05-7248. Prospective Grant of Exclusive License: Methods for Using Extracellular Adenosine Inhibitors and Adenosine Receptor Inhibitors as Applied to the Treatment of Human Cancer and Tumors

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the invention embodied in Patent Applications U.S. 60/340,772, filed on 12/12/2001, U.S. 60/342,582, filed on 12/19/2001, PCT/US2002/036829, filed on 11/14/2002, and corresponding EP, CA, AU, and JP filings, as well as U.S. 10/498,416, filed on 06/10/2004; entitled “Methods for using extracellular adenosine inhibitors and adenosine receptor inhibitors to enhance immune response and inflammation”, all by Michail V. Sitkovsky and Akio Ohta, to Adenosine Therapeutics, LLC, having a place of business in Charlottesville, VA. The patent rights in this invention have been assigned to the United States of America.

DATES:

Only written comments and/or application for a license that are received by the NIH Office of Technology Transfer on or before June 10, 2005 will be considered.

ADDRESSES:

Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Cristina Thalhammer-Reyero, Ph.D., M.B.A., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; E-mail: [e-mail]; Telephone: [phone]; Facsimile: 301-402-0220.

SUPPLEMENTARY INFORMATION:

The technology described and claimed in the subject invention relates to methods to enhance and prolong the body's immune response as well as to promote targeted tissue damage, such as for tumor destruction, by inhibiting signaling through the adenosine receptor. The inventors have shown that adenosine A2a and A3a receptors play a critical and non-redundant role in down-regulation of inflammation in vivo by acting as the physiological termination mechanism that can limit the immune response. The methods described involve administering either an adenosine-degrading drug or an adenosine receptor antagonist to exert a more effective and durable immune response and inflammation, and more specifically to the subject exclusive license application, to reduce the size of tumors. Furthermore, using the claimed method in combination with conventional anti tumor agent can be an effective treatment against cancer.

The invention has potential applications in the many markets in which therapeutic and preventive uses of manipulating the adenosine pathway are involved, including the regulation of hypoxia, tissue damage, tumor destruction, inflammation, increasing the efficacy of vaccines, and other immune responses.

This invention is further described in Ohta A et al., “Role of G-protein-coupled adenosine receptors in downregulation of inflammation and protection from tissue damage,” Nature 2001 Dec 20-27; 414(6866):916-20.

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 60 days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

The field of use may be limited to “Treatment of human cancer and tumors”.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response 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: April 4, 2005.

Steven M. Ferguson,

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