[Federal Register Volume 72, Number 144 (Friday, July 27, 2007)]
[Notices]
[Pages 41336-41337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14500]


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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, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are 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. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Monoclonal Antibodies that Neutralize B. anthracis Protective Antigen 
(PA), Lethal Factor (LF) and Edema Factor (EF)

    Description of Technology: Anthrax, whether resulting from natural 
or bioterrorist-associated exposure, is a constant threat to human 
health. The lethality of anthrax is primarily the result of the effects 
of anthrax toxin, which has 3 components: a receptor-binding protein 
known as ``protective antigen'' (PA) and 2 catalytic proteins known as 
``lethal factor'' (LF) and ``edema factor'' (EF). Although production 
of an efficient anthrax vaccine is an ultimate goal, the benefits of 
vaccination can be expected only if a large proportion of the 
population at risk is immunized. The low incidence of anthrax suggests 
that large-scale vaccination may not be the most efficient means of 
controlling this disease. In contrast, passive administration of 
neutralizing human or chimpanzee monoclonal antibody to a subject at 
risk for anthrax or exposed to anthrax could provide immediate efficacy 
for emergency prophylaxis against or treatment of anthrax.
    Four monoclonal antibodies (mAbs) against PA, three mAbs against LF 
and four mAbs specific for EF of anthrax were isolated from a phage 
display library generated from immunized chimpanzees. Two mAbs 
recognizing PA (W1 and W2), two anti-LF mAbs efficiently neutralized 
the cytotoxicity of lethal toxin in a macrophage lysis assay. One anti-
EF mAb efficiently neutralized edema toxin in cell culture. All five 
neutralizing mAbs protected animals from anthrax toxin challenge.
    Application: Prophylactics or therapeutics against B. anthracis.
    Developmental Status: Preclinical studies have been performed.
    Inventors: Zhaochun Chen, Robert Purcell, Suzanne Emerson, Stephen 
Leppla, Mahtab Moyeri (NIAID).
    Publication: Z Chen et al. Efficient neutralization of anthrax 
toxin by chimpanzee monoclonal antibodies against protective antigen. J 
Infect Dis. 2006 Mar 1;193(5):625-633. Epub 2006 Feb 2.
    Patent Status: U.S. Provisional Application No. 60/903,022 filed 23 
Feb 2007 (HHS Reference No. E-123-2007/0-US-01); U.S. Patent 
Application filed 22 Jun 2007 (HHS Reference No. E-146-2004/0-US-03).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases, Laboratory of Infectious Diseases is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
Chimpanzee/human neutralizing monoclonal antibodies against anthrax 
toxins. Please contact Dr. Robert Purcell at 301-496-5090 for more 
information.

Use of Amyloid Proteins as Vaccine Scaffolds

    Description of Technology: Amyloid proteins are composed of 
peptides

[[Page 41337]]

whose chemical properties are such that they spontaneously aggregate in 
vitro or in vivo, assuming parallel or antiparallel beta sheet 
configurations. Amyloid proteins can arise from peptides which, though 
differing in primary amino acid sequences, assume the same tertiary and 
quaternary structures. The amyloid structure presents a regular array 
of accessible N-termini of the peptide molecules.
    Claimed in this application are compositions and methods for use of 
amyloid proteins as vaccine scaffolds, on which peptide determinants 
from microorganisms or tumors may be presented to more efficiently 
generate and produce a sustained neutralizing antibody response to 
prevent infectious diseases or treat tumors. The inventors have arrayed 
peptides to be optimally immunogenic on the amyloid protein scaffold by 
presenting antigen using three different approaches. First, the N-
terminal ends of the amyloid forming peptides can be directly modified 
with the peptide antigen of interest; second, the N-termini of the 
amyloid forming peptides are modified with a linker to which the 
peptide antigens of interest are linked; and third, the scaffold 
amyloid may be modified to create a chimeric molecule.
    Aside from stability and enhanced immunogenicity, the major 
advantages of this approach are the synthetic nature of the vaccine and 
its low cost. Thus, concerns regarding contamination of vaccines 
produced from cellular substrates, as are currently employed for some 
vaccines, are eliminated; the robust stability allows the amyloid based 
vaccine to be stored at room temperature for prolonged periods of time; 
and the inexpensive synthetic amino acid starting materials, and their 
rapid spontaneous aggregation in vitro should provide substantial cost 
savings over the resource and labor-intensive current vaccine 
production platforms.
    Application: Immunization to prevent infectious diseases or treat 
chronic conditions or cancer.
    Developmental Status: Vaccine candidates have been synthesized and 
preclinical studies have been performed.
    Inventors: Amy Rosenberg (CDER/FDA), James E. Keller (CBER/FDA), 
Robert Tycko (NIDDK).
    Patent Status: U.S. Provisional Application No. 60/922,131 filed 06 
Apr 2007 (HHS Reference No. E-106-2007/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected].
    Collaborative Research Opportunity: The FDA, Division of 
Therapeutic Proteins (CDER) and Office of Vaccines, Division of 
Bacterial Products (CBER) is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize amyloid based vaccines for 
prevention of infectious disease or treatment of malignant states. 
Please contact Amy Rosenberg at [email protected] or (301) 827-
1794 for more information.

    Dated: July 19, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-14500 Filed 7-26-07; 8:45 am]
BILLING CODE 4140-01-P