[Federal Register Volume 72, Number 128 (Thursday, July 5, 2007)]
[Notices]
[Pages 36716-36717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12899]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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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 National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
an exclusive

[[Page 36717]]

patent license to practice the inventions embodied in U.S. Patent 
Application 60/870,050, entitled ``Human Cancer Therapy Using Anthrax 
Lethal Toxin Activated by Tumor Associated Proteases'' [HHS Reference 
E-070-2007/0-US-01], including background patent rights to U.S. Patent 
Application 10/088,952, entitled ``Mutated Anthrax Toxin Protective 
Antigen Proteins that Specifically Target Cells Containing High Amounts 
of Cell-Surface Metalloproteinases or Plasminogen Activator Receptors'' 
[HHS Reference E-293-1999/0-US-03] and foreign counterparts thereto, 
and U.S. Patents 5,591,631 and 5,677,274, entitled ``Anthrax Toxin 
Fusion Proteins and Uses Thereof'' [HHS References E-064-1993/0-US-01 
and E-064-1993/1-US-01, respectively] and foreign counterparts thereto, 
to FP BioPharma, LLC, which has offices in Fort Mill, South Carolina. 
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:

    A method for the treatment of cancer involving protease 
activated cancer toxins, wherein the cancer toxins comprise Anthrax 
lethal toxin (LeTx) modified at the furin-recognized cleavage site 
to contain a matrix metalloproteinase cleavage site, as defined by 
the Licensed Patent Rights, and wherein the cancers include, but are 
not limited to, melanoma, colon, thyroid, prostate, pancreatic and 
ovarian cancer. This exclusive licensed field of use shall 
explicitly exclude vaccines and immunotherapeutics for the 
prevention or treatment of human diseases.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
September 4, 2007 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, PhD, 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: Anthrax lethal toxin (LeTx) has been shown 
to have significant toxicity to cancer cells, particularly those 
associated with melanoma. However, LeTx also shows significant toxicity 
towards normal cells, preventing widespread use of the molecule as a 
cancer therapy. NIH inventors have now engineered LeTx to have 
increased specificity for cancer cells, with little to no effect on 
normal cells, enhancing the effectiveness of LeTx for cancer treatment.
    Modifying the LeTx to be activated by a matrix metalloprotease 
(MMP) increases the specificity of LeTx for cancer cells because those 
cells are more likely to activate the toxin, resulting in more 
efficient therapy. Mouse data shows that the modified LeTx (called 
PrAg-L1/LF) is less cytotoxic to ``normal'' cells in vivo when compared 
to wild-type LeTx, while maintaining high toxicity towards implanted 
human tumors. Modification of the LeTx to contain various protease 
recognition and cleavage sites can potentially extend application of 
the technology beyond melanomas to the treatment of lung and colon 
carcinomas, and various other cancers.
    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, 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 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: June 26, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-12899 Filed 7-3-07; 8:45 am]
BILLING CODE 4140-01-P