Government-Owned Inventions; Availability for Licensing, 6120-6121 [2013-01789]
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Federal Register / Vol. 78, No. 19 / Tuesday, January 29, 2013 / Notices
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and Bioethics Policy, Office of Science Policy,
National Institutes of Health.
[FR Doc. 2013–01851 Filed 1–28–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
srobinson on DSK4SPTVN1PROD with
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
VerDate Mar<15>2010
16:47 Jan 28, 2013
Jkt 229001
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUMMARY:
Novel Derivatives of
Docosahexaenoylethanolamide as
Therapeutics for Neuronal Disorders
Description of Technology: This
technology provides derivatives of
Docosahexaenoylethanolamide
(synaptamide or DEA) which have
increased potency and hydrolysis
resistance as compared to DEA
(structures of these derivatives are
available upon request), as well as
methods of using these derivatives to
promote neurogenesis, neurite growth,
and/or synaptogenesis.
Docosahexaenoic acid (DHA), an n-3
polyunsaturated fatty acid that
accumulates in the brain during
development, has been shown to play a
key role in learning and memory
development. Studies have also shown
that DEA, a metabolite derived from
DHA is very potent in accelerating
neuronal growth and development. The
inventors have discovered that the novel
DEA derivatives they have designed are
even more potent than DEA or DHA in
accelerating neuronal growth,
synaptogenesis and development. The
inventors have shown that treatment of
progenitor neural cells with some of
these novel DEA derivatives leads to an
increase in the amount of somatic
neurons produced after differentiation.
These novel compounds can be
developed as therapeutics for conditions
such as trauma, stroke, multiple
sclerosis, Alzheimer’s disease, brain and
spinal cord injuries, and peripheral
nerve injuries for rehabilitation.
Potential Commercial Applications:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
• Agents to promote neurogenesis,
neurite growth, and synaptogenesis.
• Therapeutics for neurological
conditions, such as traumatic brain
injury, spinal cord injury, peripheral
nerve injury, stroke, multiple sclerosis,
autism, Alzheimer’s disease,
Huntington’s disease, Parkinson’s
disease, and amyotrophic lateral
sclerosis.
Competitive Advantages: These
derivatives of DEA provide increased
potency and hydrolysis resistance
compared to DEA.
Development Stage:
• Prototype.
• Early-stage.
• Pre-clinical.
• In vitro data available.
Inventors: Erika Englund (NCATS),
Juan Marugan (NCATS), Samarjit
Patnaik (NCATS), Hee-Yong Kim
(NIAAA)
Publications:
1. Kim HY, et al. NDocosahexaenoylethanolamide
promotes development of hippocampal
neurons. Biochem J. 2011 Apr
15;435(2):327–36. [PMID 21281269].
2. Kim HY, et al. A synaptogenic
amide N-docosahexaenoylethanolamide
promotes hippocampal development.
Prostaglandins Other Lipid Mediat.
2011 Nov;96(1–4):114–20. [PMID
21810478].
3. Cao D, et al. Docosahexaenoic acid
promotes hippocampal neuronal
development and synaptic function. J
Neurochem. 2009 Oct;111(2):510–21.
[PMID 19682204].
Intellectual Property: HHS Reference
No. E–070–2012/0 — U.S. Provisional
Application No. 61/624,741 filed 16 Apr
2012.
Licensing Contact: Suryanarayana
(Sury) Vepa, Ph.D., J.D.; 301–435–5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity:
The National Center for Advancing
Translational Sciences is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize this technology. For
collaboration opportunities, please
contact Dr. Juan Marugan at
maruganj@mail.nih.gov or Dr. Krishna
Balakrishnan at balakrik@mail.nih.gov.
High-Affinity Rabbit Monoclonal
Antibodies to Mesothelin for Treatment
of Cancer
Description of Technology:
Mesothelin is a cell surface protein that
is highly expressed in aggressive
cancers, such as malignant
mesothelioma, ovarian cancer and
pancreatic cancer. Because of this
selective expression, mesothelin is an
E:\FR\FM\29JAN1.SGM
29JAN1
srobinson on DSK4SPTVN1PROD with
Federal Register / Vol. 78, No. 19 / Tuesday, January 29, 2013 / Notices
excellent candidate for targeted
therapeutics, such as monoclonal
antibodies (mAbs) and chimeric
molecules. Current anti-mesothelin
therapeutic mAb candidates bind to an
epitope in Region I of mesothelin.
Unfortunately, Region I contains the
interaction site MUC16/CA125, a
mesothelin-interacting protein that is
present in the serum of patients with
mesothelin-related cancers. Because the
current therapeutic mAb candidates
must compete with MUC16/CA125 for
binding to mesothelin, they may not
reach their full therapeutic potential
due to interference.
In order to address this concern, NIH
inventors generated several rabbit mAbs
that recognize unique epitopes of
mesothelin: (1) YP223, which
recognizes region II; (2) YYP218, which
recognizes region III; and (3) YP3 which
recognizes a native conformation
epitope of mesothelin. These mAbs bind
to mesothelin with sub-nanomolar
affinity and are not out-competed for
binding by the current anti-mesothelin
therapeutic mAb candidates or MUC16/
CA125. This strong binding affinity for
an alternative binding site on
mesothelin suggests that these mAbs are
excellent therapeutic candidates.
Potential Commercial Applications:
• Therapeutic use, such as treatment
of mesothelin-expressing cancers as a
stand-alone mAbs or as a mAb-drug
conjugate (e.g., an immunotoxin).
• Diagnosis of mesothelin-expressing
cancers.
• Antibody-related research use,
including immunoprecipitation,
western blot analysis,
immunohistochemistry, ELISA, etc.
Competitive Advantages:
• Binding of new epitope on
mesothelin may improve therapeutic
applications due to non-competition
from serum proteins.
• High binding affinity (subnanomolar levels) also increases
chances of binding and subsequent
therapeutic activity.
Development Stage:
• Early-stage.
• In vitro data available.
Inventors: Mitchell Ho et al. (NCI).
Publication: Ho M. Advances in liver
cancer antibody therapies: A focus on
glypican-3 and mesothelin. BioDrugs.
2011 Oct 1;25(5):275–84. doi: 10.2165/
11595360–000000000–00000. [PMID
21942912].
Intellectual Property: HHS Reference
No. E–198–2012/0—U.S. Provisional
Patent Application No. 61/691,719 filed
21 Aug 2012.
Related Technologies:
• HHS Reference No. E–021–1998/
0—U.S. Patent 6,809,184 issued 26 Oct
2004.
VerDate Mar<15>2010
16:47 Jan 28, 2013
Jkt 229001
• HHS Reference No. E–139–1999/
0—U.S. Patent 7,081,518 issued 25 Jul
2006.
• HHS Reference No. E–091–2009/
0—U.S. Patent Publication US
20120107933.
Licensing Contact: David A.
Lambertson, Ph.D.; 301–435–4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity:
The NCI Laboratory of Molecular
Biology is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize new monoclonal
antibodies to unique domains of
mesothelin for cancer therapy or
diagnostics. For collaboration
opportunities, please contact John
Hewes, Ph.D. at hewesj@mail.nih.gov.
Single Domain Human Monoclonal
Antibodies to Mesothelin for Treatment
of Cancer
Description of Technology:
Mesothelin is a cell surface protein that
is highly expressed in aggressive
cancers such as malignant
mesothelioma, ovarian cancer and
pancreatic cancer. This selective
expression makes mesothelin an
excellent candidate for targeted
therapeutics such as monoclonal
antibodies (mAbs) and corresponding
chimeric molecules. Unfortunately,
current anti-mesothelin mAb candidates
have drawbacks, such as competition
with a serum protein (MUC16/CA125)
for binding to mesothelin, the formation
of neutralizing antibodies because they
are non-human antibodies, and the
inability to trigger complementdependent cytotoxicity (CDC).
In order to address this concern, NIH
inventors generated two single domain
human mAbs: SD1 and SD2. SD1
recognizes a unique epitope in region III
of mesothelin which is not outcompeted for binding by MUC16/
CA125. SD1 was also capable of
triggering CDC, as well as antibodydependent cellular cytotoxicity (ADCC).
Due to its human origin, SD1 is also less
likely to elicit the formation of
neutralizing antibodies when
administered to patients. Each of these
characteristics suggests SD1 may be an
effective therapeutic agent. Indeed, SD1
was able to inhibit tumor growth in
mouse xenograft models, and
corresponding immunotoxins were able
to inhibit tumor cell growth in vitro,
supporting the use of SD1 as a
therapeutic mAb.
Potential Commercial Applications:
• Therapeutic use, such as treatment
of mesothelin-expressing cancers as a
PO 00000
Frm 00057
Fmt 4703
Sfmt 9990
6121
stand-alone mAbs or as a mAb-drug
conjugate (e.g., an immunotoxin).
• Diagnosis of mesothelin-expressing
cancers.
• Antibody-related research use,
including immunoprecipitation,
western blot analysis,
immunohistochemistry, ELISA, etc.
Competitive Advantages:
• Binding of a new epitope on
mesothelin may improve therapeutic
applications due to non-competition
from serum proteins.
• Human origin may significantly
limit the formation of neutralizing
antibodies, thereby increasing
therapeutic potential of the mAb.
• Ability to trigger both CDC and
ADCC may elicit a more complete
therapeutic response.
Development Stage:
• Early-stage.
• In vitro data available.
• In vivo data available (animal).
Inventors: Mitchell Ho et al. (NCI).
Publication: Ho M. Advances in liver
cancer antibody therapies: A focus on
glypican-3 and mesothelin. BioDrugs.
2011 Oct 1;25(5):275–84. doi: 10.2165/
11595360–000000000–00000. [PMID
21942912]
Intellectual Property: HHS Reference
No. E–236–2012/0—U.S. Provisional
Patent Application No. 61/706,396 filed
27 Sep 2012
Related Technologies:
• HHS Reference No. E–021–1998/
0—U.S. Patent 6,809,184 issued 26 Oct
2004.
• HHS Reference No. E–139–1999/
0—U.S. Patent 7,081,518 issued 25 Jul
2006.
• HHS Reference No. E–091–2009/
0—U.S. Patent Publication US
20120107933.
Licensing Contact: David A.
Lambertson, Ph.D.; 301–435–4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity:
The NCI Laboratory of Molecular
Biology is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize single-domain human
antibodies (SD1 and SD2) to mesothelin
for cancer therapy or diagnostics. For
collaboration opportunities, please
contact John Hewes, Ph.D. at
hewesj@mail.nih.gov.
Dated: January 23, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–01789 Filed 1–28–13; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\29JAN1.SGM
29JAN1
]]>Agencies
[Federal Register Volume 78, Number 19 (Tuesday, January 29, 2013)]
[Notices]
[Pages 6120-6121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01789]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
FOR FURTHER INFORMATION CONTACT: Licensing information and copies of
the U.S. patent applications listed below may be obtained by writing to
the indicated licensing contact at the Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to
receive copies of the patent applications.
Novel Derivatives of Docosahexaenoylethanolamide as Therapeutics for
Neuronal Disorders
Description of Technology: This technology provides derivatives of
Docosahexaenoylethanolamide (synaptamide or DEA) which have increased
potency and hydrolysis resistance as compared to DEA (structures of
these derivatives are available upon request), as well as methods of
using these derivatives to promote neurogenesis, neurite growth, and/or
synaptogenesis. Docosahexaenoic acid (DHA), an n-3 polyunsaturated
fatty acid that accumulates in the brain during development, has been
shown to play a key role in learning and memory development. Studies
have also shown that DEA, a metabolite derived from DHA is very potent
in accelerating neuronal growth and development. The inventors have
discovered that the novel DEA derivatives they have designed are even
more potent than DEA or DHA in accelerating neuronal growth,
synaptogenesis and development. The inventors have shown that treatment
of progenitor neural cells with some of these novel DEA derivatives
leads to an increase in the amount of somatic neurons produced after
differentiation. These novel compounds can be developed as therapeutics
for conditions such as trauma, stroke, multiple sclerosis, Alzheimer's
disease, brain and spinal cord injuries, and peripheral nerve injuries
for rehabilitation.
Potential Commercial Applications:
Agents to promote neurogenesis, neurite growth, and
synaptogenesis.
Therapeutics for neurological conditions, such as
traumatic brain injury, spinal cord injury, peripheral nerve injury,
stroke, multiple sclerosis, autism, Alzheimer's disease, Huntington's
disease, Parkinson's disease, and amyotrophic lateral sclerosis.
Competitive Advantages: These derivatives of DEA provide increased
potency and hydrolysis resistance compared to DEA.
Development Stage:
Prototype.
Early-stage.
Pre-clinical.
In vitro data available.
Inventors: Erika Englund (NCATS), Juan Marugan (NCATS), Samarjit
Patnaik (NCATS), Hee-Yong Kim (NIAAA)
Publications:
1. Kim HY, et al. N-Docosahexaenoylethanolamide promotes
development of hippocampal neurons. Biochem J. 2011 Apr 15;435(2):327-
36. [PMID 21281269].
2. Kim HY, et al. A synaptogenic amide N-
docosahexaenoylethanolamide promotes hippocampal development.
Prostaglandins Other Lipid Mediat. 2011 Nov;96(1-4):114-20. [PMID
21810478].
3. Cao D, et al. Docosahexaenoic acid promotes hippocampal neuronal
development and synaptic function. J Neurochem. 2009 Oct;111(2):510-21.
[PMID 19682204].
Intellectual Property: HHS Reference No. E-070-2012/0 -- U.S.
Provisional Application No. 61/624,741 filed 16 Apr 2012.
Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; vepas@mail.nih.gov.
Collaborative Research Opportunity: The National Center for
Advancing Translational Sciences is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize this technology. For collaboration
opportunities, please contact Dr. Juan Marugan at maruganj@mail.nih.gov
or Dr. Krishna Balakrishnan at balakrik@mail.nih.gov.
High-Affinity Rabbit Monoclonal Antibodies to Mesothelin for Treatment
of Cancer
Description of Technology: Mesothelin is a cell surface protein
that is highly expressed in aggressive cancers, such as malignant
mesothelioma, ovarian cancer and pancreatic cancer. Because of this
selective expression, mesothelin is an
[[Page 6121]]
excellent candidate for targeted therapeutics, such as monoclonal
antibodies (mAbs) and chimeric molecules. Current anti-mesothelin
therapeutic mAb candidates bind to an epitope in Region I of
mesothelin. Unfortunately, Region I contains the interaction site
MUC16/CA125, a mesothelin-interacting protein that is present in the
serum of patients with mesothelin-related cancers. Because the current
therapeutic mAb candidates must compete with MUC16/CA125 for binding to
mesothelin, they may not reach their full therapeutic potential due to
interference.
In order to address this concern, NIH inventors generated several
rabbit mAbs that recognize unique epitopes of mesothelin: (1) YP223,
which recognizes region II; (2) YYP218, which recognizes region III;
and (3) YP3 which recognizes a native conformation epitope of
mesothelin. These mAbs bind to mesothelin with sub-nanomolar affinity
and are not out-competed for binding by the current anti-mesothelin
therapeutic mAb candidates or MUC16/CA125. This strong binding affinity
for an alternative binding site on mesothelin suggests that these mAbs
are excellent therapeutic candidates.
Potential Commercial Applications:
Therapeutic use, such as treatment of mesothelin-
expressing cancers as a stand-alone mAbs or as a mAb-drug conjugate
(e.g., an immunotoxin).
Diagnosis of mesothelin-expressing cancers.
Antibody-related research use, including
immunoprecipitation, western blot analysis, immunohistochemistry,
ELISA, etc.
Competitive Advantages:
Binding of new epitope on mesothelin may improve
therapeutic applications due to non-competition from serum proteins.
High binding affinity (sub-nanomolar levels) also
increases chances of binding and subsequent therapeutic activity.
Development Stage:
Early-stage.
In vitro data available.
Inventors: Mitchell Ho et al. (NCI).
Publication: Ho M. Advances in liver cancer antibody therapies: A
focus on glypican-3 and mesothelin. BioDrugs. 2011 Oct 1;25(5):275-84.
doi: 10.2165/11595360-000000000-00000. [PMID 21942912].
Intellectual Property: HHS Reference No. E-198-2012/0--U.S.
Provisional Patent Application No. 61/691,719 filed 21 Aug 2012.
Related Technologies:
HHS Reference No. E-021-1998/0--U.S. Patent 6,809,184
issued 26 Oct 2004.
HHS Reference No. E-139-1999/0--U.S. Patent 7,081,518
issued 25 Jul 2006.
HHS Reference No. E-091-2009/0--U.S. Patent Publication US
20120107933.
Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity: The NCI Laboratory of Molecular
Biology is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate or
commercialize new monoclonal antibodies to unique domains of mesothelin
for cancer therapy or diagnostics. For collaboration opportunities,
please contact John Hewes, Ph.D. at hewesj@mail.nih.gov.
Single Domain Human Monoclonal Antibodies to Mesothelin for Treatment
of Cancer
Description of Technology: Mesothelin is a cell surface protein
that is highly expressed in aggressive cancers such as malignant
mesothelioma, ovarian cancer and pancreatic cancer. This selective
expression makes mesothelin an excellent candidate for targeted
therapeutics such as monoclonal antibodies (mAbs) and corresponding
chimeric molecules. Unfortunately, current anti-mesothelin mAb
candidates have drawbacks, such as competition with a serum protein
(MUC16/CA125) for binding to mesothelin, the formation of neutralizing
antibodies because they are non-human antibodies, and the inability to
trigger complement-dependent cytotoxicity (CDC).
In order to address this concern, NIH inventors generated two
single domain human mAbs: SD1 and SD2. SD1 recognizes a unique epitope
in region III of mesothelin which is not out-competed for binding by
MUC16/CA125. SD1 was also capable of triggering CDC, as well as
antibody-dependent cellular cytotoxicity (ADCC). Due to its human
origin, SD1 is also less likely to elicit the formation of neutralizing
antibodies when administered to patients. Each of these characteristics
suggests SD1 may be an effective therapeutic agent. Indeed, SD1 was
able to inhibit tumor growth in mouse xenograft models, and
corresponding immunotoxins were able to inhibit tumor cell growth in
vitro, supporting the use of SD1 as a therapeutic mAb.
Potential Commercial Applications:
Therapeutic use, such as treatment of mesothelin-
expressing cancers as a stand-alone mAbs or as a mAb-drug conjugate
(e.g., an immunotoxin).
Diagnosis of mesothelin-expressing cancers.
Antibody-related research use, including
immunoprecipitation, western blot analysis, immunohistochemistry,
ELISA, etc.
Competitive Advantages:
Binding of a new epitope on mesothelin may improve
therapeutic applications due to non-competition from serum proteins.
Human origin may significantly limit the formation of
neutralizing antibodies, thereby increasing therapeutic potential of
the mAb.
Ability to trigger both CDC and ADCC may elicit a more
complete therapeutic response.
Development Stage:
Early-stage.
In vitro data available.
In vivo data available (animal).
Inventors: Mitchell Ho et al. (NCI).
Publication: Ho M. Advances in liver cancer antibody therapies: A
focus on glypican-3 and mesothelin. BioDrugs. 2011 Oct 1;25(5):275-84.
doi: 10.2165/11595360-000000000-00000. [PMID 21942912]
Intellectual Property: HHS Reference No. E-236-2012/0--U.S.
Provisional Patent Application No. 61/706,396 filed 27 Sep 2012
Related Technologies:
HHS Reference No. E-021-1998/0--U.S. Patent 6,809,184
issued 26 Oct 2004.
HHS Reference No. E-139-1999/0--U.S. Patent 7,081,518
issued 25 Jul 2006.
HHS Reference No. E-091-2009/0--U.S. Patent Publication US
20120107933.
Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity: The NCI Laboratory of Molecular
Biology is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate or
commercialize single-domain human antibodies (SD1 and SD2) to
mesothelin for cancer therapy or diagnostics. For collaboration
opportunities, please contact John Hewes, Ph.D. at hewesj@mail.nih.gov.
Dated: January 23, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-01789 Filed 1-28-13; 8:45 am]
BILLING CODE 4140-01-P
