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Notice

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.

Methodology for Large Scale Manufacture of Stable Disulfide-Conjugated Antibody-Ribonuclease

David F. Nellis, Dianne L. Newton, Susanna M. Rybak (NCI)

U.S. Provisional Application filed 30 Sep 2005 (HHS Reference No. E-218-2005/0-US-01)

Licensing Contact: David A. Lambertson; 301/435-4632; lambertsond@mail.nih.gov

Large scale clinical production of disulfide-conjugated antibody-RNase therapeutics using previously reported technologies usually results in an unstable product that forms undesired multimeric antibody/RNase species. This invention describes improved methods for the large scale manufacture of stable disulfide-conjugated antibody therapeutics. Antibody-RNase conjugates produced by this method were specific and highly active in vitro in killing selected carcinoma, and also showed in vivo activity in the treatment of disseminated B-cell lymphoma. These methods are broadly applicable to disulfide-linked conjugation of cytotoxic proteins. The claims for this invention encompass methods for preparing a protein for disulfide conjugation with another molecule, such as an RNase to an antibody.

In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.

Identification of Biomarkers by Serum Protein Profiling

Thomas Ried and Jens Habermann (NCI)

U.S. Provisional Application No. 60/664,681 filed 22 Mar 2005 (HHS Reference No. E-106-2005/0-US-01)

Licensing Contact: Thomas P. Clouse; 301/435-4076; clouset@mail.nih.gov

This invention describes serum features that distinguish colorectal carcinoma malignant patient samples versus healthy samples using surface-enhanced laser desorption ionization time-of-flight (SELDI-TOF) mass spectrometry. By comparing healthy versus malignant samples, the investigators were able to identify thirteen (13) serum features that have been validated using an independently collected, blinded validation set of 55 sera samples. The features are characterized by the mass to charge ratio (m/z ratio). The investigators have shown that SELDI-TOF based serum marker protein profiling enables minimally invasive detection of colon cancer with 96.7 percent sensitivity and 100 percent specificity.

Colorectal cancer is the third most common cancer and the third leading cause of cancer-related mortality in the United States. Current diagnostic methods for colorectal cancer have a large non-compliance rate because of discomfort, e.g., sigmoidoscopy or colonoscopy, or have a high rate of false positive results, e.g., fecal occult blood tests. The claimed invention has the potential to be a widely used, easy-to-use, and inexpensive diagnostic.

In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.

Novel Form of Interleukin-15, Fc-IL-15, and Methods of Use

Morihiro Watanabe et al. (NCI)

U.S. Provisional Application No. 60/670,862 filed 12 Apr 2005 (HHS Reference No. E-296-2004/0-US-01)

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

Interleukin-15 (IL-15) is a potent cytokine that enhances host immune system function by proliferating and activating leukocytes. IL-15 increases innate immunity and CD8 memory. The investigators fused IL-15 with protein Fc, a fragment of immunoglobulin. The new fused moiety, Fc-IL-15, has a longer half life in vivo than naturally occurring IL-15 in a gene therapy setting and has more potent anti-tumor effects than IL-15 in some mouse tumor models. The new moiety can serve as an alternative to IL-15, particularly if long term delivery is essential for a therapy. The moiety can serve as a therapeutic for both tumors and viral infections. The moiety can include peptide linkers such as, for example, a T cell inert sequence or a non-immunogenic sequence.

In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.

ELISA Assay of Serum Soluble CD22 To Assess Tumor Burden/Relapse in Subjects with Leukemia and Lymphoma

Robert J. Kreitman et al. (NCI)

U.S. Patent Application No. 10/514,910 filed 16 Nov 2004 (HHS Reference No. E-065-2002/0-US-03), with priority to 20 May 2002 Start Printed Page 8862

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

Disclosed are methods of using previously unknown soluble forms of CD22 (sCD22) present in the serum of subjects with B-cell leukemias and lymphomas to assess tumor burden in the subjects. Also disclosed are methods of diagnosing or prognosing development or progression of a B-cell lymphoma or leukemia in a subject, including detecting sCD22 in a body fluid sample taken or derived from the subject, for instance serum. In some embodiments, soluble CD22 levels are quantified. By way of example, the B-cell lymphoma or leukemia can be hairy cell leukemia, chronic lymphocytic leukemia, or non-Hodgkin's lymphoma. Soluble CD22 in some embodiments is detected by a specific binding agent, and optionally, the specific binding agent can be detectably labeled.

Also disclosed are methods of selecting a B-cell lymphoma or leukemia therapy that include detecting an increase or decrease in sCD22 levels in a subject compared to a control, and, if such increase or decrease is identified, selecting a treatment to prevent or reduce B-cell lymphoma or leukemia or to delay the onset of B-cell lymphoma or leukemia.

Other embodiments are kits for measuring a soluble CD22 level, which kits include a specific binding molecule that selectively binds to the CD22, e.g. an antibody or antibody fragment that selectively binds CD22.

Further disclosed methods are methods for screening for a compound useful in treating, reducing, or preventing B-cell lymphomas or leukemias, or development or progression of B-cell lymphomas or leukemias, which methods include determining if application of a test compound lowers soluble CD22 levels in a subject, and selecting a compound that so lowers sCD22 levels.

In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.

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Dated: February 10, 2006.

Steven M. Ferguson,

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

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[FR Doc. E6-2362 Filed 2-17-06; 8:45 am]

BILLING CODE 4140-01-P