Prospective Grant of Exclusive License: Activation of Recombinant Diphtheria Toxin Fusion Proteins by Specific Proteases Highly Expressed on the Surface of Tumor Cells

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-331-2002/0: “Activation of Recombinant Diphtheria Toxin Fusion Proteins By Specific Proteases Highly Expressed on the Surface of Tumor Cells” filed as a PCT application on May 6, 2004, and claiming priority to U.S. provisional patent application 60/468,577, filed May 6, 2003, to Anjin Group, Inc., which is located in Cockeysville, MD. 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 treatment of cancers of the head and neck.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before September 14, 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; E-mail: heftib@mail.nih.gov.

SUPPLEMENTARY INFORMATION:

This invention relates to diphtheria toxin fusion proteins comprising a diphtheria toxin (DT) component, and a granulocyte-macrophage colony stimulating factor (GM-CSF) component, an interleukin 2 (IL-2) component, or an epidermal growth factor (EGF) component. The DT toxin fusion proteins are toxic to cells expressing: (1) Either GM-CSF receptors, IL-2 receptors, or EGF receptors, and (2) either matrix metalloproteinases or urokinase plasminogen activator, on their surface. These DT toxin fusion proteins are particularly useful for selective methods of treating cancers in which the cancers overexpress (1) GM-CSF receptors, IL-2 receptors, or EGF receptors, and (2) either matrix metalloproteinases or urokinase plasminogen activator, on their surface.

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.