[Federal Register Volume 75, Number 207 (Wednesday, October 27, 2010)]
[Notices]
[Pages 66106-66108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27181]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
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SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 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;
[email protected].
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
[email protected] 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;
[email protected].
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
[email protected] 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;
[email protected].
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 [email protected] 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;
[email protected].
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 [email protected] 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