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Government-Owned Inventions; Availability for Licensing

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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.

Megakaryocyte Potentiation Factor as a New Serum Tumor Marker for Mesothelioma

Description of Technology: Mesothelin is a glycoprotein, whose expression has been largely restricted to mesothelial cells in normal tissues, although epithelial cells of the trachea, tonsil, fallopian tube, and kidney have shown immunoreactivity. Mesothelin has been shown to be expressed in several cancers including mesothelioma, lung cancer, pancreatic carcinomas, gastric carcinomas and ovarian carcinomas, and has the potential of being used as a tumor marker and a novel target for the development of new treatments.

Mesothelin precursor protein is a 69 kDa protein that is proteolytically cleaved into two products, the megakaryocyte potentiation factor (MPF) and mesothelin. MPF is a 33 kDa soluble protein that is shed into the blood stream of patients with mesotheliomas and other tumors including ovarian and pancreatic and thus can be used as a serum marker for the diagnosis of mesothelin expressing cancers.

This invention describes the generation of monoclonal antibodies to MPF. The antibodies can be useful for diagnosing mesotheliomas and other cancers. Additionally, it can be used by the oncological research community as a research tool.

Applications: New monoclonal antibodies against MPF; A new monoclonal antibody against MPF that can be used for diagnosis method for mesotheliomas and other cancers including ovarian and pancreatic by detecting MPF in serum of patients.

Market: Cancer diagnostic market is projected to grow to approximately $8B in the next 5 years; Potential as a research tool for oncology research market.

Inventor: Ira H. Pastan et al. (NCI).

Publication: M Onda et al. Megakaryocyte potentiation factor cleaved from mesothelin precursor is a useful tumor marker in the serum of patients with mesothelioma. Clin Cancer Res. 2006 Jul 15;12 (14 Pt 1):4225-4231.

Patent Status: HHS Reference No. E-293-2006/0—Research Tool.

Licensing Status: Available for licensing under a Biological Materials license.

Licensing Contact: Jesse S. Kindra, J.D.; 301/435-5559; kindraj@mail.nih.gov.

Enriched Natural Killer Cells for Adoptive Infusion Cancer Therapy

Description of Technology: Immuno-therapy has taken a lead among the new cancer therapeutic approaches. It is one of the most promising new therapeutic approaches that exploit the innate immune mechanism of an individual to fight against a certain disease.

Natural killer (NK) cells are a form of cytotoxic lymphocytes which constitute a major portion of the innate immune system. NK cells have tumor cytotoxic properties independent of tumor specific antigens and have been shown in murine models to control and prevent tumor growth and dissemination. Inactivation of NK cells potentially allows cancer cells to evade host NK-cell-mediated immunity. Ligation of killer immunoglobulin like receptors (KIRs) by MHC class I on both normal and malignant tissues suppresses the function of NK cells.

The present invention relates to treating cancer and other hyperproliferative disorders by administering an enriched composition of allogeneic or autologous (KIR/KIR ligand incompatible) NK cell population. This enriched composition can potentially override the inactivation Start Printed Page 4275of NK cells by self HLA molecules or MHC class I expressing tumors. Claims cover compositions of enriched NK cell populations and method of treating malignancies or prevent recurrence of malignancies and treating any hyperproliferative disorders with these enriched compositions. Claims also cover a method to sensitize malignancies to NK cell TRAIL-mediated killing by pretreatment with bortezomib.

Applications and Modality: New adoptive infusion immunotherapeutic method for treating solid tumors; New cancer treatment method exploiting the function of NK cells; Enriched composition of allogeneic and autologous NK cell population; Enriched NK cell composition has potential to override the natural NK cell inactivation process by HLA or MHC class I expressing tumors; Sensitizing cancers to adoptively infused NK cells by treatment with bortezomib as a method to sensitize to NK cell TRAIL cytotoxicity.

Market: In 2006, 600,000 estimated deaths from cancer related diseases; Immunotherapy market is expected to double in the next 5 years; Adoptive immunotherapy is one of the most promising new cancer therapies.

Development Status: The technology is currently in the pre-clinical stage of development.

Inventors: Richard W. Childs et al. (NHLBI).

Related Publications: 1. T Igarashi et al. Enhanced cytotoxicity of allogeneic NK cells with killer immunoglobulin-like receptor ligand incompatibility against melanoma and renal cell carcinoma cells. Blood. 2004 Jul 1;104(1):170-177.

2. A Lundqvist et al. Bortezomib and depsipeptide sensitize tumors to tumor necrosis factor-related apoptosis-inducing ligand: a novel method to potentiate natural killer cell tumor cytotoxicity. Cancer Res. 2006 Jul 15;66(14):7317-7325.

3. A Lundqvist et al. Reduction of GVHD and enhanced anti-tumor effects after adoptive infusion of alloreactive Ly49-mismatched NK-cells from MHC-matched donors. Blood. Prepublished online 2006 Dec 19, doi 10.1182/blood-2006-05-024315.

Patent Status: PCT Application No. PCT/ U.S. 2005/039282 filed 31 Oct 2005, entitled “Compositions and Methods for Treating Hyperproliferative Disorders,” which published as WO 2006/050270 on 11 May 2006 (HHS Reference No. E-183-2004/1-PCT-01).

Licensing Status: Available for exclusive and non-exclusive licensing.

Licensing Contact: Thomas P. Clouse, J.D.; 301/435-4076; clousetp@mail.nih.gov.

Collaborative Research Opportunity: The Hematology Branch of the National Heart, Lung, and Blood Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the use of in vitro expanded adoptively infused NK cells to treat advanced and incurable cancers. Please contact Dr. Richard W. Childs at 301-496-5093 or 301-451-7128 (e-mail: childsr@nih.gov) for more information.

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Dated: January 19, 2007.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. E7-1377 Filed 1-29-07; 8:45 am]

BILLING CODE 4140-01-P