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###### Department of Health and Human Services

###### National Institutes of Health 

# 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. 

## M2e Peptide Vaccine Against Influenza Virus 

*Description of Technology:*                     The invention offered here is a vaccine candidate that can potentially confer protection against many types of influenza. Current vaccines against influenza virus are comprised of inactivated virus or purified influenza virus proteins and are targeted primarily to induce neutralizing antibodies against the viral hemagglutinin (HA) protein. The virus can mutate or shift antigenic types of HA rapidly rendering the vaccines ineffective and thus the vaccine has to be evaluated yearly to predict next year's circulating strains for vaccine preparation. Unlike HA, the small M2 protein is highly conserved among different strains of influenza virus and thus vaccines based on the M2 protein have the potential to be effective against different strains of influenza. The current invention relates to peptide vaccines composed of the extracellular domain of the M2 protein (M2e) conjugated to a carrier protein. In animals studies a mutant diphtheria toxin-M2e—conjugate induced high antibody levels to both vaccine components in mice.                 

*Applications:*
      - Preventative and therapeutic for influenza virus.
      - Vaccine against seasonal and pandemic influenza virus strains.

*Advantages:*                     Novel vaccine candidate with potential heterosubtypic protection.                 

*Development Status:**In vitro*                     and                     *in vivo*                     data can be provided upon request.                 

*Market:*                     Influenza virus vaccines.                 

*Inventors:*                     Mark A. Miller (FIC), Rachel Schneerson (NICHD), Joanna Kubler-Kielb (NICHD), John B. Robbins (NICHD), Zuzanna Biesova (NICHD), and Jerry Keith (NICHD).                 

*Patent Status:*                     U.S. Provisional Application No. 61/089,384 filed 15 Aug 2008 (HHS Reference No. E-304-2008/0-US-01).                 

*Licensing Status:*                     Available for licensing.                 

*Licensing Contact:*                     Kevin W. Chang, Ph.D.; 301-435-5018;                     *changke@mail.nih.gov*.                 

## Therapeutic HIV Vaccine and Associated Protocols 

*Description of Technology:*                     This technology describes a therapeutic HIV DNA vaccine to be administered to individuals who have previously experienced or are undergoing antiretroviral therapy (ART). The therapeutic DNA vaccine can also be administered in combination with a vector encoding an IL-15 and/or IL-15 receptor alpha (IL-15Ra) polypeptide. In primate studies, the technology was found to be particularly effective when the vaccine composition was administered by electroporation and expressed six (6) HIV antigens (including two (2) gag polypeptides and two (2) envelope polypeptides) and IL-15 and IL-15Ra. The antigens are typically modified with a destabilizing sequence, a secretory polypeptide and/or a degradation signal. Successive administration up to as many as nine resulted in continual boost of the immune response against the encoded antigen. A potent immunotherapeutic vaccine as described here could be an important technology for the fight against HIV/AIDS.                 

*Applications:*                     Therapeutic HIV DNA vaccines.                 

*Development Status:*                     Primate data available.                 

*Inventor:*                     Barbara Felber                     *et al.*                     (NCI).                 

*Patent Status:*

PCT Application No. PCT/US2008/51004 filed 14 Jan 2008, which published as WO 2008/089144 on 24 Jul 2008 (HHS Reference No. E-103-2007/0-PCT-02); claiming priority to 12 Jan 2007. 

PCT Application No. PCT/US2007/000774 filed 12 Jan 2007, which published as WO 2007/084342 on 26 Jul 2007 (HHS Reference No. E-254-2005/2-PCT-01); claiming priority to 13 Jan 2006. National Stage filed in AU, BR, CA, CN, EP, IL, IN, JP, MX, NZ, and US. 

PCT Application No. PCT/US2001/45624 filed 01 Nov 2001, which published as WO 2002/36806 on 10 May 2002 (HHS Reference No. E-308-2000/0-PCT-02); claiming priority to 01 Nov 2000. National Stage filed in AU, CA, EP, JP, and US. 

U.S. Patent Application No. 11/571,879 filed 09 Jan 2007 (HHS Reference No. E-249-2004/1-US-02). 

*Licensing Status:*                     Available for licensing.                           ( print page 14142)    

*Licensing Contact:*                     Kevin W. Chang, Ph.D.; 301-435-5018;                     *changke@mail.nih.gov*.                 

*Collaborative Research Opportunity:*                     The National Cancer Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize HIV DNA vaccines. Please contact John D. Hewes, Ph.D. at 301-435-3121 or                     *hewesj@mail.nih.gov*                     for more information.                 

 Dated: March 19, 2009. 

 Richard U. Rodriguez, 

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

[FR Doc. E9-6936 Filed 3-27-09; 8:45 am] 

BILLING CODE 4140-01-P