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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. 

## Method of Making a Vaccine 

*Description of Technology:*                     Current invention describes the methods to prepare vaccines, and to use such vaccines in the vaccination and treatment of human disease,                     *e.g.*, the human immunodeficiency virus (HIV) infections and cancer. More specifically, the present invention provides a vaccine and method for making same which is effective to elicit a desired antibody against a target antigen comprising a primary immunogen and a secondary immunogen, wherein the primary immunogen is effective to elicit B cell receptors (BCRs) that are on the maturational pathway of the desired antibody and have an intermediate degree of somatic mutational diversity, and the secondary immunogen comprises an epitope of the desired target antibody and is effective to further diversify the BCRs sufficient to form mature BCRs having the identical or substantially identical sequence as the desired antibody.                 

*Applications:*                     Treatment and prevention of HIV infection.                 

*Advantages:*                     Novel methods to design vaccines for HIV treatment and prevention; May also be used for designing vaccines for cancer treatment.                 

*Development Status:**In vitro*                     data available.                 

*Market:*                     HIV therapeutics and preventatives.                 

*Inventor:*                     Dimiter S. Dimitrov (NCI).                 

*Publications:*

1. MY Zhang, Y Shu, S Phogat, X Xiao, F Cham, P Bouma, A Choudhary, YR Feng, I Sanz, S Rybak, CC Broder, GV Quinnan, T Evans, DS Dimitrov. Broadly cross-reactive HIV neutralizing human monoclonal antibody Fab selected by sequential antigen panning of a phage display library. J Immunol Methods. 2003 Dec;283(1-2):17-25. 

2. MY Zhang, X Xiao, IA Sidorov, V Choudhry, F Cham, PF Zhang, P Bouma, M Zwick, A Choudhary, DC Montefiori, CC Broder, DR Burton, GV Quinnan Jr, DS Dimitrov. Identification and characterization of a new cross-reactive human immunodeficiency virus type 1-neutralizing human monoclonal antibody. J Virol. 2004 Sep;78(17):9233-9242. 

3. Z Zhu, AS Dimitrov, KN Bossart, G Crameri, KA Bishop, V Choudhry, BA Mungall, YR Feng, A Choudhary, MY Zhang, Y Feng, LF Wang, X Xiao, BT Eaton, CC Broder, DS Dimitrov. Potent neutralization of Hendra and Nipah viruses by human monoclonal antibodies. J Virol. 2006 Jan;80(2):891-899. 

4. MY Zhang, V Choudhry, IA Sidorov, V Tenev, BK Vu, A Choudhary, H Lu, GM Stiegler, HW Katinger, S Jiang, CC Broder, DS Dimitrov. Selection of a novel gp41-specific HIV-l neutralizing human antibody by competitive antigen panning. J Immunol Methods. 2006 Dec 20;317(1-2):21-30. 

                    5. V Choudhry, MY Zhang, IA Sidorov, JM Louis, I Harris, AS Dimitrov, P Bouma, F Cham, A Choudhary, SM Rybak, T Fouts, DA Montefiori, CC Broder, GV Quinnan Jr, DS Dimitrov. Cross-reactive HIV-1 neutralizing monoclonal antibodies selected by screening of an immune human phage library against an envelope glycoprotein (gpI40) isolated                           ( print page 14139)                        from a patient (R2) with broadly HIV-l neutralizing antibodies. Virology. 2007 Jun 20;363(1):79-90.                 

6. Z Zhu, S Chakraborti, Y He, A Roberts, T Sheahan, X Xiao, LE Hensley, P Prabakaran, B Rockx, IA Sidorov, D Corti, L Vogel, Y Feng, JO Kim, LF Wang, R Baric, A Lanzavecchia, KM Curtis, GJ Nabel, K Subbarao, S Jiang, DS Dimitrov. Potent cross-reactive neutralization of SARS coronavirus isolates by human monoclonal antibodies. Proc Natl Acad Sci USA. 2007 Jul 17;104(29):12123-12128. 

7. Z Zhu, KN Bossart, KA Bishop, G Crameri, AS Dimitrov, JA McEachern, Y Feng, D Middleton, LF Wang, CC Broder, DS Dimitrov. Exceptionally potent cross-reactive neutralization of Nipah and Hendra viruses by a human monoclonal antibody. J Infect Dis. 2008 Mar 15;197(6):846-853. 

8. MY Zhang, BK Vu, A Choudhary, H Lu, M Humbert, H Ong, M Alam, RM Ruprecht, G Quinnan, S Jiang, DC Montefiori, JR Mascola, CC Broder, BF Haynes, DS Dimitrov. Cross-reactive human immunodeficiency virus type 1-neutralizing human monoclonal antibody which recognizes a novel conformational epitope on gp41 and lacks reactivity against self antigens. J Virol. 2008 Jul;82(14):6869-6879. 

*Patent Status:*                     U.S. Provisional Application No. 61/104,706 filed 11 Oct 2008 (HHS Reference No. E-322-2008/0-US-01).                 

*Licensing Status:*                     Available for licensing.                 

*Licensing Contact:*                     Sally Hu, Ph.D.; 301-435-5606;                     *HuS@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 this method. Please contact John D. Hewes, Ph.D. at 301-435-3121 or                     *hewesj@mail.nih.gov*                     for more information.                 

## Anti-Hepatitis C Virus Activity of the Protein Scytovirin (SVN)   

*Description of Technology:*                     The invention provides compositions and methods of use for potent anti-HCV protein scytovirin to prevent and treat HCV infections. Currently there is neither effective treatment nor vaccine against HCV infection and chronic HCV infection may lead to liver cancer and death. Scytovirin can be used alone or in combination with other anti-HCV drugs for HCV treatment and prevention.                 

*Applications:*                     The treatment and prevention of HCV infections.                 

*Advantages:*                     Potent anti-HCV activity; Can be applied both systematically or locally.                 

*Development Status:**In vitro*                     data available.                 

*Market:*                     HCV therapeutics and preventatives.                 

*Inventors:*                     Barry R. O'Keefe et al. (NCI).                 

*Publications:*                     Data collection and manuscripts may be submitted in 2009.                 

*Patent Status:*                     U.S. Provisional Application No. 61/137,511 filed 31 Jul 2008 (HHS Reference No. E-161-2008/0-US-01).                 

*Related Technology:*                     HHS Reference No. E-017-2002/0—Scytovirins and Related Conjugates, Antibodies, Compositions, Nucleic Acids, Vectors, Host Cells, Methods of Production and Methods of Using Scytovirin.                 

*Licensing Status:*                     Available for licensing.                 

*Licensing Contact:*                     Sally Hu, Ph.D.; 301-435-5606,                     *HuS@mail.nih.gov*.                 

*Collaborative Research Opportunity:*                     The National Cancer Institute CCR Molecular Targets Development Program is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. 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. E9-6933 Filed 3-27-09; 8:45 am] 

BILLING CODE 4140-01-P