04-16124. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Autoantibody Detection for Cancer Diagnostics

Yoon Cho-Chung (NCI), US Provisional Application No. 60/551,776 filed 11 Mar 2004 (DHHS Reference No. E-081-2004/0-US-01)

Licensing Contact: Brenda Hefti; 301/435-4632; [e-mail].

The current patent application addresses the need to discover novel biomarkers for the diagnosis, screening and monitoring of tumor progression or regression. The invention relates to compositions and methods for detecting autoantibodies against an extracellular form of protein kinase A (ECPKA) in a biological sample for the diagnosis of cancer. ECPKA is secreted from cancer cells which then elicits the formation of serum autoantibodies which can serve as a cancer diagnostic and prognostic marker. The invention describes a highly sensitive enzyme immunoassay that measures the presence of anti-ECPKA autoantibody in biological samples of cancer patients. The present invention demonstrates that the sera presence of autoantibody directed against ECPKA is highly correlative of cancer. The immunoassay developed for anti-ECPKA antibody is highly sensitive and specific. Use of the immunoassay exhibits markedly high anti-ECPKA antibody titers in cancer patients but low or non-existent titers in normal individual controls. Furthermore, use of the invention to detect anti-ECPKA antibodies is much more sensitive and specific than results from other current assays that detect only antigen activity. The invention demonstrates that the approach of autoantibody analysis, rather than conventional antigen analysis for ECPKA and other cancer antigens, provides a valuable approach for cancer diagnosis. This ECPKA-autoantibody-based immunoassay method provides an important diagnostic procedure applicable for the detection of cancers of various cell types.

Vaccine Peptide Derived from XAGE-1 to Prevent Tumor Growth

Jay A. Berzofsky, Ira H. Pastan, and Masaki Terabe (NCI), U.S. Provisional Application No. 60/529,025 filed 12 Dec 2003 (DHHS Reference No. E-090-2003/0-US-01)

Licensing Contact: Brenda Hefti; 301/435-4632; [e-mail].

This invention describes a novel peptide derived from the protein XAGE-1 which is expressed specifically in cancer cells of prostate and breast cancer, as well as Ewing's sarcoma. This peptide is able to bind to human HLA-A2 molecules and to induce specific cytotoxic T lymphocyte response in vivo.

This peptide has therapeutic potential as an immunogen, and might induce cancer specific immune responses in cancer patients, which may cause regression of the cancer or prevent cancer metastasis.

Dated: July 6, 2004.

Steven M. Ferguson,

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