[Federal Register Volume 76, Number 208 (Thursday, October 27, 2011)]
[Notices]
[Pages 66727-66728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27857]


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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.

Protease Deficient Bacillus anthracis With Improved Recombinant Protein 
Yield Capabilities

    Description of Technology: Species of Bacillus, such as Bacillus 
anthracis, Bacillus cereus, and Bacillus subtilis, are attractive 
microorganisms for recombinant protein production in view of their fast 
growth rate, high yield, and ability to secrete produced products 
directly into the medium. Bacillus anthracis is also attractive in view 
of its ability to produce anthrax toxin and ability to fold proteins 
correctly. This application claims a B. anthracis strain in which more 
than one secreted protease is inactivated by genetic modification. Such 
a protease-deficient B. anthracis has an improved ability to produce 
recombinant secreted proteins compared to other bacteria, particularly 
other Bacillus. Improvements include production of intact (i.e., mature 
full-length) proteins, often at high yield.
    Potential Commercial Applications:
     Vaccine production
     Recombinant protein production
     B. anthracis vaccine production
    Competitive Advantages:
     Highly efficient production of recombinant proteins
     Low cost production of recombinant proteins
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Andrei Pomerantsev and Stephen Leppla (NIAID).
    Publication: Pomerantsev A, et al. A Bacillus anthracis strain 
deleted for six proteases serves as an effective host for production of 
recombinant proteins. Protein Expr Purif. 2011 Nov;80(1):80-90. [PMID 
21827967].
    Intellectual Property:
     HHS Reference No. E-202-2011/0 --U.S. Provisional 
Application No. 61/514,384 filed 02 Aug 2011
     HHS Reference No. E-202-2011/1 --U.S. Provisional 
Application No. 61/521,617 filed 09 Aug 2011
    Licensing Contact: Peter Soukas, J.D.; (301) 435-4646; 
[email protected].
    Collaborative Research Opportunity: The NIAID is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize B. anthracis 
vaccines, B. anthracis protein production. For collaboration 
opportunities, please contact Charles Rainwater at (301) 435-8617.

Parvovirus B19 Codon Optimized Structural Proteins for Vaccine and 
Diagnostic Applications

    Description of Technology: Parvovirus B19 (B19V) is the only known 
pathogenic human parvovirus. Infection by this viral pathogen can cause 
transient aplastic crisis in individuals with high red cell turnover, 
pure red cell aplasia in immunosuppressed patients, and hydrops fetalis 
during pregnancy. In children, B19V most commonly causes erythema 
infectiosum, or fifth's disease. Infection can also cause arthropathy 
and arthralgia. The virus is very erythrotropic, targeting human 
erythroid (red blood) progenitors found in the blood, bone marrow, and 
fetal liver. Currently, there are no approved vaccines or antiviral 
drugs for the treatment or prevention of B19V infection.
    The subject technology is a series of plasmid constructs with codon 
optimized B19 viral capsid genes (VP1 and VP2) that can be expressed in 
mammalian cells. Transfection of vectors encoding these optimized VP1 
and VP2 genes into different mammalian cell lines, including 293, Cos7, 
and HeLa cells produce virus-like particles (VLPs). The vectors include 
bicistronic plasmids expressing the VP1 and VP2 proteins at different 
ratios to produce B19V VLPs with optimal antigenicity for vaccine 
applications. This technology can also be used for diagnostic 
applications and development of a viral packaging system for producing 
infectious B19V virus.
    Applications:
     VLPs based vaccines for the prevention and/or treatment of 
B19V infection
     DNA based vaccines for the prevention and/or treatment of 
B19V infection
     B19V diagnostics
     Viral packaging system
    Advantages:

[[Page 66728]]

     Codon optimized VP1 and VP2 genes for better expression in 
mammalian cell lines
     Expression of B19V VLPs from ``nonpermissive'' cell lines
    Development Stage: In vitro data available.
    Inventors: Ning Zhi, Sachiko Kajigaya, and Neal S. Young (NHLBI).
    Patent Status: HHS Reference No. E-011-2010/0--PCT Application No. 
PCT/US2011/024199 filed 09 Feb 2011.
    Licensing Contact: Kevin W. Chang, Ph.D.; (301) 435-5018; 
[email protected].
    Collaborative Research Opportunity: The National Heart Lung and 
Blood Institute, Hematology Branch, is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize the subject technology. 
Please contact Cecilia Pazman, Ph.D., at [email protected] for more 
information.

    Dated: October 21, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-27857 Filed 10-26-11; 8:45 am]
BILLING CODE 4140-01-P