Government-Owned Inventions; Availability for Licensing, 12512-12515 [2014-04771]
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IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: February 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–04811 Filed 3–4–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
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
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.
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SUMMARY:
Software for 3D Spectral Fingerprint
Based Consensus Modeling Using
Orthogonal PLS and Tanimoto
Similarity KNN Techniques
Description of Technology: This
technology is a software tool for
improving molecular modeling. The
software addresses data matrices
processed in rows instead of columns
and the result of these approaches are
combined. To process data in rows, the
technique uses a measure of similarity
known as ‘‘Tanimoto Similarity’’
operating on pairs of objects. The
property values of the top most similar
objects are normalized and used as
coefficients to predict the property of
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interest. These predictions can then be
used in combination with the
predictions obtained by multivariate
techniques to improve the quality of the
consensus model in comparison to the
individual predictions. Since, in the
case of multivariate techniques, the
information is accessed in columns,
while for the similarity based technique
it is accessed in rows, the two types of
techniques provide complementary
information. Thus, more useful
information can be extracted from the
same data matrix. Also contemplated is
the use of consensus modeling by letting
two algorithms (PLS and KNN) operate
on descriptor matrices of different size.
If each of these matrices is processed by
a different model building algorithm
and a consensus model between two or
more such individual models is built,
the resulting model would benefit from
both: i) the partial orthogonality of the
modeling techniques and ii) the
complementarity of the information
contained in 3D–SDAR matrices of
different granularity.
Potential Commercial Applications:
• Drug Design
• Drug Development
Competitive Advantages:
• Matrix processing of molecules of
biological interest
• High Fit-Activity Prediction capacity
Development Stage:
• Early-stage
• In vitro data available
Inventors: Svetoslav H. Slavov, Jon G.
Wilkes, Rick Beger, Dan A. Buzatu,
Bruce A. Pearce (all of FDA)
Publications:
1. Slavov SH, et al. 13C NMR-distance
matrix descriptors: optimal abstract 3D space
granularity for predicting estrogen binding. J
Chem Inform Model. 2012 Jul 23;52(7):1845–
64. [PMID 22681591]
2. Slavov SH, et al. Complementary PLS
and KNN algorithms for improved 3D–
QSDAR consensus modeling of AhR binding.
J Cheminform. 2013 Nov 21;5(1):47–62.
[PMID 24257141]
3. Stoyanova-Slavova IB, et al. PLS and
KNN algorithms for improved 3D–QSDAR
consensus modeling of acute toxicity.
Environ Toxicol Chem. 2014 Jan 27 (Epub
ahead of print). [PMID 24464801]
Intellectual Property: HHS Reference No.
E–015–2014/0—Software Materials. Patent
protection is not being pursued for this
technology.
Related Technologies:
• HHS Reference No. E–209–1999/1—US
Patent 6,898,533 issued 24 May 2005
• HHS Reference No. E–297–2001/0—US
Patent 7,996,156 issued 09 Aug 2011
Licensing Contact: Michael Shmilovich,
Esq., CLP; 301–435–6019; shmilovm@
mail.nih.gov.
Collaborative Research Opportunity: The
Food and Drug Administration is seeking
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statements of capability or interest from
parties interested in collaborative research to
further develop, evaluate or commercialize
Molecular Modeling/Drug Design. For
collaboration opportunities, please contact
Ashley Groves at 870–543–7956.
Multivalent, Multiple-Antigenic-Peptides for
Serological Detection of HIV–1 Groups -M,
-N, -O, and HIV–2
Description of Technology: This CDCdeveloped invention pertains to multivalent
antigenic peptides (MAPs) that can be used
in a variety of HIV/AIDS diagnostics. There
are two types of HIV: HIV–1 and HIV–2.
HIV–1 is subdivided into groups M, N, and
O, while HIV–2 is subdivided into subtypes
A and B. Within HIV -1 group M, several
different subtypes and numerous forms of
recombinant viruses exist. To detect all
types, groups, and subtypes of HIV by
serological methods, a mixture of antigens
derived from different viral strains
representing different HIV types and
subtypes is needed. However, due to the
competition and dilution effect, mixing
multiple antigens may reduce the amount of
individual antigen bound to the solid phase
and lead to a reduction in assay sensitivity.
It is known that MAPs, which contain
multiple branches of an oligopeptide
sequence, are more antigenic than the
corresponding single chain linear peptides.
The MAPs encompassed by this technology
contain multiple branches of oligopeptides of
different sequences, derived from HIV–1
group M, N, O, and HIV–2. Thus, depending
on the peptide sequences incorporated, a
single MAP can be used to detect HIV–1
group M alone, HIV–2 alone, or to
simultaneously detect HIV–1 groups M, N, O,
and HIV–2 with high sensitivity and
specificity.
Potential Commercial Applications:
• Diagnostic test for HIV–1 and/or HIV–2
infection
• Blood and plasma donation screening
• HIV/AIDS surveillance and monitoring
programs
Competitive Advantages:
• Lateral flow assays for HIV detection and
discrimination
• On-site, point-of-care testing and diagnosis
• Easily formulated as an ELISA kit for
commercial or research applications
• Technology can be used to develop a rapid,
low-cost method of determining HIV
status for home-use or low-resource
settings
Development Stage: In vitro data available
Inventor: Chou-Pong Pau (CDC)
Publications:
1. Granade TC, et al. Rapid detection and
differentiation of antibodies to HIV–1 and
HIV–2 using multivalent antigens and
magnetic immunochromatography testing.
Clin Vaccine Immunol. 2010
Jun;17(6):1034–9. [PMID 20410326]
2. Pau C, et al. Chimeric multiple antigenic
peptides for the simultaneously detection
of specific antibodies to HTV–1 groups M,
N, O, and HIV–2. J Immunol Methods.
2007 Jan 10;318(1–2):59–64. [PMID
17169369]
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3. Kim P and Pau CP. Comparing tandem
repeats and multiple antigenic peptides as
the antigens to detect antibodies by
enzyme immunoassay. J Immunol
Methods. 2001 Nov 1;257(1–2):51–4.
[PMID 11687238]
Intellectual Property: HHS Reference No.
E–604–2013/0—Research Tool. Patent
protection is not being pursued for this
technology.
Related Technologies:
• HHS Reference No. E–052–2013/0
• HHS Reference No. E–053–2013/0
• HHS Reference No. E–173–2013/0
• HHS Reference No. E–232–2013/0
• HHS Reference No. E–259–2013/0
• HHS Reference No. E–294–2013/0
• HHS Reference No. E–357–2013/0
• HHS Reference No. E–358–2013/0
• HHS Reference No. E–522–2013/0
• HHS Reference No. E–555–2013/0
• HHS Reference No. E–638–2013/0
Licensing Contact: Whitney Blair, J.D.,
M.P.H.; 301–435–4937; whitney.blair@
nih.gov.
Recombinant, Multivalent Malarial Antigens
for Development of Therapeutics,
Diagnostics and/or a Multistage Vaccine for
Plasmodium falciparum
Description of Technology: This CDCgenerated technology relates to a
recombinant, multivalent and multi-stage
malaria vaccine and, more specifically, to
antigenic proteins useful for preventing or
treating Plasmodium falciparum malarial
infections. Malaria continues to be a public
health problem throughout the world and P.
falciparum is often identified as the cause of
the most severe forms of the disease. Ideally,
an effective malaria vaccine would contain a
combination of key antigens/epitopes from
different stages of the pathogen’s complex
life-cycle. This approach to vaccination
would likely result in the induction of both
humoral and cellular immunity for optimal
efficacy and a broad scope of protection.
This technology entails a multi-stage
vaccine against malaria that is effective in
inhibiting reproductive growth of the parasite
within a human or animal after initial
infection. Further, the technology includes
antibodies against a recombinant protein
containing antigenic epitopes to varied lifecycle stages of a malarial Plasmodium
species. These antigens and antibodies may
be useful as research tools or diagnostic
reagents for the detection and diagnosis of P.
falciparum at a number of different life-cycle
stages within a biological sample.
Potential Commercial Applications:
• Malaria vaccine development
• Useful for malaria vaccination and
surveillance programs
• Military, foreign service applications
• Mitigation of zoonotic disease transmission
and livestock morbidity, especially
within South Asia
Competitive Advantages:
• Single vaccine confers immunity against
the malarial parasite at multiple life
cycle stages, increasing the chances of
neutralizing sustained infection
• In vivo animal studies demonstrate vaccine
efficacy
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Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventors: Altaf A. Lal (CDC), Ya-Ping Shi
(CDC), Seyed P. Hasnain (National Institute
of Immunology—India)
Publication: Shi YP. Immunogenicity and
in vitro protective efficacy of a recombinant
multistage Plasmodium falciparum candidate
vaccine. Proc Natl Acad Sci U S A. 1999 Feb
16;96(4):1615–20. [PMID: 9990073]
Intellectual Property: HHS Reference No.
E–451–2013/0—
• US Patent No. 6,828,416 issued 07 Dec
2004
• Various international patent applications
pending or issued
Licensing Contact: Whitney Blair, J.D.,
M.P.H.; 301–435–4937; whitney.blair@
nih.gov.
Air Quality Assurance: A Monitor for
Continuous, Simultaneous Analysis of
Atmospheric or Aerosolized Particulate
Mixtures
Description of Technology: This
technology pertains to monitors for
measuring the mass concentration of ambient
particulate matter in an atmosphere
containing both larger/coarser (e.g.,
respirable dust) and smaller/finer (submicrometer particles such as diesel
particulate matter—DPM) particulate
mixtures. The monitoring device can be
configured for operation with a controller
unit adapted to ionization sensor and/or
light-scattering modules. The controller
translates the sensor output signal into a
quantifiable value, determining mass
concentration of particulate matter within the
ionization chamber. For example, practical
applications of this monitor/analysis
technology would easily extend to use in
mining operations (where both DPM and
respirable dust exist in abundance),
industrial manufacturing facilities, and
anywhere that frequent or extended exposure
to fuel-combustion exhaust or airborne
pollution is a concern. Further, by virtue of
its ability to distinguish ‘‘fire smoke’’ from
other aerosols that may be present, the device
also has significant potential for use in earlywarning fire detection.
Potential Commercial Applications:
• Airborne particle monitor for mining and
industrial manufacturing operations
• Addressing emissions control standards
and regulations
• Early-warning fire detection in locations
where traditional smoke-detector use is
impractical
Competitive Advantages:
• Inexpensive and simple to implement
• Device provides continuous, simultaneous,
and independent measurement of both
respirable dust and diesel particulate
matter (DPM) mass concentrations
• Previous particulate counting technologies
are both expensive and cannot provide
accurate quantification of coarse/fine
aerosol mixtures, concentrations
Development Stage:
• In situ data available (on-site)
• Prototype
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Inventors: Charles D. Litton, Jon C.
Volkwein, William H. Schiffbauer (all of
CDC)
Intellectual Property: HHS Reference No.
E–240–2013/0—US Patent No. 6,965,240
issued 27 Mar 2003
Licensing Contact: Whitney Blair, J.D.,
M.P.H.; 301–435–4937; whitney.blair@
nih.gov.
A Targeted Therapy for the Activated B CellLike Subtype of Diffuse Large B Cell
Lymphoma
Description of Technology: NIH scientists
have developed novel peptides that
specifically target the activated B cell like
(ABC) subtype of diffuse large B cell
lymphoma (DLBCL), which is the least
curable form of this aggressive lymphoma.
ABC DLBCL is characterized by
constitutive NF-kB pathway activation,
which depends on the binding of two protein
molecules, RNF31 and RBCK1. These cellpermeable peptides compete against
endogenous RNF31, therefore inhibit the NFkB induction pathway and kill the malignant
cells.
This technology would be a potential
targeted therapy for ABC DLBCL, and could
be combined with radiation or chemotherapy
for ABC DLBCL or other cancers.
Additionally, these peptides could also be
applied to treat rheumatoid arthritis, chronic
autoinflammation, systemic lupus
erythematosus, Crohn’s inflammatory bowel
disease, or psoriasis.
Potential Commercial Applications:
• Targeted therapies for ABC DLBCL.
• Combination cytotoxic chemotherapies for
ABC DLBCL.
• Treatment for other cancers or
autoimmune/inflammatory diseases that
depend upon the function of RNF31 and
RBCK1 combination.
Competitive Advantages:
• Novel composition of inhibitors for ABC
DLBCL.
• Novel targeted drug to ABC DLBCL.
• Effective therapies targeting at NF-kB
pathway.
Development Stage:
• Early-stage
• In vitro data available
Inventors: Louis M. Staudt, Yibin Yang,
Federico Bernal (all of NCI)
Publication: Yang Y, et al. Essential Role of
the Linear Ubiquitin Chain Assembly
Complex in Lymphoma Revealed by Rare
Germline Polymorphisms. Cancer Discov.
2014 Feb 3 (Epub ahead of print). [PMID
24491438]
Intellectual Property: HHS Reference No.
E–035–2013/0—US Provisional Application
No. 61/789,064 filed 15 March 2013
Licensing Contact: Sabarni Chatterjee,
Ph.D., MBA; 301–435–5587; chatterjeesa@
mail.nih.gov.
Collaborative Research Opportunity: The
National Cancer Institute is seeking
statements of capability or interest from
parties interested in collaborative research to
further develop, evaluate or commercialize
the inhibitors of the LUBAC ubiquitin ligase
for the therapy of lymphoma and
autoimmune diseases. For collaboration
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opportunities, please contact John D. Hewes,
Ph.D. at hewesj@mail.nih.gov.
Mutation Based Control Plasmids for
Standardizing Cancer Genomic Diagnostic
Assays
Description of Technology: To date, there
are no widely accepted standards and
controls for multi-analyte based diagnostic
assays. The ability to compare the accuracy
of different types of assay results and to
utilize in process controls is hampered by the
lack of availability of such standards/
controls. Variations resulting from different
platforms, methodologies, and bioinformatics
analyses therefore create error in the
interpretation of assay reports and different
results may occur when testing for the
presence or absence of specific gene
mutations or biomarkers.
This technology includes a library of
plasmids that can be used to test for and
control for accuracy, sensitivity, and
specificity and reproducibility within an
assay and across different assays or
laboratories and platforms. These standards
consist of normal human reference genomic
DNA that have engineered to contain known
sequence variations representing somatic
mutations of interest to cancer management.
The plasmids contain approximately 1000
bases of human sequence. Each inserted
sequence carries a specific mutation of
interest within the appropriate genomic locus
and a mutation adjacent alien barcode. The
plasmids can be mixed with non-mutant
genomes to create exact variant to normal
allele frequencies for limit of detection
studies. The alien barcode unequivocally
indicates the detected mutation is from the
plasmid spiked into a test human specimen.
If needed for certain applications the barcode
can be left out of design.
Potential Commercial Applications:
• Quantified standards for scientists to
compare, optimize and/or validate assays
• Assess specificity, sensitivity, accuracy
and limit detection of artifacts during assay
development
• Internal in process run controls to monitor
assay performance
Competitive Advantages:
• Reference materials for comparing results
of assays performed by different platforms,
operators, times, and sites
• Ability to uniquely distinguish plasmid
control mutations spiked directly into
unknown samples by alien barcode
• No limit in the number and types of
mutation plasmids introduced into the test
human specimen, unlike engineered cell
line genome based mutation controls
• Easy design and manufacture process
Development Stage: In vitro data available
Inventors: Chih-Jian Lih, Paul Williams,
David Sims, Michele Mehaffey (all of NCI)
Publications: Manuscripts in preparation.
Intellectual Property: HHS Reference No.
E–265–2012/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Contact: Jennifer Wong, M.S.;
301–435–4633; wongje@mail.nih.gov
Collaborative Research Opportunity: The
National Cancer Institute, Cancer Diagnosis
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Program, is seeking statements of capability
or interest from parties interested in
collaborative research to further develop,
evaluate or commercialize Mutation Based
Control Plasmids for Standardizing Cancer
Genomic Diagnostic Assays. For
collaboration opportunities, please contact
John Hewes, Ph.D. at john.hewes@nih.gov.
Use of Soluble CD27 as Potential
Immunotherapy and a Diagnostic and
Prognostic Serum Biomarker for Solid
Tumors
Description of Technology: The present
invention discloses methods for diagnosing a
patient with a solid tumor or a predisposition
to developing a solid tumor, a patient’s
suitability for immunotherapy and monitor
disease progression in a patient undergoing
treatment for a solid tumor, such as a prostate
or colorectal tumor, by measuring the amount
of soluble CD27 (sCD27) present in a serum
sample obtained from a patient and detecting
the amount of sCD27present in the serum
sample. Additionally, sCD27 can also be
developed an immunotherapeutic product.
Such product will constitute the
administration of a therapeutically effective
amount of sCD27 or a functional 15 fragment
thereof that is capable of stimulating a
patient’s immune system.
CD27 is a tumor necrosis factor receptor. A
soluble form of CD27 (sCD27), is a 32-kD
protein identical to the extracellular domain
of membrane-bound CD27. CD27’s role in T
cell activation has been previously
demonstrated.
Potential Commercial Applications:
• Serum biomarker for diagnosis, prognosis
and therapeutic response.
• Can potentially be developed into an
immunotherapeutic product.
Competitive Advantages:
• Potentially can be used with clinically
proven platforms.
• Can be developed into a minimally
invasive diagnostic test using patient’s
blood sample.
Development Stage:
• Early-stage
• In vitro data available
Inventors: Jeffrey Schlom and Jianping
Huang (NCI)
Publication: Huang J, et al. Soluble CD27pool in humans may contribute to T cell
activation and tumor immunity. J Immunol.
2013 Jun 15;190(12):6250–8. [PMID
23677477]
Intellectual Property: HHS Reference No.
E–005–2011/0—US Patent Application No.
61/824,898 filed 17 May 2013
Licensing Contact: Sabarni Chatterjee,
Ph.D., MBA; 301–435–5587; chatterjeesa@
mail.nih.gov.
Collaborative Research Opportunity: The
National Cancer Institute, Laboratory of
Metabolism, is seeking statements of
capability or interest from parties interested
in collaborative research to further develop,
evaluate or commercialize a non-invasive
assay for the detection of colorectal cancer.
For collaboration opportunities, please
contact John D. Hewes, Ph.D. at hewesj@
mail.nih.gov.
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The Use of alpha-4 beta-7 integrin Inhibitors
To Inhibit HIV Transmission and Infection
Description of Technology: This invention
involves the use of inhibitors of alpha-4 beta7 (a4b7) integrin to inhibit HIV transmission/
infection, as a prophylactic to inhibit onset
of the acute stage of HIV infection or to treat
HIV infection. The a4b7 integrin inhibitors
were previously developed for use in other
diseases, such as multiple sclerosis or
inflammatory bowel disease.
a4b7 integrin is a multifaceted target for
HIV infection and recent studies indicate that
it is important for establishing HIV infection
through multiple paths. Studies indicate that:
(1) CD4 T-cells present in vaginal and anal
mucosa have high levels of a4b7 integrin,
making CD4 T-cells permissive to HIV
infection; (2) a4b7 integrin is important for
cell to cell transmission of HIV; (3) a4b7
integrin is used to dysregulate the host
humoral response to HIV; and (4) HIV acts on
a4b7 integrin through an epitope in V2 loop
of GP120, identified as important for HIV
vaccine protection. Additionally, primate
studies indicate that a4b7 integrin inhibition
of HIV infection preserves gut-associated
lymphoid tissue (GALT) generally destroyed
during the acute phase of HIV infection.
Potential Commercial Applications:
Prevention and treatment of HIV infection
Competitive Advantages:
• a4b7 integrin is a multifaceted target for
HIV infection
• Previously developed a4b7 integrin
inhibitors can be used for a new purpose
Development Stage:
• Pre-clinical
• In vitro data available
• In vivo data available (animal)
Inventors: James Arthos, Claudia Cicala,
Anthony S. Fauci, Diana Goode (all of NIAID)
Publications:
1. Martinelli E, et al. The frequency of
[alpha]4[beta]7high memory CD4+ T cells
correlates with susceptibility to rectal
simian immunodeficiency virus infection. J
Acquir Immune Defic Syndr. 2013 Dec
1;64(4):325–31. [PMID 23797688]
2. Nawaz F, et.al. The genotype of earlytransmitting HIV gp120s promotes a4b7reactivity, revealing a4b7+/CD4+ T cells as
key targets in mucosal transmission. PLoS
Pathog. 2011 Feb;7(2):e1001301. [PMID
21383973]
3. Cicala C, et al. The integrin a4b7 forms a
complex with cell-surface CD4 and defines
a T-cell subset that is highly susceptible to
infection by HIV–1. Proc Natl Acad Sci U
S A. 2009 Dec 8;106(49):20877–82. [PMID
19933330]
4. Arthos J, et al. HIV–1 envelope protein
binds to and signals through integrin a4b7,
the gut mucosal homing receptor for
peripheral T cells. Nat Immunol. 2008
Mar;9(3):301–9. [PMID 18264102]
Intellectual Property:
• HHS Reference No. E–055–2007/0—US
Provisional Patent Application No. 60/
873,884 filed 07 Dec 2006
• HHS Reference No. E–055–2007/1—US
Provisional Patent Application No. 60/
920,880 filed 30 Mar 2007
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• HHS Reference No. E–055–2007/2—US
Provisional Patent Application No. 60/
957,140 filed 21 Aug 2007
• HHS Reference No. E–055–2007/3—PCT
Patent Application No. PCT/US2007/
086663 filed 06 Dec 2007, which published
as WO 2008/140602 on 20 Nov 2008, and
corresponding European Application No.
07874349.9; US Patent Application No. 12/
518,035 filed 05 Jun 2009
Licensing Contact: Cristina ThalhammerReyero, Ph.D., M.B.A.; 301–435–4507;
thalhamc@mail.nih.gov.
Collaborative Research Opportunity: The
National Institute of Allergy and Infectious
Diseases is seeking statements of capability
or interest from parties interested in
collaborative research to further develop,
evaluate or commercialize alpha-4 beta-7
integrin inhibitors. For collaboration
opportunities, please contact Bill
Ronnenberg, JD/MIP, MS at 301–451–3522 or
wr78k@nih.gov.
Beta-Amyloid and Tau Fibril Positron
Emissions Tomography (PET) Imaging
Agents
Description of Technology: The invention
relates to two novel classes of compounds
useful as radioligands for in vivo imaging of
beta-amyloid fibrils, peptides and plaques in
humans. Beta-amyloid peptide deposition in
the brain is a pathological feature of
Alzheimer’s disease (AD). Early detection of
beta-amyloid load in patients with suspected
AD is vital to initiating early treatment,
which can improve cognitive function and
quality of life for many patients. The
invention describes novel derivatives of
imidazopyridinylbenzeneamine (IMPY) and
benzothizolylbenzeneamine (BTA), which
demonstrate high in vitro binding affinity to
human beta-amyloid. The difference between
existing IMPY compounds and the novel
derivatives is the substitution of an aryl
halide with an aryl thioether group and
replacement of a sulfur group of the pyridine
ring with a nitrogen group. The new classes
of compounds have the potential of
providing improved amyloid imaging agents
for Positron Emission Tomography (PET)
with higher specificity for amyloid, low
background noise, better entry into the brain
and improved labeling efficiency.
Potential Commercial Applications:
• Alzheimer’s disease
• Alzheimer’s disease diagnostics
• Alzheimer’s disease early detection
Competitive Advantages: Specificity
Development Stage: In vitro data available
Inventors: Lisheng Cai, Victor W. Pike,
Robert B. Innis (all of NIMH)
Publications:
1. Nichols L, et al. Imaging and in vivo
quantitation of beta-amyloid: an exemplary
biomarker for Alzheimer’s disease? Biol
Psychiatry. 2006 May 15;59(10):940–7.
[PMID 16487944]
2. Toyama H, et al. PET imaging of brain with
the beta-amyloid probe, [11C]6–OH–BTA–
1, in a transgenic mouse model of
Alzheimer’s disease. Eur J Nucl Med Mol
Imaging. 2005 May;32(5):593–600. [PMID
15791432]
3. Cai L, et al. Synthesis and evaluation of
two 18F-labeled 6-iodo-2-(4’-N,N-
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dimethylamino)phenylimidazo[1,2a]pyridine derivatives as prospective
radioligands for beta-amyloid in
Alzheimer’s disease. J Med Chem. 2004
Apr 22;47(9):2208–18. [PMID 15084119]
Intellectual Property: HHS Reference No.
E–156–2006/0—
• US Patent Application 12/293,940 filed
September 17, 2008 (allowed)
• European Patent Application 07797254.5
filed April 19, 2007 (pending)
Related Technologies:
• HHS Reference No. E–136–2008/0—‘‘Beta
Amyloid PET Imaging Agents Based On 2(4-phenyl)benzo[d]thiazole Derivatives’’
• HHS Reference Nos. E–225–2011/0 and/
1—‘‘Beta-amyloid PET Imaging Agents
Based On Benzothiazoles (BTA)
Derivatives’’
Licensing Contact: Michael Shmilovich,
Esq., CLP; 301–435–5019; shmilovm@
mail.nih.gov.
Collaborative Research Opportunity: The
National Institute of Mental Health is seeking
statements of capability or interest from
parties interested in collaborative research to
further develop, evaluate or commercialize
Alzheimer’s disease diagnostics. For
collaboration opportunities, please contact
Suzanne Winfield, Ph.D. at 301–402–4324.
Dated: February 27, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–04771 Filed 3–4–14; 8:45 am]
BILLING CODE 4140–01–P
12515
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Kausik Ray, Ph.D.,
Scientific Review Officer, National Institute
on Deafness and Other Communication
Disorders, National Institutes of Health
Rockville, MD 20850, 301–402–3587, rayk@
nidcd.nih.gov.
Name of Committee: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel; VSL
Translational Applications Review.
Date: March 27, 2014.
Time: 3:30 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Christine A. Livingston,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institutes of
Health/NIDCD, 6001 Executive Blvd.—Room
8343, Bethesda, MD 20892, (301) 496–8683,
livingsc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.173, Biological Research
Related to Deafness and Communicative
Disorders, National Institutes of Health, HHS)
Dated: February 27, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–04767 Filed 3–4–14; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
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.
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: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel; Neural/
Vestibular Prosthesis Review.
Date: March 21, 2014.
Time: 2:00 p.m. to 3:30 p.m.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
BILLING CODE 4140–01–P
National Institutes of Health
National Institute of General Medical
Sciences; 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.
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: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of K99 Grant Applications.
Date: March 25, 2014.
Time: 8:00 a.m. to 5:00 p.m.
E:\FR\FM\05MRN1.SGM
05MRN1
Agencies
[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Notices]
[Pages 12512-12515]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04771]
-----------------------------------------------------------------------
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.
Software for 3D Spectral Fingerprint Based Consensus Modeling Using
Orthogonal PLS and Tanimoto Similarity KNN Techniques
Description of Technology: This technology is a software tool for
improving molecular modeling. The software addresses data matrices
processed in rows instead of columns and the result of these approaches
are combined. To process data in rows, the technique uses a measure of
similarity known as ``Tanimoto Similarity'' operating on pairs of
objects. The property values of the top most similar objects are
normalized and used as coefficients to predict the property of
interest. These predictions can then be used in combination with the
predictions obtained by multivariate techniques to improve the quality
of the consensus model in comparison to the individual predictions.
Since, in the case of multivariate techniques, the information is
accessed in columns, while for the similarity based technique it is
accessed in rows, the two types of techniques provide complementary
information. Thus, more useful information can be extracted from the
same data matrix. Also contemplated is the use of consensus modeling by
letting two algorithms (PLS and KNN) operate on descriptor matrices of
different size. If each of these matrices is processed by a different
model building algorithm and a consensus model between two or more such
individual models is built, the resulting model would benefit from
both: i) the partial orthogonality of the modeling techniques and ii)
the complementarity of the information contained in 3D-SDAR matrices of
different granularity.
Potential Commercial Applications:
Drug Design
Drug Development
Competitive Advantages:
Matrix processing of molecules of biological interest
High Fit-Activity Prediction capacity
Development Stage:
Early-stage
In vitro data available
Inventors: Svetoslav H. Slavov, Jon G. Wilkes, Rick Beger, Dan A.
Buzatu, Bruce A. Pearce (all of FDA)
Publications:
1. Slavov SH, et al. \13\C NMR-distance matrix descriptors:
optimal abstract 3D space granularity for predicting estrogen
binding. J Chem Inform Model. 2012 Jul 23;52(7):1845-64. [PMID
22681591]
2. Slavov SH, et al. Complementary PLS and KNN algorithms for
improved 3D-QSDAR consensus modeling of AhR binding. J Cheminform.
2013 Nov 21;5(1):47-62. [PMID 24257141]
3. Stoyanova-Slavova IB, et al. PLS and KNN algorithms for
improved 3D-QSDAR consensus modeling of acute toxicity. Environ
Toxicol Chem. 2014 Jan 27 (Epub ahead of print). [PMID 24464801]
Intellectual Property: HHS Reference No. E-015-2014/0--Software
Materials. Patent protection is not being pursued for this
technology.
Related Technologies:
HHS Reference No. E-209-1999/1--US Patent 6,898,533 issued
24 May 2005
HHS Reference No. E-297-2001/0--US Patent 7,996,156 issued
09 Aug 2011
Licensing Contact: Michael Shmilovich, Esq., CLP; 301-435-6019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The Food and Drug
Administration is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize Molecular Modeling/Drug Design. For
collaboration opportunities, please contact Ashley Groves at 870-
543-7956.
Multivalent, Multiple-Antigenic-Peptides for Serological Detection of
HIV-1 Groups -M, -N, -O, and HIV-2
Description of Technology: This CDC-developed invention pertains
to multivalent antigenic peptides (MAPs) that can be used in a
variety of HIV/AIDS diagnostics. There are two types of HIV: HIV-1
and HIV-2. HIV-1 is subdivided into groups M, N, and O, while HIV-2
is subdivided into subtypes A and B. Within HIV -1 group M, several
different subtypes and numerous forms of recombinant viruses exist.
To detect all types, groups, and subtypes of HIV by serological
methods, a mixture of antigens derived from different viral strains
representing different HIV types and subtypes is needed. However,
due to the competition and dilution effect, mixing multiple antigens
may reduce the amount of individual antigen bound to the solid phase
and lead to a reduction in assay sensitivity.
It is known that MAPs, which contain multiple branches of an
oligopeptide sequence, are more antigenic than the corresponding
single chain linear peptides. The MAPs encompassed by this
technology contain multiple branches of oligopeptides of different
sequences, derived from HIV-1 group M, N, O, and HIV-2. Thus,
depending on the peptide sequences incorporated, a single MAP can be
used to detect HIV-1 group M alone, HIV-2 alone, or to
simultaneously detect HIV-1 groups M, N, O, and HIV-2 with high
sensitivity and specificity.
Potential Commercial Applications:
Diagnostic test for HIV-1 and/or HIV-2 infection
Blood and plasma donation screening
HIV/AIDS surveillance and monitoring programs
Competitive Advantages:
Lateral flow assays for HIV detection and discrimination
On-site, point-of-care testing and diagnosis
Easily formulated as an ELISA kit for commercial or
research applications
Technology can be used to develop a rapid, low-cost method
of determining HIV status for home-use or low-resource settings
Development Stage: In vitro data available
Inventor: Chou-Pong Pau (CDC)
Publications:
1. Granade TC, et al. Rapid detection and differentiation of
antibodies to HIV-1 and HIV-2 using multivalent antigens and
magnetic immunochromatography testing. Clin Vaccine Immunol. 2010
Jun;17(6):1034-9. [PMID 20410326]
2. Pau C, et al. Chimeric multiple antigenic peptides for the
simultaneously detection of specific antibodies to HTV-1 groups M,
N, O, and HIV-2. J Immunol Methods. 2007 Jan 10;318(1-2):59-64.
[PMID 17169369]
[[Page 12513]]
3. Kim P and Pau CP. Comparing tandem repeats and multiple antigenic
peptides as the antigens to detect antibodies by enzyme immunoassay.
J Immunol Methods. 2001 Nov 1;257(1-2):51-4. [PMID 11687238]
Intellectual Property: HHS Reference No. E-604-2013/0--Research
Tool. Patent protection is not being pursued for this technology.
Related Technologies:
HHS Reference No. E-052-2013/0
HHS Reference No. E-053-2013/0
HHS Reference No. E-173-2013/0
HHS Reference No. E-232-2013/0
HHS Reference No. E-259-2013/0
HHS Reference No. E-294-2013/0
HHS Reference No. E-357-2013/0
HHS Reference No. E-358-2013/0
HHS Reference No. E-522-2013/0
HHS Reference No. E-555-2013/0
HHS Reference No. E-638-2013/0
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
whitney.blair@nih.gov.
Recombinant, Multivalent Malarial Antigens for Development of
Therapeutics, Diagnostics and/or a Multistage Vaccine for Plasmodium
falciparum
Description of Technology: This CDC-generated technology relates
to a recombinant, multivalent and multi-stage malaria vaccine and,
more specifically, to antigenic proteins useful for preventing or
treating Plasmodium falciparum malarial infections. Malaria
continues to be a public health problem throughout the world and P.
falciparum is often identified as the cause of the most severe forms
of the disease. Ideally, an effective malaria vaccine would contain
a combination of key antigens/epitopes from different stages of the
pathogen's complex life-cycle. This approach to vaccination would
likely result in the induction of both humoral and cellular immunity
for optimal efficacy and a broad scope of protection.
This technology entails a multi-stage vaccine against malaria
that is effective in inhibiting reproductive growth of the parasite
within a human or animal after initial infection. Further, the
technology includes antibodies against a recombinant protein
containing antigenic epitopes to varied life-cycle stages of a
malarial Plasmodium species. These antigens and antibodies may be
useful as research tools or diagnostic reagents for the detection
and diagnosis of P. falciparum at a number of different life-cycle
stages within a biological sample.
Potential Commercial Applications:
Malaria vaccine development
Useful for malaria vaccination and surveillance programs
Military, foreign service applications
Mitigation of zoonotic disease transmission and livestock
morbidity, especially within South Asia
Competitive Advantages:
Single vaccine confers immunity against the malarial
parasite at multiple life cycle stages, increasing the chances of
neutralizing sustained infection
In vivo animal studies demonstrate vaccine efficacy
Development Stage:
In vitro data available
In vivo data available (animal)
Inventors: Altaf A. Lal (CDC), Ya-Ping Shi (CDC), Seyed P.
Hasnain (National Institute of Immunology--India)
Publication: Shi YP. Immunogenicity and in vitro protective
efficacy of a recombinant multistage Plasmodium falciparum candidate
vaccine. Proc Natl Acad Sci U S A. 1999 Feb 16;96(4):1615-20. [PMID:
9990073]
Intellectual Property: HHS Reference No. E-451-2013/0--
US Patent No. 6,828,416 issued 07 Dec 2004
Various international patent applications pending or issued
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
whitney.blair@nih.gov.
Air Quality Assurance: A Monitor for Continuous, Simultaneous Analysis
of Atmospheric or Aerosolized Particulate Mixtures
Description of Technology: This technology pertains to monitors
for measuring the mass concentration of ambient particulate matter
in an atmosphere containing both larger/coarser (e.g., respirable
dust) and smaller/finer (sub-micrometer particles such as diesel
particulate matter--DPM) particulate mixtures. The monitoring device
can be configured for operation with a controller unit adapted to
ionization sensor and/or light-scattering modules. The controller
translates the sensor output signal into a quantifiable value,
determining mass concentration of particulate matter within the
ionization chamber. For example, practical applications of this
monitor/analysis technology would easily extend to use in mining
operations (where both DPM and respirable dust exist in abundance),
industrial manufacturing facilities, and anywhere that frequent or
extended exposure to fuel-combustion exhaust or airborne pollution
is a concern. Further, by virtue of its ability to distinguish
``fire smoke'' from other aerosols that may be present, the device
also has significant potential for use in early-warning fire
detection.
Potential Commercial Applications:
Airborne particle monitor for mining and industrial
manufacturing operations
Addressing emissions control standards and regulations
Early-warning fire detection in locations where traditional
smoke-detector use is impractical
Competitive Advantages:
Inexpensive and simple to implement
Device provides continuous, simultaneous, and independent
measurement of both respirable dust and diesel particulate matter
(DPM) mass concentrations
Previous particulate counting technologies are both
expensive and cannot provide accurate quantification of coarse/fine
aerosol mixtures, concentrations
Development Stage:
In situ data available (on-site)
Prototype
Inventors: Charles D. Litton, Jon C. Volkwein, William H.
Schiffbauer (all of CDC)
Intellectual Property: HHS Reference No. E-240-2013/0--US Patent
No. 6,965,240 issued 27 Mar 2003
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
whitney.blair@nih.gov.
A Targeted Therapy for the Activated B Cell-Like Subtype of Diffuse
Large B Cell Lymphoma
Description of Technology: NIH scientists have developed novel
peptides that specifically target the activated B cell like (ABC)
subtype of diffuse large B cell lymphoma (DLBCL), which is the least
curable form of this aggressive lymphoma.
ABC DLBCL is characterized by constitutive NF-kB pathway
activation, which depends on the binding of two protein molecules,
RNF31 and RBCK1. These cell-permeable peptides compete against
endogenous RNF31, therefore inhibit the NF-kB induction pathway and
kill the malignant cells.
This technology would be a potential targeted therapy for ABC
DLBCL, and could be combined with radiation or chemotherapy for ABC
DLBCL or other cancers. Additionally, these peptides could also be
applied to treat rheumatoid arthritis, chronic autoinflammation,
systemic lupus erythematosus, Crohn's inflammatory bowel disease, or
psoriasis.
Potential Commercial Applications:
Targeted therapies for ABC DLBCL.
Combination cytotoxic chemotherapies for ABC DLBCL.
Treatment for other cancers or autoimmune/inflammatory
diseases that depend upon the function of RNF31 and RBCK1
combination.
Competitive Advantages:
Novel composition of inhibitors for ABC DLBCL.
Novel targeted drug to ABC DLBCL.
Effective therapies targeting at NF-kB pathway.
Development Stage:
Early-stage
In vitro data available
Inventors: Louis M. Staudt, Yibin Yang, Federico Bernal (all of
NCI)
Publication: Yang Y, et al. Essential Role of the Linear
Ubiquitin Chain Assembly Complex in Lymphoma Revealed by Rare
Germline Polymorphisms. Cancer Discov. 2014 Feb 3 (Epub ahead of
print). [PMID 24491438]
Intellectual Property: HHS Reference No. E-035-2013/0--US
Provisional Application No. 61/789,064 filed 15 March 2013
Licensing Contact: Sabarni Chatterjee, Ph.D., MBA; 301-435-5587;
chatterjeesa@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer
Institute is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize the inhibitors of the LUBAC ubiquitin
ligase for the therapy of lymphoma and autoimmune diseases. For
collaboration
[[Page 12514]]
opportunities, please contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
Mutation Based Control Plasmids for Standardizing Cancer Genomic
Diagnostic Assays
Description of Technology: To date, there are no widely accepted
standards and controls for multi-analyte based diagnostic assays.
The ability to compare the accuracy of different types of assay
results and to utilize in process controls is hampered by the lack
of availability of such standards/controls. Variations resulting
from different platforms, methodologies, and bioinformatics analyses
therefore create error in the interpretation of assay reports and
different results may occur when testing for the presence or absence
of specific gene mutations or biomarkers.
This technology includes a library of plasmids that can be used
to test for and control for accuracy, sensitivity, and specificity
and reproducibility within an assay and across different assays or
laboratories and platforms. These standards consist of normal human
reference genomic DNA that have engineered to contain known sequence
variations representing somatic mutations of interest to cancer
management. The plasmids contain approximately 1000 bases of human
sequence. Each inserted sequence carries a specific mutation of
interest within the appropriate genomic locus and a mutation
adjacent alien barcode. The plasmids can be mixed with non-mutant
genomes to create exact variant to normal allele frequencies for
limit of detection studies. The alien barcode unequivocally
indicates the detected mutation is from the plasmid spiked into a
test human specimen. If needed for certain applications the barcode
can be left out of design.
Potential Commercial Applications:
Quantified standards for scientists to compare, optimize
and/or validate assays
Assess specificity, sensitivity, accuracy and limit
detection of artifacts during assay development
Internal in process run controls to monitor assay
performance
Competitive Advantages:
Reference materials for comparing results of assays
performed by different platforms, operators, times, and sites
Ability to uniquely distinguish plasmid control mutations
spiked directly into unknown samples by alien barcode
No limit in the number and types of mutation plasmids
introduced into the test human specimen, unlike engineered cell line
genome based mutation controls
Easy design and manufacture process
Development Stage: In vitro data available
Inventors: Chih-Jian Lih, Paul Williams, David Sims, Michele
Mehaffey (all of NCI)
Publications: Manuscripts in preparation.
Intellectual Property: HHS Reference No. E-265-2012/0--Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: Jennifer Wong, M.S.; 301-435-4633;
wongje@mail.nih.gov
Collaborative Research Opportunity: The National Cancer
Institute, Cancer Diagnosis Program, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize Mutation
Based Control Plasmids for Standardizing Cancer Genomic Diagnostic
Assays. For collaboration opportunities, please contact John Hewes,
Ph.D. at john.hewes@nih.gov.
Use of Soluble CD27 as Potential Immunotherapy and a Diagnostic and
Prognostic Serum Biomarker for Solid Tumors
Description of Technology: The present invention discloses
methods for diagnosing a patient with a solid tumor or a
predisposition to developing a solid tumor, a patient's suitability
for immunotherapy and monitor disease progression in a patient
undergoing treatment for a solid tumor, such as a prostate or
colorectal tumor, by measuring the amount of soluble CD27 (sCD27)
present in a serum sample obtained from a patient and detecting the
amount of sCD27present in the serum sample. Additionally, sCD27 can
also be developed an immunotherapeutic product. Such product will
constitute the administration of a therapeutically effective amount
of sCD27 or a functional 15 fragment thereof that is capable of
stimulating a patient's immune system.
CD27 is a tumor necrosis factor receptor. A soluble form of CD27
(sCD27), is a 32-kD protein identical to the extracellular domain of
membrane-bound CD27. CD27's role in T cell activation has been
previously demonstrated.
Potential Commercial Applications:
Serum biomarker for diagnosis, prognosis and therapeutic
response.
Can potentially be developed into an immunotherapeutic
product.
Competitive Advantages:
Potentially can be used with clinically proven platforms.
Can be developed into a minimally invasive diagnostic test
using patient's blood sample.
Development Stage:
Early-stage
In vitro data available
Inventors: Jeffrey Schlom and Jianping Huang (NCI)
Publication: Huang J, et al. Soluble CD27-pool in humans may
contribute to T cell activation and tumor immunity. J Immunol. 2013
Jun 15;190(12):6250-8. [PMID 23677477]
Intellectual Property: HHS Reference No. E-005-2011/0--US Patent
Application No. 61/824,898 filed 17 May 2013
Licensing Contact: Sabarni Chatterjee, Ph.D., MBA; 301-435-5587;
chatterjeesa@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer
Institute, Laboratory of Metabolism, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize a non-
invasive assay for the detection of colorectal cancer. For
collaboration opportunities, please contact John D. Hewes, Ph.D. at
hewesj@mail.nih.gov.
The Use of alpha-4 beta-7 integrin Inhibitors To Inhibit HIV
Transmission and Infection
Description of Technology: This invention involves the use of
inhibitors of alpha-4 beta-7 ([alpha]4[beta]7) integrin to inhibit
HIV transmission/infection, as a prophylactic to inhibit onset of
the acute stage of HIV infection or to treat HIV infection. The
[alpha]4[beta]7 integrin inhibitors were previously developed for
use in other diseases, such as multiple sclerosis or inflammatory
bowel disease.
[alpha]4[beta]7 integrin is a multifaceted target for HIV
infection and recent studies indicate that it is important for
establishing HIV infection through multiple paths. Studies indicate
that: (1) CD4 T-cells present in vaginal and anal mucosa have high
levels of [alpha]4[beta]7 integrin, making CD4 T-cells permissive to
HIV infection; (2) [alpha]4[beta]7 integrin is important for cell to
cell transmission of HIV; (3) [alpha]4[beta]7 integrin is used to
dysregulate the host humoral response to HIV; and (4) HIV acts on
a4b7 integrin through an epitope in V2 loop of GP120, identified as
important for HIV vaccine protection. Additionally, primate studies
indicate that [alpha]4[beta]7 integrin inhibition of HIV infection
preserves gut-associated lymphoid tissue (GALT) generally destroyed
during the acute phase of HIV infection.
Potential Commercial Applications: Prevention and treatment of
HIV infection
Competitive Advantages:
[alpha]4[beta]7 integrin is a multifaceted target for HIV
infection
Previously developed [alpha]4[beta]7 integrin inhibitors
can be used for a new purpose
Development Stage:
Pre-clinical
In vitro data available
In vivo data available (animal)
Inventors: James Arthos, Claudia Cicala, Anthony S. Fauci, Diana
Goode (all of NIAID)
Publications:
1. Martinelli E, et al. The frequency of
[alpha]4[beta]7\high\ memory CD4\+\ T cells
correlates with susceptibility to rectal simian immunodeficiency
virus infection. J Acquir Immune Defic Syndr. 2013 Dec 1;64(4):325-
31. [PMID 23797688]
2. Nawaz F, et.al. The genotype of early-transmitting HIV gp120s
promotes [alpha]4[beta]7-reactivity, revealing
[alpha]4[beta]7\+\/CD4\+\ T cells as key
targets in mucosal transmission. PLoS Pathog. 2011
Feb;7(2):e1001301. [PMID 21383973]
3. Cicala C, et al. The integrin
[alpha]4[beta]7 forms a complex with cell-
surface CD4 and defines a T-cell subset that is highly susceptible
to infection by HIV-1. Proc Natl Acad Sci U S A. 2009 Dec
8;106(49):20877-82. [PMID 19933330]
4. Arthos J, et al. HIV-1 envelope protein binds to and signals
through integrin [alpha]4[beta]7, the gut
mucosal homing receptor for peripheral T cells. Nat Immunol. 2008
Mar;9(3):301-9. [PMID 18264102]
Intellectual Property:
HHS Reference No. E-055-2007/0--US Provisional Patent
Application No. 60/873,884 filed 07 Dec 2006
HHS Reference No. E-055-2007/1--US Provisional Patent
Application No. 60/920,880 filed 30 Mar 2007
[[Page 12515]]
HHS Reference No. E-055-2007/2--US Provisional Patent
Application No. 60/957,140 filed 21 Aug 2007
HHS Reference No. E-055-2007/3--PCT Patent Application No.
PCT/US2007/086663 filed 06 Dec 2007, which published as WO 2008/
140602 on 20 Nov 2008, and corresponding European Application No.
07874349.9; US Patent Application No. 12/518,035 filed 05 Jun 2009
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 is seeking statements of capability
or interest from parties interested in collaborative research to
further develop, evaluate or commercialize alpha-4 beta-7 integrin
inhibitors. For collaboration opportunities, please contact Bill
Ronnenberg, JD/MIP, MS at 301-451-3522 or wr78k@nih.gov.
Beta-Amyloid and Tau Fibril Positron Emissions Tomography (PET) Imaging
Agents
Description of Technology: The invention relates to two novel
classes of compounds useful as radioligands for in vivo imaging of
beta-amyloid fibrils, peptides and plaques in humans. Beta-amyloid
peptide deposition in the brain is a pathological feature of
Alzheimer's disease (AD). Early detection of beta-amyloid load in
patients with suspected AD is vital to initiating early treatment,
which can improve cognitive function and quality of life for many
patients. The invention describes novel derivatives of
imidazopyridinylbenzeneamine (IMPY) and benzothizolylbenzeneamine
(BTA), which demonstrate high in vitro binding affinity to human
beta-amyloid. The difference between existing IMPY compounds and the
novel derivatives is the substitution of an aryl halide with an aryl
thioether group and replacement of a sulfur group of the pyridine
ring with a nitrogen group. The new classes of compounds have the
potential of providing improved amyloid imaging agents for Positron
Emission Tomography (PET) with higher specificity for amyloid, low
background noise, better entry into the brain and improved labeling
efficiency.
Potential Commercial Applications:
Alzheimer's disease
Alzheimer's disease diagnostics
Alzheimer's disease early detection
Competitive Advantages: Specificity
Development Stage: In vitro data available
Inventors: Lisheng Cai, Victor W. Pike, Robert B. Innis (all of
NIMH)
Publications:
1. Nichols L, et al. Imaging and in vivo quantitation of beta-
amyloid: an exemplary biomarker for Alzheimer's disease? Biol
Psychiatry. 2006 May 15;59(10):940-7. [PMID 16487944]
2. Toyama H, et al. PET imaging of brain with the beta-amyloid
probe, [11C]6-OH-BTA-1, in a transgenic mouse model of Alzheimer's
disease. Eur J Nucl Med Mol Imaging. 2005 May;32(5):593-600. [PMID
15791432]
3. Cai L, et al. Synthesis and evaluation of two 18F-labeled 6-iodo-
2-(4'-N,N-dimethylamino)phenylimidazo[1,2-a]pyridine derivatives as
prospective radioligands for beta-amyloid in Alzheimer's disease. J
Med Chem. 2004 Apr 22;47(9):2208-18. [PMID 15084119]
Intellectual Property: HHS Reference No. E-156-2006/0--
US Patent Application 12/293,940 filed September 17, 2008
(allowed)
European Patent Application 07797254.5 filed April 19, 2007
(pending)
Related Technologies:
HHS Reference No. E-136-2008/0--``Beta Amyloid PET Imaging
Agents Based On 2-(4-phenyl)benzo[d]thiazole Derivatives''
HHS Reference Nos. E-225-2011/0 and/1--``Beta-amyloid PET
Imaging Agents Based On Benzothiazoles (BTA) Derivatives''
Licensing Contact: Michael Shmilovich, Esq., CLP; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Mental Health is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize Alzheimer's disease diagnostics. For
collaboration opportunities, please contact Suzanne Winfield, Ph.D.
at 301-402-4324.
Dated: February 27, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-04771 Filed 3-4-14; 8:45 am]
BILLING CODE 4140-01-P