Government-Owned Inventions; Availability for Licensing, 66106-66108 [2010-27181]
Download as PDF
srobinson on DSKHWCL6B1PROD with NOTICES
66106
Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices
1. Coscia M, Biragyn A. Cancer
immunotherapy with chemoattractant
peptides. Semin Cancer Biol. 2004
Jun;14(3):209–218. [PubMed: 15246057].
2. Biragyn A, Belyakov IM, Chow YH,
Dimitrov DS, Berzofsky JA, Kwak LW.
DNA vaccines encoding human
immunodeficiency virus-1 glycoprotein
120 fusions with proinflammatory
chemoattractants induce systemic and
mucosal immune responses. Blood.
2002 Aug 15;100(4):1153–1159.
[PubMed: 12149191].
3. Schiavo R, Baatar D, Olkhanud P,
Indig FE, Restifo N, Taub D, Biragyn A.
Chemokine receptor targeting efficiently
directs antigens to MHC class I
pathways and elicits antigen-specific
CD8+ T-cell responses. Blood. 2006 Jun
15;107(12):4597–4605. [PubMed:
16514063].
4. Biragyn A, Ruffini PA, Coscia M,
Harvey LK, Neelapu SS, Baskar S, Wang
JM, Kwak LW. Chemokine receptormediated delivery directs self-tumor
antigen efficiently into the class II
processing pathway in vitro and induces
protective immunity in vivo. Blood.
2004 Oct 1;104(7):1961–1969. [PubMed:
15191951].
5. Qin H, Nehete PN, He H, Nehete B,
Buchl S, Cha SC, Sastry JK, Kwak LW.
Prime-boost vaccination using
chemokine-fused gp120 DNA and HIV
envelope peptides activates both
immediate and long-term memory
cellular responses in rhesus macaques.
J Biomed Biotechnol. 2010;2010:860160.
[PubMed: 20454526].
6. Qin H, Cha SC, Neelapu SS, Lou Y,
Wei J, Liu YJ, Kwak LW. Vaccine site
inflammation potentiates idiotype DNA
vaccine-induced therapeutic T cell-, and
not B cell-, dependent antilymphoma
immunity. Blood. 2009 Nov
5;114(19):4142–4149. [PubMed:
19749091].
7. Singh A, Nie H, Ghosn B, Qin H,
Kwak LW, Roy K. Efficient modulation
of T-cell response by dual-mode, singlecarrier delivery of cytokine-targeted
siRNA and DNA vaccine to antigenpresenting cells. Mol Ther. 2008
Dec;16(12):2011–2021. [PubMed:
18813280].
Patent Status: U.S. Patent No.
6,562,347 issued 13 May 2003 (HHS
Reference No. E–107–1998/0–US–03).
Licensing Contact: Patrick McCue,
PhD; 301–435–5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute on Aging,
Laboratory of Immunology, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize cancer vaccines that
target skin antigen-resenting cells.
VerDate Mar<15>2010
17:00 Oct 26, 2010
Jkt 223001
Please contact Nicole Guyton at 301–
435–3101 or guytonn@mail.nih.gov for
more information.
Dated: October 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–27179 Filed 10–26–10; 8:45 am]
BILLING CODE 4140–01–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.
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
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.
ADDRESSES: 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.
SUMMARY:
IL–10 and IFNg Peptide Inhibitors
Description of Invention: Available for
licensing are several potent and
selective inhibitors of IL–10 and IFN-g
signaling. Although cytokines play
important roles in cancer and
inflammation, there are no specific
inhibitors of any cytokines to date. IL–
10 and IFN-g cytokine signaling play
crucial roles in inflammation, cancer
growth, and autoimmune diseases. The
investigators have developed short
peptides that potently and selectively
interfere with dimerization of the
cytokines and their binding to the
corresponding receptor. Included in the
patent application are also metabolically
stable lipopeptides mimicking
conserved regions of IL–10 and IFN-g
receptors that interfere with STAT3 and
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
STAT1 phosphorylation and subsequent
signaling. Lipopeptides potently inhibit
STAT3 and STAT1-dependent growth
of cancer cells. These compounds are
promising drug candidates for the
treatment of cancer and many infectious
and inflammatory diseases.
Application: Cancer, viral infections
and anti-inflammatory treatments.
Advantages:
• Potent, stable peptide inhibitors.
• Selective IL–10 and IFN-g
inhibitors.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Market: The annual growth rate for
the therapeutic peptide market is
estimated at about 7.5%.
Inventors: Nadya Tarasova et al.
(NCI).
Patent Status: U.S. Provisional
Application No. 61/333,512 filed 11
May 2010 (HHS Reference No. E–167–
2010/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Collaborative Research Opportunity:
The Center for Cancer Research, Cancer
and Inflammation Program, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize inhibitors of IL10, IFNg
and STAT3 signaling. Please contact
John Hewes, Ph.D. at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Diagnostic and Prognostic HCC-Related
Metabolites
Description of Invention: Metabolite
profiling identifies and measures
changes in cellular metabolites as a
means to determine a direct correlation
between gene expression and changes in
biological function. Investigators at the
National Cancer Institute have
identified a unique set of metabolite
biomarkers associated with
hepatocellular carcinoma (HCC), early
stage HCC, HCC patient outcome and
HCC stem-cell subtype. Subsets of this
metabolite/gene signature can
distinguish HCC tumors from normal
tissues with 88–97% accuracy, identify
early stage HCC patients with 62–78%
accuracy, wherein early stage is defined
as TNM stage I, prognose negative
patient outcome, and identify a HCC
stem cell subtype with 70–77%
accuracy. These metabolites and gene
surrogates are elements of the PI3K and
Myc signaling networks which can
potentially be targeted for therapeutic
purposes.
E:\FR\FM\27OCN1.SGM
27OCN1
srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices
HCC represents an extremely poor
prognostic cancer, and patients are often
diagnosed with end-stage cancer and
have poor survival. HCC is also a very
heterogeneous disease and often arises
from chronic liver disease. Surgery and
transplantation remain the only curative
option for patients; however,
complications due to cirrhosis mean it
is a viable option for 5–10% patients.
This HCC gene signature can be
developed into assays to enable
clinicians to accurately diagnose HCC,
including early stages and subtype of
this disease, and therefore stratify
patients for appropriate treatment and
prioritizing liver transplantation
candidates based on their metabolite
profile.
Applications:
• Method to diagnose HCC, including
HCC subtypes.
• Method to prognose HCC patient
outcome.
• Method to stratify patients for
appropriate treatment.
Advantages: Highly accurate
metabolite/gene profile that can be
developed into a variety of diagnostic
and prognostic applications.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Market:
• Global oncology biomarker
discovery market is expected to grow
from $2.5 billion in 2009 to $5.7 billion
by 2014.
• North America has the largest
metabolomic market with an estimated
value of $161.4 million in 2009, and it
is projected to reach $324 million by
2014.
• HCC is the fifth most common
cancer worldwide with an estimated
one million new cases diagnosed
annually.
Inventors: Xin Wei Wang and
Anuradha S. Budhu (NCI).
Patent Status: U.S. Provisional
Application No. 61/323,420 filed 13 Apr
2010 (HHS Reference No. E–139–2010/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Collaborative Research Opportunity:
The Center for Cancer Research,
Laboratory of Human Carcinogenesis, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
metabolomic signatures for liver cancer.
Please contact John Hewes, Ph.D. at
301–435–3121 or hewesj@mail.nih.gov
for more information.
VerDate Mar<15>2010
17:00 Oct 26, 2010
Jkt 223001
66107
Stimulation of Natural Killer T-Cell
Anti-Tumor Activity
hewesj@mail.nih.gov for more
information.
Description of Invention: Natural
killer T cells (NKT) are a unique
lymphocyte population that has T-cell
and NK cell functional properties in
order to rapidly elicit an immune
response. a-galactosylceramide (aGalCer) is a potent NKT stimulator and
induces of IFN-g release to promote
immunity against tumors and infectious
agents. Humans have natural antibodies
against a-galactose, which may be one
of the reasons why the human clinical
trials of a-GalCer or KRN7000 were not
very successful.
Investigators at the National Cancer
Institute have found that bmannosylceramide (b-ManCer)
promotes immunity in an IFN-g
independent mechanism. b-ManCer is a
new class of NKT agonist that induces
immune responses alone, through nitric
oxide and TNF-a-dependent
mechanisms, or synergistically with aGalCer to enhance a-GalCer’s efficacy.
Since b-ManCer does not have agalactose, which can be neutralized by
natural antibodies, patients could be
treated with multiple doses without
negative side effects associated with the
loss of IFN-g production. Hence, bManCer is a promising anti-cancer
treatment either alone or in
combinatorial therapies with a-GalCer
to selectively induce immune responses.
Applications:
• Cancer therapeutics.
• Potent stimulator of NKT activity.
Advantages:
• Induces tumor immunity through a
novel mechanism.
• Decreased possibility of
neutralization by natural antibodies.
• Synergize with a-GalCer.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Market: Global cancer market is worth
more than eight percent of total global
pharmaceutical sales.
Inventors: Masaki Terabe (NCI) et al.
Patent Status: U.S. Provisional
Application No. 61/313,508 filed 12 Mar
2010 (HHS Reference No. E–034–2010/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Collaborative Research Opportunity:
The Vaccine Branch of the National
Cancer Institute is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize b-ManCer. Please contact
John Hewes, Ph.D. at 301–435–3121 or
Modified POTE Peptides for Cancer
Immunotherapy
Description of Invention: Investigators
at the National Cancer Institute have
identified and enhanced
immunogenicity of POTE epitopes to
improve their efficacy in cancer
vaccines. POTE is a novel tumor antigen
expressed in a variety of cancers
including breast, prostate, colon, lung,
ovary, and pancreas cancers. POTE has
limited expression in normal tissues
and therefore a specific target for cancer
treatments, including immunotherapy.
Immunotherapy has great potential as a
cancer therapeutic because of its
specificity and freedom from toxic
effects of chemotherapies.
Antigen-specific cancer
immunotherapy often relies on
identification of epitopes expressed by
cancer cells that can be targeted by
cytotoxic T cells (CTL). However, the
CTL repertoire against high-affinity
cancer epitopes is often ineffective
because cancer epitopes may share a
similar structure to natural ‘‘self’’
antigens. As a result, cancer cells are not
recognized by CTLs and destroyed. The
enhanced POTE epitopes induce a
stronger immune response than natural
responses. These modified epitopes are
more effective at inducing CTL against
POTE expressing cancer cells and have
greater potential to serve as cancer
vaccine targets.
Applications:
• Therapeutic cancer vaccine.
• Method to treat cancer.
Advantages:
• Enhanced immunogenic peptides.
• Cancer vaccines that overcome selftolerance to target a variety of tumor
cells.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Market: The therapeutic cancer
market will be worth an estimated $633
million in 2014.
Inventors: Jay A. Berzofsky, Yi-Hisang
Huang, Ira Pastan, Masaki Terabe (NCI).
Patent Status: U.S. Provisional
Application No. 61/313,559 filed 12 Mar
2010 (HHS Reference No. E–003–2010/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Collaborative Research Opportunity:
The Center for Cancer Research, Vaccine
Branch, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
E:\FR\FM\27OCN1.SGM
27OCN1
66108
Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices
commercialize this technology. Please
contact John Hewes, Ph.D. at 301–435–
3121 or hewesj@mail.nih.gov for more
information.
Dated: October 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–27181 Filed 10–26–10; 8:45 am]
BILLING CODE 4140–01–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.
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
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.
ADDRESSES: 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.
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
Photosensitizing Antibody-Fluorophore
Conjugate for Photo-Immunotherapy
Description of Invention: A major goal
of targeted cancer therapy is to improve
the sensitivity and specificity of the
therapy so that cancer cells can be
detected and targeted for elimination,
while normal cells in the surrounding
area remain largely intact.
Photodynamic therapy (PDT) is a
treatment for cancer and non-cancerous
lesions involving light and a
photosensitizer. The photosensitizer can
be targeted to a specific cell using
antibodies specific for proteins
expressed on the target cell surface, the
target cells will then be destroyed after
being exposed to light at appropriate
wavelength.
VerDate Mar<15>2010
17:00 Oct 26, 2010
Jkt 223001
The NIH technology describes a
method of photosensitizing cancerous
cells by irradiating an antibody
fluorophore conjugate. The NIH
investigators have conducted in vitro
studies using a proprietary IRDye
700DX NHS Ester. The IR700 dye was
conjugated to a proprietary humanized
anti-HER1 or anti-HER2 or anti-PSMA
antibody, Panitumumab or Trastuzumab
or huJ591. Subsequent irradiation of
non-ionizing near infrared light showed
rapid cell death of tumor cells, while
normal cells were not noticeably killed.
The studies were repeated in mice with
similar results.
Applications and Market:
• Photodynamic therapy for cancer by
selective targeting and killing of cells
without suffering normal tissue side
effects.
• Cancer was responsible for about
13% of all human deaths in 2007. There
remains a need for therapies that
effectively kill the tumor cells while not
harming non-cancerous cells.
Development Status: Both in vitro and
in vivo data available.
Inventors: Hisataka Kobayashi, Peter
L. Choyke, Makoto Mitsunaga (NCI)
Publications: Manuscript in
submission.
Patent Status: U.S. Provisional Patent
Application No. 61/363,079, filed July 9,
2010 (HHS Reference No. E–205–2010/
0–US–01)
Licensing Status: Available for
licensing.
Licensing Contact: Betty B. Tong,
PhD; 301–594–6565;
tongb@mail.nih.gov.
Soluble Glypican-3 Protein for
Treatment of Cancer
Description of Technology:
Hepatocellular carcinoma (HCC) is a
form of liver cancer that is among the
more deadly cancers in the world. HCC
is typically only detected at the later
stages of cancer development, which is
always associated with poor prognosis.
Because HCC is often associated with
liver disease, traditional chemotherapy
is not an option, making surgery the
most common form of treatment. As a
result, there is a need for new
treatments.
Glypican-3 (GPC3) is a cell surface
protein that is normally involved in cell
growth and differentiation. GPC3 has
been shown to act through the Wntsignaling pathway, a pathway that is
often activated in a number of different
cancer cell types. Significantly, the
ability of GPC3 to activate signaling
through Wnt requires that GPC3 be
bound to the cell membrane. GPC3 is
also preferentially expressed on HCC
cells, suggesting it could play a
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
particularly important role in
tumorigenesis in HCC.
This invention concerns a soluble
form of GPC3 that lacks its cell
membrane anchoring domain. This
soluble form of GPC3 maintains its
ability to interact with the Wnt signaling
pathway, but cannot induce the
activation of the pathway because it is
not bound to the cell membrane. By
competing with fully functional GPC3,
the soluble GPC3 is able to inhibit the
growth of HCC cells, thereby decreasing
the ability of tumors to grow and
metastasize. This suggests that soluble
GPC3 represents a possible therapeutic
for HCC.
Applications:
• Soluble GPC3 represents a potential
therapeutic for patients with cancer
with hyperactivated Wnt-signaling
pathways.
• Specific cancers include
hepatocellular cancer (HCC), melanoma,
thyroid cancer, lung squamous cell
carcinoma, Wilms’ tumor,
neuroblastoma, hepatoblastoma, and
testicular germ-cell tumors.
Advantages:
• Removal of the glycosylphosphatidylinositol (GPI) anchor
results in a soluble form of GPC3 that
can interrupt Wnt-signaling.
• Soluble GPC3 maintains the ability
to compete with fully functional GPC3
despite its inability to activate signaling.
• For treatment of HCC, offers a noninvasive, potentially non-liver toxic
alternative to current strategies.
Development Status: Preclinical stage
of development; cell culture data with
HCC cells
Inventors: Ho (NCI) et al.
For more information, see:
• ‘‘Recombinant soluble glypican 3
protein inhibits the growth of
hepatocellular carcinoma in vitro’’ Feng
et al. Int. J. Cancer: E-pub (8 July 2010).
• ‘‘Soluble Glypican 3 inhibits the
growth of Hepatocellular Carcinoma in
vitro and in vivo’’ Zitterman et al. Int.
J. Cancer: 126, 1291–1301 (2010).
Patent Status: U.S. provisional
applications 61/334,135 (E–176–2010/
0–US–01) and 61/350,722 (E–176–2010/
1–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: David A.
Lambertson, PhD; 301–435–4632;
lambertsond@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute,
Laboratory of Molecular Biology, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize this
technology. Please contact John Hewes,
E:\FR\FM\27OCN1.SGM
27OCN1
Agencies
[Federal Register Volume 75, Number 207 (Wednesday, October 27, 2010)]
[Notices]
[Pages 66106-66108]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27181]
-----------------------------------------------------------------------
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.
ADDRESSES: 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.
IL-10 and IFN[gamma] Peptide Inhibitors
Description of Invention: Available for licensing are several
potent and selective inhibitors of IL-10 and IFN-[gamma] signaling.
Although cytokines play important roles in cancer and inflammation,
there are no specific inhibitors of any cytokines to date. IL-10 and
IFN-[gamma] cytokine signaling play crucial roles in inflammation,
cancer growth, and autoimmune diseases. The investigators have
developed short peptides that potently and selectively interfere with
dimerization of the cytokines and their binding to the corresponding
receptor. Included in the patent application are also metabolically
stable lipopeptides mimicking conserved regions of IL-10 and IFN-
[gamma] receptors that interfere with STAT3 and STAT1 phosphorylation
and subsequent signaling. Lipopeptides potently inhibit STAT3 and
STAT1-dependent growth of cancer cells. These compounds are promising
drug candidates for the treatment of cancer and many infectious and
inflammatory diseases.
Application: Cancer, viral infections and anti-inflammatory
treatments.
Advantages:
Potent, stable peptide inhibitors.
Selective IL-10 and IFN-[gamma] inhibitors.
Development Status: The technology is currently in the pre-clinical
stage of development.
Market: The annual growth rate for the therapeutic peptide market
is estimated at about 7.5%.
Inventors: Nadya Tarasova et al. (NCI).
Patent Status: U.S. Provisional Application No. 61/333,512 filed 11
May 2010 (HHS Reference No. E-167-2010/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Jennifer Wong; 301-435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The Center for Cancer Research,
Cancer and Inflammation Program, is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize inhibitors of IL10, IFN[gamma] and
STAT3 signaling. Please contact John Hewes, Ph.D. at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Diagnostic and Prognostic HCC-Related Metabolites
Description of Invention: Metabolite profiling identifies and
measures changes in cellular metabolites as a means to determine a
direct correlation between gene expression and changes in biological
function. Investigators at the National Cancer Institute have
identified a unique set of metabolite biomarkers associated with
hepatocellular carcinoma (HCC), early stage HCC, HCC patient outcome
and HCC stem-cell subtype. Subsets of this metabolite/gene signature
can distinguish HCC tumors from normal tissues with 88-97% accuracy,
identify early stage HCC patients with 62-78% accuracy, wherein early
stage is defined as TNM stage I, prognose negative patient outcome, and
identify a HCC stem cell subtype with 70-77% accuracy. These
metabolites and gene surrogates are elements of the PI3K and Myc
signaling networks which can potentially be targeted for therapeutic
purposes.
[[Page 66107]]
HCC represents an extremely poor prognostic cancer, and patients
are often diagnosed with end-stage cancer and have poor survival. HCC
is also a very heterogeneous disease and often arises from chronic
liver disease. Surgery and transplantation remain the only curative
option for patients; however, complications due to cirrhosis mean it is
a viable option for 5-10% patients. This HCC gene signature can be
developed into assays to enable clinicians to accurately diagnose HCC,
including early stages and subtype of this disease, and therefore
stratify patients for appropriate treatment and prioritizing liver
transplantation candidates based on their metabolite profile.
Applications:
Method to diagnose HCC, including HCC subtypes.
Method to prognose HCC patient outcome.
Method to stratify patients for appropriate treatment.
Advantages: Highly accurate metabolite/gene profile that can be
developed into a variety of diagnostic and prognostic applications.
Development Status: The technology is currently in the pre-clinical
stage of development.
Market:
Global oncology biomarker discovery market is expected to
grow from $2.5 billion in 2009 to $5.7 billion by 2014.
North America has the largest metabolomic market with an
estimated value of $161.4 million in 2009, and it is projected to reach
$324 million by 2014.
HCC is the fifth most common cancer worldwide with an
estimated one million new cases diagnosed annually.
Inventors: Xin Wei Wang and Anuradha S. Budhu (NCI).
Patent Status: U.S. Provisional Application No. 61/323,420 filed 13
Apr 2010 (HHS Reference No. E-139-2010/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Jennifer Wong; 301-435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The Center for Cancer Research,
Laboratory of Human Carcinogenesis, is seeking statements of capability
or interest from parties interested in collaborative research to
further develop, evaluate, or commercialize metabolomic signatures for
liver cancer. Please contact John Hewes, Ph.D. at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Stimulation of Natural Killer T-Cell Anti-Tumor Activity
Description of Invention: Natural killer T cells (NKT) are a unique
lymphocyte population that has T-cell and NK cell functional properties
in order to rapidly elicit an immune response. [alpha]-
galactosylceramide ([alpha]-GalCer) is a potent NKT stimulator and
induces of IFN-[gamma] release to promote immunity against tumors and
infectious agents. Humans have natural antibodies against [alpha]-
galactose, which may be one of the reasons why the human clinical
trials of [alpha]-GalCer or KRN7000 were not very successful.
Investigators at the National Cancer Institute have found that
[beta]-mannosylceramide ([beta]-ManCer) promotes immunity in an IFN-
[gamma] independent mechanism. [beta]-ManCer is a new class of NKT
agonist that induces immune responses alone, through nitric oxide and
TNF-[alpha]-dependent mechanisms, or synergistically with [alpha]-
GalCer to enhance [alpha]-GalCer's efficacy. Since [beta]-ManCer does
not have [alpha]-galactose, which can be neutralized by natural
antibodies, patients could be treated with multiple doses without
negative side effects associated with the loss of IFN-[gamma]
production. Hence, [beta]-ManCer is a promising anti-cancer treatment
either alone or in combinatorial therapies with [alpha]-GalCer to
selectively induce immune responses.
Applications:
Cancer therapeutics.
Potent stimulator of NKT activity.
Advantages:
Induces tumor immunity through a novel mechanism.
Decreased possibility of neutralization by natural
antibodies.
Synergize with [alpha]-GalCer.
Development Status: The technology is currently in the pre-clinical
stage of development.
Market: Global cancer market is worth more than eight percent of
total global pharmaceutical sales.
Inventors: Masaki Terabe (NCI) et al.
Patent Status: U.S. Provisional Application No. 61/313,508 filed 12
Mar 2010 (HHS Reference No. E-034-2010/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Jennifer Wong; 301-435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The Vaccine Branch of the
National Cancer Institute is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize [beta]-ManCer. Please contact John
Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more
information.
Modified POTE Peptides for Cancer Immunotherapy
Description of Invention: Investigators at the National Cancer
Institute have identified and enhanced immunogenicity of POTE epitopes
to improve their efficacy in cancer vaccines. POTE is a novel tumor
antigen expressed in a variety of cancers including breast, prostate,
colon, lung, ovary, and pancreas cancers. POTE has limited expression
in normal tissues and therefore a specific target for cancer
treatments, including immunotherapy. Immunotherapy has great potential
as a cancer therapeutic because of its specificity and freedom from
toxic effects of chemotherapies.
Antigen-specific cancer immunotherapy often relies on
identification of epitopes expressed by cancer cells that can be
targeted by cytotoxic T cells (CTL). However, the CTL repertoire
against high-affinity cancer epitopes is often ineffective because
cancer epitopes may share a similar structure to natural ``self''
antigens. As a result, cancer cells are not recognized by CTLs and
destroyed. The enhanced POTE epitopes induce a stronger immune response
than natural responses. These modified epitopes are more effective at
inducing CTL against POTE expressing cancer cells and have greater
potential to serve as cancer vaccine targets.
Applications:
Therapeutic cancer vaccine.
Method to treat cancer.
Advantages:
Enhanced immunogenic peptides.
Cancer vaccines that overcome self-tolerance to target a
variety of tumor cells.
Development Status: The technology is currently in the pre-clinical
stage of development.
Market: The therapeutic cancer market will be worth an estimated
$633 million in 2014.
Inventors: Jay A. Berzofsky, Yi-Hisang Huang, Ira Pastan, Masaki
Terabe (NCI).
Patent Status: U.S. Provisional Application No. 61/313,559 filed 12
Mar 2010 (HHS Reference No. E-003-2010/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Jennifer Wong; 301-435-4633;
wongje@mail.nih.gov.
Collaborative Research Opportunity: The Center for Cancer Research,
Vaccine Branch, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate, or
[[Page 66108]]
commercialize this technology. Please contact John Hewes, Ph.D. at 301-
435-3121 or hewesj@mail.nih.gov for more information.
Dated: October 21, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-27181 Filed 10-26-10; 8:45 am]
BILLING CODE 4140-01-P