E7-13542. 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.

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.

Cyclic Phosphopeptide Inhibitors of Protein Phosphatase 2C Delta, Wip1

Description of Technology: This technology involves the development of specific peptides that can be used as anti-cancer agents, particularly as promoters of apoptosis. The inventors have modified the natural substrate of the Wip1 protein phosphatase in order to produce the inhibitors, allowing for specific and efficient inhibition of Wip1. These peptides represent the first Wip1 peptide inhibitors. The inhibitors can be combined with other pro-apoptosis therapeutics to improve patient survival, providing an advantage to previous pro-apoptosis approaches.

Wip1 (PP2Cdelta or PPM1D) is a protein phosphatase that negatively regulates cell-cycle arrest and apoptosis by preventing p53-mediated cell-cycle arrest and apoptosis. Wip1 is overexpressed in several human cancers, including breast cancer, ovarian clear cell adenocarcinoma and neuroblastoma, suggesting it may play an important role in oncogenesis. Inhibiting Wip1 may be a necessary step for inducing apoptosis and prohibiting tumor growth, accentuating the need for Wip1-directed therapies. Because these peptide inhibitors are the first specific Wip1 inhibitors, they represent the first opportunity to pursue this therapeutic strategy.

Applications: Applicable as anti-cancer therapeutics for a wide variety of tumors, including breast cancer, ovarian cancer, and neuroblastomas. Inhibitors can also be combined with other cancer therapeutics.

Advantages: Inhibitors are designed based on strucural similarity to the native substrate, providing a high degree of specificity to the target. First inhibitors directed to Wip1 as a target for cancer therapy.

Benefits: Cancer is the second leading cause of death in the United States, with approximately 600,000 cancer-related deaths occurring in 2006 alone. Wip1 inhibitors may provide a social benefit by reducing that number or improving the quality/length of patient life. Furthermore, the cancer therapeutic market is expected to reach $27 billion by 2009. Because these molecules are the first inhibitors of Wip1, there is an opportunity to occupy a significant niche in that predicted market.

Inventors: Ettore Appella et al. (NCI).

U.S. Patent Status: U.S. Provisional Application No. 60/850,218 (HHS Reference No. E-288-2006/0-US-01).

Licensing Contact: David A. Lambertson, Ph.D.; Phone: [phone]; E-mail: [e-mail].

Collaborative Research Opportunity: The National Cancer Institute Center for Cancer Research, Laboratory for Cell Biology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Cyclic Phosphopeptide Inhibitors of Protein Phosphatase 2C Delta, Wip1. Please contact John D. Hewes, Ph.D. at 301/435-3121 or [e-mail] for more information.

A Gene Therapy to Treat Lung Cancer

Description of Technology: This invention relates to the identification of a new tumor suppressor gene named Caliban from Drosophila melanogaster and Serologically determined colon cancer antigen gene 1 (Sdccag1) from humans. Sdccag1 is inactive in human lung cancer cells but active in normal lung cells. When full length Caliban or Sdccag1 is expressed in human lung cancer cells they lose their tumorigenicity. This suggests that Caliban/Sdccag1 could be used as both a therapeutic and diagnostic for cancer.

Applications: Using gene therapy to replace the inactive gene with full length Caliban/Sdccag1 to treat cancer(s); A diagnostic assay that can determine whether the tumor suppressor Caliban/Sdccag1 gene product is functioning in cells.

Advantages: Caliban/Sdccag1 can be easily adopted into already standard gene therapy applications; Provides a novel therapeutic and diagnostic target for cancer.

Benefits: It is estimated that there will be approximately 160,000 deaths caused by lung cancer in 2007. This technology will help in improving the quality of life of lung cancer patients as well as other cancers. Additionally, the gene therapy market is now a multi-million dollar industry.

Inventors: Mark A. Mortin (NICHD), Xiaolin Bi (NCI).

U.S. Patent Status: Pending PCT Application PCT/US2006/022180, published as WO 2006/13316 (E-118-2005/0-PCT-02).

Licensing Contact: David A. Lambertson, Ph.D.; Phone: [phone]; Fax: [phone]; E-mail: [e-mail].

Collaborative Research Opportunity: The National Institute of Child Health and Human Development is seeking statements of capability or interest from parties interested in collaborative research to obtain pre-clinical data to be used to further develop, evaluate, or commercialize Caliban/Sdccag1 as a novel therapeutic and diagnostic target for cancer and other diseases. Please contact John D. Hewes, Ph.D. at 301-435-3121 or [e-mail] for more information.

Dated: July 5, 2007.

Steven M. Ferguson,

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