E9-26309. Prospective Grant of Exclusive License: Development of a Companion Diagnostic Kit To Detect Asparagine Synthetase Expression Levels as a Method To Screen for the Drug Efficacy in Treatments for Pancreatic Cancer, Ovarian Cancer, and ...

AGENCY:

National Institutes of Health, Public Health Service, HHS.

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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 12/281,589 and PCT Application No. PCT/US07/05555 entitled “Materials and Methods Directed to Asparagine Synthetase and Asparaginase Therapies” (HHS Ref. No. E-132-2006/2), to the French-based ERYtech Pharma LLC which is located in Lyon, France (with an additional office in Philadelphia, Pennsylvania). The patent rights in this invention have been assigned to the United States of America.

The prospective exclusive license territory may be worldwide and the field of use may be for to the use of the Licensed Patent Rights limited to a FDA-approved companion diagnostic test predictive of L-asparaginase therapeutic effect in the treatment of pancreatic cancer, ovarian cancer, and multiple myeloma as claimed in the Licensed Patent Rights.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before January 4, 2010 will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Samuel E. Bish, Ph.D., Licensing and Patenting Manager, 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 technology describes methods and therapies involving asparagine synthetase (ASNS) and L-asparaginase (L-asp). Included are methods to decrease cell proliferation, most notably in order to treat various cancers, by administrating to a subject a combination of an ASNS antagonist and a formulation of L-asp. The main ASNS antagonist utilized in these methods are small interfering RNAs (siRNAs) that reduce ASNS expression. Also included are methods of screening for the efficacy of L-asp in a subject by detecting the expression of the ASNS gene in a sample. The technology also describes a kit that probes to detect ASNS gene expression in a sample to identify the efficacy of L-asp treatment. ASNS serves as a key biomarker for acute lymphoblastic leukemia (ALL) and other malignancies because these cancer cells express little or no ASNS compared to normal cells. As a result, the cancerous cells must acquire asparagine from the bloodstream to survive and proliferate to form tumors. Over several decades, patients with ALL and other leukemias have been treated with L-asparaginase (L-asp) to break down asparagine in the body and starve leukemia cells of asparagine. L-asp treatment is usually more effective when ASNS expression in the patient is limited.

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 part 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 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.

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: October 26, 2009.

Richard U. Rodriguez,

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