Notice: Government-Owned Inventions; Availability for Licensing

Federal Register: April 3, 2008 (Volume 73, Number 65)            
                  Page 18290-18291

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

[[Page 18291]]

the 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.

    Dated: March 25, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-6893 Filed 4-2-08; 8:45 am]

BILLING CODE 4140-01-P