[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Notices]
[Pages 57380-57383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24137]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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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.
SUPPLEMENTARY INFORMATION: Technology descriptions follow.
A Novel Rapid Point-of-Care Diagnostic Method for Infectious and
Autoimmune Diseases
Description of Technology: Rapid point-of-care, antibody-based
testing is not available for the diagnosis of autoimmune and most
infectious diseases. For detecting autoantibodies associated with most
autoimmune conditions, fluid-phase immunoprecipitation assays are
required. However, these assays usually involve radioactivity and are
not feasible for point-of-care applications. The subject invention
describes methods of using neodymium magnet for diagnosis of infectious
and autoimmune diseases including lupus, Sj[ouml]gren's syndrome, type
I diabetes, HIV and Lyme disease. The assay takes 3.5 minutes, is
highly efficient, and has low background.
Potential Commercial Applications
A rapid assay for point-of-care diagnosis of infectious
and autoimmune diseases.
Applications to different assay platforms, such as a
portable, commercially available hand-held luminometer or an automated,
high-throughput device.
Competitive Advantages
Highly efficient, rapid, and easy to perform.
Low background signals.
Development Stage
Early-stage
In vitro data available
Prototype.
Inventor: Peter D. Burbelo (NIDCR)
Publications
1. Burbelo PD, et al. Luciferase immunoprecipitation systems for
measuring antibodies in autoimmune and infectious diseases. Transl
Res. 2015 Feb; 165(2):325-335. [PMID 25241936]
2. Burbelo PD, et al. New autoantibody detection technologies
yield novel insights into autoimmune disease. Curr Opin Rheumatol.
2014 Nov; 26(6):717-723. [PMID 25203116]
3. Burbelo PD, et al. Searching for biomarkers: humoral response
profiling with luciferase immunoprecipitation systems. Expert Rev
Proteomics. 2011 Jun; 8(3):309-316. [PMID 21679112]
4. Burbelo PD, et al. Antibody profiling by luciferase
immunoprecipitation systems (LIPS). J Vis Exp. 2009 Oct 7; (32).
[PMID 19812534]
Intellectual Property: HHS Reference No. E-190-2015/0--US
Provisional Application No. 62/212,973 filed 01 Oct 2015.
Related Technologies
E-036-2010 family: PCT/US2011/027888, US 8,926,989,
issued. US 14/562,068 and EP 11730770.1, pending.
E-281-2010: US 13/882,850, allowed.
E-063-2009: US 8,951,723, issued.
Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5606;
[email protected].
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 using neodymium magnet for rapid
diagnosis. For collaboration opportunities, please contact David
Bradley, Ph.D. at [email protected].
A Mobile Health Platform
Description of Technology: The NIH inventors have developed a
mobile health technology to monitor and predict a user's psychological
status and to deliver an automated intervention when needed. The
technology uses smartphones to monitor the user's location and ask
questions about psychological status throughout the day. Continuously
collected ambulatory psychological data are fused with data on location
and responses to questions. The mobile data are combined with
geospatial risk maps to quantify exposure to risk and predict a future
psychological state. The future predictions are used to warn the user
when he or she is at especially high risk of experiencing a negative
event that might lead to an unwanted outcome (e.g., lapse to drug use
in a recovering addict).
An internally developed mobile app is now being deployed to deliver
an intervention in the context of drug addiction. The inventors are
also seeking to test the technology for other health applications.
Potential Commercial Applications
Real time behavior monitoring
Therapeutic delivery of an intervention via a mobile
device
Competitive Advantages
Mobile device
Real time
Exposure to risk
Development Stage: Prototype
Inventors: Kenzie L. Preston, David H. Epstein, Matthew Tyburski,
Massoud Vahabzadeh (all of NIDA)
Publications
1. Epstein DH, et al. Real-time tracking of neighborhood
surroundings and mood in urban drug misusers: Application of a new
method to study behavior in its geographical context. Drug Alcohol
Depend. 2014 Jan 1;134:22-9. [PMID 24332365]
2. Kennedy AP, et al. Continuous in-the-field measurement of
heart rate: Correlates of drug use, craving, stress and mood in
polydrug users. Drug Alcohol Depend. 2015 June 1;151:159-66. [PMID
25920802]
Intellectual Property: HHS Reference No. E-049-2015/0--US
Provisional Application No. 62/186, 983 filed 30 June 2015
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
[email protected]
Collaborative Research Opportunity: The National Institute on Drug
Abuse is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate or
commercialize
[[Page 57381]]
mhealth system to analyze and intervene. For collaboration
opportunities, please contact Vio Conley at [email protected].
Detection and Discrimination of Classical and Atypical L-Type BSE
Strains by RT-QuIC
Description of Technology: Statutory surveillance of bovine
spongiform encephalopathy (BSE) indicates that cattle are susceptible
to both classical (C-BSE) and atypical forms of BSE. Atypical forms of
BSE appear to be sporadic and thus may never be eradicated. A major
challenge is the lack of sufficiently practical and sensitive tests for
routine BSE detection and strain discrimination. The RT-QuIC test,
which is based on prion-seeded fibrillization of recombinant prion
protein (rPrPSen), is known to be highly specific and
sensitive for detection of multiple human and animal prion diseases,
but not BSE. This application claims methods for distinguishing whether
a sheep, cow or goat has atypical L-bovine spongiform encephalopathy
prion or classical bovine spongiform encephalopathy.
Potential Commercial Applications
Detection and distinguishing of both BSE forms
Rapid detection and discrimination of BSE forms
Competitive Advantages
Orders of magnitude more sensitive than ELISA tests
Eliminates need for multi-phase analyses of samples
Can be applied to large scale testing of multiple samples
Development Stage
In vitro data available
In vivo data available (animal)
Prototype
Inventors: Byron W. Caughey (NIAID), Christina D. Orr[uacute]
(NIAID), Alessandra Favolez (EM), Cristina Casalone (EM), Maria Mazza
(EM), Cristiano Corona (EM)
Publications
1. Orr[uacute] CD, et al. Detection and discrimination of
classical and atypical L-type bovine spongiform encephalopathy by
real-time quaking-induced conversion. J Clin Microbiol. 2015
Apr;53(4):1115-20. [PMID 25609728]
2. Orr[uacute] CD, et al. Correction: Bank Vole Prion Protein As
an Apparently Universal Substrate for RT-QuIC-Based Detection and
Discrimination of Prion Strains. PLoS Pathog. 2015 Aug
18;11(8):e1005117. [PMID 26284358]
3. Orr[uacute] CD, et al. Bank Vole Prion Protein As an
Apparently Universal Substrate for RT-QuIC-Based Detection and
Discrimination of Prion Strains. PLoS Pathog. 2015 Jun
18;11(6):e1004983. [PMID 26086786]
Intellectual Property: HHS Reference E-048-2015/0--US Provisional
Application No. 62/092,645 filed 16 Dec 2014
Licensing Contact: Peter A. Soukas; 301-435-4646; [email protected]
Lenalidomide Analogs for the Treatment of Neurodegenerative Disorders
and Cancer
Description of Technology: Inflammatory processes associated with
the over-production of tumor necrosis-alpha (TNF-alpha), a potent
activator of the immune system accompany numerous neurodegenerative
diseases. TNF-alpha has been validated as a drug target with the
development of the inhibitors Enbrel and Remicade (fusion antibodies)
as prescription medications. Both, however, are large macromolecules
that require direct injection and have limited brain access. The
classical drug, thalidomide is being increasingly used in the clinical
management of a wide spectrum of immunologically-mediated and
infectious diseases, and cancers. The NIA inventors developed and
assessed novel thio analogs of lenalidomide (Celegene's Revlimid and an
analog of thalidomide) as immunomodulatory agents, with the potential
to reduce chronic systemic and central nervous system inflammation.
These compounds were synthesized and evaluated for their TNF-alpha
inhibitory activity. This invention was extended from the inventors'
prior work to develop potent compounds to reduce neuroinflammation as a
treatment strategy for neurodegenerative disorders. The current studies
focus the compounds activity in classical models of neurodegeneration
as well as cancer.
Potential Commercial Applications
Treatment for blood disorders (myelodysplastic syndrome),
cancer (multiple myeloma), inflammatory processes and erythema
Immunomodulatory agents
Reduce chronic systemic and central nervous system
inflammation
Competitive Advantages
Effective smaller molecular weight compound that can enter
brain among current agents
Experimental therapeutic to reduce inflammation
systematically and within the brain
Effective in reducing proinflammatory cytokines than
existing agents
Development Stage
In vitro data available
In vivo data available (animal)
Prototype
Inventors: Nigel H. Greig, Weiming Luo, David Tweedie, Harold W.
Holloway, Qian-sheng Yu (all of NIA)
Publication: Luo W, et al. Design, synthesis and biological
assessment of novel N-substituted 3-(phthalimidin-2-yl)-2,6-
dioxopiperidines and 3-substituted 2,6-dioxopiperidines for TNF-alpha
inhibitory activity. Bioorg Med Chem. 2011 Jul 1;19(13):3965-3972.
[PMID 21658960]
Intellectual Property: HHS Reference No. E-045-2012/0--
US Patent No. 8,927,725 issued 06 Jan 2015
US Patent No. 9,084,783 issued 21 Jul 2015
US Patent Application No. 14/746,512 filed 22 Jun 2015
Related Technologies: HHS Reference No. E-189-2003/0--
US Patent No. 7,973,057 issued 05 Jul 2011
US Patent No. 8,546,430 issued 01 Oct 2013
US Patent Application No. 13/648,625 filed 10 Oct 2012
US Patent Application No. 14/314,124 filed 25 Jun 2014
and related international patents/patent applications
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
[email protected]
Novel Regulatory B Cells for Treatment of Cancer and Autoimmune Disease
Description of Technology: The manner by which cancers evade the
immune response is not well-understood. What is known is that the
manner is an active process that regulates immune responses employing
at least two types of suppressive cells, myeloid-derived suppressive
cells and regulatory T cells (Tregs), a key subset of CD4\+\ T cells
that controls peripheral tolerance to self- and allo-antigens. Tregs
are considered to play a key role in the escape of cancer cells from
anti-tumor effector T cells.
Cancer cells have been found to directly activate resting B cells
to form suppressive regulatory B cells (tBregs) and utilize them to
evade immune surveillance and mediate metastasis. tBregs directly
inhibit CD4\+\ and CD8\+\ T cell activity in a cell contact-dependent
manner, induce FoxP3\+\ T cell activity, and promote Treg-dependent
metastasis.
Researchers from the National Institute on Aging (NIA), NIH, have
developed methods for the generation of tBregs, and for using tBregs to
produce
[[Page 57382]]
Tregs, and methods that inactivate or deplete tBregs. These methods
have significant therapeutic value in the combat with cancer immune
escape and metastasis, and in the control of harmful autoimmune
diseases.
Potential Commercial Applications:
Production of cellular cancer vaccines
Treatments for immune-mediated disorders
Treatments for cancer
Treatments for chronic viral infections
Development Stage:
Early-stage
In vitro data available
In vivo data available (animal)
In situ data available
Ex vivo data available
Inventors: Bira Arya and Purevdorj Olkhanud (NIA)
Intellectual Property: HHS Reference No. E-101-2010/0--US Patent
Application No. 13/577,226 filed 03 Aug 2012
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
[email protected]
Collaborative Research Opportunity: The National Institute on
Aging, Laboratory of Molecular Biology and Immunology, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
the utilization of regulatory B cells to control autoimmune diseases
and strategies that inactivate tBregs to control cancer immune escape.
Please contact Nicole Darack, Ph.D. at 240-276-5493 or
[email protected] for more information.
Immunogenic Tumor-associated Antigen SPANX-B for Selective Cancer
Immunotherapy
Description of Technology: Researchers at the National Institute on
Aging (NIA) have characterized a novel tumor-associated antigen, SPANX-
B, which is naturally immunogenic and is expressed in a variety of
human malignancies, including melanoma and lung, colon, renal, ovarian
and breast carcinomas. In melanoma specifically, SPANX-B expression is
associated with advanced and metastatic disease. Moreover, the
researchers have found several agonist epitope peptides from SPANX-B
which can be used to activate the immune system to eradicate tumors
utilizing T cells. SPANX-B peptides have significant clinical and
immunotherapeutic potential for the development of cancer diagnostic
assays and potent protective and/or therapeutic vaccines to combat a
wide-range of cancers.
Potential Commercial Applications:
In vitro diagnostic assays for highly-metastatic melanomas
or other cancers
Therapeutic monoclonal antibodies
Cancer vaccine development
Competitive Advantages:
Immunogenic: SPANX-B peptides are naturally able to elicit
immune response.
Expressed in a wide-range of cancers.
Use of epitope peptides facilitates the activation of
cells of the more therapeutically effective branch of the immune
system.
Small epitope peptides: Can be more easily manufactured in
contrast to recombinant proteins.
Development Stage:
In vitro data available
In vivo data available (animal)
Publication: Almanzar G, et al. Sperm-derived SPANX-B is a
clinically relevant tumor antigen that is expressed in human tumors and
readily recognized by human CD4+ and CD8+ T cells. Clin Cancer Res.
2009 Mar 15;15(6):1954-63. [PMID 19276289]
Inventors: Bira Arya (NIA) and Vladimir Larionov (NCI)
Intellectual Property: HHS Reference No. E-089-2009/0--
US Patent No. 8,664,183 issued 04 Mar 2014
US Patent Application No. 14/155,230 filed 14 Jan 2014
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
[email protected]
Collaborative Research Opportunity: The National Institute on
Aging, Laboratory of Molecular Biology and Immunology, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
the use of SPANX-B-based therapeutic approaches to combat cancers.
Please contact Nicole Darack, Ph.D. at 240-276-5493 or
[email protected] for more information.
Method for the Diagnosis and Prognosis of Age-Related Cardiovascular
Disorders
Description of Technology: NIH investigators have discovered a
method for the diagnosis and prognosis of cardiovascular aging. Current
methodologies include the measurement of patient lipid profiles or
expression of up to two proteins. In contrast, this technology utilizes
the expression levels of a panel of proteins not previously known to be
related to cardiovascular aging and may prove to be a more accurate
diagnostic or prognostic of cardiovascular aging than currently
available tests or it may improve the accuracy of currently available
tests when used in concert.
The technology relates to methods for determining susceptibility to
having an extremely common age-associated vascular disorder. It also
describes the subsequent use of these proteins as markers for disease.
While the underlying cellular and molecular mechanisms of age-related
vascular disease remain largely undefined, the expression levels of the
genes described in this technology have been empirically determined to
differ between healthy and age-inflamed arterial tissue. Further, this
technology includes a companion mass spectroscopic-based methodology
for reproducible quantification of specific expression levels of
interest.
Potential Commercial Applications: Diagnosis of age-related
vascular disorder.
Inventors: Mingyi Wang et al. (NIA)
Intellectual Property: HHS Reference No. E-219-2008/0--US Patent
Application No. 13/202,319 filed 18 Aug 2011
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
[email protected]
Collaborative Research Opportunity: The National Institute on
Aging, Laboratory of Cardiovascular Science, Cardiac Biology Section--
Vascular Group, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or commercialize idea of how to assess and retard accelerated
arterial aging and its attendant risks for atherosclerosis and
hypertension. Please contact Vio Conley at 240-276-5531 or
[email protected] for more information.
A Novel and Efficient Technology for Targeted Delivery of siRNA
Description of Technology: The biological phenomenon of RNA
interference (RNAi) has much promise for developing therapeutics to a
variety of diseases. However, development of RNAi therapies remains
mainly in preclinical stages largely because of difficulties in
delivering small inhibitory RNAs (siRNA) and short hairpin RNAs (shRNA)
into target cells. Although viral vector-based siRNA delivery systems
have been widely used, their specificity and safety remains significant
issue. Without a
[[Page 57383]]
solution to this delivery problem, RNAi cannot fulfill its therapeutic
promise.
Investigators at the National Institutes of Health have developed
novel compositions and methods for delivering inhibitory
oligonucleotides to cells in a targeted and efficient manner. The
compositions and methods are based on utilizing a cell surface receptor
targeting ligand, such as cytokine or chemokine, and a domain that
binds an inhibitory oligonucleotide, to efficiently deliver the
inhibitory oligonucleotide to the cell that expresses the cell surface
receptor targeting ligand. Chemokine receptors are differentially
expressed on various cells, including tumors; hence this technology
allows targeting siRNA to aberrant cells. Gene silencing can also be
achieved in variety of immune cells by targeting cytokine receptors.
This technology has great potential for developing into a safe and
effective means of delivering therapeutic siRNAs.
Potential Commercial Applications
Treatment of cancers and autoimmune diseases by delivery
of siRNA to tumor cells or various aberrantly functioning immune cells.
This technology can be used to boost vaccine responses
against cancers and chronic infectious diseases.
Targeted delivery of fluorochrome-labeled RNA both in
vitro and in vivo for diagnostic purposes, for example, to trace or
localize various cells and to determine tumor metastasis and aberrant
proliferation or homing of immune cells.
Competitive Advantages
Simple method for linking siRNA to polypeptides to create
non-covalent or covalent complexes
In vivo targeted delivery of inhibitory RNAs into cells
rather than systemically
Delivery of multiple inhibitory RNAs to target multiple
genes
Long-term repression of target gene expression through
RNAi phenomenon
Development Stage
In vitro data available
In vivo data available (animal)
In situ data available
Inventors: Bira Arya, Purevdorj Olkhanud, Juan Espinoza (all of
NIA)
Intellectual Property: HHS Reference No. E-051-2008/0--
US Patent No. 8,703,921 issued 22 Apr 2014
US Patent Application No. 14/220,726 filed 20 Mar 2014
Various international patents/patent applications
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
[email protected]
Collaborative Research Opportunity: The National Institute on
Aging, Laboratory of Molecular Biology and Immunology, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
chemokine-based siRNA/shRNA technology for treatment of cancers and
autoimmune diseases, i.e. to control expression of immunomodulatory
cytokines and other factors that facilitate tumor escape, activity of
regulatory T cells or Th2 type of cells. This technology can be also
utilized to boost vaccine responses against cancers and chronic
infectious diseases. Please contact John D. Hewes, Ph.D. at 240-276-
5515 or [email protected] for more information.
Dated: September 17, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-24137 Filed 9-22-15; 8:45 am]
BILLING CODE 4140-01-P