[Federal Register Volume 64, Number 49 (Monday, March 15, 1999)]
[Notices]
[Pages 12815-12816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6205]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally funded research and development.

ADDRESSES: Licensing information and a copy of the U.S. patent 
application referenced below may be obtained by contacting J.R. Dixon, 
Ph.D., at the Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-
3804 (telephone 301/496-7056 ext 206; fax 301/402-0220). A signed 
Confidential Disclosure Agreement is required to receive a copy of any 
patent application.

Title: ``Anthrax Lethal Factor is a MAPK Kinase Protease''

Inventors: Drs. Nicholas S. Duesbery (NCI-FCRDC), Craig Webb (NCI-
FCRDC), Stephen H. Leppla (NIDCR), and Dr. George Vande Woude (NCI-
FCRDC)
DHHS Ref. No. E-066-98/0--Filed April 1, 1998

    Anthrax toxin, produced by Bacillus anthracis, is composed of three 
proteins; protective antigen (PA), edema factor (EF), and lethal factor 
(LF). PA by itself has little or no toxic effect upon cells, but serves 
to bind cell surface receptors and mediate the entry of EF and LF into 
the cell. EF has been identified as an adenylate cyclase and together 
with PA forms a toxin (edema toxin; EdTx) which can induce edema 
formation when injected subcutaneously. LF and PA together form a toxin 
(lethal toxin; LeTx) which can cause rapid lysis of certain

[[Page 12816]]

macrophage-derived cell lines in vitro as well as death when injected 
intravenously.
    Indirect evidence had suggested that LF was a metalloprotease. 
However, the intracellular target of LF remained unknown until recently 
when NIH scientists discovered that LF proteolytically inactivates 
mitogen activated protein kinase kinase 1 and 2 (MAPKK1, 2). Using 
oocytes of the frog Xenopus laevis as well as tumor derived NIH3T3 
(490) cell expressing an effector domain mutant form of the human 
V12HaRas oncogene these scientists demonstrated that LF induced 
proteolysis of MAPKK 1 and 2, resulting in their irreversible 
inactivation. MAPKK 1 and 2 are components of the mitogen activated 
protein kinase (MAPK) signal transduction pathway, an evolutionarily 
conserved pathway that controls cell proliferation and differentiation 
in response to extracellular signal and also plays a crucial role in 
regulating oocyte meiotic maturation. Further, the MAPK pathway has 
been shown to be constitutively activated in many primary human as well 
as in tumor-derived cell lines. Consistent with this, treatment of 
V12Ha-Ras transformed NIH 3T3 cells with LeTx inhibits cell 
proliferation and causes their reversion to a non-transformed 
phenotype.
    This invention specifically relates to in vitro and ex vivo methods 
of screening for modulators, homologues, and mimetics of LF mitogen 
activated protein kinase kinase (MAPKK) protease activity. Applications 
for this technology could be:
    1. A novel tool (LF) for the study of the cellular role of the MAPK 
pathway in normal or tumor cells.
    2. Investigation of LF for developing inhibitors for cancer 
therapy. By analyzing structural-functional relationships, additional 
compounds with improved specificity, increased potency, and reduced 
toxicity can be generated. Mimetics which block MAPKK activity or the 
determination of mechanisms of regulation of proteases that target 
MAPKK at or near the same site targeted by LF could be developed.
    3. A protease-based assay for LF by using a peptide to test for LF 
cleavage. There is no commercial test for anthrax. This assay could be 
used for testing soldiers for anthrax exposure. Characterization of the 
interaction between LT and MAPKK at the amino acid level may lead to 
the generation of inhibitors which may prove useful in treating 
anthrax.
    The above mentioned invention is available for licensing on an 
exclusive or non-exclusive basis.

    Dated: March 5, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 99-6205 Filed 3-12-99; 8:45 am]
BILLING CODE 4140-01-M