E8-3165. Prospective Grant of an Exclusive License: Development and Commercialization of Therapeutic Products for Breast Cancer

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent Application No. 09/693,600 filed October 20, 2000 entitled “Method and Composition for Enhancing Immune Response” [E-037-2001/1-US-01]; Japanese Patent Application No. 2002-555834 filed October 22, 2001 entitled “Method and Composition for Enhancing Immune Response” [E-037-2001/1-JP-03]; and European Patent Application No. 01989341.1 filed October 22, 2001 entitled “Method and Composition for Enhancing Immune Response” [E-037-2001/1-EP-04]; to ODC Therapy, Inc.

The prospective exclusive license territory may be worldwide and the field of use may be limited to therapeutic applications for breast cancer patients expressing high levels of serum or plasma IgE.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before April 21, 2008 will be considered.

ADDRESSES:

Requests for copies of the patent and/or patent applications, inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: Mojdeh Bahar, J.D., M.A., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD. 20852-3804. Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The invention relates to a method of inhibiting tumor growth which comprises the administration of an IL-13 inhibitor. Additionally, the invention relates to a method and composition for enhancing an immune response in a subject by administering to a subject an inhibitor of IL-13 or an inhibitor of an NK-T cell. The method can be used to prevent growth of a tumor in a subject, e.g., to inhibit tumor recurrence or metastasis. The method can also be used to enhance a response to a vaccine in a subject. IL-13 is an interleukin which has potent immunomodulatory effects. It is primarily secreted by TH2 lymphocytes. This invention relates to the discovery of a role for IL-13 in the down-regulation of tumor immunosurveillance. Using a mouse model in which tumors show a growth-regression-recurrence pattern, the mechanisms for down-regulation of cytotoxic T lymphocyte-mediated tumor immunosurveillance was investigated. It was discovered that interleukin 4 receptor (IL-4R) knockout mice, and downstream signal transducer and activator of transcription 6 (STAT6) knockout mice, but not IL-4 knockout mice, resisted tumor recurrence. Thus, IL-13, the only other cytokine that uses the IL-4R-STAT6 pathway, was discovered to have a role in the down-regulation of tumor immunosurveillance.

The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless within sixty (60) days from the date of this published notice, the NIH receives written evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Dated: February 11, 2008.

Steven M. Ferguson,

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