E7-18798. Government-Owned Inventions; Availability for Licensing

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

A Transgenic Mouse Expressing Reverse Tetracycline-Controlled Transactivator in Melanocytes

Description of Technology: Available for licensing are transgenic mice that allow for specific and inducible expression of proteins in melanocytes. Melanocytes are difficult to study because of their paucity in mammalian skin, and these mice present a readily available source of these cells and model to study melanocyte diseases such as melanoma of the skin and eye. The mice can be crossed with transgenic mice that harbor the green fluorescent protein (GFP) gene, resulting in melanocyte-specific GFP labeling. GFP labeling can aid in imaging and/or isolation of melanocytes via fluorescence activated cell sorting, and it can be used to study melanocytes at both the cellular and molecular level.

Applications: Research tool to study melanocytes and melanocyte related diseases such as melanoma of the skin and eye.

Model to develop and test cosmetic dermatology products such as skin tanners.

Advantages: Research tool to study melanocytes at the cellular and molecular level.

Melanocytes compose a minute fraction of mammalian skin. These mice present a significant advantage in labeling, imaging and isolating these cells.

Market: An estimated 59,940 Americans will be diagnosed with skin cancer in 2007.

An estimated 8,110 Americans will die of skin cancer in 2007.

Intraocular melanoma is a rare disease. For every 100,000 Americans, there are approximately 17.7 new cases of intraocular melanoma.

Cosmetic dermatology industry is worth billions of dollars.

Inventors: Glenn T. Merlino, M. Raza Zaidi, et al. (NCI)

Publication: Planned oral presentation at the Fourth International Congress on Melanoma in New York City, November 1-4, 2007. The technology is mentioned in the Abstract for this meeting.

Patent Status: HHS Reference No. E-308-2007/0—Research Tool. Patent protection is not being sought for this technology.

Licensing Status: Available for non-exclusive licensing.

Licensing Contact: Jennifer Wong; 301-435-4633; [e-mail].

Collaborative Research Opportunity: The Laboratory of Cancer Biology and Genetics of the National Cancer Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize use of transgenic mice that allow for specific and inducible expression of proteins in melanocytes. Please contact John D. Hewes, Ph.D. at 301-435-3121 or [e-mail] for more information.

Chimeric Peptide Antigen Library: A Novel Tool for the Development of Vaccines Against Variable Pathogens Such as HIV, Tuberculosis, Hepatitis C and Malaria

Description of Technology: Many pathogens of dangerous human diseases such as HIV-1, HIV-2, viruses of hepatitis B and C, virus of influenza, viruses of dengue fever of types 1-4, pathogens of malaria and tuberculosis all possess significant variability.

Libraries of chimeric peptides, which imitate the genetic variability of the variable sections of the pathogenic protein, can cause a defensive immune response to the wide spectrum of the pathogen diversity. The immunogenic collections of chimeric peptides (libraries of variable chimeric peptides) in total reflect the natural and potential variability of the sections which determine antigenic activity.

The present invention relates to antigenic peptides, the methods of their preparation and their peptide libraries and it can be used for preparation of vaccines and medicine diagnostics. More specifically, the invention describes that the number of sequences in the library (size of library) is equal to the product of the number of possible residues in each position of peptide. The size of library can be reduced by sequential removal of residues which have the lowest frequency until the size will reach the required value.

Applications: Variable chimeric peptide libraries (VPCLs) can help construct effective vaccines capable of treating variable infectious agents such as HIV, TB, and Malaria.

Advantages: VPCLs represent naturally occurring and potential variability of antigenically active regions in one vaccine.

Such VPCLs can induce production of a wide range of antibodies and cytotoxic T-lymphocytes (CTLs) with joint specificity that covers the diversity of antigenic variants of the variable infectious agent.

Benefits: Several million people worldwide are suffering from diseases caused by variable pathogens. Variable pathogens important for human health include but are not limited to HIV, hepatitis, influenza, malaria and tuberculosis. The HIV market is currently $10 billion U.S. dollars. Additionally, the HIV market is forecast to grow at a rate of 10.3% over the next five years.

Inventors: Amir Maksyutov (VECTOR, Russia) et al.

Development Status: Method of constructing VPCLs has been established.

Patent Status: PCT Patent Application PCT/RU2003/000421 was filed 25 Sep, 2003 (HHS Ref. No. E-167-2007/0).

PCT Publication: Antigenic Peptides.

Licensing Contact: Sabarni K. Chatterjee at 301-594-4697 or by e-mail at [e-mail]; or Jasbir Kindra at 301-435-5559 or by e-mail at [e-mail].

Treatment of Primary Tumors and Tumor Metastases With TNF-alpha Antagonists

Description of Technology: The role of TGF-β1 in tumorigenesis is well-documented. However, the mechanism behind the induction of TGF-β1 remains poorly understood. As a result, potential targets for the treatment of cancers associated with TGF-β1 have escaped detection. This invention uncovers a two-step process of TGF-β1 induction, thereby providing alternative targets for cancer treatment.

TGF-β1 induction requires signaling through by IL-13 through IL13-Rα2. However, IL13-Rα2 must first be induced, requiring signaling by TNFα and IL4 or IL-13 through IL13-Rα1. Thus, by blocking TNFα signaling, one can block the expression of TGF-β1. This invention concerns new methods of treating cancers associated with TGF-β1 expression involving the administration of TNFα antagonists.

Applications and Advantages: New cancer treatment for a wide variety of cancers, including colon cancer.

Provides a treatment option for patients who don't respond to currently available anti-cancer agents.

Benefits: This new method may provide a social benefit by improving the quality/length of patient life for cancer patients who do not respond to currently available treatment methods.

The cancer therapeutic market is expected to reach $27 billion by 2009, providing an excellent financial opportunity.

Inventors: Warren Strober (NIAID) et al.

U.S. Patent Status: U.S. Provisional Application filed (HHS Reference No. E-161-2007/0-US-01)

Licensing Contact: David A. Lambertson, Ph.D.; Phone: [phone]; Fax: [phone]; E-mail: [e-mail]

Collaborative Research Opportunity: The National Institutes of Health, NIAID, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize “Treatment of Primary Tumors and Tumor Metastases with TNF-alpha Antagonists.” Please contact Dr. Warren Strober at [e-mail] for more information.

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.

Inventor: Barbara Felber et al. (NCI).

Patent Status: U.S. Provisional Application filed 12 Jun 2007 (HHS Reference No. E-103-2007/0-US-01).

PCT Application No. PCT/US2007/000774 filed 12 Jan 2007 (HHS Reference No. E-254-2005/2-PCT-01).

PCT Application No. PCT/US2001/45624, filed 1 Nov 2001, and National Stage filed in AU, JP, US, CA, and EP (HHS Reference No. E-308-2000/0).

U.S. Patent Application No. 11/571,879 filed 9 Jan 2007 (HHS Reference No. E-249-2004/1-US-02).

Development Status: Primate data available

Licensing Status: Available for licensing

Licensing Contact: Susan Ano, Ph.D.; 301-435-5515; [e-mail]

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 [e-mail] for more information.

Optically Active Radio-Labeled Reverse Transcriptase Inhibitors

Description of Technology: Researchers at the NIH developed a novel and efficient method for preparing F-18 labeled reverse transcriptase inhibitors, particularly, F-18 labeled tenofovir analogues for use as PET imaging agents to monitor anti-retroviral drug biodistribution in anatomic compartments in HIV-1 infected patients. Fluorine-18 is often used to prepare radiotracers and radiopharmaceuticals, but its short half-life of 109 minutes demands efficient and rapid radiochemical syntheses and purification techniques. This technology provides high yields of labeled compounds utilizing rapid synthetic methods and HPLC purification in both racemic and optically active forms.

Available for licensing and commercial development are compositions of F-18 labeled tenofovir analogues, as well as methods of synthesis and methods of use for such labeled compounds.

Applications: Non-invasive in vivo molecular imaging tracer useful for:

Evaluating the penetration and kinetics of anti-HIV drugs into anatomic compartments in vivo, Addressing changes in drug penetration in anatomic compartments during prolonged exposure to anti-HIV drugs.

Market: U.S. sales of diagnostic radiopharmaceuticals reached 1.69 billion dollars in 2005 and are expected to reach 3.52 billion dollars by 2012.

Development Status: Early stage

Inventors: Dale O. Kiesewetter (NIBIB), Michele Di Mascio (NIAID), Esther Lim (CC)

Patent Status: U.S. Provisional Application No. 60/914,732 filed 28 Apr 2007 (HHS Reference No. E-072-2007/0-US-01)

Licensing Status: Available for licensing.

Licensing Contact: Chekesha S. Clingman, Ph.D.; 301/435-5018; [e-mail]

Collaborative Research Opportunity: The NIBIB/IR/Positron Emission Tomography Radiochemistry Group and the NIAID Biostatistic Research Branch are seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize a Fluorine-18 radiolabeled analog of tenofovir. Please contact Peter Moy (NIBIB); 301/496-9270; [e-mail] for more information.

Dated: September 17, 2007.

Steven M. Ferguson,

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