E7-22595. Prospective Grant of Exclusive License: Use of Anti-TAG72 Monoclonal Antibodies as a Tumor-Specific Imaging Agent and Drug Delivery Therapeutic

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 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 the following patents or patent applications U.S. Provisional Patent Application Nos. 60/106,534 and 60/106,757 filed October 31, 1998 and November 2, 1998; U.S. Patent No. 6,818,749 issued November 16, 2004; and U.S. Patent Application 10/927,433 filed August 25, 2004 as well as issued and pending foreign counterparts [HHS Ref. No. E-259-1998/0, /1, and /2]; U.S. Provisional Patent Application No. 60/498,903 filed August 29, 2003 and U.S. Patent Application No. 10/570,220 filed February 28, 2006 as well as issued and pending foreign counterparts [HHS Ref. No. E-323-2003/0]; U.S. Patent Application Nos. 07/510,697 filed July 17, 1990; 07/964,536 filed October 20, 1992; 08/261,354 filed June 16, 1994 and issued as U.S. Patent No. 5,976,531 on November 2, 1999; 08/487,743 filed June 7, 1995; 08/961,309 filed June 30, 1997 and issued as U.S. Patent No. 6,495,137 on December 17, 2002; and 10/255,478 filed September 25, 2002 and issued as U.S. Patent No. 7,179,899 on February 20, 2007 as well as issued and pending foreign counterparts [HHS Ref. E-347-2003/0, /1, /2, and /3]; U.S. Patent Application Nos. 07/259,943 filed October 19, 1988; 07/261,942 filed January 28, 1988; 07/424,362 filed October 19, 1989; 08/017,570 filed February 16 and issued as U.S. Patent No. 5,472,693 on December 5, 1995, 1993; 08/040,687 filed March 31, 1993 and issued as U.S. Patent No. 6,051,225 on April 18, 2000; 08/822,028 filed March 24, 1997 and issued as U.S. Patent No. 5,993,813 on November 30, 1999; 08/479,285 filed June 7, 1997 and issued as U.S. Patent No. 6,207,815 on March 27, 2001; 08/823,105 filed March 24, 1997; and 09/503,653 filed February 14, 2000 and issued as U.S. Patent No. 6,641,999 on November 4, 2003 as well as issued and pending foreign counterparts [HHS Ref. D-003-1992/0, /1, /2, /3, and /4]; U.S. Patent Application Nos. 07/259,943 filed December 11, 1992; 08/263,911 filed June 21, 1994 and issued as U.S. Patent No. 5,877,291 on March 2, 1999; 08/263,911 filed June 21, 1994; 08/481,006 filed June 6, 1995 and issued as U.S. Patent No. 5,892,020 on April 6, 1999 as well as issued and pending foreign counterparts [HHS Ref. D-004-1992/0 and /1]; U.S. Provisional Patent Application No. 60/030,173; U.S. Patent Application Nos. 09/025,203 filed February 18, 1998 and issued as U.S. Patent No. 6,348,581 on February 19, 2002; 09/998,817 filed October 31, 2001 and issued as U.S. Patent No. 6,753,420 on June 22, 2004; 09/999,021 October 31, 2001 and issued as U.S. Patent No. 6,737,060 on May 18, 2004; 09/999,025 filed October 31, 2001 and issued as U.S. Patent No. 6,737,061 on May 18, 2004; 09/999,040 filed October 31, 2001 and issued as U.S. Patent No. 6,753,152 issued June 22, 2004; 10/040,997 filed October 31, 2001 and issued as U.S. Patent No. 6,752,990 on June 22, 2004 as well as issued and pending foreign counterparts [HHS Ref. D-001-1996/0 and /1] to Enlyton, Ltd., which is located in Columbus, Ohio. 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 Anti-TAG72 monoclonal antibodies with (i) Licensee's proprietary fluorescence-based, tumor-specific imaging agent for use in tumor localization and visualization; (ii) Licensee's proprietary tumor-specific imaging agent for use in positron emission tomography (“PET”) for tumor localization and visualization; and (iii) Licensee's proprietary tumor-specific agent coupled with a proprietary compound for therapeutic use in targeted drug therapy. For the avoidance of doubt, gamma emitting isotopes are specially excluded from the field of use.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before January 18, 2008 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, PhD, 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 humanization of a murine anti-carcinoma antibody CC49 which has been shown to react with Tumor Associated Glycoprotein 72 (TAG-72), an antigen which is expressed on human breast, ovarian, colorectal, and other carcinomas.

The invention includes a new method of humanization of a rodent antibody which is based on grafting all the Complementarity Determining Residues (CDRs) of a rodent antibody onto a human antibody framework. Additionally, the method identifies Specificity Determining Residues (SDRs), the amino acid residues in the hypervariable regions of an antibody that are most critical for antigen binding activity and of rendering any antibody minimally immunogenic in humans by transferring the SDRs of the antibody to a human antibody framework. The resulting humanized antibodies, including CDR variants thereof (including a CH2 deleted version), are also embodied in the invention, as are methods of using the antibodies for therapeutic and diagnostic purposes.

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 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: November 7, 2007.

Steven M. Ferguson,

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