Government-Owned Inventions; Availability for Licensing, 3834-3836 [2014-01186]
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3834
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
hour burden
FY 2014
Clinical Center Patients ...................................................................................
Family Members of Patients ............................................................................
Visitors to the Clinical Center ..........................................................................
NIH Intramural Collaborators ...........................................................................
Vendors and Collaborating Commercial Enterprises ......................................
Professionals and Organizations Referring Patients .......................................
Regulators ........................................................................................................
Volunteers ........................................................................................................
5000
2000
500
2000
500
2000
30
275
1
1
1
1
1
1
1
1
30/60
30/60
10/60
10/60
20/60
20/60
20/60
30/60
2500
1000
84
334
167
667
10
138
5000
2000
500
2000
500
2000
30
275
1
1
1
1
1
1
1
1
30/60
30/60
10/60
10/60
20/60
20/60
20/60
30/60
2500
1000
84
334
167
667
10
138
5000
2000
500
2000
500
2000
30
275
1
1
1
1
1
1
1
1
30/60
30/60
10/60
10/60
20/60
20/60
20/60
30/60
2500
1000
84
334
167
667
10
138
FY 2015
Clinical Center Patients ...................................................................................
Family Members of Patients ............................................................................
Visitors to the Clinical Center ..........................................................................
NIH Intramural Collaborators ...........................................................................
Vendors and Collaborating Commercial Enterprises ......................................
Professionals and Organizations Referring Patients .......................................
Regulators ........................................................................................................
Volunteers ........................................................................................................
FY 2016
Clinical Center Patients ...................................................................................
Family Members of Patients ............................................................................
Visitors to the Clinical Center ..........................................................................
NIH Intramural Collaborators ...........................................................................
Vendors and Collaborating Commercial Enterprises ......................................
Professionals and Organizations Referring Patients .......................................
Regulators ........................................................................................................
Volunteers ........................................................................................................
Dated: January 14, 2014.
David K. Henderson,
Deputy Director for Clinical Care, CC,
National Institutes of Health.
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.
[FR Doc. 2014–01343 Filed 1–22–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
Improved Therapeutic Immunotoxins
National Institutes of Health,
HHS.
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. 209 and 37 CFR part 404 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.
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
21:50 Jan 22, 2014
Jkt 232001
Description of Technology:
Immunotoxins kill cancer cells while
allowing healthy, essential cells to
survive. As a result, patients receiving
immunotoxins are less likely to
experience the deleterious side-effects
associated with non-discriminate
therapies, such as chemotherapy or
radiation therapy. Unfortunately, the
continued administration of
immunotoxins often leads to a reduced
patient response due to the formation of
neutralizing antibodies against
immunogenic epitopes contained within
the toxin. One such toxin is
Pseudomonas exotoxin A (PE). To
improve the therapeutic effectiveness of
PO 00000
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Fmt 4703
Sfmt 4703
PE-based immunotoxins through
multiple rounds of drug administration,
NIH inventors previously reduced the
immunogenicity of PE through the
removal of B-cell and T-cell epitopes by
mutation or deletion. Although this
resulted in immunotoxins with
improved therapeutic activity, the
modifications to reduce
immunogenicity decreased the activity
of PE. Through further specific
modification, the inventors have now
created a PE that has reduced
immunogenicity with limited loss of
activity. The resulting PE-based
immunotoxins have increased resistance
to the formation of neutralizing
antibodies, while retaining greater
activity, and are expected to have
improved therapeutic efficacy.
Potential Commercial Applications:
• Essential payload component of
immunotoxins
• Treatment of any disease associated
with increased or preferential
expression of a specific cell surface
receptor
• Specific diseases include
hematological cancers, lung cancer,
ovarian cancer, breast cancer, and head
and neck cancers
Competitive Advantages:
E:\FR\FM\23JAN1.SGM
23JAN1
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
• New modifications allow for the
reduction of immunogenicity with less
loss of activity
• Less immunogenic immunotoxins
with greater activity results in improved
therapeutic efficacy by permitting
multiple rounds of administration in
humans
• Targeted therapy decreases nonspecific killing of healthy, essential
cells, resulting in fewer non-specific
side-effects and healthier patients
Development Stage:
• Early-stage
• In vitro data available
• In vivo data available (animal)
Inventors: Ira H. Pastan et al. (NCI)
Intellectual Property:
• HHS Reference No. E–771–2013/
0—U.S. Provisional Patent Application
No. 61/887,418 filed 06 October 2013
• HHS Reference No. E–771–2013/
1—U.S. Provisional Patent Application
No. 61/908,464 filed 25 November 2013
Related Technologies:
• HHS Reference No. E–117–2011/
0—PCT Patent Publication WO 2012/
154530
• HHS Reference No. E–174–2011/
0—PCT Patent Publication WO 2012/
170617
• HHS Reference No. E–263–2011/
0—PCT Patent Publication WO 2012/
032022
• HHS Reference No. E–269–2009/
0—US Patent Publication 20120263674
A1
• HHS Reference No. E–292–2007/
0—US Patent Publication US
20100215656 A1
• HHS Reference No. E–262–2005/
0—US Patent Publication US
20090142341 A1
• Multiple additional patent families
Licensing Contact: David A.
Lambertson, Ph.D.; 301–435–4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute, Center for
Cancer Research, Laboratory of
Molecular Biology, is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize a new immunotoxin
target. For collaboration opportunities,
please contact John D. Hewes, Ph.D., at
hewesj@mail.nih.gov.
sroberts on DSK5SPTVN1PROD with NOTICES
Respiratory Syncytial Virus Vaccines
Based on G Protein Subunit
Description of Technology: The
invention pertains to cross-neutralizing
vaccines against human respiratory
syncytial virus subtypes A and B
employing immunogenic G protein
subunit and fragments thereof that are
preferably derived from the ectodomain.
Various candidate G protein subunits
VerDate Mar<15>2010
21:50 Jan 22, 2014
Jkt 232001
are provided spanning amino acid
sequence 67–298 of RSV G protein and
combinations thereof. Also envisioned
within the scope of this invention are
tandem repeated recombinant G protein
subunit vaccines that provide higher
immunogenicity. Recombinant G
protein can be codon optimized for
expression in various hosts (e.g.,
mammalian cells or E. coli).
Potential Commercial Applications:
• Vaccine
• Childhood vaccines
Competitive Advantages: Cross
neutralizing
Development Stage:
• Early-stage
• In vitro data available
Inventors: Surender Khurana and
Hana Golding (FDA)
Intellectual Property: HHS Reference
No. E–735–2013/0—U.S. Provisional
Patent Application No. 61/863,100 filed
02 December 2013
Licensing Contact: Michael
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov
Collaborative Research Opportunity:
The Food and Drug Administration,
Center for Biologics Evaluation and
Research, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize RSV G protein subunit
vaccine. For collaboration
opportunities, please contact Surender
Khurana, Ph.D., at 301–827–0739.
Pyrrole Derivative Inhibitors of Wip1
for the Treatment of Cancer
Description of Technology: Wild-type
p53-induced phosphatase 1 (Wip1) is an
enzyme that is overexpressed in a
number of human cancers, including
breast cancer, neuroblastoma and
ovarian cancer. Wip1 has a suppressive
effect on the tumor suppressor p53,
allowing the unregulated growth that is
associated with tumors. Inhibiting Wip1
could restore the tumor suppressor
activity of p53, leading to the arrest of
unregulated tumor growth and
induction of apoptosis. This suggests
that inhibitors of Wip1 could be of
therapeutic value for the treatment of
cancer.
This invention concerns novel small
molecules that can inhibit Wip1
activity. The particular structure of the
small molecules allows for specific
targeting to Wip1. Specifically, the
structure is a derivative of a pyrrole ring
having five (5) points of substitution.
These small molecules have the ability
to significantly inhibit Wip1
phosphatase activity at the micromolar
level, with substitutions of biphenyl
groups having the highest level of
PO 00000
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Fmt 4703
Sfmt 4703
3835
inhibition. Based on their potential
ability to restore the activity of a tumor
suppressor protein and activate
apoptosis, these small molecules may be
useful in the treatment of cancers that
overexpress Wip1.
Potential Commercial Applications:
• Treatment of cancer, including but
not limited to breast cancer, ovarian
cancer and neuroblastoma
• Can be used either alone or in
combination with other known anticancer therapeutics
Competitive Advantages:
• Structure of the inhibitor allows
specific targeting of Wip1, possibly
leading to fewer undesired effects
during treatment
• The molecules are designed to be
more stable and effectively penetrate
mammalian cells
• The current lack of Wip1 inhibitors
can lead the occupation of a significant
position in the cancer therapeutic
market with a first-in-class drug
Development Stage: Early-stage
Inventors: Daniel H. Appella et al.
(NIDDK)
Publication: Hayashi R, et al.
Optimization of a cyclic peptide
inhibitor of Ser/Thr phosphatase
PPM1D (Wip1). Biochemistry. 2011 May
31;50(21):4537–49. [PMID 21528848]
Intellectual Property: HHS Reference
No. E–537–2013/0—U.S. Provisional
Patent Application No. 61/865,845 filed
14 August 2013
Related Technology: HHS Reference
No. E–302–2007/0—US Patent
Application No. 12/675,167 filed 25
February 2010
Licensing Contact: David A.
Lambertson, Ph.D.; 301–435–4632;
lambertsond@mail.nih.gov
Methods of Treating or Preventing
Pruritis (Itch)
Description of Technology: This
technology provides a novel method of
treating or preventing pruritis (itch)
using natriuretic polypeptide b (Nppb)
blocking agents. Itch (also known as
pruritis) is a sensation that may be
perceived as an unpleasant skin
irritation and may drive an urge to
scratch. Conditions such as, for
example, psoriasis, atopic dermatitis,
renal failure, liver cirrhosis and some
cancers may cause persistent itch. Itch
is triggered by somatosensory neurons
expressing the ion channel TRPV1
(transient receptor potential cation
channel subfamily V member 1). The
inventors of this technology show that
the Nppb is expressed in a subset of
TRPV1 neurons and found that Nppb–
/– mice selectively lose all behavioral
responses to itch-inducing agents. Nppb
triggered potent scratching when
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23JAN1
3836
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
injected intrathecally in wild-type and
Nppb–/– mice. Itch responses were
blocked by toxin-mediated ablation of
Nppb-receptor-expressing cells, but a
second neuropeptide, gastrin-releasing
peptide, still induced strong responses
in the toxin-treated animals.
Potential Commercial Applications:
• Therapeutics for preventing or
treating pruritis/itching.
• Screening of novel Nppb blocking
agents.
Competitive Advantages: A new mode
of treating itch and itch induced
conditions using selective Nppb
antagonists.
Development Stage:
• Early-stage
• In vitro data available
Inventors: Mark A. Hoon and Santosh
K. Mishra (NIDCR)
Publication: Mishra SK, Hoon MA.
The cells and circuitry for itch
responses in mice. Science. 2013 May
24;340(6135):968–71. [PMID 23704570]
Intellectual Property: HHS Reference
No. E–485–2013/0—U.S. Provisional
Patent Application No. 61/912,334 filed
05 December 2013
Licensing Contact: Suryanarayana
(Sury) Vepa, Ph.D., J.D.; 301–435–5020;
vepas@mail.nih.gov
Recombinant Stabilized Prefusion
Protein of Respiratory Syncytial Virus
for Use as a Subunit Vaccine
Description of Technology: The
invention, a stabilized recombinant
prefusion F protein (pre F), is a
candidate subunit vaccine for
Respiratory Syncytial Virus (RSV). PreF is stabilized in the prefusion
conformation and displays epitopes not
present in postfusion F protein. Several
potent RSV neutralizing antibodies bind
pre F, but not postfusion F. Therefore,
immunization with pre F may elicit an
immune response superior to the
response generated by postfusion F.
NIH researchers have engineered pre
F to expose an antigenic site 0, which
is targeted by extremely potent RSV
neutralizing antibodies. Structure-based
design yielded several stabilized
variants of pre F that maintained
exposure of antigenic site 0 when
subjected to extremes of pH, osmolality
and temperature.
Preclinical in vivo data on stabilized
pre F is available. Immunization of mice
and macaques with antigenic site 0
stabilized pre F variants elicited high
levels of RSV specific neutralizing
activity.
Potential Commercial Applications:
Vaccine for Respiratory Syncytial Virus
Competitive Advantages:
• Vaccine stably exposes antigenic
site in RSV F that permits generation of
potent RSV neutralizing antibodies.
VerDate Mar<15>2010
21:50 Jan 22, 2014
Jkt 232001
• There is currently no RSV vaccine
on the market.
Development Stage:
• Pre-clinical
• In vivo data available (animal)
Inventors: Jason S. McLellan, Barney
S. Graham, Peter D. Kwong (all of VRC/
NIAID)
Publications:
1. McLellan JS, et al. Structure of RSV
fusion glycoprotein trimer bound to a
prefusion-specific neutralizing
antibody. Science 2013 May
31;340(6136):1113–7. [PMID 23618766]
2. McLellan JS, et al. Structure-based
design of a fusion glycoprotein vaccine
for respiratory syncytial virus. Science
2013 Nov 1:342 (6158)592–8. [PMID
24179220]
Intellectual Property:
• HHS Reference No. E–081–2013/
0—U.S. Application No. 61/780,910
filed 13 March 2013
• HHS Reference No. E–081–2013/
1—U.S. Application No. 61/798,389
filed 15 March 2013
• HHS Reference No. E–081–2013/
2—U.S. Application No. 61/857,613
filed 23 July 2013
• HHS Reference No. E–081–2013/
3—U.S. Application No. 61/863,909
filed 09 August 2013
Licensing Contact: Cristina
Thalhammer-Reyero, Ph.D., M.B.A.;
301–435–4507; ThalhamC@
mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases, Vaccine Research
Center, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize an RSV vaccine based on
pre F, a stabilized recombinant RSV F
protein. For collaboration opportunities,
please contact Rosemary C. Walsh,
Ph.D. at 301–541–3528 or rcwalsh@
niaid.nih.gov.
Dated: January 16, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–01186 Filed 1–22–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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.
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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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Hypersensitivity, Autoimmune, and Immunemediated Disease Overflow.
Date: February 7, 2014.
Time: 8:00 a.m. to 11:30 a.m.
Agenda: To review and evaluate grant
applications.
Place: The Westin St. Francis, 335 Powell
Street, San Francisco, CA 94102.
Contact Person: Jin Huang, PhD., Scientific
Review Administrator, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 4095G, MSC 7812,
Bethesda, MD 20892, 301–435–1187,
jh377p@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Liver and Gastrointestinal
Physiology & Pathophysiology.
Date: February 11, 2014.
Time: 1:30 p.m. to 5:00 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: Martha Garcia, PhD.,
Scientific Reviewer Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2186,
Bethesda, MD 20892, 301–435–1243,
garciamc@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Molecular
Neuroscience.
Date: February 13, 2014.
Time: 1:00 p.m. to 3:00 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: Laurent Taupenot, PhD.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4811,
MSC 7850, Bethesda, MD 20892, 301–435–
1203, taupenol@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Developmental Brain Disorders Study
Section.
Date: February 20–21, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: Hilton Woodland Hills/Los Angeles,
6360 Canoga Avenue, Woodlands Hills, CA
91367.
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3834-3836]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01186]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, 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. 209 and 37 CFR part 404 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.
Improved Therapeutic Immunotoxins
Description of Technology: Immunotoxins kill cancer cells while
allowing healthy, essential cells to survive. As a result, patients
receiving immunotoxins are less likely to experience the deleterious
side-effects associated with non-discriminate therapies, such as
chemotherapy or radiation therapy. Unfortunately, the continued
administration of immunotoxins often leads to a reduced patient
response due to the formation of neutralizing antibodies against
immunogenic epitopes contained within the toxin. One such toxin is
Pseudomonas exotoxin A (PE). To improve the therapeutic effectiveness
of PE-based immunotoxins through multiple rounds of drug
administration, NIH inventors previously reduced the immunogenicity of
PE through the removal of B-cell and T-cell epitopes by mutation or
deletion. Although this resulted in immunotoxins with improved
therapeutic activity, the modifications to reduce immunogenicity
decreased the activity of PE. Through further specific modification,
the inventors have now created a PE that has reduced immunogenicity
with limited loss of activity. The resulting PE-based immunotoxins have
increased resistance to the formation of neutralizing antibodies, while
retaining greater activity, and are expected to have improved
therapeutic efficacy.
Potential Commercial Applications:
Essential payload component of immunotoxins
Treatment of any disease associated with increased or
preferential expression of a specific cell surface receptor
Specific diseases include hematological cancers, lung
cancer, ovarian cancer, breast cancer, and head and neck cancers
Competitive Advantages:
[[Page 3835]]
New modifications allow for the reduction of
immunogenicity with less loss of activity
Less immunogenic immunotoxins with greater activity
results in improved therapeutic efficacy by permitting multiple rounds
of administration in humans
Targeted therapy decreases non-specific killing of
healthy, essential cells, resulting in fewer non-specific side-effects
and healthier patients
Development Stage:
Early-stage
In vitro data available
In vivo data available (animal)
Inventors: Ira H. Pastan et al. (NCI)
Intellectual Property:
HHS Reference No. E-771-2013/0--U.S. Provisional Patent
Application No. 61/887,418 filed 06 October 2013
HHS Reference No. E-771-2013/1--U.S. Provisional Patent
Application No. 61/908,464 filed 25 November 2013
Related Technologies:
HHS Reference No. E-117-2011/0--PCT Patent Publication WO
2012/154530
HHS Reference No. E-174-2011/0--PCT Patent Publication WO
2012/170617
HHS Reference No. E-263-2011/0--PCT Patent Publication WO
2012/032022
HHS Reference No. E-269-2009/0--US Patent Publication
20120263674 A1
HHS Reference No. E-292-2007/0--US Patent Publication US
20100215656 A1
HHS Reference No. E-262-2005/0--US Patent Publication US
20090142341 A1
Multiple additional patent families
Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Center for Cancer Research, Laboratory of Molecular Biology, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize a
new immunotoxin target. For collaboration opportunities, please contact
John D. Hewes, Ph.D., at hewesj@mail.nih.gov.
Respiratory Syncytial Virus Vaccines Based on G Protein Subunit
Description of Technology: The invention pertains to cross-
neutralizing vaccines against human respiratory syncytial virus
subtypes A and B employing immunogenic G protein subunit and fragments
thereof that are preferably derived from the ectodomain. Various
candidate G protein subunits are provided spanning amino acid sequence
67-298 of RSV G protein and combinations thereof. Also envisioned
within the scope of this invention are tandem repeated recombinant G
protein subunit vaccines that provide higher immunogenicity.
Recombinant G protein can be codon optimized for expression in various
hosts (e.g., mammalian cells or E. coli).
Potential Commercial Applications:
Vaccine
Childhood vaccines
Competitive Advantages: Cross neutralizing
Development Stage:
Early-stage
In vitro data available
Inventors: Surender Khurana and Hana Golding (FDA)
Intellectual Property: HHS Reference No. E-735-2013/0--U.S.
Provisional Patent Application No. 61/863,100 filed 02 December 2013
Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov
Collaborative Research Opportunity: The Food and Drug
Administration, Center for Biologics Evaluation and Research, is
seeking statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize
RSV G protein subunit vaccine. For collaboration opportunities, please
contact Surender Khurana, Ph.D., at 301-827-0739.
Pyrrole Derivative Inhibitors of Wip1 for the Treatment of Cancer
Description of Technology: Wild-type p53-induced phosphatase 1
(Wip1) is an enzyme that is overexpressed in a number of human cancers,
including breast cancer, neuroblastoma and ovarian cancer. Wip1 has a
suppressive effect on the tumor suppressor p53, allowing the
unregulated growth that is associated with tumors. Inhibiting Wip1
could restore the tumor suppressor activity of p53, leading to the
arrest of unregulated tumor growth and induction of apoptosis. This
suggests that inhibitors of Wip1 could be of therapeutic value for the
treatment of cancer.
This invention concerns novel small molecules that can inhibit Wip1
activity. The particular structure of the small molecules allows for
specific targeting to Wip1. Specifically, the structure is a derivative
of a pyrrole ring having five (5) points of substitution. These small
molecules have the ability to significantly inhibit Wip1 phosphatase
activity at the micromolar level, with substitutions of biphenyl groups
having the highest level of inhibition. Based on their potential
ability to restore the activity of a tumor suppressor protein and
activate apoptosis, these small molecules may be useful in the
treatment of cancers that overexpress Wip1.
Potential Commercial Applications:
Treatment of cancer, including but not limited to breast
cancer, ovarian cancer and neuroblastoma
Can be used either alone or in combination with other
known anti-cancer therapeutics
Competitive Advantages:
Structure of the inhibitor allows specific targeting of
Wip1, possibly leading to fewer undesired effects during treatment
The molecules are designed to be more stable and
effectively penetrate mammalian cells
The current lack of Wip1 inhibitors can lead the
occupation of a significant position in the cancer therapeutic market
with a first-in-class drug
Development Stage: Early-stage
Inventors: Daniel H. Appella et al. (NIDDK)
Publication: Hayashi R, et al. Optimization of a cyclic peptide
inhibitor of Ser/Thr phosphatase PPM1D (Wip1). Biochemistry. 2011 May
31;50(21):4537-49. [PMID 21528848]
Intellectual Property: HHS Reference No. E-537-2013/0--U.S.
Provisional Patent Application No. 61/865,845 filed 14 August 2013
Related Technology: HHS Reference No. E-302-2007/0--US Patent
Application No. 12/675,167 filed 25 February 2010
Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632;
lambertsond@mail.nih.gov
Methods of Treating or Preventing Pruritis (Itch)
Description of Technology: This technology provides a novel method
of treating or preventing pruritis (itch) using natriuretic polypeptide
b (Nppb) blocking agents. Itch (also known as pruritis) is a sensation
that may be perceived as an unpleasant skin irritation and may drive an
urge to scratch. Conditions such as, for example, psoriasis, atopic
dermatitis, renal failure, liver cirrhosis and some cancers may cause
persistent itch. Itch is triggered by somatosensory neurons expressing
the ion channel TRPV1 (transient receptor potential cation channel
subfamily V member 1). The inventors of this technology show that the
Nppb is expressed in a subset of TRPV1 neurons and found that Nppb-/-
mice selectively lose all behavioral responses to itch-inducing agents.
Nppb triggered potent scratching when
[[Page 3836]]
injected intrathecally in wild-type and Nppb-/- mice. Itch responses
were blocked by toxin-mediated ablation of Nppb-receptor-expressing
cells, but a second neuropeptide, gastrin-releasing peptide, still
induced strong responses in the toxin-treated animals.
Potential Commercial Applications:
Therapeutics for preventing or treating pruritis/itching.
Screening of novel Nppb blocking agents.
Competitive Advantages: A new mode of treating itch and itch
induced conditions using selective Nppb antagonists.
Development Stage:
Early-stage
In vitro data available
Inventors: Mark A. Hoon and Santosh K. Mishra (NIDCR)
Publication: Mishra SK, Hoon MA. The cells and circuitry for itch
responses in mice. Science. 2013 May 24;340(6135):968-71. [PMID
23704570]
Intellectual Property: HHS Reference No. E-485-2013/0--U.S.
Provisional Patent Application No. 61/912,334 filed 05 December 2013
Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; vepas@mail.nih.gov
Recombinant Stabilized Prefusion Protein of Respiratory Syncytial Virus
for Use as a Subunit Vaccine
Description of Technology: The invention, a stabilized recombinant
prefusion F protein (pre F), is a candidate subunit vaccine for
Respiratory Syncytial Virus (RSV). Pre-F is stabilized in the prefusion
conformation and displays epitopes not present in postfusion F protein.
Several potent RSV neutralizing antibodies bind pre F, but not
postfusion F. Therefore, immunization with pre F may elicit an immune
response superior to the response generated by postfusion F.
NIH researchers have engineered pre F to expose an antigenic site
0, which is targeted by extremely potent RSV neutralizing antibodies.
Structure-based design yielded several stabilized variants of pre F
that maintained exposure of antigenic site 0 when subjected to extremes
of pH, osmolality and temperature.
Preclinical in vivo data on stabilized pre F is available.
Immunization of mice and macaques with antigenic site 0 stabilized pre
F variants elicited high levels of RSV specific neutralizing activity.
Potential Commercial Applications: Vaccine for Respiratory
Syncytial Virus
Competitive Advantages:
Vaccine stably exposes antigenic site in RSV F that
permits generation of potent RSV neutralizing antibodies.
There is currently no RSV vaccine on the market.
Development Stage:
Pre-clinical
In vivo data available (animal)
Inventors: Jason S. McLellan, Barney S. Graham, Peter D. Kwong (all
of VRC/NIAID)
Publications:
1. McLellan JS, et al. Structure of RSV fusion glycoprotein trimer
bound to a prefusion-specific neutralizing antibody. Science 2013 May
31;340(6136):1113-7. [PMID 23618766]
2. McLellan JS, et al. Structure-based design of a fusion
glycoprotein vaccine for respiratory syncytial virus. Science 2013 Nov
1:342 (6158)592-8. [PMID 24179220]
Intellectual Property:
HHS Reference No. E-081-2013/0--U.S. Application No. 61/
780,910 filed 13 March 2013
HHS Reference No. E-081-2013/1--U.S. Application No. 61/
798,389 filed 15 March 2013
HHS Reference No. E-081-2013/2--U.S. Application No. 61/
857,613 filed 23 July 2013
HHS Reference No. E-081-2013/3--U.S. Application No. 61/
863,909 filed 09 August 2013
Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-
435-4507; ThalhamC@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Allergy and Infectious Diseases, Vaccine Research Center, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize an
RSV vaccine based on pre F, a stabilized recombinant RSV F protein. For
collaboration opportunities, please contact Rosemary C. Walsh, Ph.D. at
301-541-3528 or rcwalsh@niaid.nih.gov.
Dated: January 16, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-01186 Filed 1-22-14; 8:45 am]
BILLING CODE 4140-01-P
