04-5222. Prospective Grant of Exclusive License: Immunoconjugate for the Treatment of Mesothelin-Expressing Cancers

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 part 404.7(a)(1)(i), that the Food and Drug Administration and the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in: E-002-1996/0: Nucleic Acid Encoding Mesothelin, a Differentiation Antigen Present on Mesothelium, Mesotheliomas and Ovarian Cancers (issued as U.S. patent 6,153,430); E-002-1996/1: Mesothelium Antigen and Methods and Kits for Targeting It (issued as U.S. patent 6,083,502); E-021-1998/0: Antibodies, Including Fv Molecules, and Immunoconjugates Having High Binding Affinity for Mesothelin and Methods for Their Use (filed as PCT/US98/25270 on November 25, 1998); and E-216-2000/1 (PCT application PCT/US01/18503, combining 60/211,331 and 60/213,804): Pegylation of Linkers Improves Antitumor Activity and Reduces Toxicity of Immunoconjugates, to Enzon Pharmaceuticals, Inc., which is located in Needham, MA. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory will be worldwide and the field of use may be limited to the use of the SS1P immunoconjugate for the treatment of mesothelin-expressing cancers.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before May 10, 2004, will be considered.

ADDRESSES:

Requests for copies of the patent, inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: Brenda J. Hefti, 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:

This technology is an immunocongugate, consisting of an anti-mesothelin antibody coupled to a killing moiety, specifically pseudomonas exotoxin (PE38). This immunotoxin is targeted towards mesothelin, and might be useful as a therapeutic for the treatment of mesothelin-expressing cancers such as mesotheliomas, ovarian cancers and pancreatic cancers.

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 establish 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.

Dated: March 2, 2004.

Steven M. Ferguson,

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