Dehydrogenase 1 (mIDH1) inhibitors for the Treatment of Human Cancers.
Category: Routine.
Action Needed By: There is no specific date that this needs to be
approved by, but the sooner the document is approved, the sooner NIH
can make a potential therapeutic available to the public.
Summary: Administration of an inhibitor of mIDH1 can potentially
treat cancers resulting from or characterized by the presence of mIDH1.
Industrial partners are being sought for licensing and to help further
develop this technology for use in humans. There are currently few
effective therapeutics to treat resulting from aberrant activity of
mIDH1, such as acute myeloid leukemia.
Justification: Although there is no specific date requirement,
rapid approval is requested in order to make a potential therapeutic
available to the public quickly.
SUPPLEMENTARY INFORMATION:
Intellectual Property
1. International Application No. PCT/US15/067406 filed on 12/22/2015
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating
Cancer'' (HHS Ref. No: E-243-2014/0-PCT-02), and
2. U.S. Provisional Application No. 62/353298 filed on 06/22/2016
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating
Cancer'' (HHS Ref. No. E-189-2016/0-US-01)
The patent rights in these inventions have been assigned and/or
exclusively licensed to the government of the United States of America
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 use of Licensed Patent Rights
for the following: ``Therapeutics for cancers in humans which result
from or characterized by the presence of mutant IDH1.''
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
thirty (30) days from the date of this published notice, the National
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.
Complete applications for a license in the prospective field of use
that are filed in response to this notice will be treated as objections
to the grant of the contemplated Exclusive Patent License Agreement.
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: May 25, 2017.
Pamela McInnes,
Deputy Director, Office of the Director, National Center for Advancing
Translational Sciences.
[FR Doc. 2017-11241 Filed 5-31-17; 8:45 am]
BILLING CODE 4140-01-P