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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.

Prolactin Receptor Antibodies as a Diagnostic Marker and Therapeutic Agent for Cancer

Description of Technology: Prolactin is a key hormone in the normal breast development and plays a role in the growth and development of other major organs such as the prostate. The biologic function of prolactin is mediated by specific receptors on the cell surface, with breast cancer cells containing more receptors than normal tissue. The prolactin receptor, a member of the large class-1 cytokine receptor superfamily, has three major isoforms that are cell associated. The specific isoform concentration and distribution determines biological activity and may determine susceptibility to antiprolactin drugs.

This technology describes several antibodies, both polyclonal and monoclonal, to the prolactin receptor. These include antibodies to the three major isoforms: the long isoform (LF), two short isoforms (SF1a and SF1b), and the secreted form, prolactin receptor Δ7-11. These antibodies can be used for the diagnosis of prolactin sensitive tumors. Furthermore, the presence of the secreted prolactin receptor Δ7-11 may provide a blood test for prolactin responsive tumors.

Applications:

  • Diagnostic tool for the detection of prolactin sensitive tumors.
  • Antibodies as a serum diagnostic in high-throughput assays.
  • Conjugated antibodies used in targeted therapy of cancer.

Market:

  • In the U.S. over 2 million women have been treated for breast cancer and with more than 200,000 women diagnosed in the year 2007 alone. Breast cancer is the second leading cause of cancer death in women.
  • Prostate cancer is the most common type of cancer found in American men, and it has been estimated that there were more than 230,000 new cases in the U.S. in 2007. Prostate cancer is also the second leading cause of cancer death in men.

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

Inventors: Barbara Vonderhaar, Erika Ginsburg, Paul Goldsmith (NCI).

Patent Status: HHS Reference No. E-232-2008/0—Research Material. Patent protection is not being pursued for this technology.

Licensing Status: Available for licensing.

Licensing Contact: Whitney A. Hastings; 301-451-7337; hastingw@mail.nih.gov.

Collaborative Research Opportunity: The National Cancer Institute, Mammary Biology and Tumorigenesis Laboratory is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize isoform specific antibodies to the human prolactin receptor. Please contact John D. Hewes, PhD, at 301-435-3121 or hewesj@mail.nih.gov for more information.

Mouse Embryonic Stem Cell-Based Functional Assay To Evaluate Mutations in BRCA2

Description of Technology: Mutations in breast cancer susceptibility genes BRCA1 and BRCA2 have up to an 80% life time risk in developing breast cancer. There are no “mutation hot spots” and to date, more than 1,500 different mutations have been identified in BRCA2. The absence of tumor cell lines expressing various mutant BRCA2 alleles has hindered evaluations to determine the functional differences between different mutations.

A simple, versatile and reliable mouse embryonic stem cell and bacterial artificial chromosome based assay to generate cell lines expressing mutant human BRCA2 has been developed and it has been used to classify 17 sequence variants. Available for licensing are a wild-type and eleven mutant BRCA2 cell lines developed from this assay that have either truncations or point mutations. These cell lines may be used to evaluate the effect of DNA damaging agents, genotoxins and chemotherapeutic efficacy.

Applications:

  • Research tool to generate and study BRCA2 mutations.
  • Method to screen for chemotherapeutics.
  • Method to evaluate DNA damaging agents.

Advantages: Ready to use portfolio of BRCA2 mutant cell lines to study BRCA2 mutant functional analysis.

Market: An estimated 180,510 new cases of breast cancer will be diagnosed and may cause 40,480 deaths in the U.S. in 2008.

Inventors: Shyam K. Sharan and Sergey Kuznetsov (NCI).

Publication: SG Kuznetsov et al. Mouse embryonic stem cell-based functional assay to evaluate mutations in BRCA2. Nat Med. 2008, in press. Published online 11 July 2008, doi:10.1038/nm.1719.

Patent Status: HHS Reference No. E-261-2007/0—Research Tool. Patent protection is not being pursued for this technology.

Licensing Status: Available for biological materials licensing only.

Licensing Contact: Jennifer Wong; (301) 435-4633; wongje@mail.nih.gov.

Collaborative Research Opportunity: The Mouse Cancer Genetics Program, Center for Cancer Research, National Cancer Institute, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize mouse embryonic stem cell lines suitable for functional analysis of BRCA2 variants. Please contact John D. Hewes, PhD, at 301-435-3121 or hewesj@mail.nih.gov for more information.

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Dated: July 17, 2008.

Richard U. Rodriguez,

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

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[FR Doc. E8-17031 Filed 7-24-08; 8:45 am]

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