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Government-Owned Inventions; Availability for Licensing

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AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

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; soukasp@mail.nih.gov.

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 Start Printed Page 41337whose 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; soukasp@mail.nih.gov.

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 amy.rosenberg@fda.hhs.gov or (301) 827-1794 for more information.

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Dated: July 19, 2007.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. E7-14500 Filed 7-26-07; 8:45 am]

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