[Federal Register Volume 72, Number 19 (Tuesday, January 30, 2007)]
[Notices]
[Pages 4274-4275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1377]


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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.

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; 
[email protected].

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

[[Page 4275]]

of 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; 
[email protected].
    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: [email protected]) for more information.

    Dated: January 19, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-1377 Filed 1-29-07; 8:45 am]
BILLING CODE 4140-01-P