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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.

HPV Virus-Like Particles for Delivery of Gene-Based Vaccines

Description of Technology: The invention describes methods of eliciting immune responses and treating disease based on novel vaccine compositions and vaccination strategies employing human papilloma virus (HPV) virus-like particles (VLPs), comprising L1 and L2 proteins. These VLPs have the capacity to incorporate up to 8 kb of DNA into the shell and express only the target antigen. These compositions are effective at eliciting an immune response to the transgene product expressed by the DNA when administered at epithelial surfaces including the mucosa (e.g. nasal or respiratory passages or genital tract) or skin in conjunction with disruption of the epithelial layer. It is typically difficult to elicit an immune response in Start Printed Page 18291the genital tract, so this technology overcomes a previous deficiency. Robust B and T cell responses were elicited in mice using the subject technology with representative DNA expressing M/M2 from respiratory syncytial virus (RSV). This technology could be used in a prime-boost vaccination regimen as well to enhance the immune response.

Applications: Vaccines against a number of pathogens, including HPV, HIV, HSV, HCV, and RSV.

Advantages:

Novel, non-invasive vaccine strategy to elicit both systemic and mucosal immunity in typically poorly inductive sites.

Packaging system that can accommodate up to 8 kb of DNA.

No expression of viral genes.

Potential for multivalent vaccine development against heterologous pathogens.

Development Status: Animal (mouse) data available.

Inventors: Barney S. Graham et al. (NIAID) and John T. Schiller et al. (NCI).

Publications:

1. Meeting abstract from the Keystone Symposium on Viral Immunity 2008 can be provided upon request.

2. CB Buck, DV Pastrana, DR Lowy, JT Schiller. Efficient intracellular assembly of papillomaviral vectors. J. Virol. 2004 Jan;78(2):751-757.

Patent Status: U.S. Provisional Application No. 61/022,324 filed 19 Jan 2008 (HHS Reference No. E-077-2008/0-US-01).

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

Licensing Contact: Susan Ano, Ph.D.; 301-435-5515, anos@mail.nih.gov.

Collaborative Research Opportunity: The NIAID/OTD is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize HPV Virus-Like Particles for Delivery of Gene-Based Vaccines. Please contact either Cecelia Pazman or Barry Buchbinder at 301-496-2644 for more information.

Avian Influenza Vaccine

Description of Technology: Sustained outbreaks of highly pathogenic avian influenza H5N1 in avian species increase the risk of reassortment and adaptation to humans. The ability to contain its spread in birds would reduce this threat and help maintain the capacity for egg-based vaccine production.

This technology describes DNA vaccines against avian influenza. These vaccines were used to elicit antibodies in animals that were effective against homologous and heterologous H5 challenge studies. One vaccine, a trivalent combination of H5 immunogens, was particularly effective in conferring protection. These vaccines can be delivered intramuscularly or through needle-free delivery mechanism.

Applications: Avian influenza vaccine specifically designed for poultry and other avian species.

Advantages: Protects against homologous and heterologous challenges; Needle-free delivery elicits robust immune response.

Development Status: Animal (mouse and chicken) data available.

Inventors: Gary Nabel, Srinivas Rao, Wing-pui Kong, Zhi-yong Yang, and Chih-jen Wei (VRC/NIAID).

Patent Status:

U.S. Provisional Application No. 61/021,586 filed 16 Jan 2008 (HHS Reference No. E-050-2008/0-US-01).

U.S. Provisional Application No. 61/023,341 filed 24 Jan 2008 (HHS Reference No. E-050-2008/1-US-01).

U.S. Patent No. 7,094,598 issued 22 Aug 2006 (HHS Reference No. E-241-2001/1-US-01) and associated foreign rights (CMV/R vector).

Licensing Status: Available for exclusive or non-exclusive licensing; CMV/R vector is available on a non-exclusive basis only.

Licensing Contact: Susan Ano, Ph.D.; 301-435-5515; anos@mail.nih.gov.

Codon Optimized Genes for Subunit Vaccines

Description of Technology: Available for licensing from the NIH are gene constructs that express immunogenic proteins based on viral genes that have been optimized for expression in mammalian cells. Using vaccine vectors expressing respiratory syncytial virus (RSV) proteins from the optimized genes, this technology was shown to result in a potent RSV-specific cellular immune responses with favorable phenotypic patterns. This technology was shown to generate a superior immune (both humoral and cellular) response when utilized as part of a heterologous vector prime-boost regimen. Such optimized genes could be an important component of an effective RSV vaccine. Further, this optimization could have possible application of to other viral genes and their respective vaccines.

Applications: Vaccines; Improved protein expression.

Development Status: Animal (mouse) data available.

Inventors: Barney S. Graham and Teresa R. Johnson (VRC/NIAID).

Patent Status:

U.S. Provisional Application No. 60/872,071 filed 30 Nov 2006 (HHS Reference No. E-326-2006/0-US-01).

PCT Application No. PCT/US2007/024625 filed 30 Nov 2007 (HHS Reference No. E-326-2006/1-PCT-01).

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

Licensing Contact: Susan Ano, Ph.D.; 301-435-5515; anos@mail.nih.gov.

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Dated: March 25, 2008.

Steven M. Ferguson,

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

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[FR Doc. E8-6893 Filed 4-2-08; 8:45 am]

BILLING CODE 4140-01-P