E9-26313. 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.

Novel Inhibitors of Interleukin-6 for Kaposi Sarcoma Therapy

Description of Invention: The cancer therapy market is forecast to reach $40.9 billion by 2012. With immunosuppressant drugs set for phenomenal growth over the next six years, revenues could reach $26.2 billion by 2014. One market for which there is a significant need for new therapies is cancers induced by Kaposi Sarcoma-associated Herpesvirus (KSHV).

Researchers at the National Cancer Institute have identified novel nucleic acid sequences that act through a unique mechanism to inhibit the expression of interleukin-6 that occurs in cancerous cells transformed by KSHV infection and which promotes cancer cell proliferation. The researchers have also identified a key protein involved in the mechanism which could be inhibited using antibodies.

These inhibitors are likely to be accepted in the marketplace because their unique specificity in mechanism of action gives them a distinct advantage over the mechanisms of other existing therapies.

Applications:

• Therapies for KSHV-induced cancers (Kaposi sarcoma (KS), primary effusion lymphoma (PEL)) and multicentric Castleman disease (MCD).
• Therapies for KSHV infection.
• Therapies for interleukin-6 associated inflammatory diseases.
• Immunosuppression of interleukin-6.

Advantages:

• Utilizes available small-molecule and antibody technologies.
• Targets a key pathway in interleukin-6 production.
• Specificity of mechanism of action may reduce/limit potential side-effects.

Development Status: Pre-clinical.

Inventors: Zhi-Ming Zheng and Jeong-Gu Kang (NCI).

Relevant Publication: JG Kang et al. KSHV infection induces IL6 expression by interrupting microRNA-mediated translational repression. Submitted.

Patent Status: U.S. Provisional Application No. 61/241,678 filed 11 Sep 2009 (HHS Reference No. E-296-2009/0-US-01).

Licensing Status: Available for licensing.

Licensing Contact: Patrick P. McCue, Ph.D.; 301-435-5560; [e-mail].

Collaborative Research Opportunity: The NCI Center for Cancer Research, HIV and AIDS Malignancy Branch, 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 [e-mail] for more information.

Prediction of Immune Response Outcomes to Keyhole Limpet Hemocyanin (KLH) Treatment

Description of Invention: Keyhole limpet hemocyanin (KLH) is a large, heterogeneous glycosylated protein that is being tested as an immunotherapeutic agent to treat bladder cancer. KLH is approved for use in parts of Europe and Asia and is in late stage clinical trials in the U.S. KLH immunotherapy however only produces a clinical response in approximately 40-50% of patients, and currently there is no good method to select the subset of patients that will respond best to this treatment. This invention revealed that levels of certain serum antibodies can be used as biomarkers to predict the magnitude of the antibody response to the glycoprotein KLH. The best correlations are obtained by using a combination of markers. Since the size of the antibody response correlates with the clinical response, the invention provides a method to select the subset of patients that may benefit most from this form of treatment.

Applications and Market:

• It is estimated that 70,980 men and women will be diagnosed with and 14,330 men and women will die of cancer of the urinary bladder in 2009;
• Biomarkers for immune response outcomes to keyhole limpet hemocyanin (KLH);
• Patient selection based on prediction of response.

Development Status: Pre-clinical stage of development.

Inventors: Jeffrey C. Gildersleeve and Oyindasola Oyelaran (NCI).

Publications: Manuscript accepted, Proteomics—Clinical Applications.

Patent Status: U.S. Provisional Application No. 61/243,849 filed 18 Sep 2009, (HHS Reference No. E-295-2009/0-US-01).

Licensing Status: Available for licensing.

Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; [e-mail].

Collaborative Research Opportunity: The NCI Center for Cancer Research, Laboratory of Medicinal Chemistry, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize a set of serum antibody-based biomarkers for personalized cancer immunotherapy using keyhole limpet hemocyanin (KLH). Please contact John D. Hewes, Ph.D. at 301-435-3121 or [e-mail] for more information.

Dated: October 26, 2009.

Richard U. Rodriguez,

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