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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/                              ( print page 48217)                            496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.                     

## Broadly Neutralizing Anti-HIV Monoclonal Antibody That Targets a New Epitope on gp41 

*Description of Technology*                    : Blocking entry of HIV into cells and vaccine development against HIV are the prime targets of HIV therapy and prevention, respectively. Current invention describes a monoclonal Fab anti-HIV antibody isolated through panning against the chimeric construct NCCG                    -gp41 by Antibodies-by-Design (Morphosys). One of the antibodies has broadly neutralization ability against several HIV subtypes in an envelope-pseudotyped-virus neutralization assay. This antibody was also shown to have synergistic effect with a gp41-derived peptide discovered in this laboratory in inhibiting HIV-1 fusion.                 

*Applications:*                     Research tool or screening for HIV vaccine.                 

*Advantages:*                     Can be potentially used as a therapeutic agent to block HIV-1 entry into cells.                 

*Development Status:*                     In vitro data available.                 

*Market:*                     For the development of drugs against HIV.                 

*Inventors:*                     G. Marius Clore                     *et al.*                     (NIDDK).                 

*Publications:*

                    1. E Gustchina                     *et al.*                     A monoclonal Fab derived from a human nonimmune phage library reveals a new epitope on gp41 and neutralizes diverse human immunodeficiency virus type 1 strains. J Virol. 2007 Dec;81(23):12946-12953.                 

                    2. E Gustchina                     *et al.*                     Sequestering the pre-hairpin intermediate of gp41 by peptide N36Mut(e,g)                     potentiates the human immunodeficiency virus type 1 neutralizing activity of monoclonal antibodies against the N-terminal helical repeat of gp41. J. Virol. in press (2008).                 

*Patent Status*: HHS Reference No. E-229-2008/0—Research Tool. Patent protection is not being pursued for this technology.                 

*Licensing Status*: This invention is available for non-exclusive licensing as a research tool.                 

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

*Collaborative Research Opportunity*: The NIH, Laboratory of Chemical Physics is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this monoclonal Fab. Please contact Dr. G.M. Clore at 301-496 0782 and/or e-mail at                     *mariusc@mail.nih.gov*                     for more information.                 

## Polyamine Compounds That Bind Tar RNA of HIV and Methods of Treating Viral Disorders 

*Description of Technology*: Current HIV treatment involves applying cocktail of drugs targeting either virus entry or one of three viral enzymes. Because patients eventually develop resistance to the cocktail, a new class of drugs is urgently needed. Current invention describes a new class of polyamine compounds that specifically bind to HIV RNA at micromolar range to prevent binding of viral RNA to viral proteins and therefore blocking viral replication. This differs with the mechanisms of current HIV drugs in the market and therefore offers new strategy in HIV treatment and prevention. Furthermore, this class of compound may aid future development of drugs targeting RNA.                 

*Applications:*                     Treatment and prevention of HIV infection.                 

*Advantages*: Novel strategy for HIV treatment and prevention; Specific binding to HIV RNA and strong activity.                 

*Development Status: In vitro*                     data available.                 

*Market:*                     HIV therapeutics and preventatives.                 

*Inventors:*                     Daniel Appella                     *et al.*                     (NIDDK).                 

*Publications:*                     Manuscripts in preparation.                 

*Patent Status*: U.S. Provisional Application No. 61/123,076 filed 04 Apr 2008 (HHS Reference No. E-159-2008/0-US-01).                 

*Licensing Status*: This invention is available for exclusive or non-exclusive licensing.                 

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

*Collaborative Research Opportunity*: The NIDDK, Laboratory of Bioorganic Chemistry, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the application of TAR-binding polyamines for the treatment of HIV infections. Please contact Daniel Appella at 301-451-1052 or                     *appellad@niddk.nih.gov*                     for more information.                 

## Monoclonal Antibodies to HIV-1 Vpr 

*Description of Technology:*                     Available for licensing are monoclonal antibodies against HIV-1 viral protein R (Vpr) and the respective hybridoma cell lines expressing the same. The antibodies provide a means for detecting HIV-1 Vpr. Currently, the mechanism of HIV pathogenesis believed to involve viral replication inside immune cells and other cells. At present, there are no clinical assays for detecting HIV-1 Vpr. Vpr circulates at detectable levels in the blood and is likely derived from degraded virions or released from infected cells. Vpr facilitates viral replication and disrupt normal cell function. Thus measurement of Vpr levels in blood, extracellular fluid, and tissue may be of benefit in understanding the pathogenesis of HIV-1 infection and its myriad complications.                 

The hybridoma cell lines (9F12 and 10F2) were selected from a group of hybridoma cell lines. These antibodies can be used for detection, including immunoasssays (ELISA) and immunoaffinity-capillary electrophoresis. The amount of detected HIV-1 Vpr is compared to a standardized control sample for determining the progress of disease or the presence of known complications like neuropathy, dementia, metabolic syndrome, or nephropathy. 

*Inventors*: Jeffrey Kopp (NIDDK), Terence Philips (NBIB), Schubert Ulrich (NIAID), John Yewell (NIAID).                 

*Patent Status*: U.S. Patent Application No. 11/630,880 filed 27 Jun 2005 (HHS Reference No. E-141-2003/0-US-03).                 

*Licensing Status:*                     Available for licensing.                 

*Licensing Contact:*                     Michael Shmilovich, Esq.; 301-435-5019;                     *shmilovm@mail.nih.gov*.                 

## Anti-Pax 2 Antibody 

*Description of Technology:*                     Available for licensing and commercialization are anti-Pax 2 polyclonal antibodies that can be used for the detection of Pax-2 protein expression in a variety of kidney and neuronal tissues. Pax-2 protein, a transcription factor active during early kidney development, is expressed at high levels in almost all renal proliferative diseases such as renal cancer, polycystic kidney disease and acute renal failure.                 

                    The Pax-2 protein has also been linked to Wilms' tumor, a cancerous kidney tumor accounting for ~6% of childhood cancers, and for which ~500 new cases are diagnosed each year in the U.S. Wilms' tumors are hard to diagnose in the early stage because they can grow quite large without causing any pain. While abdominal ultrasound may be used for detection, it is not a practical screening test for otherwise healthy children. There are no blood tests or other tests for screening for Wilms' tumors which, if diagnosed sufficiently early, may be treated with surgery, chemotherapy, and/or radiation therapy.                           ( print page 48218)    

Potential applications of this technology may also include detection of Pax-2 protein in urine for both chronic and acute renal disease. 

*Applications*: Diagnostics for renal diseases; Research tools for evaluating disease processes of the kidney and other tissues through Pax-2 protein expression in the relevant tissues.                 

*Development Status*: Ready for commercialization.                 

*Patent Status*: HHS Reference No. B-039-1996/0—Research Tool. Patent protection is not being pursued for this technology.                 

*Inventor:*                     Gregory Dressler (NICHD).                 

*Relevant Publications:*

1. GR Dressler. Another niche for Notch. Kidney Int. 2008 Jun;73(11):1207-1209. 

2. SR Patel et al. The BRCT-domain containing protein PTIP links PAX2 to a histone H3, lysine 4 methyltransferase complex. Dev Cell. 2007 Oct;13(4):580-592. 

3. GR Dressler. The cellular basis of kidney development. Annu Rev Cell Dev Biol. 2006;22:509-529. 

4. GB Silberstein et al. Expression of the PAX2 oncogene in human breast cancer and its role in progesterone-dependent mammary growth. Oncogene. 2002 Feb7;21(7):1009-1016. 

5. GR Dressler and AS Woolf. Pax2 in development and renal disease. Int J Dev Biol. 1999;43(5):463-468 (Review). 

6. GR Dressler. Pax-2, kidney development, and oncogenesis. Med Pediatr Oncol. 1996 Nov;27(5):440-444. 

7. GR Dressler and EC Douglass. Pax-2 is a DNA-binding protein expressed in embryonic kidney and Wilms tumor. Proc Natl Acad Sci USA. 1992 Feb 15;89(4):1179-1183. 

*Licensing Status*: Available for non-exclusive licensing as biological materials (internal use or commercial use).                 

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

Dated: August 7, 2008. 

Richard U. Rodriguez, 

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

[FR Doc. E8-18983 Filed 8-19-08; 8:45 am] 

BILLING CODE 4140-01-P