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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.

## Vaccine for Shigella sonnei

*Description of Technology:*                     Shigellosis, an inflammatory enteric infection is on the World Health Organization's priority list of disease to be prevented. It can be prevented by O-specific polysaccharide (O-SP)-protein conjugate vaccines in adults. But the highest incidence and severity of                     *S. sonnei*                     shigellosis is in young children and the O-SP-protein conjugate that was effective in adults cannot overcome the age-related immunogenicity of vaccines in this age group. Thus, a better immunogen is needed.                

                    The immunogen claimed in this application uses O-SP formed by isolation of low molecular mass of O-SP-core fragments from the native product that allows a conjugate to be formed with a “sun” configuration as opposed to “lattice” type conjugates made previously, based on a synthetic saccharide conjugate of                     *S. dysenteriae*                     type 1 that induced significantly higher antibody levels than the “lattice” type conjugate. IgG antibody levels induced in young outbred mice with the “sun” configuration                     *S. sonnei*                     conjugate were higher than conjugates made with the full length O-SP.                

This application claims the vaccine compositions described above, methods of making the vaccine compositions of the technology, and methods of preventing and/or treating Shigellosis.

*Application:*                     Development of                     *Shigella sonnei*                     vaccines and diagnostics.                

*Advantages:*                     Known regulatory path for conjugate vaccines, potential reduction in number of doses of vaccine, pediatric vaccine.                

*Development Status:*                     Vaccine candidates have been synthesized and preclinical studies have been performed.                

*Inventors:*                     John B. Robbins (NICHD), Rachel Schneerson (NICHD), Joanna Kubler-Kielb (NICHD), Christopher P. Mocca (NICHD),                     *et al.*

*Publications:*

                    1. J Kubler-Kielb et al. The elucidation of the structure of the core part of the LPS from                     *Plesiomonas shigelloides*                     serotype O17 expressing O-polysaccharide chain identical to the                     *Shigella sonnei*                     O-chain. Carbohydr Res. 2008 Dec 8;343(18):3123-3127.                

                    2. JB Robbins                     *et al.*                     Shigella sonnei O-specific oligosaccharide-core-protein conjugates: synthesis, characterization and immunogenicity in mice. Proc Natl Acad Sci. 2009; doi 10.1073/pnas.0900891106.                

*Patent Status:*                     U.S. Provisional Application No. 61/089,394 filed 15 Aug 2008 (HHS Reference No. E-308-2008/0-US-01)                          ( print page 14570)    

*Licensing Status:*                     Available for licensing.                

*Licensing Contact:*                     Peter A. Soukas, J.D.; 301-435-4646;                     *soukasp@mail.nih.gov*

## Radiotracers for Imaging P-glycoprotein Transporter Function

*Description of Technology:*                     This invention offers technology to help treat certain brain diseases, such as Alzheimer's disease and Parkinson's, and may lead to more effective and personalized treatments. P-glycoprotein transporter (P-gp) acts as a pump at the blood-brain barrier to exclude a wide range of xenobiotics (                    *e.g.*, toxins, drugs, etc.) from the brain and is also expressed in a tumor in response to exposure to established/prospective chemotherapeutics (a phenomenon known as multidrug resistance; MDR). The instant invention relates to compounds that are avid substrates for P-gp, and their preparation and use as radiotracers for imaging P-gp function                     *in vitro*                     and                     *in vivo*.                

*Applications:*                     These radiotracers have potential application for investigating the function of P-gp at the blood-brain barrier for human subjects and patients in relation to neuropsychiatric disorders and in cancer. Their application may lead to a better general understanding of the role of P-gp in the unfolding of certain brain diseases (                    *e.g.,*                     Alzheimer's disease, Parkinson's disease), and ultimately to more effective and personalized treatment. Likewise, these radiotracers may be applied in oncology to help understand MDR and its clinical manifestation, and to help seek out cancer therapies that avoid MDR.                

*Advantages:*                     This class of radiotracer, typified by the described [11                     C]dLop, is designed to restrict the formation of radiometabolites that would obstruct the measurement of P-gp function at the blood-brain barrier or at tumors. In this sense these radiotracers are vastly superior to progenitors (                    *e.g.,*                     [11                     C]verapamil, [11                     C]loperamide), which can only give qualitative not quantitative information.                

*Development Status:*                     Radiotracer studies in human subjects are in progress. Longer-lived versions of the radiotracers are in development.                

*Market:*                     These radiotracers may be of interest to those wishing to market and/or apply such radiotracers in the medical imaging field.                

*Inventors:*                     Victor W. Pike, Robert B. Innis, Sami S. Zoghbi, and Neva Lazarova (NIMH).                

*Publications:*

                    1. SS Zoghbi, JS Liow, F Yasuno, J Hong, E Tuan, N Lazarova, RL Gladding, VW Pike, RB Innis.11                     C-Loperamide and its N-desmethyl radiometabolite are avid substrates for brain P-glycoprotein efflux. J Nucl Med. 2008 Apr;49(4):649-656.                

                    2. N Lazarova, SS Zoghbi, J Hong, N Seneca, E Tuan; RL Gladding, JS Liow, A Taku, RB Innis, VW Pike. Synthesis and evaluation of [N-methyl-11                     C]N-desmethyl-loperamide as a new and improved PET radiotracer for imaging P-gp function. J Med Chem. 2008 Oct 9;51(19):6034-6043.                

                    3. JS Liow, W Kreisl, SS Zoghbi, N Lazarova, N Seneca, RL Gladding, A Taku, P Herscovitch, VW Pike, RB Innis. P-glycoprotein function at the blood-brain barrier imaged using11                     C-N-desmethyl-loperamide in monkeys. J Nucl Med. 2009 Jan;50(1):108-115.                

*Patent Status:*                     U.S. Patent Application No. 12/112,994 filed 30 Apr 2008 (HHS Reference No. E-318-2007/0-US-01)                

*Licensing Status:*                     Available for licensing.                

*Licensing Contact:*                     RC Tang, JD, LLM; 301-435-5031;                     *tangrc@mail.nih.gov*.                

*Collaborative Research Opportunity:*                     The National Institute of Mental Health Molecular Imaging Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize radiotracers for imaging P-gp function. Please contact Victor Pike at                     *pikev@mail.nih.gov*                     for more information.                

Dated: March 24, 2009.

Richard U. Rodriguez,

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

[FR Doc. E9-7213 Filed 3-30-09; 8:45 am]

BILLING CODE 4140-01-P