2011-27858. 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.

New Non-HLA-A2 Restricted Human T Cell Receptors (TCRs) That Could Be Used To Treat a Broader Cancer Patient Population Via TCR Adoptive Immunity

Description of Technology: NIH scientists have developed T cell receptors (TCRs) that recognize melanoma antigen family A3 (MAGE-A3) or MAGE-A12 peptide antigens. The TCRs recognize these antigens in the context of major histocompatibility complex (MHC) class I molecules, HLA-A1 and HLA-Cw7, respectively. Since these TCRs are not HLA-A2 restricted, their therapeutic use would expand the number of treatable cancer patients using MAGE-A3 or A12-specific TCR adoptive immunotherapy.

There are twelve MAGE-A superfamily antigens designated A1—A12. Their normal function is not well defined, but in cancer cells they block the functions of tumor suppressor proteins to mediate tumor growth and spreading. The MAGE-A proteins are some of the most widely expressed cancer testis antigens expressed on human tumors. Other than non-MHC expressing germ cells of the testis, normal cells do not express these antigens, which make them ideal targets for cancer immunotherapies anticipated to generate less toxic side effects than conventional cancer treatments. These TCRs deliver a robust immune response against MAGE-A3 or A12 expressing cells and could prove to be a powerful approach for selectively attacking tumors without generating toxicity against healthy cells.

Potential Commercial Applications:

• Personalized immunotherapy for a variety of cancers using human T cells expressing these TCRs
• Component of a combination immunotherapy regimen aimed at targeting specific tumor-associated antigens, including MAGE-A3 and MAGE-A12, expressed by cancer cells.
• A research tool to investigate signaling pathways in MAGE-A3 or MAGE-A12 antigen expressing cancer cells.
• An in vitro diagnostic tool to screen for cells expressing MAGE-A3 or MAGE-A12 antigens.

Competitive Advantages:

• Highly expressed targets: MAGE-A proteins (especially MAGE-A3) are some of the most highly expressed cancer testis antigens on human tumors
• Limited side effects: MAGE-A proteins are only expressed on tumor cells and non-MHC expressing testis germ cells. Infused cells expressing these TCRs should target MAGE-A3 or A12 expressing tumor cells with little or no toxicity to the patient's normal cells.
• Not HLA-A2 restricted: Expands patient population treatable with MAGE-A TCRs since they recognize antigen in the context of HLA-A1 or HLA-Cw7.

Development Stage:

• Pre-clinical
• In vitro data available

Inventors: Steven A. Rosenberg, Paul F. Robbins, Richard A. Morgan, Steven A. Feldman, and Shiqui Zhu (NCI).

Publication: Chinnasamy N, et al. A TCR targeting the HLA-A*0201-restricted epitope of MAGE-A3 recognizes multiple epitopes of the MAGE-A antigen superfamily in several types of cancer. J Immunol. 2011 Jan 15;186(2):685-696. [PMID 21149604].

Intellectual Property: HHS Reference No. E-266-2011/0—U.S. Patent Application No. 61/535,086 filed 15 September 2011.

Related Technology: HHS Reference No. E-236-2010/0—U.S.Patent Application No. 61/405,668 filed 22 October 2010.

Licensing Contact: Samuel E. Bish, Ph.D.; [phone]; [e-mail].

Collaborative Research Opportunity: The Surgery Branch of the National Cancer Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize T cell receptors that target cancer/testis antigens for use in cancer adoptive immunotherapy. For collaboration opportunities, please contact John Hewes, Ph.D. at [e-mail].

Antiandrogen Small Molecules for the Treatment of Prostate Cancer

Description of Technology: The present licensing opportunity is for a new class of small molecule compounds, and the method of using them to treat prostate cancer. This year it is estimated there will be over 32,000 deaths from prostate cancer showing an unmet need for a more effective treatment particularly for castrate-resistant prostate cancer (CRPC). CRPC is characterized by androgen-independent cancer cells that have adapted to the depletion of hormones and continue to grow. Abnormal androgen receptor signaling is known to drive advanced castrate-resistant prostate cancer. The small molecule compounds of the instant invention are antiandrogens that target androgen receptor signaling in both androgen-independent and androgen-sensitive androgen receptor activity, and androgen receptors that are resistant to the current antiandrogens available. Unlike the currently available antiandrogens, the new small molecules induce androgen receptor degradation and cell death in prostate cancer cells. Further, these compounds and methods can also induce degradation of other steroid hormone receptors demonstrating the possibility of treating a wider range of cancers.

Potential Commercial Applications:

• Series of steroid receptor compounds that cause cancer cell death
• Method of using the compounds in cancer treatment

Competitive Advantages:

• First small molecule antiandrogen treatment
• Causes cell death, not just loss of function
• Potential to treat other cancers through degradation of other steroid hormone receptors

Development Stage: In vitro data available.

Inventors: Jane B. Trepel, Yeong Sang Kim, Sunmin Lee, Vineet Kumar, and Sanjay V. Malhotra (NCI).

Intellectual Property: HHS Reference No. E-015-2011/0—U.S. Patent Application No. 61/497,129 filed 15 Jun 2011.

Licensing Contact: Whitney Hastings; [phone]; [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 Small Molecules for the Treatment of Prostate Cancer. For collaboration opportunities, please contact John Hewes, PhD at [e-mail] or [phone].

Dated: October 21, 2011.

Richard U. Rodriguez,

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