[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