E7-10711. 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.

Human and Avian Influenza Whole Genome Phage Display Libraries

Description of Technology: Available for use in developing research reagents, therapeutics or diagnostics are recombinant bacteriophage display libraries for identifying influenza viral gene products in preparation for pandemic threats the cross-reactivity and long-term protection of interpandemic influenza vaccines. Influenza vaccines predominantly include haemagglutinin (HA) and Neuraminidase (NA) antigens that characterize annual circulating influenza types A and type B. Analyses of the immune responses against new candidate vaccines is required in order to identify the best correlate of protection against seasonal human influenza strains and potential pandemic strains.

These “Whole Viral Genome Phage Display Libraries” express complete sets of protein fragments encoded by several Human and Avian Influenza strains including HlN1, H3N2, H5N1 and H7N7 and can be used for in depth analyses of plasma samples from: (a) Individuals exposed to human influenza; (b) individuals exposed to avian influenza; (c) individuals vaccinated with traditional influenza vaccines; (d) individuals vaccinated with new generation vaccines against human and bird influenza viruses.

Applications: Serological assays for surveillance of pandemic influenza outbreaks; Serological assays for distinguishing between exposure to human and bird influenza strains; Serological assays for diagnosing true infections in previously vaccinated individuals; Rapid analyses of immune sera from pre-clinical and clinical trials of novel influenza vaccines; Mapping of monoclonal and polyclonal antibodies against different influenza gene products; Identification of highly conserved “protective” epitopes for inclusion in future broadly-reactive influenza vaccines (against either inter-pandemic or pandemic influenza strains); Studies of viral protein-protein, viral RNA-protein and viral-host protein interactions (viral pathogenesis studies).

Market: Influenza diagnostics and vaccines.

Development Status: Materials available as research tools.

Inventors: Hana Golding, Ph.D. (FDA), Surender Khurana, Ph.D. (FDA).

Patent Status: HHS Reference No. E-031-2007/0—Research Tool.

Licensing Status: Available for licensing as a biological material.

Scientific Contact: Hana Golding, Ph.D.; FDA/CBER/OVRR/DVP/LR; 9000 Rockville Pike, Building 29B, Room 4N04, Bethesda, MD 20892; E-mail: [e-mail]; Phone: [phone].

Licensing Contact: Michael A. Shmilovich, Esq.; National Institutes of Health, Office of Technology Transfer; 6011 Executive Blvd., Suite 325, Rockville, MD 20852; E-mail: [e-mail]; Phone: [phone]; Fax: [phone].

Diagnostic and Therapeutic Use of Brother of the Regulator of Imprinted Sites (BORIS) Alternative Splice Forms

Description of Technology: This technology identifies twenty five (25) new alternatively spliced transcripts of the BORIS gene. The transcripts lead to the expression of seventeen different protein isoforms with variable N- and C-termini encoded by BORIS gene locus. Differential expression levels of BORIS isoforms were observed in different cancers. While some BORIS alternative splice variants were expressed at different levels in all types of cancers, other expressed forms are specific to particular cancer(s).

Advantages and Applications: Simple, rapid, RT-PCR based diagnostic test to detect BORIS isoforms in cancer patients; Profiling of BORIS splice variants can be useful as a diagnostic tool for the detection of cancers; BORIS can be a therapeutic target antigen for immunotherapeutic and/or siRNA based treatments for cancer; BORIS can be used in combination with other established immunogens for immunotherapeutic treatment of several cancers.

Market: Approximately 600,000 deaths from cancer related diseases are estimated in 2007. The technology, involving a differential expression of BORIS isoforms in cancer, can be useful for the diagnostics and treatment of several cancers having a potential market of more than 7 billion U.S. dollars.

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

Inventors: Victor V. Lobanenkov et al. (NIAID).

Patent Status: U.S. Provisional Application No. 60/841,342 filed 31 Aug 2006 (HHS Reference No. E-117-2006/0-US-01).

Licensing Status: Available for exclusive and non-exclusive licensing.

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

Collaborative Research Opportunity: The NIAID Laboratory of Immunopathology is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize methods of cancer diagnostics and treatment based on detection of BORIS isoforms. Please contact Cecilia Pazman at [e-mail] or [phone] for more information.

Dated: May 23, 2007.

Steven M. Ferguson,

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