Prospective Grant of Exclusive License: “BL22, an Immunotoxin That Shows Efficacy in Clinical Trials in Treating Patients With Chemotherapy-Resistant Hairy Cell Leukemia, and HA22, a Newly Engineered Immunotoxin, Which Shows Improved Cytotoxic Activity Over BL22”

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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 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-146-1999/0, entitled Reduction of Nonspecific Animal Toxicity of Immunotoxin by Mutating Framework Regions of Fv To Lower Isoelectric Point, which includes: Pending U.S. Patent Application 10/416,129, based on PCT application PCT/US01/43602; E-216-2000/2, entitled Pegylation of Linkers Improves Antitumor Activity and Reduces Toxicity of Immunoconjugates, which includes: Pending U.S. Patent Application 10/297,337, based on PCT application PCT/US01/18503; E-129-2001/0, entitled Mutated Anti-CD22 Antibodies With Increased Affinity to CD22 Expressing Leukemia Cells, which includes: PCT application PCT/US02/30316; and E-046-2004/0, entitled Mutated Anti-CD22 Antibodies and Immunoconjugates, which includes: U.S. Patent Application number 60/525,371; to Genencor International, Inc., which is located in Palo Alto, California. 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 to use of the BL22 and HA22 immunoconjugates for the treatment of hematologic malignancies.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before October 25, 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: (301) 435-4632; Facsimile: (301) 402-0220; and E-mail: heftib@od.nih.gov.

SUPPLEMENTARY INFORMATION:

This technology is a family of two immunoconjugates, each consisting of an anti-CD22 antibody coupled to a killing moiety, specifically pseudomonas exotoxin (PE38). The immunotoxins are both targeted towards CD22, and might be useful as therapeutics for the treatment of leukemias, lymphomas, and autoimmune diseases. The BL22 immunoconjugate has shown success in early clinical trials, and it is believed by the investigators that the HA22 immunoconjugate will be superior to the BL22 because of its increased affinity for CD22.

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.