2010-17579. Prospective Grant of Exclusive License: The Development of Human Therapeutics for the Treatment of Cancer

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

This is a 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 US Patent Application 61/241,620 entitled “Development of an Immunotoxin in Which All B-Cell Epitopes Have Been Removed and Which Has High Cytotoxic Activity” [HHS Ref. E-269-2009/0-US-01], US Patent Application 60/969,929 entitled “Deletions in Domain II of Pseudomonas Exotoxin A That Reduce Non-Specific Toxicity” [HHS Ref. E-292-2007/0-US-01], US Patent Application 60/703,798 entitled “Mutated Pseudomonas Exotoxins with Reduced Antigenicity” [HHS Ref. E-262-2005/0-US-01], and all continuing applications and foreign counterparts, to MedImmune, LLC. This license may also include non-exclusive rights to US Patent Application 60/525,371 entitled “Mutated Anti-CD22 Antibodies and Immunoconjugates” [HHS Ref. E-046-2004/0-US-01], US Patent Application 60/325,360 entitled “Mutated Anti-CD22 Antibodies with Increased Affinity to CD22 Expressing Leukemia Cells” [HHS Ref. E-129-2001/0-US-01], US Patent Application 60/041,437 entitled “Recombinant Immunotoxins Targeted to CD22 Bearing Cells and Tumors” [HHS Ref. E-059-1997/0-US-01], US Patent 5,747,654 entitled “Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding Specificity” [HHS Ref. E-163-1993/0-US-01], PCT application PCT/US96/16327 entitled “Immunotoxin Containing A Disulfide-Stabilized Antibody Fragment” [HHS Ref. E-163-1993/2-PCT-01], and all continuing applications and foreign counterparts. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of 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 the HA22-LR, HA22-6X, HA22-8X, HA22-LR/6X and HA22-LR/8X immunotoxins for the treatment of CD22-expressing hematological malignancies.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before August 3, 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: David A. Lambertson, Ph.D., Senior 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:

These inventions concern immunotoxins and methods of using the immunotoxins for the treatment of hematological malignancies such as hairy cell leukemia (HCL), chronic lymphocytic leukemia (CLL), acute lymphocytic leukemia (ALL) and non-Hodgkin's lymphoma (NHL). Several specific immunotoxins are covered by this technology, including HA22-LR, HA22-6X, HA22-8X, HA22-LR/6X and HA22-LR/8X.

Each of these immunotoxins comprises (1) a toxin moiety that is a modified version of the Pseudomonas exotoxin A (“PE”) and (2) an antibody fragment domain that is capable of binding to the CD22 cell surface receptor. The PE moieties have been modified in various manners in order reduce the immunogenicity of the molecule. The modifications improve the therapeutic value of PE while maintaining its ability to trigger cell death. Since CD22 is preferentially expressed on several types of hematological cancer cells, the anti-CD22 antibody binding fragment allows the immunotoxins to be targeted selectively to cancer cells so that only the cancer cells are killed. This results in an effective therapeutic strategy with fewer side effects due to less non-specific killing of cells.

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 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 within fifteen (15) days from the date of this published notice.

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: July 13, 2010.

Richard U. Rodriguez,

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