Government-Owned Inventions; Availability for Licensing, 26294-26300 [2012-10637]
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assessments of knowledge be structured
to achieve valid, reliable, and
informative results; (2) how can surveys
be used to assess changes in patient and
prescriber behavior, burden to the
health care system, and patient access to
the drug; and (3) what are appropriate
alternatives to surveys to assess
educational components of REMS? Two
panel discussions will focus on areas in
which the Agency requests specific
input.
• Panel 1 will focus on using surveys
to assess knowledge. Topics will
include, but are not limited to,
recruiting a representative sample,
sample size, question design, process,
and endpoints.
• Panel 2 will focus on alternatives to
surveys and the use of surveys to assess
patient and prescriber behavior changes,
burden on the health care system, and
patient access to the drug. Topics will
include, but are not limited to,
recruiting a representative sample,
question design, interpretation of
results, and specific pros and cons of
the alternatives.
V. Transcripts
Please be advised that as soon as a
transcript of the workshop is available,
it will be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see Comments). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
Dated: April 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–10646 Filed 5–2–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
wreier-aviles on DSK7SPTVN1PROD with NOTICES
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
SUMMARY:
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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: 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.
Mouse Monoclonal Antibody Targeting
Human NOX1, a Target for Cancer and
Inflammation
Description of Technology: Available
for licensing is a mouse monoclonal
antibodies targeting human
nicotinamide adenine dinucleotide
phosphate-oxidase (NAPH) oxidase 1
(NOX1) enzyme. NOX mediates the
homeostasis of reactive oxygen species,
which play a critical regulatory role in
cancer cell signal transduction and
tumor cell differentiation. NOX1generated hydrogen peroxide can trigger
an ‘‘angiogenic switch’’ that includes
the induction of angiogenic factors that
promote tumor cell vascularization.
Additionally, NOX1 may play a role in
inflammation.
Investigators at the National Cancer
Institute found NOX1 is significantly
expressed more in colon and gastric
cancers compared with adjacent normal
bowel and gastric mucosa respectively.
To the best of NIH’s knowledge, this is
the only monoclonal antibody that can
be used to detect human NOX1. This
antibody detects endogenous levels of
the NOX1 protein and could potentially
be used in biochemical laboratory
studies as well as diagnostic tests that
involve the functional significance of
NOX1 in human physiology and
pathophysiology, particularly its role in
cancer and inflammation.
Potential Commercial Applications:
• Research tool to study cancer and
inflammation
• Method to diagnose colon and
gastric cancer
• Treatment for cancer and
inflammation
Competitive Advantages: To the best
of NIH’s knowledge, this is the only
available monoclonal antibody to detect
human NOX1.
Development Stage:
• Early-stage
• In vitro data available
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Inventors: James Doroshaw,
Krishnendu Roy, Guojian Jiang, Jiamo
Lu, and Smitha Antony (all of NCI).
Intellectual Property: HHS Reference
No. E–097–2012/0—Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Contact: Sabarni K.
Chatterjee, Ph.D.; 301–435–5587;
chatterjeesa@mail.nih.gov.
A Non-Invasive Post-Treatment
Strategy for Stroke by Intranasal
Delivery of Cocaine- and
Amphetamine-Regulated Transcript
(CART)
Description of Technology: Cocaine
and amphetamine-regulated transcript
(CART) is a neuropeptide known to
protect against ischemic brain injury
when administered before the onset of
stroke in mice, both in vivo and in vitro.
Utilizing a classic stroke model in
rodents, middle cerebral artery
occlusion (MCAo), inventors at NIDA
discovered a novel post-stroke
therapeutic approach involving the
intranasal administration of CART. This
new non-invasive treatment strategy for
stroke patients is effective when
initiated three days after stroke,
providing a longer treatment window.
Nasal delivery of CART improved
behavioral recovery and reduced
neurological scores in stroke animals.
CART, given after stroke, modifies
endogenous neural repair in stroke brain
by facilitating neuroprogenitor cell
proliferation and migration, enhancing
reinnervation, and improving the
functional recovery.
Potential Commercial Applications:
Method of treating stroke
Competitive Advantages:
• New treatment strategy for stroke
patients
• Non-invasive (nasal spray)
• Longer treatment window (3 days
post-stroke)
• Current strategies aim to protect
lesion site from damage, whereas this
method helps brain repair
Development Stage:
• Early-stage
• Pre-clinical
• In vitro data available
• In vivo data available (animal)
Inventors: Yun Wang, Hui Shen,
Seong Jin Yu, Yihong Yang (all of
NIDA).
Publications: Manuscript in
preparation.
Intellectual Property: HHS Reference
No. E–058–2012/0—U.S. Provisional
Application No. 61/592,761 filed 31 Jan
2012.
Licensing Contact: Betty B. Tong,
Ph.D.; 301–594–6565;
tongb@mail.nih.gov.
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Chimeric Antigen Receptors That
Recognize BCMA/CD269 for Treating
Multiple Myeloma
Description of Technology: Available
for licensing are chimeric antigen
receptors (CARs) that specifically target
B-cell maturation antigen (BCMA,
CD269), a protein that is highly
expressed on the surface of multiple
myeloma cells. Multiple myeloma is a
malignancy of plasma cells. It is almost
always incurable.
A CAR is a fusion protein that can
recognize a specific protein on a tumor
cell and activate an adaptive immune
response to attack the tumor cell. When
cultured with multiple myeloma cells in
vitro, T-cells engineered to express the
CARs were able to induce cell death in
the myeloma cells. CARs currently are
being evaluated in clinical trials as a
promising new area of cancer therapy.
The technology available for licensing
includes vectors incorporating the
CARs, as well as methods of destroying
multiple myeloma cells using T-cells
engineered to express a CAR.
Potential Commercial Applications:
• Development of a tumor-specific
T-cell treatment for multiple myeloma
• Development of a tumor-specific
T-cell treatment for Hodgkin’s
lymphoma
• Treatment of diseases associated
with increased or preferential
expression of BCMA/CD269
Competitive Advantages:
• Specifically targets an antigen that
is highly expressed in tumor cells of
multiple myeloma and Hodgkin’s
lymphoma
• Amenable for adoptive transfer
approaches
• No other anti-BCMA
immunotherapies are in clinical trials
• Targeted therapy decreases nonspecific killing of healthy, essential
cells, resulting in fewer non-specific
side-effects and healthier patients
Development Stage:
• Pre-clinical
• Clinical.
• In vitro data available.
Inventor: James N. Kochenderfer
(NCI).
Intellectual Property: HHS Reference
No. E–040–2012/0—U.S. Provisional
Application 61/622,600 filed 11 April
2012.
Related Technologies:
• HHS Reference No. E–205–2009/
0—Treating Cancer with Antiangiogenic Chimeric Antigen Receptors.
• HHS Reference No. E–148–2011/
0—Breakthrough Immunotherapy for
Brain Cancer: Epidermal Growth Factor
Receptor Variant III Chimeric Antigen
Receptors.
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• HHS Reference No. E–086–2006/
0—Hybrid T–Cell Receptors for the
Development of Improved Vaccines.
• HHS Reference No. E–265–2011/
0—Chimeric Antigen Receptors to CD22
for Treating Hematological Cancers.
Licensing Contact: Patrick McCue,
Ph.D.; 301–435–5560; mccuepat@mail.
nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute,
Experimental Transplantation and
Immunology Branch, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize chimeric antigen
receptors to genetically-modify T cells
to recognize BCMA/CD269. For
collaboration opportunities, please
contact John Hewes, Ph.D. at hewesj@
mail.nih.gov.
ROCK Inhibitors for the Prevention of
Breast Cancer Metastasis and Tumor
Relapse
Description of Technology: The recent
success of therapeutic approaches has
significantly reduced breast cancer
mortality, however, breast cancers that
are diagnosed as ‘‘triple-negative’’
(lacking the estrogen receptors, HER2/
Neu, and progesterone receptors) don’t
respond to these available therapies and
some hormone receptor or NER2/Neupositive breast cancers have shown a
resistance to these treatments. These
breast cancers account for nearly 90% of
all breast cancer deaths. Therefore,
examining the mechanisms by which
the breast cancer cells spread from their
primary sites to distant organs is an
active area of research. The NIH
inventors have discovered that by
blocking a key biochemical route
necessary for the egress of breast cancer
cells into circulation, the CXCR4Galpha13-Rho signaling pathway, they
can prevent the dissemination of breast
cancer cells and thereby prevent breast
cancer metastasis. In particular, they
have discovered that ROCK inhibitors,
such as Fasudil, can be used to treat of
breast cancer patients after the initial
clinical intervention (i.e., surgery,
radiation, chemo-radiation, or their
combination) to delay or prevent patient
relapse due to the metastasis of any
residual or prior undetected breast
cancer cells.
Potential Commercial Applications:
• Treatment of ‘‘triple-negative’’
breast cancers.
• Treatment of hormone receptor or
NER2/Neu-positive breast cancers that
are resistant to currently available
therapies.
Competitive Advantages: ROCK
inhibitors can delay or prevent breast
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cancer metastasis in patients where
there are no effective therapies currently
available.
Development Stage:
• Pre-clinical.
• In vitro data available.
• In vivo data available (animal)
Inventors: Silvio Gutkind and Alfredo
Molinolo (NIDCR).
Intellectual Property: HHS Reference
No. E–280–2011/0—U.S. Application
No. 61/536,434 filed 19 Sep 2011.
Licensing Contact: Whitney Hastings;
301–451–7337; hastingw@mail.nih.gov.
Cell Line for Producing Furin That Can
Cleave Papillomavirus L2, Toxins and
Other Substrates
Description of Technology: Human
papillomavirus (HPV) is an infectious
agent that is responsible for several
different diseases. Although HPV often
manifests as warts, it can also result in
certain types of cancer. Since HPV can
remain latent for long periods of time,
the disease can be transmitted by
someone who is not aware they are
contagious. This partially explains why
HPV is the most common sexually
transmitted disease. The HPV genome
consists of several genes, including the
two late-expressed genes known as L1
and L2. The HPV L1 and HPV L2 genes
encapsulate amplified HPV genomes
prior to their release in virions, which
infect other cells. Since HPV L2 is
present on the HPV virion when it is
released from a cell, people infected
with HPV will generate an immune
response against HPV L2 to help contain
the infection. This includes the
generation of neutralizing antibodies
against HPV L2. By examining a sample
for the presence of these neutralizing
antibodies, it can be determined
whether a patient has HPV and is
capable of spreading the disease.
This technology describes a Chinese
Hamster Ovary (CHO) cell line which
expresses a truncated version of mouse
furin which retains activity. Furin is an
enzyme that cleaves proteins at a
specific, defined amino acid sequence.
The cleavage of HPV L2 makes it more
susceptible to detection by neutralizing
antibodies. As a result, the cell line can
increase the sensitivity of an assay for
detecting neutralizing antibodies to HPV
L2.
Potential Commercial Applications:
• The cell line secretes a truncated
mouse furin for use in any assays which
benefit from furin activity.
• A specific use for the cell line is
testing samples for neutralizing
antibodies to HPV L2.
• The cells can be developed into a
validated assay for detecting
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neutralizing antibodies to HPV L2 as a
means of diagnosing HPV infection.
Competitive Advantages:
• Neutralizing antibodies to HPV L2
are more readily detected when the
protein is first cleaved by furin.
• The cell lines represent an
established and efficient research tool
for cleaving HPV L2 for more efficient
detection of neutralizing antibodies to
the protein.
• An assay for detecting HPV
infection can be useful for detecting
those who are asymptomatic, which is
common with HPV infections.
Development Stage: In vitro data
available.
Inventors: David FitzGerald et al.
(NCI)
Publications:
1. Chiron MF, et al. Furin-mediated
cleavage of Pseudomonas exotoxinderived chimeric toxins. J Biol Chem.
1997 Dec 12;272(50):31707–11. [PMID
9395513]
2. Richards RM, et al. Cleavage of the
papillomavirus minor capsid protein,
L2, at a furin consensus site is necessary
for infection. Proc Natl Acad Sci U.S.A.
2006 Jan 31;103(5):1522–7. [PMID
16432208]
3. Day PM, Schiller JT. The role of
furin in papillomavirus infection.
Future Microbiol. 2009 Dec;4(10):1255–
62. Review. [PMID 19995186]
Intellectual Property: HHS Reference
No. E–233–2011/0—Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Contact: David A.
Lambertson, Ph.D.; 301–435–4632;
lambertsond@mail.nih.gov
Novel Reduced Toxicity Tropolone
Derivative Compounds That Have AntiViral Activity Through Inhibiting
RNase H Activity
Description of Technology: Several
novel tropolone derivatives have been
identified that inhibit HIV–1 RNase H
function and have potential for antiviral activity due to reduced cellular
toxicity. Inhibiting RNase H function is
a potential treatment for many viral
infections, since RNase H function is
essential for viral replication for many
pathogenic retroviruses such as HIV–1
and HIV–2. Although many
hydroxytropolone compounds are
potent RNase H inhibitors biding at the
enzymatic active site, they are limited as
therapeutic candidates by their toxicity
in mammalian cells. The toxicity
thought to be a result of inhibition of
multiple essential mammalian
metalloenzymes. We reasoned that the
potential beneficial application of
tropolone RNase H inhibition might be
of therapeutic use if the toxic effects in
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mammalian cell were eliminated. By
selectively adding steric bulk to add
new drug-enzyme contacts for the
RNase H active site, a number of novel
compounds, that have initially
demonstrated reduced cytotoxicity,
have been produced. Importantly, these
novel compounds appear to retain
antiviral activity essential for use as
therapeutics.
Potential Commercial Applications:
Anti-viral therapeutic: HIV–1 and other
RNase H-dependent viral infections
Competitive Advantages:
• Potentially reduced toxicity
• Availability of x ray
crystallographic information to guide
analog design
Development Stage:
• Pre-clinical
• In vitro data available
Inventors: John Beutler, Suhman
Chung, Stuart F. LeGrice, Jennifer A.
Wilson (NCI); Craig J. Thomas and Jiankang Jiang (NCATS)
Publications:
1. Chung S, et al. Synthesis, activity
and structural analysis of novel alphahydroxytropolone inhibitors of human
immunodeficiency virus reverse
transcriptase-associated ribonuclease H.
J Med Chem 2011 Jul 14;54(13):4462–
4473. [PMID 21568335]
2. Budihas SR, et al. Selective
inhibition of HIV–1 reverse
transcriptase-associated ribonuclease H
activity by hydroxylated tropolones.
Nucl Acids Res 2005 33 (4):1249–1256.
[PMID 15741178]
Intellectual Property: HHS Reference
No. E–081–2011/0 — U.S. Provisional
Application No. 61/484,779 filed 11
May 2011
Licensing Contact: Edward ‘‘Tedd’’
Fenn, J.D.; 301–435–5031;
fenned@mail.nih.gov
Collaborative Research Opportunity:
The Molecular Targets Laboratory,
National Cancer Institute, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize antiviral tropolone
derivatives developed by systematic
medicinal chemistry on the lead series.
For collaboration opportunities, please
contact John Hewes, Ph.D. at
hewesj@mail.nih.gov.
Hspa2 Knockout Mice for Study of
Spermatogenesis and Male Infertility
Description of Technology: HSPA2 is
a member of the HSP70 family of heatshock proteins that serve as molecular
chaperones. Researchers discovered that
HSPA2 protein is expressed in
spermatogenesis during the meiotic
phase. Spermatogenic cells lacking the
HSPA2 protein arrest in mid-meiosis
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and undergo apoptosis. HSPA2 is
present in the synaptonemal complex of
wild-type mice and the chromosomes
fail to separate in HSPA2-deficient mice
(previously known as Hsp70–2-/-mice),
suggesting that HSPA2 is required for
the chromosomal events of meiosis such
as synapsis, crossing over, or
recombination.
Researchers at NIEHS developed a
knockout strain of mice in which the
heat shock protein gene (Hspa2) is
disrupted. This mouse model is useful
in studying the process of
spermatogenesis and the influence of
various environmental toxins or drugs
on sperm production and male
infertility.
Potential Commercial Applications:
• Mouse model to study
spermatogenesis and male infertility
• Mouse model to study meiosis or
the roles of heat-shock proteins in
general
• Mouse model to evaluate effects of
meiosis-disrupting agents on meiotic
recombination and generation of
mutations transmitted to offspring
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventor: Edward M. Eddy (NIEHS)
Publication: Dix DJ, et al. Targeted
gene disruption of Hsp70–2 results in
failed meiosis, germ cell apoptosis, and
male infertility. Proc Natl Acad Sci
USA. 1996 Apr 93(8):3264–3268. [PMID
8622925]
Intellectual Property: HHS Reference
No. E–052–2011/0—Research Tool.
Patent protection is not being pursued
for this technology.
Related Technology: HHS Reference
No. E–290–2011/0—Research Tool
(Transgenic Hspa2-Cre Mice for
Studying Spermatogenesis and Male
Infertility). Patent protection is not
being pursued for this technology.
Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074;
Lauren.Nguyen-Antczak@nih.gov
Collaborative Research Opportunity:
The NIEHS is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize this mouse strain. For
collaboration opportunities, please
contact Elizabeth Denholm, Ph.D. at
denholme@niehs.nih.gov.
Transgenic Hspa2-Cre Mice for
Studying Spermatogenesis and Male
Infertility
Description of Technology: HSPA2 is
a member of the HSP70 family of heatshock proteins that serve as molecular
chaperones. Hspa2-cre expression
mimics the spermatogenic cell-specific
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expression of endogenous HSPA2
within the testis, being first observed in
leptotene/zygotene spermatocytes.
Expression of the transgene is also
detected at restricted sites in the brain,
as occurs for endogenous HSPA2.
Researchers at NIEHS developed the
first transgenic mouse line that
expresses Cre-recombinase under the
control of the promoter of the heat
shock protein A2 (Hspa2) gene.
Expression of the Hspa2-Cre transgene
during meiosis in male germ cells makes
these mice a useful tool for defining the
roles of genes expressed at different
times during spermatogenesis or
expressed in spermatogenic cells.
Potential Commercial Applications:
• New mouse model to study
spermatogenesis and male infertility
• New mouse model to study meiosis
or the roles of heat-shock proteins in
general
Competitive Advantages: Researchers
generated an Hspa2-cre line that
expresses cre in spermatocytes to
overcome the limitations of other
transgenic lines.
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventor: Edward M. Eddy (NIEHS)
Publication: Inselman AL, et al. Heat
shock protein 2 promoter drives cre
expression in spermatocytes of
transgenic mice. Genesis. 2010 Feb
48(2):114–120. [PMID 20027617]
Intellectual Property: HHS Reference
No. E–290–2011/0—Research Tool.
Patent protection is not being pursued
for this technology.
Related Technology: HHS Reference
No. E–052–2011/0—Research Tool
(Hspa2 Knockout Mice for Study of
Spermatogenesis and Male Infertility).
Patent protection is not being pursued
for this technology.
Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074;
Lauren.Nguyen-Antczak@nih.gov
Collaborative Research Opportunity:
The NIEHS is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize this mouse strain. For
collaboration opportunities, please
contact Elizabeth Denholm, Ph.D. at
denholme@niehs.nih.gov.
Diagnostic H5N1 Avian Influenza Virus
Peptides
Description of Technology: The recent
spread of highly pathogenic H5N1 avian
influenza viruses among poultry and
transmission of these viruses to humans
raises concerns of a potential influenza
pandemic. There is a need to track the
spread of these viruses both in the
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animal and human populations to avert
or reduce the impact of any potential
influenza pandemic as well as to know
the actual number (accurate
surveillance) of people infected with
H5N1, including individuals with
subclinical H5N1 infection.
The subject technology is a specific
combination of H5N1 peptides useful
for assays to detect antibodies generated
against a wide range of different H5N1
strains. The combination of peptides
was able to specifically detect antiH5N1 antibodies from serum samples of
H5N1 survivors at early and later times
post infection while excluding
antibodies generated in individuals
infected with other strains of influenza
virus. Also, the peptides did not react
with sera from individuals vaccinated
with H5N1 vaccine, in contrast to the
strain-specific detection of anti-H5N1
antibodies in sera from infected
individuals. Immunoassays using the
H5N1 peptide combination provide
highly specific, sensitive and
reproducible methods for diagnosing
H5N1 infection in humans and animals.
Potential Commercial Applications:
Diagnostics for influenza virus specific
antibodies in humans and animals.
Competitive Advantages: High
specificity, sensitivity, and
reproducibility
Development Stage:
• Pre-clinical
• In vitro data available
Inventors: Hana Golding and Surender
Khurana (FDA)
Publication: Khurana S, et al. H5N1–
SeroDetect EIA and rapid test: a novel
differential diagnostic assay for
serodiagnosis of H5N1 infections and
surveillance. J Virol. 2011
Dec;85(23):12455–63. [PMID 21957281]
Patent Status: HHS Reference No. E–
093–2010/0 — PCT Application No.
PCT/US2011/032555 filed 14 Apr 2011,
which published as WO 2011/130555
on 20 Oct 2011
Related Technology: HHS Reference
No. E–236–2007/3 — U.S. Patent
Application No. 12/664,052 filed 10 Dec
2009
Licensing Contact: Kevin W. Chang,
Ph.D.; 301–435–5018;
changke@mail.nih.gov
Parvovirus B19 Codon Optimized
Structural Proteins for Vaccine and
Diagnostic Applications
Description of Technology: Parvovirus
B19 (B19V) is the only known
pathogenic human parvovirus. Infection
by this viral pathogen can cause
transient aplastic crisis in individuals
with high red cell turnover, pure red
cell aplasia in immunosuppressed
patients, and hydrops fetalis during
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pregnancy. In children, B19V most
commonly causes erythema
infectiosum, or fifth’s disease. Infection
can also cause arthropathy and
arthralgia. The virus is very
erythrotropic, targeting human erythroid
(red blood) progenitors found in the
blood, bone marrow, and fetal liver.
Currently, there are no approved
vaccines or antiviral drugs for the
treatment or prevention of B19V
infection.
The subject technology is a series of
plasmid constructs with codon
optimized B19 viral capsid genes (VP1
and VP2) that can be expressed in
mammalian cells. Transfection of
vectors encoding these optimized VP1
and VP2 genes into different
mammalian cell lines, including 293,
Cos7, and Hela cells produce virus-like
particles (VLPs). The vectors include
bicistronic plasmids expressing the VP1
and VP2 proteins at different ratios to
produce B19V VLPs with optimal
antigenicity for vaccine applications.
This technology can also be used for
diagnostic applications and
development of a viral packaging system
for producing infectious B19V virus.
Potential Commercial Applications:
• VLPs based vaccines for the
prevention and/or treatment of B19V
infection
• DNA based vaccines for the
prevention and/or treatment of B19V
infection
• B19V diagnostics
• Viral packaging system
Competitive Advantages:
• Codon optimized VP1 and VP2
genes for better expression in
mammalian cell lines
• Expression of B19V VLPs from
‘‘nonpermissive’’ cell lines
Development Stage: In vitro data
available
Inventors: Ning Zhi, Sachiko Kajigaya,
and Neal S. Young (NHLBI)
Patent Status: HHS Reference No. E–
011–2010/0—PCT Application No. PCT/
US2011/024199 filed 09 Feb 2011,
which published as WO 2011/100330
on 22 Dec 2011
Licensing Contact: Kevin W. Chang,
Ph.D.; 301–435–5018;
changke@mail.nih.gov
Collaborative Research Opportunity:
The National Heart Lung and Blood
Institute, Hematology Branch, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize the subject technology.
Please contact Cecilia Pazman, Ph.D., at
pazmance@mail.nih.gov for more
information.
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Construct for Tetracycline Inducible
Podocyte Specific Gene Expression in
Mice
Description of Technology: The
National Institutes of Health announces
the generation of a construct by ligating
2.5kb human podocin promoter
sequence to gene encoding reverse
tetracycline-controlled transcriptional
activator which enables tetracyclineinducible podocyte specific gene of
interest expression with another
construct consisting of tetracycline
responsive element, minimal CMV
promoter and gene of interest.
Podocytes are post-mitotic epithelial
cells that are positioned on the exterior
aspect of the glomerular capillary wall
and contribute to the selective
molecular permeability of glomeruli.
Podocyte damage or dysfunction results
in loss of the characteristic foot
processes that normally interdigitate
and form the selective permeability
barriers composed of filtration slits
bridged by slit diaphragms. Minimal
damage causes proteinuria that in the
case of minimal change disease can be
reversed by steroid treatment. In focal
segmental glomerulosclerosis, more
severe loss of podocytes ultimately
results in glomerulosclerosis. The
podocyte-specific inducible transgene
system can be used to identify factors
that exacerbate or ameliorate podocyte
injury, and can be used to express Crerecombinase.
Potential Commercial Applications:
This technology can be used for the
study of renal disease.
Competitive Advantages: The
podocyte-specific inducible transgene
system can be used to identify factors
that exacerbate or ameliorate podocyte
injury, and can be used to express Crerecombinase.
Development Stage: Pre-clinical
Inventors: Jeffrey B. Kopp et al.
(NIDDK)
Publication: Shigehara T, et al.
Inducible podocyte-specific gene
expression in transgenic mice. J Am Soc
Nephrol. 2003 Aug;14(8):1998–2003.
[PMID 12874453]
Intellectual Property: HHS Reference
No. E–299–2007/0 — Research Material.
Patent protection has not been pursued
for this technology.
Note: The use of Tetracycline controllable
expression systems is covered by a series of
patents including US #5,464,758 and
5,814,618 which are proprietary to TET
systems GmbH & Co. KG. Interested parties
are also advised to contact TET Systems,
info@tetsystems.com or by electronic request
at www.tetsystems.com/main_inquiry.htm]
Licensing Contact: Fatima Sayyid,
M.H.P.M.; 301–435–4521;
Fatima.Sayyid@nih.hhs.gov
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Parallel High Speed Single Molecule
Nucleic Acid Sequencing
Description of Technology: This
invention entails a new system,
methods, and compositions for DNA
sequencing, known as Two Dye
Sequencing (TDS). The system utilizes
Forster Resonance Energy Transfer
(FRET). The TDS method consists of the
following steps:
(1) Attaching to a microscope
chamber, DNA polymerases labeled
with a donor fluorophore.
(2) Adding to the chamber DNA
molecules annealed to a primer.
(3) Adding four dNTPs, each labeled
with a different fluorescent acceptor
dye.
(4) Exciting the donor fluorophore
with light, causing energy transfer
(FRET) to the acceptor fluorophore for a
given dNTP, that then radiates light of
a different wavelength.
(5) Identifying nucleotides as they are
added to the nascent polynucleotide by
recording the FRET signals at the
location of each DNA polymerase in the
microscope field of view.
(6) Converting the sequential signals
into a DNA sequence for each DNA
molecule in the microscope field of
view.
Potential Commercial Applications:
High throughput sequencing of single
DNA molecules on a substrate.
Competitive Advantages:
• Detection of individual DNA
molecule sequences
• Sequences multiple DNA molecules
in parallel with one microscope
• Eliminates washing steps, because
all four nucleotides are added at once
• Rapid, works at the speed of the
DNA polymerase
Development Stage: Early-stage
Inventors: Thomas D. Schneider and
Denise Rubins (NCI)
Intellectual Property: HHS Reference
No. E–033–1999/0 —
• US Patent No. 6,982,146 issued 03
Jan 2006
• PCT Application No. PCT/US00/
23736 filed 29 Aug 2000
• US Application No. 12/886,686
filed 29 Aug 2000
Related Technologies: HHS Reference
No. E–194–2005/0 —
• US Patent No. 7,871,777 issued 18
Jan 2011
• EP Patent No. 1960550 issued 15
Sep 2010, validated in DE, FR, and GB
• JP Application No. 2009–545768
filed 12 Dec 2006
• US Application No. 12/980,802
filed 29 Dec 2010
Licensing Contact: Cristina
Thalhammer-Reyero, Ph.D., MBA; 301–
435–4507; thalhamc@mail.nih.gov
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The MedusaTM; Sequencer: A DNA or
RNA Sequencing Machine the Size of a
Molecule
Description of Technology: Current
high-throughput DNA sequencing
methods suffer from several limitations.
Many methods require multiple fluid
handling steps, fixing of molecules on
beads or a 2D surface, and provide very
short read-lengths. The NIH inventors
offer a DNA or RNA sequencing device
that drastically simplifies the process by
combining all elements for sequence
detection in a single molecule, the
MedusaTM; Sequencer.
The MedusaTM; Sequencer utilizes
Forster Resonance Energy Transfer
(FRET) to read a polynucleotide
sequence while synthesizing a
complementary strand. The device
consists of a DNA (or RNA) polymerase
labeled with a FRET donor fluorophore
and attached to a set of four flexible
arms. The tip of each arm carries a
distinct set including one
nonhydrolyzable nucleotide and one
FRET acceptor fluorophore. While a
MedusaTM; Sequencer synthesizes a
complementary polynucleotide strand,
the four different arms continuously
‘‘test’’ the polymerase pocket creating a
characteristic FRET signal for the
correct nucleotide. The series of FRET
signals reveals the unknown
polynucleotide sequence.
Potential Commercial Applications:
• High-throughput DNA or RNA
sequencing
• Alternative to microarrays for
expression analysis
• Diagnostics of genetic diseases
Competitive Advantages:
• Single reagent for synthesis and
sequencing
• Eliminates repetitive fluid handling
steps
• Able to count single mRNA or DNA
molecules
• Exceptionally low manufacturing
cost
• Could be injected in living cells to
read/count mRNA sequences directly
• Low error rate per base
• High speed; one microscope obtains
many sequences in parallel
• Can be 3D-arrayed in a gel for ultrahigh density
• Use with Sequence Walkers for
diagnostics (https://alum.mit.edu/www/
toms/g863a.html)
Development Stage: Early-stage
Inventors: Thomas D. Schneider, IIya
G. Lyakhov, Danielle Needle (NCI)
Publication: The technology is further
described at https://alum.mit.edu/www/
toms/patent/medusa.
Intellectual Property: HHS Reference
No. E–194–2005/0 —
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• US Patent No. 7,871,777 issued 18
Jan 2011
• EP Patent No. 1960550 issued 15
Sep 2010, validated in DE, FR, and GB
• JP Application No. 2009–545768
filed 12 Dec 2006
• US Application No. 12/980,802
filed 29 Dec 2010
Related Technologies:
HHS Reference No. E–195–2005/0 —
• US Application No. 60/749,858
filed 12 Dec 2005
• US Application No. 11/638,160
filed 12 Dec 2006
HHS Reference No. E–033–1999/0 —
• US Patent No. 6,982,146 issued 03
Jan 2006
• PCT Application No. PCT/US00/
23736 filed 29 Aug 2000
• US Application No. 12/886,686
filed 29 Aug 2000
Licensing Contact: Cristina
Thalhammer-Reyero, Ph.D., MBA; 301–
435–4507; thalhamc@mail.nih.gov
Collaborative Research Opportunity:
The National Cancer Institute, Gene
Regulation and Chromosome Biology
Laboratory, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize the MedusaTM;
Sequencer. For collaboration
opportunities, please contact John
Hewes, Ph.D. at hewesj@mail.nih.gov.
Nanoprobes for Detection or
Modification of Molecules
Description of Technology: This
invention describes ‘‘Rod-tether
Nanoprobes’’, devices consisting of a
rigid molecular rod with a flexible
molecular tether attached at both ends
that can detect and/or modify
molecules. Each tether tip has a
functional group, such as an antibody or
oligonucleotide that recognizes a target
molecule. In addition, one tip carries a
donor fluorophore and the other carries
an acceptor fluorophore. The
fluorophores form a pair for Forster
Resonance Energy Transfer (FRET). In
the absence of the target molecule, the
rod keeps the tether arms apart, while
in the presence of the target molecule,
both recognizers bind to the target. This
binding holds the donor and acceptor
fluorophores close together, allowing a
FRET signal. By reducing an ELISA-like
assay entirely to the molecular level,
complex macroscopic or microfluidic
washing and pumping systems can be
eliminated. Rod-tether Nanoprobes can
detect a wide variety of clinical and
biowarfare reagents. The nanoprobes
can also rapidly and simply detect,
modify, and/or destroy endogenous
molecules (e.g., proteins, mRNA)
involved in a broad range of diseases.
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The simplest ssDNA-detecting
nanoprobe has been created.
Potential Commercial Applications:
• Instantly detect molecules of
interest (e.g., proteins, mRNA) in
multiple settings:
—Clinical
—Scientific research
—Biowarfare
• An improved substitute for ELISA
assays
• Modify or destroy target molecules,
while detecting them
• Detect genetic diseases in the clinic
from patient blood samples
Competitive Advantages:
• Only one reagent required for
detection
• Entire reaction contained in a single
molecule
• Eliminates washing steps
• Complicated and expensive
microfluidic chips are eliminated
• High speed
• Exceptionally low cost
Development Stage: Early-stage
Inventors: Thomas D. Schneider, IIya
G. Lyakhov, Danielle Needle (NCI)
Publication: The technology is further
described at https://alum.mit.edu/www/
toms/patent/nanoprobe/.
Intellectual Property: HHS Reference
No. E–195–2005/0—
• US Application No. 60/749,858
filed 12 Dec 2005
• US Application No. 11/638,160
filed 12 Dec 2006
Related Technologies: HHS Reference
No. E–194–2005/0—
• US Patent No. 7,871,777 issued 18
Jan 2011
• EP Patent No. 1960550 issued 15
Sep 2010, validated in DE, FR, and GB
• JP Application No. 2009–545768
filed 12 Dec 2006
• US Application No. 12/980,802
filed 29 Dec 2010
Licensing Contact: Cristina
Thalhammer-Reyero, Ph.D., MBA; 301–
435–4507; thalhamc@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute, Gene
Regulation and Chromosome Biology
Laboratory, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize Rod-Tether Nanoprobes.
For collaboration opportunities, please
contact John Hewes, Ph.D. at hewesj@
mail.nih.gov.
Immunogenic Peptides (Vaccines) for
the Treatment of Prostate and Breast
Cancer
Description of Technology:
Collectively, cancer is the second
leading cause of death in the United
States. Current treatments of cancer
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26299
often involve non-specific strategies
(such as chemotherapy) which attack
healthy cells as well as diseased cells,
leading to harmful side-effects. As a
result, the development of more targeted
means of treating cancer are highly
sought. One option for a targeted
treatment is the creation of a vaccine
that induces an immune response only
against cancer cells. In this sense,
vaccination involves the introduction of
a peptide into a patient that causes the
formation of T cells that recognize the
peptide. If those recognize a peptide
found in a protein found selectively on
cancer cells, those T cells can trigger the
death of those cancer cells without
harming non-cancer cells. This can
result in fewer side effects for the
patient. TARP (T cell receptor gamma
alternate reading frame protein) is a
protein that is selectively expressed on
the cells of certain types of prostate and
breast cancer. This invention concerns
the identification of immunogenic
peptides within TARP, and their use to
create an anti-cancer immune response
in patients. By introducing these
peptides into a patient, an immune
response against these cancer cells can
be initiated by the peptides, resulting in
treatment of the cancer. A phase I
clinical trial in stage D0 prostate cancer
patients is nearing completion. Initial
results indicate a statistically significant
decrease in the slope of PSA for 48
weeks after vaccination.
Potential Commercial Applications:
• Peptides can be used as cancer
vaccines.
• Treatment of any cancer associated
with increased or preferential
expression of TARP.
• Specific diseases include breast
cancer and prostate cancer.
Competitive Advantages: Targeted
therapy decreases non-specific killing of
healthy, essential cells, resulting in
fewer non-specific side-effects and
healthier patients.
Development Stage:
• Pre-clinical
• Clinical
• In vivo data available (animal)
• In vivo data available (human)
Publications:
1. Epel M, et al. Targeting TARP, a
novel breast and prostate tumorassociated antigen, with T cell receptorlike human recombinant antibodies. Eur
J Immunol. 2008 Jun;38(6):1706–1720.
[PMID 18446790]
2. Oh S, et al. Human CTLs to wildtype and enhanced epitopes of a novel
prostate and breast tumor-associated
protein, TARP, lyse human breast
cancer cells. Cancer Res. 2004 Apr
1;64(7):2610–2618. [PMID 15059918]
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Intellectual Property: HHS Reference
No. E–116–2003/0—
• US Patent 7,541,035 issued 02 Jun
2009
• US Patent 8,043,623 issued 25 Oct
2011
Licensing Contact: David A.
Lambertson, Ph.D.; 301–435–4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute, Vaccine
Branch, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize a prostate cancer vaccine
targeting the TARP antigen currently
completing phase I clinical trials. For
collaboration opportunities, please
contact John Hewes, Ph.D. at hewesj@
mail.nih.gov.
Dated: April 27, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–10637 Filed 5–2–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
wreier-aviles on DSK7SPTVN1PROD with NOTICES
National Institute of Environmental
Health Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, NIEHS.
The meeting will be open to the
public as indicated below, 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.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute of Environmental
Health Sciences, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NIEHS.
VerDate Mar<15>2010
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Date: June 3–5, 2012.
Closed: June 3, 2012, 7:00 p.m. to 10:00
p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Doubletree Guest Suites, 2515
Meridian Parkway, Research Triangle Park,
NC 27713.
Open: June 4, 2012, 8:30 a.m. to 11:50 a.m.
Agenda: An overview of the organization
and research in the Laboratory of Structural
Biology.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Closed: June 4, 2012, 11:50 a.m. to 12:35
p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Open: June 4, 2012, 1:30 p.m. to 3:00 p.m.
Agenda: Scientific Presentations and
Poster Sessions.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Closed: June 4, 2012, 3:15 p.m. to 3:45 p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Open: June 4, 2012, 3:45 p.m. to 5:25 p.m.
Agenda: Scientific Presentations.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Closed: June 4, 2012, 5:30 p.m. to 6:00 p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Closed: June 4, 2012, 8:00 p.m. to 10:00
p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Doubletree Guest Suites, 2515
Meridian Parkway, Research Triangle Park,
NC 27713.
Open: June 5, 2012, 8:30 a.m. to 10:10 a.m.
Agenda: Scientific Presentations.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Closed: June 5, 2012, 10:25 a.m. to 1:00
p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Contact Person: Darryl Zeldin, M.D.,
Scientific Director & Principal Investigator,
Division of Intramural Research, National
Institute of Environmental Health Sciences,
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NIH, 111 TW Alexander Drive, Maildrop A2–
09, Research Triangle Park, NC 27709, 919–
541–1169, zeldin@niehs.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS).
Dated: April 26, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–10729 Filed 5–2–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Gastrointestinal Pathophysiology.
Date: May 17, 2012.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Patricia Greenwel, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2178,
MSC 7818, Bethesda, MD 20892, 301–435–
1169, greenwep@csr.nih.gov.
E:\FR\FM\03MYN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 86 (Thursday, May 3, 2012)]
[Notices]
[Pages 26294-26300]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10637]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
FOR FURTHER INFORMATION: 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.
Mouse Monoclonal Antibody Targeting Human NOX1, a Target for Cancer and
Inflammation
Description of Technology: Available for licensing is a mouse
monoclonal antibodies targeting human nicotinamide adenine dinucleotide
phosphate-oxidase (NAPH) oxidase 1 (NOX1) enzyme. NOX mediates the
homeostasis of reactive oxygen species, which play a critical
regulatory role in cancer cell signal transduction and tumor cell
differentiation. NOX1-generated hydrogen peroxide can trigger an
``angiogenic switch'' that includes the induction of angiogenic factors
that promote tumor cell vascularization. Additionally, NOX1 may play a
role in inflammation.
Investigators at the National Cancer Institute found NOX1 is
significantly expressed more in colon and gastric cancers compared with
adjacent normal bowel and gastric mucosa respectively. To the best of
NIH's knowledge, this is the only monoclonal antibody that can be used
to detect human NOX1. This antibody detects endogenous levels of the
NOX1 protein and could potentially be used in biochemical laboratory
studies as well as diagnostic tests that involve the functional
significance of NOX1 in human physiology and pathophysiology,
particularly its role in cancer and inflammation.
Potential Commercial Applications:
Research tool to study cancer and inflammation
Method to diagnose colon and gastric cancer
Treatment for cancer and inflammation
Competitive Advantages: To the best of NIH's knowledge, this is the
only available monoclonal antibody to detect human NOX1.
Development Stage:
Early-stage
In vitro data available
Inventors: James Doroshaw, Krishnendu Roy, Guojian Jiang, Jiamo Lu,
and Smitha Antony (all of NCI).
Intellectual Property: HHS Reference No. E-097-2012/0--Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: Sabarni K. Chatterjee, Ph.D.; 301-435-5587;
chatterjeesa@mail.nih.gov.
A Non-Invasive Post-Treatment Strategy for Stroke by Intranasal
Delivery of Cocaine- and Amphetamine-Regulated Transcript (CART)
Description of Technology: Cocaine and amphetamine-regulated
transcript (CART) is a neuropeptide known to protect against ischemic
brain injury when administered before the onset of stroke in mice, both
in vivo and in vitro. Utilizing a classic stroke model in rodents,
middle cerebral artery occlusion (MCAo), inventors at NIDA discovered a
novel post-stroke therapeutic approach involving the intranasal
administration of CART. This new non-invasive treatment strategy for
stroke patients is effective when initiated three days after stroke,
providing a longer treatment window. Nasal delivery of CART improved
behavioral recovery and reduced neurological scores in stroke animals.
CART, given after stroke, modifies endogenous neural repair in stroke
brain by facilitating neuroprogenitor cell proliferation and migration,
enhancing reinnervation, and improving the functional recovery.
Potential Commercial Applications: Method of treating stroke
Competitive Advantages:
New treatment strategy for stroke patients
Non-invasive (nasal spray)
Longer treatment window (3 days post-stroke)
Current strategies aim to protect lesion site from damage,
whereas this method helps brain repair
Development Stage:
Early-stage
Pre-clinical
In vitro data available
In vivo data available (animal)
Inventors: Yun Wang, Hui Shen, Seong Jin Yu, Yihong Yang (all of
NIDA).
Publications: Manuscript in preparation.
Intellectual Property: HHS Reference No. E-058-2012/0--U.S.
Provisional Application No. 61/592,761 filed 31 Jan 2012.
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
tongb@mail.nih.gov.
[[Page 26295]]
Chimeric Antigen Receptors That Recognize BCMA/CD269 for Treating
Multiple Myeloma
Description of Technology: Available for licensing are chimeric
antigen receptors (CARs) that specifically target B-cell maturation
antigen (BCMA, CD269), a protein that is highly expressed on the
surface of multiple myeloma cells. Multiple myeloma is a malignancy of
plasma cells. It is almost always incurable.
A CAR is a fusion protein that can recognize a specific protein on
a tumor cell and activate an adaptive immune response to attack the
tumor cell. When cultured with multiple myeloma cells in vitro, T-cells
engineered to express the CARs were able to induce cell death in the
myeloma cells. CARs currently are being evaluated in clinical trials as
a promising new area of cancer therapy. The technology available for
licensing includes vectors incorporating the CARs, as well as methods
of destroying multiple myeloma cells using T-cells engineered to
express a CAR.
Potential Commercial Applications:
Development of a tumor-specific T-cell treatment for
multiple myeloma
Development of a tumor-specific T-cell treatment for
Hodgkin's lymphoma
Treatment of diseases associated with increased or
preferential expression of BCMA/CD269
Competitive Advantages:
Specifically targets an antigen that is highly expressed
in tumor cells of multiple myeloma and Hodgkin's lymphoma
Amenable for adoptive transfer approaches
No other anti-BCMA immunotherapies are in clinical trials
Targeted therapy decreases non-specific killing of
healthy, essential cells, resulting in fewer non-specific side-effects
and healthier patients
Development Stage:
Pre-clinical
Clinical.
In vitro data available.
Inventor: James N. Kochenderfer (NCI).
Intellectual Property: HHS Reference No. E-040-2012/0--U.S.
Provisional Application 61/622,600 filed 11 April 2012.
Related Technologies:
HHS Reference No. E-205-2009/0--Treating Cancer with Anti-
angiogenic Chimeric Antigen Receptors.
HHS Reference No. E-148-2011/0--Breakthrough Immunotherapy
for Brain Cancer: Epidermal Growth Factor Receptor Variant III Chimeric
Antigen Receptors.
HHS Reference No. E-086-2006/0--Hybrid T-Cell Receptors
for the Development of Improved Vaccines.
HHS Reference No. E-265-2011/0--Chimeric Antigen Receptors
to CD22 for Treating Hematological Cancers.
Licensing Contact: Patrick McCue, Ph.D.; 301-435-5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Experimental Transplantation and Immunology Branch, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize
chimeric antigen receptors to genetically-modify T cells to recognize
BCMA/CD269. For collaboration opportunities, please contact John Hewes,
Ph.D. at hewesj@mail.nih.gov.
ROCK Inhibitors for the Prevention of Breast Cancer Metastasis and
Tumor Relapse
Description of Technology: The recent success of therapeutic
approaches has significantly reduced breast cancer mortality, however,
breast cancers that are diagnosed as ``triple-negative'' (lacking the
estrogen receptors, HER2/Neu, and progesterone receptors) don't respond
to these available therapies and some hormone receptor or NER2/Neu-
positive breast cancers have shown a resistance to these treatments.
These breast cancers account for nearly 90% of all breast cancer
deaths. Therefore, examining the mechanisms by which the breast cancer
cells spread from their primary sites to distant organs is an active
area of research. The NIH inventors have discovered that by blocking a
key biochemical route necessary for the egress of breast cancer cells
into circulation, the CXCR4-Galpha13-Rho signaling pathway, they can
prevent the dissemination of breast cancer cells and thereby prevent
breast cancer metastasis. In particular, they have discovered that ROCK
inhibitors, such as Fasudil, can be used to treat of breast cancer
patients after the initial clinical intervention (i.e., surgery,
radiation, chemo-radiation, or their combination) to delay or prevent
patient relapse due to the metastasis of any residual or prior
undetected breast cancer cells.
Potential Commercial Applications:
Treatment of ``triple-negative'' breast cancers.
Treatment of hormone receptor or NER2/Neu-positive breast
cancers that are resistant to currently available therapies.
Competitive Advantages: ROCK inhibitors can delay or prevent breast
cancer metastasis in patients where there are no effective therapies
currently available.
Development Stage:
Pre-clinical.
In vitro data available.
In vivo data available (animal)
Inventors: Silvio Gutkind and Alfredo Molinolo (NIDCR).
Intellectual Property: HHS Reference No. E-280-2011/0--U.S.
Application No. 61/536,434 filed 19 Sep 2011.
Licensing Contact: Whitney Hastings; 301-451-7337;
hastingw@mail.nih.gov.
Cell Line for Producing Furin That Can Cleave Papillomavirus L2, Toxins
and Other Substrates
Description of Technology: Human papillomavirus (HPV) is an
infectious agent that is responsible for several different diseases.
Although HPV often manifests as warts, it can also result in certain
types of cancer. Since HPV can remain latent for long periods of time,
the disease can be transmitted by someone who is not aware they are
contagious. This partially explains why HPV is the most common sexually
transmitted disease. The HPV genome consists of several genes,
including the two late-expressed genes known as L1 and L2. The HPV L1
and HPV L2 genes encapsulate amplified HPV genomes prior to their
release in virions, which infect other cells. Since HPV L2 is present
on the HPV virion when it is released from a cell, people infected with
HPV will generate an immune response against HPV L2 to help contain the
infection. This includes the generation of neutralizing antibodies
against HPV L2. By examining a sample for the presence of these
neutralizing antibodies, it can be determined whether a patient has HPV
and is capable of spreading the disease.
This technology describes a Chinese Hamster Ovary (CHO) cell line
which expresses a truncated version of mouse furin which retains
activity. Furin is an enzyme that cleaves proteins at a specific,
defined amino acid sequence. The cleavage of HPV L2 makes it more
susceptible to detection by neutralizing antibodies. As a result, the
cell line can increase the sensitivity of an assay for detecting
neutralizing antibodies to HPV L2.
Potential Commercial Applications:
The cell line secretes a truncated mouse furin for use in
any assays which benefit from furin activity.
A specific use for the cell line is testing samples for
neutralizing antibodies to HPV L2.
The cells can be developed into a validated assay for
detecting
[[Page 26296]]
neutralizing antibodies to HPV L2 as a means of diagnosing HPV
infection.
Competitive Advantages:
Neutralizing antibodies to HPV L2 are more readily
detected when the protein is first cleaved by furin.
The cell lines represent an established and efficient
research tool for cleaving HPV L2 for more efficient detection of
neutralizing antibodies to the protein.
An assay for detecting HPV infection can be useful for
detecting those who are asymptomatic, which is common with HPV
infections.
Development Stage: In vitro data available.
Inventors: David FitzGerald et al. (NCI)
Publications:
1. Chiron MF, et al. Furin-mediated cleavage of Pseudomonas
exotoxin-derived chimeric toxins. J Biol Chem. 1997 Dec
12;272(50):31707-11. [PMID 9395513]
2. Richards RM, et al. Cleavage of the papillomavirus minor capsid
protein, L2, at a furin consensus site is necessary for infection. Proc
Natl Acad Sci U.S.A. 2006 Jan 31;103(5):1522-7. [PMID 16432208]
3. Day PM, Schiller JT. The role of furin in papillomavirus
infection. Future Microbiol. 2009 Dec;4(10):1255-62. Review. [PMID
19995186]
Intellectual Property: HHS Reference No. E-233-2011/0--Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632;
lambertsond@mail.nih.gov
Novel Reduced Toxicity Tropolone Derivative Compounds That Have Anti-
Viral Activity Through Inhibiting RNase H Activity
Description of Technology: Several novel tropolone derivatives have
been identified that inhibit HIV-1 RNase H function and have potential
for anti-viral activity due to reduced cellular toxicity. Inhibiting
RNase H function is a potential treatment for many viral infections,
since RNase H function is essential for viral replication for many
pathogenic retroviruses such as HIV-1 and HIV-2. Although many
hydroxytropolone compounds are potent RNase H inhibitors biding at the
enzymatic active site, they are limited as therapeutic candidates by
their toxicity in mammalian cells. The toxicity thought to be a result
of inhibition of multiple essential mammalian metalloenzymes. We
reasoned that the potential beneficial application of tropolone RNase H
inhibition might be of therapeutic use if the toxic effects in
mammalian cell were eliminated. By selectively adding steric bulk to
add new drug-enzyme contacts for the RNase H active site, a number of
novel compounds, that have initially demonstrated reduced cytotoxicity,
have been produced. Importantly, these novel compounds appear to retain
antiviral activity essential for use as therapeutics.
Potential Commercial Applications: Anti-viral therapeutic: HIV-1
and other RNase H-dependent viral infections
Competitive Advantages:
Potentially reduced toxicity
Availability of x ray crystallographic information to
guide analog design
Development Stage:
Pre-clinical
In vitro data available
Inventors: John Beutler, Suhman Chung, Stuart F. LeGrice, Jennifer
A. Wilson (NCI); Craig J. Thomas and Jian-kang Jiang (NCATS)
Publications:
1. Chung S, et al. Synthesis, activity and structural analysis of
novel alpha-hydroxytropolone inhibitors of human immunodeficiency virus
reverse transcriptase-associated ribonuclease H. J Med Chem 2011 Jul
14;54(13):4462-4473. [PMID 21568335]
2. Budihas SR, et al. Selective inhibition of HIV-1 reverse
transcriptase-associated ribonuclease H activity by hydroxylated
tropolones. Nucl Acids Res 2005 33 (4):1249-1256. [PMID 15741178]
Intellectual Property: HHS Reference No. E-081-2011/0 -- U.S.
Provisional Application No. 61/484,779 filed 11 May 2011
Licensing Contact: Edward ``Tedd'' Fenn, J.D.; 301-435-5031;
fenned@mail.nih.gov
Collaborative Research Opportunity: The Molecular Targets
Laboratory, National Cancer Institute, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize antiviral
tropolone derivatives developed by systematic medicinal chemistry on
the lead series. For collaboration opportunities, please contact John
Hewes, Ph.D. at hewesj@mail.nih.gov.
Hspa2 Knockout Mice for Study of Spermatogenesis and Male Infertility
Description of Technology: HSPA2 is a member of the HSP70 family of
heat-shock proteins that serve as molecular chaperones. Researchers
discovered that HSPA2 protein is expressed in spermatogenesis during
the meiotic phase. Spermatogenic cells lacking the HSPA2 protein arrest
in mid-meiosis and undergo apoptosis. HSPA2 is present in the
synaptonemal complex of wild-type mice and the chromosomes fail to
separate in HSPA2-deficient mice (previously known as Hsp70-2-/-mice),
suggesting that HSPA2 is required for the chromosomal events of meiosis
such as synapsis, crossing over, or recombination.
Researchers at NIEHS developed a knockout strain of mice in which
the heat shock protein gene (Hspa2) is disrupted. This mouse model is
useful in studying the process of spermatogenesis and the influence of
various environmental toxins or drugs on sperm production and male
infertility.
Potential Commercial Applications:
Mouse model to study spermatogenesis and male infertility
Mouse model to study meiosis or the roles of heat-shock
proteins in general
Mouse model to evaluate effects of meiosis-disrupting
agents on meiotic recombination and generation of mutations transmitted
to offspring
Development Stage:
In vitro data available
In vivo data available (animal)
Inventor: Edward M. Eddy (NIEHS)
Publication: Dix DJ, et al. Targeted gene disruption of Hsp70-2
results in failed meiosis, germ cell apoptosis, and male infertility.
Proc Natl Acad Sci USA. 1996 Apr 93(8):3264-3268. [PMID 8622925]
Intellectual Property: HHS Reference No. E-052-2011/0--Research
Tool. Patent protection is not being pursued for this technology.
Related Technology: HHS Reference No. E-290-2011/0--Research Tool
(Transgenic Hspa2-Cre Mice for Studying Spermatogenesis and Male
Infertility). Patent protection is not being pursued for this
technology.
Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; Lauren.Nguyen-Antczak@nih.gov
Collaborative Research Opportunity: The NIEHS is seeking statements
of capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize this mouse
strain. For collaboration opportunities, please contact Elizabeth
Denholm, Ph.D. at denholme@niehs.nih.gov.
Transgenic Hspa2-Cre Mice for Studying Spermatogenesis and Male
Infertility
Description of Technology: HSPA2 is a member of the HSP70 family of
heat-shock proteins that serve as molecular chaperones. Hspa2-cre
expression mimics the spermatogenic cell-specific
[[Page 26297]]
expression of endogenous HSPA2 within the testis, being first observed
in leptotene/zygotene spermatocytes. Expression of the transgene is
also detected at restricted sites in the brain, as occurs for
endogenous HSPA2.
Researchers at NIEHS developed the first transgenic mouse line that
expresses Cre-recombinase under the control of the promoter of the heat
shock protein A2 (Hspa2) gene. Expression of the Hspa2-Cre transgene
during meiosis in male germ cells makes these mice a useful tool for
defining the roles of genes expressed at different times during
spermatogenesis or expressed in spermatogenic cells.
Potential Commercial Applications:
New mouse model to study spermatogenesis and male
infertility
New mouse model to study meiosis or the roles of heat-
shock proteins in general
Competitive Advantages: Researchers generated an Hspa2-cre line
that expresses cre in spermatocytes to overcome the limitations of
other transgenic lines.
Development Stage:
In vitro data available
In vivo data available (animal)
Inventor: Edward M. Eddy (NIEHS)
Publication: Inselman AL, et al. Heat shock protein 2 promoter
drives cre expression in spermatocytes of transgenic mice. Genesis.
2010 Feb 48(2):114-120. [PMID 20027617]
Intellectual Property: HHS Reference No. E-290-2011/0--Research
Tool. Patent protection is not being pursued for this technology.
Related Technology: HHS Reference No. E-052-2011/0--Research Tool
(Hspa2 Knockout Mice for Study of Spermatogenesis and Male
Infertility). Patent protection is not being pursued for this
technology.
Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; Lauren.Nguyen-Antczak@nih.gov
Collaborative Research Opportunity: The NIEHS is seeking statements
of capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize this mouse
strain. For collaboration opportunities, please contact Elizabeth
Denholm, Ph.D. at denholme@niehs.nih.gov.
Diagnostic H5N1 Avian Influenza Virus Peptides
Description of Technology: The recent spread of highly pathogenic
H5N1 avian influenza viruses among poultry and transmission of these
viruses to humans raises concerns of a potential influenza pandemic.
There is a need to track the spread of these viruses both in the animal
and human populations to avert or reduce the impact of any potential
influenza pandemic as well as to know the actual number (accurate
surveillance) of people infected with H5N1, including individuals with
subclinical H5N1 infection.
The subject technology is a specific combination of H5N1 peptides
useful for assays to detect antibodies generated against a wide range
of different H5N1 strains. The combination of peptides was able to
specifically detect anti-H5N1 antibodies from serum samples of H5N1
survivors at early and later times post infection while excluding
antibodies generated in individuals infected with other strains of
influenza virus. Also, the peptides did not react with sera from
individuals vaccinated with H5N1 vaccine, in contrast to the strain-
specific detection of anti-H5N1 antibodies in sera from infected
individuals. Immunoassays using the H5N1 peptide combination provide
highly specific, sensitive and reproducible methods for diagnosing H5N1
infection in humans and animals.
Potential Commercial Applications: Diagnostics for influenza virus
specific antibodies in humans and animals.
Competitive Advantages: High specificity, sensitivity, and
reproducibility
Development Stage:
Pre-clinical
In vitro data available
Inventors: Hana Golding and Surender Khurana (FDA)
Publication: Khurana S, et al. H5N1-SeroDetect EIA and rapid test:
a novel differential diagnostic assay for serodiagnosis of H5N1
infections and surveillance. J Virol. 2011 Dec;85(23):12455-63. [PMID
21957281]
Patent Status: HHS Reference No. E-093-2010/0 -- PCT Application
No. PCT/US2011/032555 filed 14 Apr 2011, which published as WO 2011/
130555 on 20 Oct 2011
Related Technology: HHS Reference No. E-236-2007/3 -- U.S. Patent
Application No. 12/664,052 filed 10 Dec 2009
Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018;
changke@mail.nih.gov
Parvovirus B19 Codon Optimized Structural Proteins for Vaccine and
Diagnostic Applications
Description of Technology: Parvovirus B19 (B19V) is the only known
pathogenic human parvovirus. Infection by this viral pathogen can cause
transient aplastic crisis in individuals with high red cell turnover,
pure red cell aplasia in immunosuppressed patients, and hydrops fetalis
during pregnancy. In children, B19V most commonly causes erythema
infectiosum, or fifth's disease. Infection can also cause arthropathy
and arthralgia. The virus is very erythrotropic, targeting human
erythroid (red blood) progenitors found in the blood, bone marrow, and
fetal liver. Currently, there are no approved vaccines or antiviral
drugs for the treatment or prevention of B19V infection.
The subject technology is a series of plasmid constructs with codon
optimized B19 viral capsid genes (VP1 and VP2) that can be expressed in
mammalian cells. Transfection of vectors encoding these optimized VP1
and VP2 genes into different mammalian cell lines, including 293, Cos7,
and Hela cells produce virus-like particles (VLPs). The vectors include
bicistronic plasmids expressing the VP1 and VP2 proteins at different
ratios to produce B19V VLPs with optimal antigenicity for vaccine
applications. This technology can also be used for diagnostic
applications and development of a viral packaging system for producing
infectious B19V virus.
Potential Commercial Applications:
VLPs based vaccines for the prevention and/or treatment of
B19V infection
DNA based vaccines for the prevention and/or treatment of
B19V infection
B19V diagnostics
Viral packaging system
Competitive Advantages:
Codon optimized VP1 and VP2 genes for better expression in
mammalian cell lines
Expression of B19V VLPs from ``nonpermissive'' cell lines
Development Stage: In vitro data available
Inventors: Ning Zhi, Sachiko Kajigaya, and Neal S. Young (NHLBI)
Patent Status: HHS Reference No. E-011-2010/0--PCT Application No.
PCT/US2011/024199 filed 09 Feb 2011, which published as WO 2011/100330
on 22 Dec 2011
Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018;
changke@mail.nih.gov
Collaborative Research Opportunity: The National Heart Lung and
Blood Institute, Hematology Branch, is seeking statements of capability
or interest from parties interested in collaborative research to
further develop, evaluate, or commercialize the subject technology.
Please contact Cecilia Pazman, Ph.D., at pazmance@mail.nih.gov for more
information.
[[Page 26298]]
Construct for Tetracycline Inducible Podocyte Specific Gene Expression
in Mice
Description of Technology: The National Institutes of Health
announces the generation of a construct by ligating 2.5kb human podocin
promoter sequence to gene encoding reverse tetracycline-controlled
transcriptional activator which enables tetracycline-inducible podocyte
specific gene of interest expression with another construct consisting
of tetracycline responsive element, minimal CMV promoter and gene of
interest.
Podocytes are post-mitotic epithelial cells that are positioned on
the exterior aspect of the glomerular capillary wall and contribute to
the selective molecular permeability of glomeruli. Podocyte damage or
dysfunction results in loss of the characteristic foot processes that
normally interdigitate and form the selective permeability barriers
composed of filtration slits bridged by slit diaphragms. Minimal damage
causes proteinuria that in the case of minimal change disease can be
reversed by steroid treatment. In focal segmental glomerulosclerosis,
more severe loss of podocytes ultimately results in glomerulosclerosis.
The podocyte-specific inducible transgene system can be used to
identify factors that exacerbate or ameliorate podocyte injury, and can
be used to express Cre-recombinase.
Potential Commercial Applications: This technology can be used for
the study of renal disease.
Competitive Advantages: The podocyte-specific inducible transgene
system can be used to identify factors that exacerbate or ameliorate
podocyte injury, and can be used to express Cre-recombinase.
Development Stage: Pre-clinical
Inventors: Jeffrey B. Kopp et al. (NIDDK)
Publication: Shigehara T, et al. Inducible podocyte-specific gene
expression in transgenic mice. J Am Soc Nephrol. 2003 Aug;14(8):1998-
2003. [PMID 12874453]
Intellectual Property: HHS Reference No. E-299-2007/0 -- Research
Material. Patent protection has not been pursued for this technology.
Note: The use of Tetracycline controllable expression systems is
covered by a series of patents including US 5,464,758 and
5,814,618 which are proprietary to TET systems GmbH & Co. KG.
Interested parties are also advised to contact TET Systems,
info@tetsystems.com or by electronic request at www.tetsystems.com/main_inquiry.htm]
Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521;
Fatima.Sayyid@nih.hhs.gov
Parallel High Speed Single Molecule Nucleic Acid Sequencing
Description of Technology: This invention entails a new system,
methods, and compositions for DNA sequencing, known as Two Dye
Sequencing (TDS). The system utilizes Forster Resonance Energy Transfer
(FRET). The TDS method consists of the following steps:
(1) Attaching to a microscope chamber, DNA polymerases labeled with
a donor fluorophore.
(2) Adding to the chamber DNA molecules annealed to a primer.
(3) Adding four dNTPs, each labeled with a different fluorescent
acceptor dye.
(4) Exciting the donor fluorophore with light, causing energy
transfer (FRET) to the acceptor fluorophore for a given dNTP, that then
radiates light of a different wavelength.
(5) Identifying nucleotides as they are added to the nascent
polynucleotide by recording the FRET signals at the location of each
DNA polymerase in the microscope field of view.
(6) Converting the sequential signals into a DNA sequence for each
DNA molecule in the microscope field of view.
Potential Commercial Applications: High throughput sequencing of
single DNA molecules on a substrate.
Competitive Advantages:
Detection of individual DNA molecule sequences
Sequences multiple DNA molecules in parallel with one
microscope
Eliminates washing steps, because all four nucleotides are
added at once
Rapid, works at the speed of the DNA polymerase
Development Stage: Early-stage
Inventors: Thomas D. Schneider and Denise Rubins (NCI)
Intellectual Property: HHS Reference No. E-033-1999/0 --
US Patent No. 6,982,146 issued 03 Jan 2006
PCT Application No. PCT/US00/23736 filed 29 Aug 2000
US Application No. 12/886,686 filed 29 Aug 2000
Related Technologies: HHS Reference No. E-194-2005/0 --
US Patent No. 7,871,777 issued 18 Jan 2011
EP Patent No. 1960550 issued 15 Sep 2010, validated in DE,
FR, and GB
JP Application No. 2009-545768 filed 12 Dec 2006
US Application No. 12/980,802 filed 29 Dec 2010
Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., MBA; 301-435-
4507; thalhamc@mail.nih.gov
The MedusaTM; Sequencer: A DNA or RNA Sequencing Machine the
Size of a Molecule
Description of Technology: Current high-throughput DNA sequencing
methods suffer from several limitations. Many methods require multiple
fluid handling steps, fixing of molecules on beads or a 2D surface, and
provide very short read-lengths. The NIH inventors offer a DNA or RNA
sequencing device that drastically simplifies the process by combining
all elements for sequence detection in a single molecule, the
MedusaTM; Sequencer.
The MedusaTM; Sequencer utilizes Forster Resonance
Energy Transfer (FRET) to read a polynucleotide sequence while
synthesizing a complementary strand. The device consists of a DNA (or
RNA) polymerase labeled with a FRET donor fluorophore and attached to a
set of four flexible arms. The tip of each arm carries a distinct set
including one nonhydrolyzable nucleotide and one FRET acceptor
fluorophore. While a MedusaTM; Sequencer synthesizes a
complementary polynucleotide strand, the four different arms
continuously ``test'' the polymerase pocket creating a characteristic
FRET signal for the correct nucleotide. The series of FRET signals
reveals the unknown polynucleotide sequence.
Potential Commercial Applications:
High-throughput DNA or RNA sequencing
Alternative to microarrays for expression analysis
Diagnostics of genetic diseases
Competitive Advantages:
Single reagent for synthesis and sequencing
Eliminates repetitive fluid handling steps
Able to count single mRNA or DNA molecules
Exceptionally low manufacturing cost
Could be injected in living cells to read/count mRNA
sequences directly
Low error rate per base
High speed; one microscope obtains many sequences in
parallel
Can be 3D-arrayed in a gel for ultra-high density
Use with Sequence Walkers for diagnostics (https://alum.mit.edu/www/toms/g863a.html)
Development Stage: Early-stage
Inventors: Thomas D. Schneider, IIya G. Lyakhov, Danielle Needle
(NCI)
Publication: The technology is further described at https://alum.mit.edu/www/toms/patent/medusa.
Intellectual Property: HHS Reference No. E-194-2005/0 --
[[Page 26299]]
US Patent No. 7,871,777 issued 18 Jan 2011
EP Patent No. 1960550 issued 15 Sep 2010, validated in DE,
FR, and GB
JP Application No. 2009-545768 filed 12 Dec 2006
US Application No. 12/980,802 filed 29 Dec 2010
Related Technologies:
HHS Reference No. E-195-2005/0 --
US Application No. 60/749,858 filed 12 Dec 2005
US Application No. 11/638,160 filed 12 Dec 2006
HHS Reference No. E-033-1999/0 --
US Patent No. 6,982,146 issued 03 Jan 2006
PCT Application No. PCT/US00/23736 filed 29 Aug 2000
US Application No. 12/886,686 filed 29 Aug 2000
Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., MBA; 301-435-
4507; thalhamc@mail.nih.gov
Collaborative Research Opportunity: The National Cancer Institute,
Gene Regulation and Chromosome Biology Laboratory, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize
the MedusaTM; Sequencer. For collaboration opportunities,
please contact John Hewes, Ph.D. at hewesj@mail.nih.gov.
Nanoprobes for Detection or Modification of Molecules
Description of Technology: This invention describes ``Rod-tether
Nanoprobes'', devices consisting of a rigid molecular rod with a
flexible molecular tether attached at both ends that can detect and/or
modify molecules. Each tether tip has a functional group, such as an
antibody or oligonucleotide that recognizes a target molecule. In
addition, one tip carries a donor fluorophore and the other carries an
acceptor fluorophore. The fluorophores form a pair for Forster
Resonance Energy Transfer (FRET). In the absence of the target
molecule, the rod keeps the tether arms apart, while in the presence of
the target molecule, both recognizers bind to the target. This binding
holds the donor and acceptor fluorophores close together, allowing a
FRET signal. By reducing an ELISA-like assay entirely to the molecular
level, complex macroscopic or microfluidic washing and pumping systems
can be eliminated. Rod-tether Nanoprobes can detect a wide variety of
clinical and biowarfare reagents. The nanoprobes can also rapidly and
simply detect, modify, and/or destroy endogenous molecules (e.g.,
proteins, mRNA) involved in a broad range of diseases. The simplest
ssDNA-detecting nanoprobe has been created.
Potential Commercial Applications:
Instantly detect molecules of interest (e.g., proteins,
mRNA) in multiple settings:
--Clinical
--Scientific research
--Biowarfare
An improved substitute for ELISA assays
Modify or destroy target molecules, while detecting them
Detect genetic diseases in the clinic from patient blood
samples
Competitive Advantages:
Only one reagent required for detection
Entire reaction contained in a single molecule
Eliminates washing steps
Complicated and expensive microfluidic chips are
eliminated
High speed
Exceptionally low cost
Development Stage: Early-stage
Inventors: Thomas D. Schneider, IIya G. Lyakhov, Danielle Needle
(NCI)
Publication: The technology is further described at https://alum.mit.edu/www/toms/patent/nanoprobe/.
Intellectual Property: HHS Reference No. E-195-2005/0--
US Application No. 60/749,858 filed 12 Dec 2005
US Application No. 11/638,160 filed 12 Dec 2006
Related Technologies: HHS Reference No. E-194-2005/0--
US Patent No. 7,871,777 issued 18 Jan 2011
EP Patent No. 1960550 issued 15 Sep 2010, validated in DE,
FR, and GB
JP Application No. 2009-545768 filed 12 Dec 2006
US Application No. 12/980,802 filed 29 Dec 2010
Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., MBA; 301-435-
4507; thalhamc@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Gene Regulation and Chromosome Biology Laboratory, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize
Rod-Tether Nanoprobes. For collaboration opportunities, please contact
John Hewes, Ph.D. at hewesj@mail.nih.gov.
Immunogenic Peptides (Vaccines) for the Treatment of Prostate and
Breast Cancer
Description of Technology: Collectively, cancer is the second
leading cause of death in the United States. Current treatments of
cancer often involve non-specific strategies (such as chemotherapy)
which attack healthy cells as well as diseased cells, leading to
harmful side-effects. As a result, the development of more targeted
means of treating cancer are highly sought. One option for a targeted
treatment is the creation of a vaccine that induces an immune response
only against cancer cells. In this sense, vaccination involves the
introduction of a peptide into a patient that causes the formation of T
cells that recognize the peptide. If those recognize a peptide found in
a protein found selectively on cancer cells, those T cells can trigger
the death of those cancer cells without harming non-cancer cells. This
can result in fewer side effects for the patient. TARP (T cell receptor
gamma alternate reading frame protein) is a protein that is selectively
expressed on the cells of certain types of prostate and breast cancer.
This invention concerns the identification of immunogenic peptides
within TARP, and their use to create an anti-cancer immune response in
patients. By introducing these peptides into a patient, an immune
response against these cancer cells can be initiated by the peptides,
resulting in treatment of the cancer. A phase I clinical trial in stage
D0 prostate cancer patients is nearing completion. Initial results
indicate a statistically significant decrease in the slope of PSA for
48 weeks after vaccination.
Potential Commercial Applications:
Peptides can be used as cancer vaccines.
Treatment of any cancer associated with increased or
preferential expression of TARP.
Specific diseases include breast cancer and prostate
cancer.
Competitive Advantages: Targeted therapy decreases non-specific
killing of healthy, essential cells, resulting in fewer non-specific
side-effects and healthier patients.
Development Stage:
Pre-clinical
Clinical
In vivo data available (animal)
In vivo data available (human)
Publications:
1. Epel M, et al. Targeting TARP, a novel breast and prostate
tumor-associated antigen, with T cell receptor-like human recombinant
antibodies. Eur J Immunol. 2008 Jun;38(6):1706-1720. [PMID 18446790]
2. Oh S, et al. Human CTLs to wild-type and enhanced epitopes of a
novel prostate and breast tumor-associated protein, TARP, lyse human
breast cancer cells. Cancer Res. 2004 Apr 1;64(7):2610-2618. [PMID
15059918]
[[Page 26300]]
Intellectual Property: HHS Reference No. E-116-2003/0--
US Patent 7,541,035 issued 02 Jun 2009
US Patent 8,043,623 issued 25 Oct 2011
Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Vaccine Branch, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize a prostate cancer vaccine targeting the TARP
antigen currently completing phase I clinical trials. For collaboration
opportunities, please contact John Hewes, Ph.D. at hewesj@mail.nih.gov.
Dated: April 27, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-10637 Filed 5-2-12; 8:45 am]
BILLING CODE 4140-01-P
