Prospective Grant of Exclusive Evaluation Option License: Pre-clinical Evaluation of Human Therapeutics Utilizing Ubiquitin Based Fusion Proteins With Apoptosis Modifying Proteins Such as BCL-XL, 65698-65699 [2012-26601]
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Federal Register / Vol. 77, No. 210 / Tuesday, October 30, 2012 / Notices
Dated: October 24, 2012.
Mary K. Wakefield,
Administrator.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
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 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.
wreier-aviles on DSK7SPTVN1PROD with NOTICES
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Dating
Violence and Marketing.
Date: November 13, 2012.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Anna L Riley, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3114,
MSC 7759, Bethesda, MD 20892, 301–435–
2889, rileyann@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: October 24, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–26602 Filed 10–29–12; 8:45 am]
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
[FR Doc. 2012–26565 Filed 10–29–12; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Prospective Grant of Exclusive
Evaluation Option License: Pre-clinical
Evaluation of Human Therapeutics
Utilizing Ubiquitin Based Fusion
Proteins With Apoptosis Modifying
Proteins Such as BCL–XL
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 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 of Diabetes and Digestive and
Kidney Diseases Special Emphasis
Panel, Ancillary Studies to the ISC
Consortium.
Date: November 29, 2012.
Time: 3:30 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Two Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Maria E. DavilaBloom, Ph.D., Scientific Review Officer,
Review Branch, DEA, NIDDK, National
Institutes of Health, Room 758, 6707
Democracy Boulevard, Bethesda, MD
20892–5452, (301) 594–7637, davilabloomm@extra.niddk.nih.gov.
Dated: October 23, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
evaluation option license to practice the
inventions covered under the scope of
United States Patent No. 6,737,511
issued May 18, 2004 entitled ‘‘Receptormediated Uptake of an Extracellular
BCL-xL Fusion Protein Inhibits
Apoptosis’’ (HHS Ref. No. E–073–1999/
0–US–02; Inventors Richard Youle et
al.) and International Patent Application
No. PCT/US2012/032762 filed April 9,
2012 entitled ‘‘Ubiquitin Fusions for
Improving the Efficacy of Cytosolic
Acting Targeted Toxins’’ (HHS Ref. No.
E–150–2011/0–PCT–02; Inventors
Christopher Bachran et al.) to
Medicenna Therapeutics,
(‘‘MEDICENNA’’) a Canada based
company. The patent rights in this
invention have been assigned to the
government of the United States of
America.
The prospective exclusive evaluation
option license territory may be
worldwide and the field of use may be
limited to the pre-clinical evaluation of
lead therapeutic candidates for the
development of human therapeutics
within the field of cancer and
neurological diseases. Upon expiration
or termination of the exclusive
evaluation option license, MEDICENNA
will have the right to execute an
exclusive patent commercialization
license which will supersede and
replace the exclusive evaluation option
license with no broader territory than
granted in the exclusive evaluation
option license and the field of use will
be commensurate with the commercial
development plan at the time of
conversion.
[FR Doc. 2012–26603 Filed 10–29–12; 8:45 am]
DATES:
(Catalogue of Federal Domestic
Assistance Program Nos. 93.847,
Diabetes, Endocrinology and Metabolic
Research; 93.848, Digestive Diseases and
Nutrition Research; 93.849, Kidney
Diseases, Urology and Hematology
Research, National Institutes of Health,
HHS)
BILLING CODE 4140–01–P
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National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
PO 00000
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SUMMARY:
Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
November 14, 2012 will be considered.
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Federal Register / Vol. 77, No. 210 / Tuesday, October 30, 2012 / Notices
Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive evaluation
option license should be directed to:
Sabarni K. Chatterjee, Ph.D., M.B.A.
Licensing and Patenting Manager, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
5587; Facsimile: (301) 402–0220; Email:
chatterjeesa@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
technologies covered under the present
inventions relate to (1) apoptosismodifying fusion proteins with at least
two domains, one of which targets the
fusion proteins to a target cell, and
another of which modifies an apoptotic
response of the target cell. For example,
fusing various cell-binding domains to
Bcl-XL and Bad allows targeting to
specific subsets of cells in vivo,
permitting treatment and/or prevention
of cell-death related consequences of
various diseases and injuries. This
technology could be used to minimize
or prevent apoptotic damage that can be
caused by neurodegenerative disorders,
e.g., Alzheimer’s disease, Huntington’s
disease or spinal-muscular atrophy,
stroke episodes or transient ischemic
neuronal injury, e.g., spinal cord
injuries. Additionally, apoptoticenhancing fusion proteins of the current
invention could be used to inhibit cell
growth, e.g., uncontrolled cellular
proliferation and (2) a platform
technology using ubiquitin to improve
the delivery and efficacy of cytosolic
targeted toxins. This invention describes
generation of fusion proteins via the
introduction of the protein ubiquitin, a
small protein in eukaryotic cells that
plays a role in protein recycling, in
between a targeting moiety and a
catalytic moiety. Ubiquitin contains a
cleavable motif at its C-terminus, which
can help in the decoupling of the two
moieties. Decoupling of the two
moieties would increase the cytotoxicity
of the treatment, since the catalytic
domain of a Targeted Toxin (TT)
remains longer in the cytosol. This
method of generating fusion proteins
would be highly useful for all TT and
immunotoxins that access the cytosol to
either affect cytosolic targets or traffic to
further sites of action.
The prospective exclusive evaluation
option license is being considered under
the small business initiative launched
on October 1, 2011 and will comply
with the terms and conditions of 35
U.S.C. 209 and 37 CFR Part 404.7. The
prospective exclusive evaluation option
license, and a subsequent exclusive
wreier-aviles on DSK7SPTVN1PROD with NOTICES
ADDRESSES:
VerDate Mar<15>2010
13:17 Oct 29, 2012
Jkt 229001
patent commercialization license, may
be granted unless within fifteen (15)
days from the date of this published
notice, the NIH 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 404.7.
Any additional, properly filed, and
complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated exclusive
evaluation option 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: October 23, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–26601 Filed 10–29–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of
Chemopreventive Treatments for Head
and Neck Squamous Cell Carcinoma
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
evaluation option license to practice the
inventions embodied in PCT Patent
Application No. PCT/US2009/054478,
U.S. Patent Application No. 13/059,335
and foreign equivalents thereof entitled
‘‘Chemopreventive of Head and Neck
Squamous Cell Carcinoma’’ (HHS Ref.
No. E–302–2008/0) and PCT Patent
Application No. PCT/IL2010/000694,
U.S. Patent Application No. 13/391,756
and foreign equivalents thereof entitled
‘‘Prevention and Treatment of Oral and
Lips Diseases Using Sirolimus and
Derivatives Sustained Release Delivery
Systems for Local Application to the
Oral Cavity’’ (HHS Ref. No. E–282–
2009/0) to Rapamycin Holdings, Inc.,
which is located in San Antonio, TX.
The patent rights in these inventions
SUMMARY:
PO 00000
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Fmt 4703
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65699
have been assigned to the United States
of America.
The prospective exclusive evaluation
option license territory may be
worldwide and the field of use may be
limited to use of the Licensed Patent
Rights for the prevention and treatment
of head and neck cancers.
Upon the expiration or termination of
the exclusive evaluation option license,
Rapamycin Holdings, Inc. will have the
exclusive right to execute an exclusive
commercialization license which will
supersede and replace the exclusive
evaluation option license with no
greater field of use and territory than
granted in the exclusive evaluation
option license.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
November 14, 2012 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Whitney A. Hastings,
Ph.D., Licensing and Patenting Manager,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 451–
7337; Facsimile: (301) 402–0220; Email:
hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: In head
and neck squamous cell carcinoma
(HNSCC), a cancer occurring mostly in
the mouth, it is frequently observed that
the Akt/mTOR pathway is abnormally
activated. Therefore, inhibiting this
signaling pathway may help in treating
this disease. Rapamycin and its analogs
are known to inhibit the activity of
mTOR so in principle they could serve
as therapeutics for treating HNSCC.
This technology describes a method of
potentially preventing or treating
HNSCC through the inhibition of mTOR
activity. The proof of this principle was
demonstrated by rapid regression of
mouth tumors in mice afflicted with
Cowden syndrome with the
administration of rapamycin. Like
HNSCC, development of this disease is
linked to over activation of the Akt/
mTOR pathway. Furthermore, the
therapeutic potential of rapamycin was
demonstrated using mice in
experiments that model chronic
exposure to tobacco, which promotes
the development of HNSCC. Therefore,
inhibitors of mTOR have considerable
potential in the prevention and
treatment of HNSCC. Moreover, using a
local, sustained-release oral drug
delivery system for early intervention to
prevent potentially malignant or
E:\FR\FM\30OCN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 210 (Tuesday, October 30, 2012)]
[Notices]
[Pages 65698-65699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-26601]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Evaluation Option License: Pre-
clinical Evaluation of Human Therapeutics Utilizing Ubiquitin Based
Fusion Proteins With Apoptosis Modifying Proteins Such as BCL-XL
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR 404.7(a)(1)(i), that the National Institutes of Health, Department
of Health and Human Services, is contemplating the grant of an
exclusive evaluation option license to practice the inventions covered
under the scope of United States Patent No. 6,737,511 issued May 18,
2004 entitled ``Receptor-mediated Uptake of an Extracellular BCL-
xL Fusion Protein Inhibits Apoptosis'' (HHS Ref. No. E-073-
1999/0-US-02; Inventors Richard Youle et al.) and International Patent
Application No. PCT/US2012/032762 filed April 9, 2012 entitled
``Ubiquitin Fusions for Improving the Efficacy of Cytosolic Acting
Targeted Toxins'' (HHS Ref. No. E-150-2011/0-PCT-02; Inventors
Christopher Bachran et al.) to Medicenna Therapeutics, (``MEDICENNA'')
a Canada based company. The patent rights in this invention have been
assigned to the government of the United States of America.
The prospective exclusive evaluation option license territory may
be worldwide and the field of use may be limited to the pre-clinical
evaluation of lead therapeutic candidates for the development of human
therapeutics within the field of cancer and neurological diseases. Upon
expiration or termination of the exclusive evaluation option license,
MEDICENNA will have the right to execute an exclusive patent
commercialization license which will supersede and replace the
exclusive evaluation option license with no broader territory than
granted in the exclusive evaluation option license and the field of use
will be commensurate with the commercial development plan at the time
of conversion.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
November 14, 2012 will be considered.
[[Page 65699]]
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
evaluation option license should be directed to: Sabarni K. Chatterjee,
Ph.D., M.B.A. Licensing and Patenting Manager, Office of Technology
Transfer, National Institutes of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-5587;
Facsimile: (301) 402-0220; Email: chatterjeesa@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The technologies covered under the present
inventions relate to (1) apoptosis-modifying fusion proteins with at
least two domains, one of which targets the fusion proteins to a target
cell, and another of which modifies an apoptotic response of the target
cell. For example, fusing various cell-binding domains to Bcl-
XL and Bad allows targeting to specific subsets of cells in
vivo, permitting treatment and/or prevention of cell-death related
consequences of various diseases and injuries. This technology could be
used to minimize or prevent apoptotic damage that can be caused by
neurodegenerative disorders, e.g., Alzheimer's disease, Huntington's
disease or spinal-muscular atrophy, stroke episodes or transient
ischemic neuronal injury, e.g., spinal cord injuries. Additionally,
apoptotic-enhancing fusion proteins of the current invention could be
used to inhibit cell growth, e.g., uncontrolled cellular proliferation
and (2) a platform technology using ubiquitin to improve the delivery
and efficacy of cytosolic targeted toxins. This invention describes
generation of fusion proteins via the introduction of the protein
ubiquitin, a small protein in eukaryotic cells that plays a role in
protein recycling, in between a targeting moiety and a catalytic
moiety. Ubiquitin contains a cleavable motif at its C-terminus, which
can help in the decoupling of the two moieties. Decoupling of the two
moieties would increase the cytotoxicity of the treatment, since the
catalytic domain of a Targeted Toxin (TT) remains longer in the
cytosol. This method of generating fusion proteins would be highly
useful for all TT and immunotoxins that access the cytosol to either
affect cytosolic targets or traffic to further sites of action.
The prospective exclusive evaluation option license is being
considered under the small business initiative launched on October 1,
2011 and will comply with the terms and conditions of 35 U.S.C. 209 and
37 CFR Part 404.7. The prospective exclusive evaluation option license,
and a subsequent exclusive patent commercialization license, may be
granted unless within fifteen (15) days from the date of this published
notice, the NIH 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 404.7.
Any additional, properly filed, and complete applications for a
license in the field of use filed in response to this notice will be
treated as objections to the grant of the contemplated exclusive
evaluation option 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: October 23, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-26601 Filed 10-29-12; 8:45 am]
BILLING CODE 4140-01-P
