05-3965. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Broadly Cross-Reactive HIV-1 Neutralizing Human Monoclonal Antibodies

Drs. Dimiter S. Dimitrov and Mei-yun Zhang (NCI), U.S. Provisional Application No. 60/623,394 filed 29 Oct 2004 (DHHS Reference No. E-251-2004/0-US-01) Licensing Contact: Sally Hu; 301/435-5606; [e-mail].

The invention provides for pharmaceutical compositions of, and methods of using potent cross-reactive human monoclonal antibodies to HIV. Specifically, the invention describes a competitive antigen panning (CAP) method of isolating antibodies that bind to the gp41 subunit of the HIV-1 envelop glycoprotein. Additionally, the invention includes compositions of the aforementioned antibodies and the epitopes recognized by the antibodies. Methods of using the invention in the development of vaccine immunogens for the treatment and prevention of HIV, as well as the detection of HIV in a mammal are also described. The invention has significant implications in the development of HIV inhibitors, vaccines, and research tools for understanding mechanisms of HIV entry. Further development of the disclosed invention may yield novel therapies and methods in the prevention of mother-to-child transmission of HIV, treatment of accidental exposure to HIV, and chronic infection in patients with resistance to current therapies.

In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.

Endotoxin-Free Vaccine Candidate for Moraxella Catarrhalis

Xin-Xing Gu and Daxin Peng (NIDCD), U.S. Provisional Application No. 60/577,244 filed 04 Jun 2004 (DHHS Reference No. E-174-2004/0-US-01); U.S. Provisional Application No. 60/613,139 filed 23 Sep 23 (DHHS Reference No. E-174-2004/1-US-01), Licensing Contact: Susan Ano; 301/435-5515; [e-mail].

This invention relates to a strain of Moraxella catarrhalis containing a gene mutation that prevents endotoxic lipooligosaccharide (LOS) synthesis and potential use of the mutant for developing novel vaccines against the pathogen, for which there is currently no licensed vaccine. The mutant is defective in the lpxA gene, whose enzyme product is relevant in lipid A biosynthesis (lipid A is part of the LOS). Previous attempts to produce similar mutants for other bacteria were unsuccessful. The nontoxic mutant was found to elicit high levels of antibodies with bactericidal activity and provided protection against wild type bacterial challenge. Use of this mutant bacterium is envisioned as a new approach for vaccines against M. catarrhalis.

In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.

Single Lipid Nanoparticle

S. Narasimhan Danthi, King Li, Jianwu Xie (NIH/CC/LDRR), U.S. Provisional Application filed 19 Jan 2005 (DHHS Reference No. E-100-2004/0-US-01), Michael Shmilovich; 301/435-5019; [e-mail].

Available for licensing and commercial development are nanoparticle compositions comprising a phospholipid or diphosphatidyl glycerol component, an optional linker and a multifunctional ligand. A patent application has been filed covering the nanoparticle compositions and their methods of use as site-specific imaging or therapeutic agents. The particles are preferably single lipid compounds or single lipid nanoparticles (SLNs) prepared from single lipids (e.g., being a lipid molecule of a single lipid type or of a uniform structural type).

In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.

Identification of a G-protein Coupled Receptor, FPR, as a Functional Receptor for the Leukocyte Chemotactic Activity of the Neutrophil Granule Protein Cathepsin G (CaG)

Ji Ming Wang, Ronghua Sun, Joost Oppenheim, and Ye Zhou (NCI), U.S. Provisional Application No. 60/581,765 filed 23 Jun 2004 (DHHS Reference No. E-281-2003/0-US-01), Licensing Contact: Cristina Thalhammer-Reyero; 301/435-4507; [e-mail].

This invention relates to methods for identifying peptides of Cathepsin G (CaG), or active variants thereof, which modulate activities of the receptor for bacterial chemotactic formyl peptides (FPR), including chemotactic behavior. It provides methods of designing therapeutic approaches related to the host defense based on the interaction of CaG and FPR, as CaG binds to FPR to mediate the proinflammatory activities of CaG. The inventive aspects relate to the finding that CaG induces a more partial and selective effects upon activation of FPR to mediate a certain and more limited immunological activity than other agonists that are also capable of binding FPR. The limitations in the activity include not inducing calcium flux, having only a week activation of mitogen-activated protein kinases (MAPKs), and being able to activate certain types of atypical protein kinase C (PKC), such as PKCzeta, while not activating PKCalpha and PKCbeta. These limitations are advantageous in attempting to limit the response in mobilizing the phagocytic leukocyte infiltration to mediate the clearance and repair of damaged tissue while not amplifying the general inflammatory response, which may result in damage to healthy and normal tissue.

The technology is further described in R. Sun et al., “Identification of Neutrophil Granule Protein Cathepsin G as a Novel Chemotactic Agonist for the G Protein-Coupled Formyl Peptide Receptor”, J. Immunol. 2004 173:428-436.

In addition to licensing, the technology is available for further development through collaborative research with the inventors via a Cooperative Research and Development Agreement (CRADA).

Dated: February 22, 2005.

Steven M. Ferguson,

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