[Federal Register Volume 69, Number 136 (Friday, July 16, 2004)]
[Notices]
[Page 42759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16125]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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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: [email protected].

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.

    Dated: July 6, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-16125 Filed 7-15-04; 8:45 am]
BILLING CODE 4140-01-P