Government-Owned Inventions; Availability for Licensing, 21936-21938 [2014-08881]
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21936
Federal Register / Vol. 79, No. 75 / Friday, April 18, 2014 / Notices
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project contact: Dr. David Thomas,
Director of the NIH Centers of
Excellence in Pain Education Program,
National Institute on Drug Abuse, 6001
Executive Blvd., Room 3165, Rockville,
MD 20852, or call non-toll free number
(301) 435–1313, or Email your request,
including your address to:
dthomas1@nida.nih.gov. Formal
requests for additional plans and
tailored to its specific courses, therefore
a generic clearance is requested.
Different methods of assessment will be
used.
Data collection methods to be used in
these studies include multiple choice
questions pre- and post-training for each
learner group; Information collected
from patient charts (of patients treated
by learners after training); Reflective
essays from students on effect of
training on their knowledge; Post Test
questionnaires and interviews of
learners, and or instructors, to examine
satisfaction with quality of content,
quality of instructional methods,
usability; Invited expert review, formal
peer review; Questionnaires at
workshops on quality of content, quality
of educational methods, usability of
technology; Telephone and in-person
surveys; Focus groups and individual
in-depth unstructured interviews. The
results from the evaluations will be used
to (1) improve the courses; (2) identify
the best courses and platforms for
teaching pain management to various
care providers; and for the subsequent
evaluation of the overall Program that
the NIH will conduct to assess its
impact.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
2200.
instruments must be requested in
writing.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60-days of the date of
this publication.
Proposed Collection: Evaluations of
the Clinical Courses Developed at the
National Institutes of Health Centers of
Excellence in Pain Education, 0925New, National Institute on Drug Abuse
(NIDA), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The NIH Centers on Pain
Education were funded to develop
clinical training courses for pain
management curricula that will advance
the assessment, diagnosis, and safe
treatment of a wide variety of pain
conditions while minimizing the abuse
of opioid pain relievers. These courses
have been developed and assessed for
feasibility, reliability, content validity,
at their respective Centers. They need to
be assessed for effectiveness in teaching
and learning, to make improvements to
them, before they are made available for
the public. Course development was
conducted independently by each
Center, and followed the policies and
practices of the teaching institutions,
and the emphases that each institution
may place on training. Each Center will
need information collection instruments
DATES:
ESTIMATED ANNUALIZED BURDEN HOURS
Average time
per response
(in hours)
Type of
respondent
In-person and electronic surveys
pre-test.
In-person and electronic surveys
post-test.
Reflective essays ..............................
Electronic surveys—second post-test
Focus Groups and Individual indepth interviews.
Telephone surveys Practitioners
using the e-curricula resources.
Adults trained in the courses ...........
2400
1
15/60
600
Adults trained in the courses ...........
2400
1
15/60
600
Adults trained in the courses ...........
Adults trained in the courses ...........
Adults ...............................................
200
1200
200
1
1
1
1
15/60
2
200
300
400
Adults ...............................................
200
1
30/60
100
Dated: April 11, 2014.
Glenda J. Conroy,
Executive Officer (OM Director), NIDA, NIH.
[FR Doc. 2014–08907 Filed 4–17–14; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
BILLING CODE 4140–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES
Number of
respondents
Number of
responses per
respondent
Form name (data collection activity)
AGENCY:
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
SUMMARY:
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Total annual
burden hour
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
E:\FR\FM\18APN1.SGM
18APN1
Federal Register / Vol. 79, No. 75 / Friday, April 18, 2014 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
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.
Compositions for Modification of
Genomic DNA and Exogenous Gene
Expression
Description of Technology: A novel
method of targeted insertion of
transgenes at CLYBL locus directly in
human cells is disclosed. Also, methods
and compositions for increasing targeted
insertion of a transgene into a specific
location within the cell or increasing the
frequency of gene modification in a
targeted locus are disclosed. Genome
modification by precise gene targeting at
specific sequence/locus has great
advantages over conventional transient
expression or random integration
methodologies and, therefore, has
tremendous therapeutic potential. NIH
investigators identified CLYBL gene in
Chromosome 13 as a potential safe
harbor locus. To directly target CLYBL
safe-harbor in human cells without preengineering, they identified a unique
transcription activator-like effector
nuclease (TALEN) target sequence at
CLYBL locus. The CLYBL TALENs (also
termed as C13 TALENs) constructed
using pZT backbone showed high gene
editing efficiency in human 293T cells
measured by both T7E1 mismatch assay
and targeted sequencing. The inventors
have used TALENs to simultaneously
knock-in multiple reporter genes at up
to four alleles of PPP1R12C/AAVS1 and
new CLYBL safe-harbors in human
induced pluripotent stem cells (iPSCs)
and neural stem cells (NSCs). The
engineered safe-harbor knock-in cell
lines maintain robust transgene
expression during iPSC/NSC selfrenewal and differentiation, and CLYBL
locus allowed 10-fold stronger transgene
expression than other loci. NSC lines
engineered by this methodology as well
as constructs and protocols for
evaluation are also available.
Potential Commercial Applications:
• Human stem cell-based gene
therapy.
• Drug screening.
Competitive Advantages: CLYBL safe
harbor on Chromosome 13 allows 5∼10fold stronger transgene expression than
AAVS1 safe harbor, providing an
alternative and potentially better
solution for targeted gene transfer/
knock-in and drug-screening, especially
for weak promoter-driven transgenes.
Development Stage:
• Early-stage.
VerDate Mar<15>2010
16:54 Apr 17, 2014
Jkt 232001
• In vitro data available.
Inventors: Jizhong Zou and Mahendra
S. Rao (NIAMS).
Intellectual Property: HHS Reference
No. E–763–2013/0–US–01—US.
Application No. 61/905,002 filed 15
Nov 2013.
Related Technology: HHS Reference
No. E–762–2013/0–US–01—US.
Application No. 61/904,999 filed 15
Nov 2013.
Licensing Contact: Sury Vepa, Ph.D.,
J.D.; 301–435–5020; vepas@
mail.nih.gov.
Engineering Neural Stem Cells Using
Homologous Recombination
Description of Technology: Methods
for modifying the genome of a Neural
Stem Cell (NSC) are disclosed. Also,
methods for differentiating NSCs into
neurons and glia are described. NSCs
are multipotent, self-renewing cells
found in the central nervous system,
capable of differentiating into neurons
and glia. NSCs can be generated
efficiently from pluripotent stem cells
(PSCs) and have the capacity to
differentiate into any neuronal or glial
cell type of the central nervous system.
Improvements in genome engineering of
NSCs can potentially facilitate cellular
replacement therapies for the treatment
of neurodegenerative disorders.
Recently, NIH investigators have
developed a procedure to efficiently
engineer NSCs through homologous
recombination by introducing TAL
effector nucleases (TALENs) and donor
vectors. They have designed TALENs
that efficiently generate double stranded
breaks at two safe harbor loci (AAVS1
and CLYBL). These TALENs facilitate
homologous recombination without
silencing at these loci. The TALENs
were delivered along with a DNA donor
vector with a ubiquitous promoter
driving expression of a cDNA using a
nucleofector to get high transfection
efficiencies. NSCs modified in this
manner have therapeutic potential in
treating neurodegenerative diseases.
NSC lines engineered by this
methodology as well as constructs and
protocols for evaluation are also
available.
Potential Commercial Applications:
Cellular replacement therapies for
neurodegenerative disorders.
Competitive Advantages:
• The novel methods provide highly
pure engineered NSC populations
which maintain the capacity to selfrenew and differentiate to neurons and
astrocytes suitable for cell replacement
therapies.
• Safe harbor TALEN-mediated
homologous recombination is a highefficiency method to generate targeted
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21937
mini-gene transfer or reporter knock-in
cell lines in both human iPSCs and
NSCs.
Development Stage:
• Early-stage.
• In vitro data available.
Inventors: Nasir S. Malik, Mahendra
S. Rao, Jizhong Zou, Raymond
Funahashi (all of NIAMS).
Intellectual Property: HHS Reference
No. E–762–2013/0–US–01—US.
Application No. 61/904,999 filed 15
Nov 2013.
Related Technology: HHS Reference
No. E–763–2013/0–US–01—US.
Application No. 61/905,002 filed 15
Nov 2013.
Licensing Contact: Sury Vepa, Ph.D.,
J.D.; 301–435–5020; vepas@
mail.nih.gov.
Role of Novel Hepatitis Delta Virus
¨
Variant in Sjogren’s Syndrome
¨
Description of Technology: Sjogren’s
is a chronic autoimmune disease
characterized by dry mouth and eyes,
fatigue, and musculoskeletal pain
resulting from the attack of the
moisture-producing glands by the
body’s own white blood cells. The
subject invention is based on the
discovery of an association between
infection by a novel clade 1 variant of
hepatitis delta virus (HDV) and primary
¨
Sjogren’s syndrome. The association
was made after detection of the HDV
nucleic acid in the salivary glands of
¨
patients diagnosed with Sjogren’s
syndrome and in vivo studies in mice
¨
that developed Sjogren’s syndrome-like
pathogenesis after expression of HDV
antigen. The discovery of this link
opens the possibilities for developing
diagnostics against HDV to determine
¨
who are at risk for developing Sjogren’s
syndrome. The novel HDV variant can
also serve as a potential therapeutic
target for preventing or treating
¨
Sjogren’s.
Potential Commercial Applications:
• Diagnostic for novel HDV clade 1
variant as a risk factor for developing
¨
Sjogren’s.
• Therapeutics against this newly
discovered HDV clade 1 variant for
¨
prevention and/or treatment of Sjogren’s
syndrome.
Competitive Advantages:
• Novel diagnostic for a potentially
significant risk factor in developing
¨
Sjogren’s syndrome.
• Newly discovered potential targets
¨
for treatment of Sjogren’s.
Development Stage:
• Early-stage.
• In vitro data available.
• In vivo data available (animal).
Inventors: Melodie L. Weller and John
Chiorini (NIDCR).
E:\FR\FM\18APN1.SGM
18APN1
21938
Federal Register / Vol. 79, No. 75 / Friday, April 18, 2014 / Notices
Intellectual Property: HHS Reference
No. E–736–2013/0—US Provisional.
Application No. 61/888,706 filed 09 Oct
2013.
Licensing Contact: Kevin W. Chang,
Ph.D.; 301–435–5018; changke@
mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Dental and
Craniofacial Research is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize Role of Novel Hepatitis
Delta Virus Variant. For collaboration
opportunities, please contact David W.
Bradley, Ph.D. at bradleyda@
nidcr.nih.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
Treating or Inhibiting JC Polyomavirus
Infection and JC PolyomavirusAssociated Progressive Multifocal
Leukoencephalopathy
Description of Technology: Available
for licensing are novel findings to
generate immune response to JC
polyomavirus (JCV). An immunogenic
composition with a single JCV subtype
VP1 polypeptide generates neutralizing
antibodies to all JCV subtypes,
including JCV with variant VP1
polypeptides. The invention is useful
for the prevention, treatment, or
inhibition of JCV infection and JCVassociated pathologies, such as
progressive multifocal
leukoencephalopathy (PML).
Also available for licensing are
techniques for identifying a subject at
risk for developing PML, based on
detecting the absence of JCV
neutralizing antibodies in the subject.
Potential Commercial Applications:
• Pharmaceutical treatments of JC
virus infection.
• Pharmaceutical treatments or
prevention of PML.
• Prediction or early diagnosis of the
development of PML.
Competitive Advantages:
• Generating an immune response to
all JC virus subtypes utilizing a JC virus
capsid polypeptide from a single
subtype.
• No known methods for identifying
a subject at risk for developing PML by
detecting the absence of JC virus
neutralizing antibodies in the subject.
Development Stage:
• Early-stage.
• In vitro data available.
• In vivo data available (animal).
• In vivo data available (human).
Inventors: Christopher B. Buck (NCI),
Upasana Ray (NCI), and Diana V.
Pastrana.
Publication: Buck CB. Developing
vaccines against BKV and JCV.
Presentation, 5th International
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Jkt 232001
Conference on Polyomaviruses and
Human Diseases: Basic and Clinical
Perspectives, Stresa, Italy, May 9–11,
2013. Abstract published online in June
2013 in J Neurovirol. 2013;19:307. [DOI
10.1007/s13365–013–0171–0].
Intellectual Property: HHS Reference
No. E–549–2013/0—US Provisional.
Application No. 61/919,043 filed 20 Dec
2013.
Licensing Contact: Patrick McCue,
Ph.D.; 301–435–5560; mccuepat@
mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute,
Laboratory of Cellular Oncology, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate or commercialize
methods of treating JC polyomavirusrelated disorders. For collaboration
opportunities, please contact John D.
Hewes, Ph.D. at hewesj@mail.nih.gov.
• Potential for viral and non-viral
gene delivery.
• Potential for Genome Editing
Therapy.
Development Stage:
• Early-stage.
• In vitro data available.
• In vivo data available (animal).
Inventors: Jeffery L. Miller (NIDDK),
Yuanwei T. Lee (NIDDK), Colleen
Byrnes (NIDDK), Jaira Vasconcellos
(NIDDK), Stefan A. Muljo (NIAID).
Publication: Lee YT, et al. LIN28Bmediated expression of fetal hemoglobin
and production of fetal-like erythrocytes
from adult human erythroblasts ex vivo.
Blood. 2013 Aug 8;122(6):1034–41.
[PMID 23798711].
Intellectual Property: HHS Reference
No. E–456–2013/2—International.
Application No. PCT/US2013/067811
filed 31 Oct 2013.
Licensing Contact: Vince Contreras,
Ph.D.; 301–435–4711; contrerasv@
mail.nih.gov.
Therapeutic for Sickle Cell Disease and
Beta Thalassemias
Dated: April 14, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
Description of Technology: Sickle-cell
disease and beta thalassemia are among
the most common hereditary blood
disorders in the world. It has been
shown that patients exhibit less severe
symptoms of these disorders when they
produce unusually high levels of fetal
hemoglobin (HbF). HbF production,
which normally shuts off after birth, has
been considered as a viable treatment
because of inability to form hemoglobin
aggregates within red blood cells
responsible for painful episodes in
patients. Researchers at the National
Institute of Diabetes and Digestive and
Kidney Diseases have identified a
method of regulating the expression of
fetal hemoglobin in adult red blood
cells. The lead inventor and colleagues
have developed novel expression
vectors designed to reactivate
production of HbF proteins through
increased erythroid-specific expression
of Lin28 or decreased expression of Let7 micro-RNAs. This technology could
lead to development of multiple types of
therapeutics that ameliorate or eliminate
the pathologies associated with human
sickle-cell anemia and beta thalassemia.
Potential Commercial Applications:
Ex vivo and in vivo therapeutics for
treatment of sickle-cell anemia and beta
thalassemias.
Competitive Advantages:
• Amplification of HbF expression
10-fold higher than existing methods.
• Reduced production of symptomassociated adult hemoglobin.
• Regulation of Lin28 and Let-7
expression with no immunogenic
effects.
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[FR Doc. 2014–08881 Filed 4–17–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Cancer Institute Clinical Trials
and Translational Research Advisory
Committee.
The meeting will be open to the
public, 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.
Name of Committee: National Cancer
Institute Clinical Trials and Translational
Research Advisory Committee.
Date: July 16, 2014.
Time: 9:00 a.m. to 4:00 p.m.
Agenda: Strategic Discussion of NCI’s
Clinical and Translational Research
Programs.
Place: National Institutes of Health,
Building 31, Room 10, 31 Center Drive,
Bethesda, MD 20892.
Contact Person: Sheila A. Prindiville, MD,
MPH, Director, Coordinating Center for
E:\FR\FM\18APN1.SGM
18APN1
]]>Agencies
[Federal Register Volume 79, Number 75 (Friday, April 18, 2014)]
[Notices]
[Pages 21936-21938]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08881]
-----------------------------------------------------------------------
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
[[Page 21937]]
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.
Compositions for Modification of Genomic DNA and Exogenous Gene
Expression
Description of Technology: A novel method of targeted insertion of
transgenes at CLYBL locus directly in human cells is disclosed. Also,
methods and compositions for increasing targeted insertion of a
transgene into a specific location within the cell or increasing the
frequency of gene modification in a targeted locus are disclosed.
Genome modification by precise gene targeting at specific sequence/
locus has great advantages over conventional transient expression or
random integration methodologies and, therefore, has tremendous
therapeutic potential. NIH investigators identified CLYBL gene in
Chromosome 13 as a potential safe harbor locus. To directly target
CLYBL safe-harbor in human cells without pre-engineering, they
identified a unique transcription activator-like effector nuclease
(TALEN) target sequence at CLYBL locus. The CLYBL TALENs (also termed
as C13 TALENs) constructed using pZT backbone showed high gene editing
efficiency in human 293T cells measured by both T7E1 mismatch assay and
targeted sequencing. The inventors have used TALENs to simultaneously
knock-in multiple reporter genes at up to four alleles of PPP1R12C/
AAVS1 and new CLYBL safe-harbors in human induced pluripotent stem
cells (iPSCs) and neural stem cells (NSCs). The engineered safe-harbor
knock-in cell lines maintain robust transgene expression during iPSC/
NSC self-renewal and differentiation, and CLYBL locus allowed 10-fold
stronger transgene expression than other loci. NSC lines engineered by
this methodology as well as constructs and protocols for evaluation are
also available.
Potential Commercial Applications:
Human stem cell-based gene therapy.
Drug screening.
Competitive Advantages: CLYBL safe harbor on Chromosome 13 allows
5~10-fold stronger transgene expression than AAVS1 safe harbor,
providing an alternative and potentially better solution for targeted
gene transfer/knock-in and drug-screening, especially for weak
promoter-driven transgenes.
Development Stage:
Early-stage.
In vitro data available.
Inventors: Jizhong Zou and Mahendra S. Rao (NIAMS).
Intellectual Property: HHS Reference No. E-763-2013/0-US-01--US.
Application No. 61/905,002 filed 15 Nov 2013.
Related Technology: HHS Reference No. E-762-2013/0-US-01--US.
Application No. 61/904,999 filed 15 Nov 2013.
Licensing Contact: Sury Vepa, Ph.D., J.D.; 301-435-5020;
vepas@mail.nih.gov.
Engineering Neural Stem Cells Using Homologous Recombination
Description of Technology: Methods for modifying the genome of a
Neural Stem Cell (NSC) are disclosed. Also, methods for differentiating
NSCs into neurons and glia are described. NSCs are multipotent, self-
renewing cells found in the central nervous system, capable of
differentiating into neurons and glia. NSCs can be generated
efficiently from pluripotent stem cells (PSCs) and have the capacity to
differentiate into any neuronal or glial cell type of the central
nervous system. Improvements in genome engineering of NSCs can
potentially facilitate cellular replacement therapies for the treatment
of neurodegenerative disorders. Recently, NIH investigators have
developed a procedure to efficiently engineer NSCs through homologous
recombination by introducing TAL effector nucleases (TALENs) and donor
vectors. They have designed TALENs that efficiently generate double
stranded breaks at two safe harbor loci (AAVS1 and CLYBL). These TALENs
facilitate homologous recombination without silencing at these loci.
The TALENs were delivered along with a DNA donor vector with a
ubiquitous promoter driving expression of a cDNA using a nucleofector
to get high transfection efficiencies. NSCs modified in this manner
have therapeutic potential in treating neurodegenerative diseases. NSC
lines engineered by this methodology as well as constructs and
protocols for evaluation are also available.
Potential Commercial Applications: Cellular replacement therapies
for neurodegenerative disorders.
Competitive Advantages:
The novel methods provide highly pure engineered NSC
populations which maintain the capacity to self-renew and differentiate
to neurons and astrocytes suitable for cell replacement therapies.
Safe harbor TALEN-mediated homologous recombination is a
high-efficiency method to generate targeted mini-gene transfer or
reporter knock-in cell lines in both human iPSCs and NSCs.
Development Stage:
Early-stage.
In vitro data available.
Inventors: Nasir S. Malik, Mahendra S. Rao, Jizhong Zou, Raymond
Funahashi (all of NIAMS).
Intellectual Property: HHS Reference No. E-762-2013/0-US-01--US.
Application No. 61/904,999 filed 15 Nov 2013.
Related Technology: HHS Reference No. E-763-2013/0-US-01--US.
Application No. 61/905,002 filed 15 Nov 2013.
Licensing Contact: Sury Vepa, Ph.D., J.D.; 301-435-5020;
vepas@mail.nih.gov.
Role of Novel Hepatitis Delta Virus Variant in Sj[ouml]gren's Syndrome
Description of Technology: Sj[ouml]gren's is a chronic autoimmune
disease characterized by dry mouth and eyes, fatigue, and
musculoskeletal pain resulting from the attack of the moisture-
producing glands by the body's own white blood cells. The subject
invention is based on the discovery of an association between infection
by a novel clade 1 variant of hepatitis delta virus (HDV) and primary
Sj[ouml]gren's syndrome. The association was made after detection of
the HDV nucleic acid in the salivary glands of patients diagnosed with
Sj[ouml]gren's syndrome and in vivo studies in mice that developed
Sj[ouml]gren's syndrome-like pathogenesis after expression of HDV
antigen. The discovery of this link opens the possibilities for
developing diagnostics against HDV to determine who are at risk for
developing Sj[ouml]gren's syndrome. The novel HDV variant can also
serve as a potential therapeutic target for preventing or treating
Sj[ouml]gren's.
Potential Commercial Applications:
Diagnostic for novel HDV clade 1 variant as a risk factor
for developing Sj[ouml]gren's.
Therapeutics against this newly discovered HDV clade 1
variant for prevention and/or treatment of Sj[ouml]gren's syndrome.
Competitive Advantages:
Novel diagnostic for a potentially significant risk factor
in developing Sj[ouml]gren's syndrome.
Newly discovered potential targets for treatment of
Sj[ouml]gren's.
Development Stage:
Early-stage.
In vitro data available.
In vivo data available (animal).
Inventors: Melodie L. Weller and John Chiorini (NIDCR).
[[Page 21938]]
Intellectual Property: HHS Reference No. E-736-2013/0--US
Provisional. Application No. 61/888,706 filed 09 Oct 2013.
Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018;
changke@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Dental and Craniofacial Research is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize Role of Novel Hepatitis Delta Virus
Variant. For collaboration opportunities, please contact David W.
Bradley, Ph.D. at bradleyda@nidcr.nih.gov.
Treating or Inhibiting JC Polyomavirus Infection and JC Polyomavirus-
Associated Progressive Multifocal Leukoencephalopathy
Description of Technology: Available for licensing are novel
findings to generate immune response to JC polyomavirus (JCV). An
immunogenic composition with a single JCV subtype VP1 polypeptide
generates neutralizing antibodies to all JCV subtypes, including JCV
with variant VP1 polypeptides. The invention is useful for the
prevention, treatment, or inhibition of JCV infection and JCV-
associated pathologies, such as progressive multifocal
leukoencephalopathy (PML).
Also available for licensing are techniques for identifying a
subject at risk for developing PML, based on detecting the absence of
JCV neutralizing antibodies in the subject.
Potential Commercial Applications:
Pharmaceutical treatments of JC virus infection.
Pharmaceutical treatments or prevention of PML.
Prediction or early diagnosis of the development of PML.
Competitive Advantages:
Generating an immune response to all JC virus subtypes
utilizing a JC virus capsid polypeptide from a single subtype.
No known methods for identifying a subject at risk for
developing PML by detecting the absence of JC virus neutralizing
antibodies in the subject.
Development Stage:
Early-stage.
In vitro data available.
In vivo data available (animal).
In vivo data available (human).
Inventors: Christopher B. Buck (NCI), Upasana Ray (NCI), and Diana
V. Pastrana.
Publication: Buck CB. Developing vaccines against BKV and JCV.
Presentation, 5th International Conference on Polyomaviruses and Human
Diseases: Basic and Clinical Perspectives, Stresa, Italy, May 9-11,
2013. Abstract published online in June 2013 in J Neurovirol.
2013;19:307. [DOI 10.1007/s13365-013-0171-0].
Intellectual Property: HHS Reference No. E-549-2013/0--US
Provisional. Application No. 61/919,043 filed 20 Dec 2013.
Licensing Contact: Patrick McCue, Ph.D.; 301-435-5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Laboratory of Cellular Oncology, is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize methods of treating JC polyomavirus-
related disorders. For collaboration opportunities, please contact John
D. Hewes, Ph.D. at hewesj@mail.nih.gov.
Therapeutic for Sickle Cell Disease and Beta Thalassemias
Description of Technology: Sickle-cell disease and beta thalassemia
are among the most common hereditary blood disorders in the world. It
has been shown that patients exhibit less severe symptoms of these
disorders when they produce unusually high levels of fetal hemoglobin
(HbF). HbF production, which normally shuts off after birth, has been
considered as a viable treatment because of inability to form
hemoglobin aggregates within red blood cells responsible for painful
episodes in patients. Researchers at the National Institute of Diabetes
and Digestive and Kidney Diseases have identified a method of
regulating the expression of fetal hemoglobin in adult red blood cells.
The lead inventor and colleagues have developed novel expression
vectors designed to reactivate production of HbF proteins through
increased erythroid-specific expression of Lin28 or decreased
expression of Let-7 micro-RNAs. This technology could lead to
development of multiple types of therapeutics that ameliorate or
eliminate the pathologies associated with human sickle-cell anemia and
beta thalassemia.
Potential Commercial Applications: Ex vivo and in vivo therapeutics
for treatment of sickle-cell anemia and beta thalassemias.
Competitive Advantages:
Amplification of HbF expression 10-fold higher than
existing methods.
Reduced production of symptom-associated adult hemoglobin.
Regulation of Lin28 and Let-7 expression with no
immunogenic effects.
Potential for viral and non-viral gene delivery.
Potential for Genome Editing Therapy.
Development Stage:
Early-stage.
In vitro data available.
In vivo data available (animal).
Inventors: Jeffery L. Miller (NIDDK), Yuanwei T. Lee (NIDDK),
Colleen Byrnes (NIDDK), Jaira Vasconcellos (NIDDK), Stefan A. Muljo
(NIAID).
Publication: Lee YT, et al. LIN28B-mediated expression of fetal
hemoglobin and production of fetal-like erythrocytes from adult human
erythroblasts ex vivo. Blood. 2013 Aug 8;122(6):1034-41. [PMID
23798711].
Intellectual Property: HHS Reference No. E-456-2013/2--
International. Application No. PCT/US2013/067811 filed 31 Oct 2013.
Licensing Contact: Vince Contreras, Ph.D.; 301-435-4711;
contrerasv@mail.nih.gov.
Dated: April 14, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-08881 Filed 4-17-14; 8:45 am]
BILLING CODE 4140-01-P
