E6-15216. Prospective Grant of Exclusive License: Use of a Complete T-Cell Receptor Recognizing MART-1 Peptide Restricted by HLA-A2, Incorporated in a Continuous T-Lymphocyte Cell Line Developed or Owned by Licensee To Treat 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), 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 5,830,755 filed March 27, 1995 [HHS Ref. No. E-093-1995/0-US-01] and Australian Patent 709122 filed March 27, 1996 [HHS Ref. No. E-093-1995/0-AU-03], entitled T-Cell Receptors and Their Use in Therapeutic and Diagnostic Methods, to CellCure A/S, which is located in Aarhus, Denmark. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of a complete T-cell receptor MART-1 peptide restricted by HLA-A2 incorporated into a continuous T-Lymphocyte cell line developed or owned by licensee to treat cancer.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before November 13, 2006 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: Michelle A. Booden, Ph.D., 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 technology describes the composition and use of nucleic acid sequences that encode polypeptides capable of forming a T-cell receptor (TCR) in a genetically engineered cell. Specifically, these nucleic acid sequences will encode TCR's specific to tumor associated antigens (TAA), MART-1. T-Cells engineered with these tumor associated antigen specific TCRs show specific immune responses against TAA expressing cancer cells. Additionally, a method of treating or preventing cancer by administrating the above described TCRs is also disclosed.

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 part 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.

Date: September 7, 2006.

Steven M. Ferguson,

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