From March 11, 1997 Federal Register. See patent 5,614,191, acc. no. 99685, in the database.
National Institutes of Health

Prospective Grant of Exclusive License: IL-13 Receptor Specific Chimeric Proteins and Uses Thereof

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 404.7(a) (1) (I), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive world-wide license in the field of therapeutics to treat cancer to NeoPharm, Inc. of Delaware to practice the inventions embodied in U.S. Patent Application 08/404,685 and corresponding foreign patent applications entitled AIL-13 Receptor Specific Chimeric Proteins and Uses Thereof and E-266-94/1 entitled ACompositions and Methods for Specifically Targeting Tumors. These inventions are owned by the Government of the United States of America as represented by the Department of Health and Human Services and the Pennsylvania State University.
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, 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.

SUPPLEMENTARY INFORMATION: The patent application discloses the conjugation of human interleukin-13 (IL-13) to genetically engineered bacterial toxin--pseudomonas exotoxin (PE38QQR) molecule and its use as a diagnostic and therapeutic agent. The resulting chimeric toxin known as hIL13-PE38QQR binds only to cells expressing IL-13 receptors. Because of the chimeric molecule binds only to cells expressing the IL-13 receptor, i.e., tumor cells, the technology can be used to targets those cells. The improved specific targeting of this molecule, which is premised upon the discovery that tumor cells overexpress IL-13 receptors at extremely high levels, permits the use of lower dosages of chimeric molecules to deliver effector molecules to the targeted tumor cells. The targeting of this chimeric molecule has been improved by adding a blocker of the interleukin-4 receptor. This invention will be useful in the treatment of cancer. Specifically, the targeting method could be used in conjunction with current methods, e.g., chemotherapy, to kill tumor cells while maintaining healthy cells. To date, the molecule has been shown to be effective against a variety of solid tumor cancers, including adenocarcinoma, colon cancer, breast cancer, ovarian cancer, kidney cancer, brain cancer and AIDS associated Karposi*s sarcoma.

ADDRESS: Requests for copies of the patent applications, inquiries, comments and other materials relating to the contemplated licenses should be directed to: Jaconda Wagner, J.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; Telephone: (301) 496-7735 ext. 284; Facsimile: (301) 402-0220. A signed Confidentiality Agreement will be required to receive copies of the patent applications. 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 licenses. Only written comments and/or applications for a license which are received by NIH on or before May 12, 1997 will be considered. 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.
Published in the Federal Register on Tuesday, March 11, 1997 [62 FR 11217]