Government-Owned Inventions; Availability for Licensing, 21636-21638 [2010-9642]

Download as PDF 21636 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Notices sroberts on DSKD5P82C1PROD with NOTICES Licensing Status: Available for licensing. Licensing Contact: Kevin W. Chang, PhD; 301–435–5018; changke@mail.nih.gov. Collaborative Research Opportunity: The NIH Chemical Genomics Center (NCGC) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize appropriate lead compounds described in the patent application. Please contact Dr. Craig J. Thomas (craigt@nhgri.nih.gov) or Claire Driscoll (cdriscol@mail.nih.gov), Director of the NHGRI Technology Transfer Office, for more information. Topical Formulation of Histone Deacetylase (HDAC) Inhibitors: Treatments for Cancer and Immunological Skin Disorders Description of Invention: This technology relates to topical formulations of Histone Deacetylase (HDAC) inhibitors (HDIs) that can be used to treat cancers such as cutaneous T-cell lymphoma (CTCL) and skin disorders such as lupus, contact dermatitis, and drug eruptions which are associated with malignant or autoreactive lymphocytes from the immune system. HDIs, such as depsipeptide, have been demonstrated to be effective against CTCL when administered internally but a topical preparation may be more useful for treatment at earlier stages of the disease. HDIs are molecules that inhibit the activity of a group of enzymes that remove small chemical groups called acetyl groups from many different proteins, including proteins that regulate gene expression. By altering the acetylation of these proteins, HDAC inhibitors can induce tumor cell differentiation, cell cycle arrest, and cell death. A variety of chemically distinct molecules exhibit HDAC inhibitory activity and their potential as therapeutics for cancer and other indications is being investigated. The HDI depsipeptide is a cyclical peptide derived from a bacterium and is indicated as a second line treatment for CTCL through intravenous administration. Development of a topical preparation of depsipeptide and/ or other HDAC inhibitors may help reduce their toxicity and increase their effectiveness in treating CTCL, other cancers, as well as other diseases. Applications: • Use as a topical therapeutic for treatment of skin lymphomas. • Use as a topical therapeutic for treatment of immunological skin disorders. VerDate Nov<24>2008 16:56 Apr 23, 2010 Jkt 220001 Advantages: • HDIs such as vorinostat and depsipeptide have received regulatory approval for clinical use in systemic treatment of CTCL. • Localized topical treatment reduces potential for adverse reactions, compared to systemic treatments. • Clinical data illustrating the effectiveness of the topical formulation of depsipeptide are available. Development Status: In early stage of clinical development. Market: There is a need for effective low toxicity therapies to treat skin disorders due to activity of aberrant lymphocytes. CTCL is a rare form (800– 1,000 new cases per year) of lymphoma in which the advanced disease can lead to disfigurement and pain. Patient mortality usually results from infections arising from eventual breach of the skin. An autoimmune disease, cutaneous lupus erythematosus accounts for about 10% of all lupus cases (1.4 million people in U.S.) and produces persistent skin lesions that may lead to scarring and hair loss. In the U.S., skin eruptions caused by prescribed medications are estimated to occur in approximately 2– 5% of hospital patients. Most drug eruptions are delayed-type immune reactions with lymphocyte-mediated hypersensitivity which result in contact dermatitis, exanthematous reactions, and photoallergic reactions. A topical formulation of HDIs has potential of ameliorating the symptoms of these conditions. Inventors: Susan Bates et al. (NCI). Publication: Piekarz RL et al. Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2009 Nov 10;27(32):5410–5417. [PubMed: 19826128] Patent Status: U.S. Patent Application No. 12/064,220 filed 19 Feb 2008 (HHS Reference No. E–238–2005/0–US–07) and foreign counterparts in Europe, Canada, Australia and Japan. Licensing Status: Available for licensing. Licensing Contact: Sabarni Chatterjee, PhD; 301–435–5587; chatterjeesa@mail.nih.gov. Collaborative Research Opportunity: The Center for Cancer Research, Medical Oncology Branch and Affiliates, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize topical therapy using HDIs. Please contact John Hewes, PhD at 301–435–3131 or hewesj@mail.nih.gov for more information. PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 Variable Curve Catheter Description of Invention: The invention provides a deflectable tip guiding device, such as a catheter, that enables the operator to vary the radius of curvature of the tip of the catheter. This is a novel variation on the classic ‘‘fixed fulcrum’’ tip deflectors used in minimally invasive procedures in open surgical treatments. The described device permits a more comprehensive ability to navigate complex geometric pathways in patient’s body and enables better access to target structures (e.g., to all endomyocardial walls from a transaortic approach). The guiding device can be made compatible with imaging methods like MRI. The described technology can be used as a platform for a variety of interventional devices for delivery of drugs, cells, energy, or sutures through complex trajectories of the body. Inventors: Robert J. Lederman and Parag V. Karmarkar (NHLBI). Patent Status: U.S. Patent Application No. 10/534,362 filed 07 Nov 2005 (HHS Reference No. E–035–2003/0–US–03). Licensing Status: Available for licensing. Licensing Contact: Jeffrey A. James; 301–435–5474; jeffreyja@mail.nih.gov. Collaborative Research Opportunity: The NHLBI Translational Medicine Branch Cardiovascular Intervention Program is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize technology for imageguided cardiovascular interventions. Please contact Peg Koelble at koelblep@nhlbi.nih.gov for more information. Dated: April 20, 2010. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2010–9640 Filed 4–23–10; 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 E:\FR\FM\26APN1.SGM 26APN1 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Notices 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. 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. ADDRESSES: sroberts on DSKD5P82C1PROD with NOTICES Thermostable Y-Family Polymerases From Fungi for Use in Forensic DNA Services and Analysis of Damaged or Ancient DNA Description of Invention: Y-family polymerases are able to bypass lesions in DNA that would otherwise block replication by high fidelity DNA polymerases and are key to the effective study of ancient DNA and for use in forensic medicine. These enzymes are ubiquitous and are found in all kingdoms of life: Bacteria, archaea and eukaryotes. The number of proteins related to the Y-family polymerases is well over 200 orthologs and despite being closely related at the phylogenetic level, the few polymerases now characterized, each show a unique set of properties including processivity, fidelity, and the ability to bypass certain types of DNA. Y-family polymerases from thermostable organisms are of particular interest because the enzymes isolated from such species tend to be more stable, easy to work with and may have more utility in assays at higher temperatures, such as Polymerase Chain Reaction (PCR). For example, the thermostable archeal Sulfolobus solfataricus DinB-like polymerase Dpo4 can bypass lesions by generally inserting the correct complementary nucleotide opposite a variety of damaged bases and can, under appropriate conditions substitute for Taq polymerase in PCR applications [Nucleic Acids Res. 2001 Nov 15;29(22):4607–4616; HHS Ref. No. E– 232–2001/0]. Additionally, functional and structural organization of this family of polymerases permits domain swapping designed to optimize specific properties of use in novel applications [J Biol Chem. 2004 Jul 30;279(31):32932–32940]. VerDate Nov<24>2008 16:56 Apr 23, 2010 Jkt 220001 Dr. Woodgate’s group at the National Institute of Child Health and Development have expanded their earlier work (HHS Ref. Nos. E–166– 2004/0,/1, &/2) and have now cloned and expressed full length Y-family polymerases Thermoascus auranticus Pol eta, Thermomyces lanuginosus Pol eta, Thermomyces lanuginosus Pol iota, Thermomyces lanuginosus Pol kappa, Thermomyces lanuginosus REV1, Sporotrichum thermophile Pol eta, Sporotrichum thermophile Pol iota, Sporotrichum thermophile Pol kappa, and Sporotrichum thermophile REV1. These full length enzymes may be a good substitute for Taq polymerase in applications utilizing fluorescent nucleoside triphosphate derivatives. These lesion-bypassing polymerases could also be included along with a conventional thermostable polymerase in a PCR protocol designed to amplify old or damaged DNA samples which could greatly increase recoverability, accuracy and length of products. Other applications could include labelling or tagging DNA, real-time PCR, detection of SNPs, mismatches or DNA lesions, mutagenic PCR, directed-evolution methods and expanding the ‘‘DNA alphabet’’ utilizing non-natural nucleotides. Available for licensing are several full length novel Y-family polymerases. These enzymes and methods should be of interest to forensic DNA service companies as well as to research reagent companies pursuing novel thermophilic enzymes for use in ancient and damaged DNA analysis and for novel applications with modified nucleotides. Inventors: Roger Woodgate and John P. McDonald (NICHD). Patent Status: U.S. Provisional Application No. 61/289,901 filed 23 Dec 2009 (HHS Reference No. E–254–2009/ 0–US–01). Related Patents and Technologies: HHS Reference No. E–166–2004/2— • U.S. Patent Application No. 11/ 596,783 filed 17 Nov 2006. • Australian Patent Application No. 2005245966 filed 20 May 2005. • Canadian Patent Application No. 2567563 filed 20 May 2005. • South African Patent Application No. 2006/10533 filed 20 May 2005. Licensing Status: Available for licensing. Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301–435–5020; vepas@mail.nih.gov. Collaborative Research Opportunity: The National Institute of Child Health and Human Development, Laboratory of Genomic Integrity, is seeking statements of capability or interest from parties interested in collaborative research to PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 21637 further develop, evaluate, or commercialize the aforementioned thermostable fungal Y-family DNA polymerases. Please contact Joseph Conrad, Ph.D. at 301–435–3107 or jmconrad@mail.nih.gov for more information. Compositions and Methods for Immunotherapy Description of Invention: Granulysin is a cytolytic and proinflammatory molecule expressed by activated human cytotoxic T lymphocytes (CTLs) and natural killer (NK) cells. It has been implicated in many of diseases including infection, cancer, transplantation, autoimmunity, skin and reproductive maladies. Small synthetic forms of granulysin are being developed as novel antibiotics and studies suggest that granulysin may be a useful diagnostic biomarker and/or therapeutic for a wide variety of diseases. The invention relates to methods of stimulating or enhancing an immune response using 15 kD granulysin. Investigators at the NIH have discovered that 15 kD granulysin (but not 9 kD granulysin) activates monocytes and induces them to differentiate into mature dendritic cells and activates allospecific T cells. This activation and subsequent differentiation induced by 15 kD granulysin may prove important in inducing or regulating immune responses in a host. Consequently, this invention could be used treat tumors and infections, particularly as an adjuvant for vaccines and immunotherapies. Further, this technology could be used to treat autoimmune disorders and organ transplant rejection. Applications: • Stimulating immunity to vaccinations, tumors or infections. • Blocking the induction of an immune response in an autoimmune disease or organ transplant rejection. Advantages: • An immune response activator with broad applicability to the treatment of several diseases, including cancer, atherosclerosis, diabetes, autoimmune disorders, allergies, and infections. • Co-administering 15kD granulysin could increase the efficacy of vaccines and immunotherapeutics. Development Status: • Pre-clinical stage. • Animal data available. Inventors: Alan M. Krensky and Carol Clayberger (NCI). Publications: 1. Stenger S, Hanson DA, Teitlebaum R, Dewan P, Niazi KR, Froelich CJ, Ganz ´ T, Thoma-Uszynski S, Melian A, Bogdan C, Porcelli SA, Bloom BR, E:\FR\FM\26APN1.SGM 26APN1 21638 Federal Register / Vol. 75, No. 79 / Monday, April 26, 2010 / Notices sroberts on DSKD5P82C1PROD with NOTICES Krensky AM, Modlin RL. An antimicrobial activity of cytolytic T cells mediated by granulysin. Science 1998 Oct 2;282(5386):121–125. [PubMed: 9756476] 2. Krensky AM and Clayberger C. Biology and clinical relevance of granulysin. Tissue Antigens 2009 Mar;73(3):193–198. [PubMed: 19254247] Patent Status: U.S. Provisional Application No. 61/250,601 filed 12 Oct 2009 (HHS Reference No. E–158–2009/ 0–US–01). Licensing Status: Available for licensing. Licensing Contact: Whitney Hastings, M.S.; 301–451–7337; hastingw@mail.nih.gov. Collaborative Research Opportunity: The Center for Cancer Research, Laboratory of Cellular and 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, Ph.D. at 301–435– 3131 or hewesj@mail.nih.gov for more information. Fully-Human Monoclonal Antibodies Against Human EphrinB2 and EphB4 for Use in the Study of Cancer Pathogenesis Description of Invention: Ephrin receptor tyrosine kinases and their ephrin ligands have been implicated in cancer pathogenesis. Ephrin receptors and ligands affect tumor growth, invasiveness, angiogenesis, and metastasis. Ephrin signaling activities in cancer are complex and are only now beginning to be uncovered. Researchers at the National Cancer Institute-Frederick, NIH, have developed a set of five fully-human monoclonal antibodies against human Ephrin-B2 and Ephrin type-B receptor 4 (‘‘EphB4’’). The antibodies were ¨ identified by screening a naıve human antibody phage display library against Ephrin-B2 and EphB4. These human monoclonal antibodies have high affinity and specificity for Ephrin-B2 and EphB4. Applications: • Research reagents for in vitro/in vivo investigation of Ephrin receptor and ligand interactions. • Targeting reagents for in vivo imaging. • Research reagents for protein cocrystallization. Advantages: • High affinity and antigen specificity. • Bind both soluble ectodomains and cell surface-expressed molecules. Inventors: Dimiter S. Dimitrov et al. (NCI). VerDate Nov<24>2008 16:56 Apr 23, 2010 Jkt 220001 Patent Status: HHS Reference No. E– 331–2008/0 & E–331–2008/1—Research Material. Patent protection is not being pursued for this technology. Licensing Status: Available for licensing. Licensing Contact: Patrick P. McCue, Ph.D.; 301–435–5560; mccuepat@mail.nih.gov. Collaborative Research Opportunity: The Center for Cancer Research Nanobiology Program 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, Ph.D. at 301–435– 3131 or hewesj@mail.nih.gov for more information. Dated: April 20, 2010. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2010–9642 Filed 4–23–10; 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. 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. ADDRESSES: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 New Mouse Strain With Conditional Deletion of SMAD7: Analysis of Disease Processes Involving Immunological, Fibrotic or Cardiovascular Indications Description of Invention: SMAD7 conditional knockout mice are available for licensing. SMAD7 can be knocked out by breeding with CRE-recombinase transgenic mice with a variety of promoters to yield tissue or cell typespecific deletions of SMAD7. SMAD7 has been shown to play a role in bone morphogenesis, cardiovascular tissue generation, immune regulation and fibrosis. Therefore, these mice provide a unique model to examine the role of the SMAD7 gene in disease processes that involve immunological, fibrotic, or cardiovascular components. Specifically, these mice may represent a novel model of Scleroderma, a disease with both an immunological and fibrotic component. Applications: • Mouse model of Scleroderma. • Means of studying bone morphogenesis and cardiovascular tissue generation. • Means of studying the role of SMAD7 in immune regulation. Inventors: Marilyn Diaz (NIEHS). Related Publication: Dong C, Zhu S, Wang T, Yoon W, Li Z, Alvarez RJ, Dijke P, White B, Wigley FM, GodschmidtClermont PJ. Deficient Smad7 expression: A putative molecular defect in scleroderma. Proc Natl Acad Sci USA. 2002 Mar 19;99(6):3908–3913. [PubMed: 11904440] Patent Status: HHS Reference No. E– 040–2010/0—Research Material. Patent protection is not being pursued for this technology. Licensing Status: This technology is available as a research tool under a Biological Materials License. Licensing Contact: Steve Standley, Ph.D.; 301–435–4074; sstand@od.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 technology. Please contact Dr. Elizabeth M. Denholm, denholme@niehs.nih.gov, for more information. A Method of Reducing Cholesterol Biosynthesis With Specific MicroRNAs Description of Invention: This technology is directed to the discovery of specific microRNAs that target and downregulate enzymes within the cholesterol biosynthetic pathway and is currently being tested in vivo. Briefly, microRNAs regulate the translation of messenger RNAs (mRNAs) E:\FR\FM\26APN1.SGM 26APN1

Agencies

[Federal Register Volume 75, Number 79 (Monday, April 26, 2010)]
[Notices]
[Pages 21636-21638]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9642]


-----------------------------------------------------------------------

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

[[Page 21637]]

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.

Thermostable Y-Family Polymerases From Fungi for Use in Forensic DNA 
Services and Analysis of Damaged or Ancient DNA

    Description of Invention: Y-family polymerases are able to bypass 
lesions in DNA that would otherwise block replication by high fidelity 
DNA polymerases and are key to the effective study of ancient DNA and 
for use in forensic medicine. These enzymes are ubiquitous and are 
found in all kingdoms of life: Bacteria, archaea and eukaryotes. The 
number of proteins related to the Y-family polymerases is well over 200 
orthologs and despite being closely related at the phylogenetic level, 
the few polymerases now characterized, each show a unique set of 
properties including processivity, fidelity, and the ability to bypass 
certain types of DNA. Y-family polymerases from thermostable organisms 
are of particular interest because the enzymes isolated from such 
species tend to be more stable, easy to work with and may have more 
utility in assays at higher temperatures, such as Polymerase Chain 
Reaction (PCR). For example, the thermostable archeal Sulfolobus 
solfataricus DinB-like polymerase Dpo4 can bypass lesions by generally 
inserting the correct complementary nucleotide opposite a variety of 
damaged bases and can, under appropriate conditions substitute for Taq 
polymerase in PCR applications [Nucleic Acids Res. 2001 Nov 
15;29(22):4607-4616; HHS Ref. No. E-232-2001/0]. Additionally, 
functional and structural organization of this family of polymerases 
permits domain swapping designed to optimize specific properties of use 
in novel applications [J Biol Chem. 2004 Jul 30;279(31):32932-32940].
    Dr. Woodgate's group at the National Institute of Child Health and 
Development have expanded their earlier work (HHS Ref. Nos. E-166-2004/
0,/1, &/2) and have now cloned and expressed full length Y-family 
polymerases Thermoascus auranticus Pol eta, Thermomyces lanuginosus Pol 
eta, Thermomyces lanuginosus Pol iota, Thermomyces lanuginosus Pol 
kappa, Thermomyces lanuginosus REV1, Sporotrichum thermophile Pol eta, 
Sporotrichum thermophile Pol iota, Sporotrichum thermophile Pol kappa, 
and Sporotrichum thermophile REV1. These full length enzymes may be a 
good substitute for Taq polymerase in applications utilizing 
fluorescent nucleoside triphosphate derivatives. These lesion-bypassing 
polymerases could also be included along with a conventional 
thermostable polymerase in a PCR protocol designed to amplify old or 
damaged DNA samples which could greatly increase recoverability, 
accuracy and length of products. Other applications could include 
labelling or tagging DNA, real-time PCR, detection of SNPs, mismatches 
or DNA lesions, mutagenic PCR, directed-evolution methods and expanding 
the ``DNA alphabet'' utilizing non-natural nucleotides.
    Available for licensing are several full length novel Y-family 
polymerases. These enzymes and methods should be of interest to 
forensic DNA service companies as well as to research reagent companies 
pursuing novel thermophilic enzymes for use in ancient and damaged DNA 
analysis and for novel applications with modified nucleotides.
    Inventors: Roger Woodgate and John P. McDonald (NICHD).
    Patent Status: U.S. Provisional Application No. 61/289,901 filed 23 
Dec 2009 (HHS Reference No. E-254-2009/0-US-01).
    Related Patents and Technologies:
    HHS Reference No. E-166-2004/2--
     U.S. Patent Application No. 11/596,783 filed 17 Nov 2006.
     Australian Patent Application No. 2005245966 filed 20 May 
2005.
     Canadian Patent Application No. 2567563 filed 20 May 2005.
     South African Patent Application No. 2006/10533 filed 20 
May 2005.
    Licensing Status: Available for licensing.
    Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; vepas@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of Child 
Health and Human Development, Laboratory of Genomic Integrity, is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
the aforementioned thermostable fungal Y-family DNA polymerases. Please 
contact Joseph Conrad, Ph.D. at 301-435-3107 or jmconrad@mail.nih.gov 
for more information.

Compositions and Methods for Immunotherapy

    Description of Invention: Granulysin is a cytolytic and 
proinflammatory molecule expressed by activated human cytotoxic T 
lymphocytes (CTLs) and natural killer (NK) cells. It has been 
implicated in many of diseases including infection, cancer, 
transplantation, autoimmunity, skin and reproductive maladies. Small 
synthetic forms of granulysin are being developed as novel antibiotics 
and studies suggest that granulysin may be a useful diagnostic 
biomarker and/or therapeutic for a wide variety of diseases.
    The invention relates to methods of stimulating or enhancing an 
immune response using 15 kD granulysin. Investigators at the NIH have 
discovered that 15 kD granulysin (but not 9 kD granulysin) activates 
monocytes and induces them to differentiate into mature dendritic cells 
and activates allospecific T cells. This activation and subsequent 
differentiation induced by 15 kD granulysin may prove important in 
inducing or regulating immune responses in a host. Consequently, this 
invention could be used treat tumors and infections, particularly as an 
adjuvant for vaccines and immunotherapies. Further, this technology 
could be used to treat autoimmune disorders and organ transplant 
rejection.
    Applications:
     Stimulating immunity to vaccinations, tumors or 
infections.
     Blocking the induction of an immune response in an 
autoimmune disease or organ transplant rejection.
    Advantages:
     An immune response activator with broad applicability to 
the treatment of several diseases, including cancer, atherosclerosis, 
diabetes, autoimmune disorders, allergies, and infections.
     Co-administering 15kD granulysin could increase the 
efficacy of vaccines and immunotherapeutics.
    Development Status:
     Pre-clinical stage.
     Animal data available.
    Inventors: Alan M. Krensky and Carol Clayberger (NCI).
    Publications:
    1. Stenger S, Hanson DA, Teitlebaum R, Dewan P, Niazi KR, Froelich 
CJ, Ganz T, Thoma-Uszynski S, Meli[aacute]n A, Bogdan C, Porcelli SA, 
Bloom BR,

[[Page 21638]]

Krensky AM, Modlin RL. An antimicrobial activity of cytolytic T cells 
mediated by granulysin. Science 1998 Oct 2;282(5386):121-125. [PubMed: 
9756476]
    2. Krensky AM and Clayberger C. Biology and clinical relevance of 
granulysin. Tissue Antigens 2009 Mar;73(3):193-198. [PubMed: 19254247]
    Patent Status: U.S. Provisional Application No. 61/250,601 filed 12 
Oct 2009 (HHS Reference No. E-158-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Whitney Hastings, M.S.; 301-451-7337; 
hastingw@mail.nih.gov.
    Collaborative Research Opportunity: The Center for Cancer Research, 
Laboratory of Cellular and 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, Ph.D. at 301-435-3131 or 
hewesj@mail.nih.gov for more information.

Fully-Human Monoclonal Antibodies Against Human EphrinB2 and EphB4 for 
Use in the Study of Cancer Pathogenesis

    Description of Invention: Ephrin receptor tyrosine kinases and 
their ephrin ligands have been implicated in cancer pathogenesis. 
Ephrin receptors and ligands affect tumor growth, invasiveness, 
angiogenesis, and metastasis. Ephrin signaling activities in cancer are 
complex and are only now beginning to be uncovered.
    Researchers at the National Cancer Institute-Frederick, NIH, have 
developed a set of five fully-human monoclonal antibodies against human 
Ephrin-B2 and Ephrin type-B receptor 4 (``EphB4''). The antibodies were 
identified by screening a na[iuml]ve human antibody phage display 
library against Ephrin-B2 and EphB4. These human monoclonal antibodies 
have high affinity and specificity for Ephrin-B2 and EphB4.
    Applications:
     Research reagents for in vitro/in vivo investigation of 
Ephrin receptor and ligand interactions.
     Targeting reagents for in vivo imaging.
     Research reagents for protein co-crystallization.
    Advantages:
     High affinity and antigen specificity.
     Bind both soluble ectodomains and cell surface-expressed 
molecules.
    Inventors: Dimiter S. Dimitrov et al. (NCI).
    Patent Status: HHS Reference No. E-331-2008/0 & E-331-2008/1--
Research Material. Patent protection is not being pursued for this 
technology.
    Licensing Status: Available for licensing.
    Licensing Contact: Patrick P. McCue, Ph.D.; 301-435-5560; 
mccuepat@mail.nih.gov.
    Collaborative Research Opportunity: The Center for Cancer Research 
Nanobiology Program 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, 
Ph.D. at 301-435-3131 or hewesj@mail.nih.gov for more information.

    Dated: April 20, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-9642 Filed 4-23-10; 8:45 am]
BILLING CODE 4140-01-P
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