E5-6803. 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.

Mitotic Spindle ASPM as a Diagnostic Marker for Neoplasia and Uses Thereof

Paul K. Goldsmith, Vladmir Larionov, Natalay Kouprina and John I. Risinger (NCI)

U.S. Provisional Application No. 60/696,212 filed 01 Jul 2005 (HHS Reference No. E-210-2005/0-US-01)

Licensing Contact: Mojdeh Bahar; 301/435-2950; [e-mail].

Cancer is responsible for approximately 23% of deaths in the United States of America. A high percentage of these deaths are caused by the lack of a precise diagnostic method that can detect malignancy in a particular tissue at an early stage. This invention provides for diagnostic methods, compositions, and kits that are useful for identifying neoplasia by measuring Abnormal Spindle-like Microcephaly associated (ASPM) expression in a patient sample. The ASPM gene is the human ortholog of the Drosophila melanogaster ‘abnormal spindle’ gene (asp), which is essential for normal mitotic spindle function in embryonic neuroblasts. By measuring ASPM expression levels one can also determine if a particular subject has a higher propensity to develop neoplasia. This invention is particularly useful in detecting neoplasia in hard to diagnose cancers like ovarian and uterine cancer.

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

Monoclonal Antibodies That Bind or Neutralize Hepatitis B Virus

Robert H. Purcell (NIAID) et al.

U.S. Provisional Application No. 60/644,309 filed 14 Jan 2005 (HHS Reference No. E-144-2004/0-US-01)

Licensing Contact: Chekesha S. Clingman; 301/435-5018; [e-mail]..

Hepatitis B virus (HBV) chronically infects over 300 million people worldwide. Many of them will die of chronic hepatitis or hepatocellular carcinoma. The present technology relates to the isolation and characterization of a novel neutralizing chimpanzee monoclonal antibody to HBV. The antibody was identified through a combinatorial antibody library constructed from bone marrow cells of a chimpanzee experimentally infected with HBV. The selected monoclonal antibody has been shown to react equally well with wild-type HBV and the most common neutralization escape mutant variants. Therefore, this monoclonal antibody with high affinity and broad reactivity may have distinct advantages over other approaches to immunoprophylaxis and immunotherapy of chronic HBV infection, as most of the monoclonal antibodies currently in use are not sufficiently and broadly reactive to prevent the emergence of neutralization escape mutants of HBV. This technology describes such antibodies, fragments of such antibodies retaining hepatitis B virus-binding ability, fully human or humanized antibodies retaining hepatitis B virus-binding ability, and pharmaceutical compositions including such antibodies. This invention further describes isolated nucleic acids encoding the antibodies and host cells transformed with nucleic acids. In addition, this invention provides methods of employing these antibodies and nucleic acids in the in vitro and in vivo diagnosis, prevention and therapy of HBV diseases.

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

Polypeptide Multimers Having Antiviral Activity

Carol Weiss et al. (FDA)

PCT Application No. PCT/US03/25295 filed 14 Aug 2003, which published as WO 2005/018666 on 03 Mar 2005 (HHS Reference No. E-155-2003/0-PCT-01)

Licensing Contact: Susan Ano; 301/435-5515; [e-mail].

The technology describes polypeptide multimers that have antiviral and immunogenic activity against HIV. These multimers consist of at least one monomer of the highly conserved N and C heptad regions of gp41 in a ratio of at least 2:1 N to C heptad, with the N and C heptads being connected by linkers. The monomer forms homodimers and homotrimers in solution and mimic fusion intermediate structure. Further, the technology also describes a method of raising a broadly neutralizing antibody response to HIV by administering the polypeptide multimers mentioned above. Thus, these polypeptide multimers may be used as antiviral (anti-HIV) agents. Because the structure of these polypeptide multimers mimics the gp41 fusion intermediate, they can also be used to identify compounds that may inhibit the fusion process.

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

Dated: November 15, 2005.

Steven M. Ferguson,

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