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. 

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 

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 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 

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. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices 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. 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 

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 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 


srobinson on DSKHWCL6B1PROD with NOTICES
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 

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. 

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. 

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 

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, 


srobinson on DSKHWCL6B1PROD with NOTICES