[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Notices]
[Pages 3440-3441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-00737]


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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.

FOR FURTHER INFORMATION CONTACT: 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.

Transmission-Blocking Malaria Vaccine

    Description of Technology: There is no vaccine for malaria, and 
there is growing resistance to existing anti-malarial drugs. Sexual 
stage-specific antigens are of interest as vaccine candidates because 
disruption of these antigens would reduce the fertility and, thus, the 
infectivity of the parasite.
    This invention claims methods and compositions for delivering a 
Plasmodium P47 vaccine or antibody to P47 to prevent Plasmodium 
falciparum or Plasmodium vivax malaria. P47 and other antigens have 
been mentioned as potential transmission-blocking vaccines due to their 
surface location on gametes. The gene for P47 antigens is also well 
characterized. Recent discoveries have noted that P47 allows the 
parasite to suppress or evade the immune system, thereby ensuring the 
mosquitoes' survival. Recent discoveries have also shown the mechanism 
by which P47 enables survival of the parasite by manipulation of the 
mosquito immune system. Based on the critical role of P47 antigens in 
transmission, the disruption of the function of P47 by various means 
can be an innovative and forceful means to control and/or reduce the 
prevalence of malaria.
    Potential Commercial Applications: Malaria vaccine, diagnostic and 
therapeutic.
    Competitive Advantages:
     Single protein malaria transmission-blocking vaccine.
     Cost-effective, simple manufacturing process for vaccine.
     Potentially lower-cost malarial vaccine for developing/
developed countries.
    Development Stage:
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Carolina Barillas-Mury and Alvaro Molina-Cruz (NIAID).
    Publication: Molina-Cruz A, et al. Some strains of Plasmodium 
falciparum, a human malaria parasite, evade the complement-like system 
of Anopheles gambiae mosquitoes. Proc Natl Acad Sci U S A. 2012 Jul 
10;109(28):E1957-62. [PMID 22623529]
    Intellectual Property: HHS Reference No. E-222-2012/0 -- US 
Application No. 61/684,333 filed 17 Aug 2012.
    Licensing Contact: Peter A. Soukas; 301-435-4646; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases (NIAID) is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize malaria 
vaccines, diagnostics and therapeutics. For collaboration 
opportunities, please contact Tristan J. Mahyera at 
[email protected] or 301-827-0251.

Methods and Composition for Identification of Variants of JC Virus DNA; 
An Etiologic Agent for Progressive Multifocal Leukoencephalopathy (PML)

    Description of Technology: JC Virus causes a fatal disease in the 
brain called progressive multifocal leukoencephalopathy (PML) that 
occurs in many patients with immunocompromised conditions. The finding 
of JCV DNA in the patients with neurological symptoms of PML is a 
diagnostic criterion and is needed to confirm the diagnosis of PML to 
rule out other neurological conditions. Certain JC virus variants are 
known to have a greater association with PML. For example, 
``Prototype'' JC virus is far more pathogenic than ``Archetype'' JC 
virus.
    This invention claims novel assays for identifying Archetype and/or 
Prototype JC virus by detecting the presence or absence of the unique 
Archetype nucleic acid sequence in the non-coding regulatory region of 
JC virus. While the sequences of Archetype and Prototype JC virus are 
known, these are the first assays that allow discrimination between 
Prototype and Archetype JC virus in a simple assay without the need for 
DNA sequencing. The identification of a JC virus as a prototype can 
lead to early treatment of infected individuals.
    Potential Commercial Applications:
     JCV diagnostic kits.
     JCV diagnostics.
    Competitive Advantages:
     DNA sequencing not required.
     Single assay format using same template to identify 
prototype and archetype with 10c/ml sensitivity.
    Development Stage:
     Clinical.
     In vitro data available.
     In vivo data available (human).
    Inventors: Eugene O. Major and Caroline F. Ryschkewitsch (NINDS).
    Publication: Perkins MR, et al. Changes in JC Virus-Specific T Cell 
Responses during Natalizumab Treatment and in Natalizumab-Associated 
Progressive Multifocal Leukoencephalopathy. PLoS Pathog. 2012 
Nov;8(11):e1003014. [PMID 23144619]
    Intellectual Property: HHS Reference No. E-088-2012--US Application 
No. 61/661,289 filed 18 Jun 2012.
    Related Technology: HHS Reference No. E-152-2009/0--Research 
Material. Patent protection is not being pursued for this technology.
    Licensing Contact: Peter A. Soukas; 301-435-4646; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Neurological Disorders and Stroke is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate or commercialize assays for the detection of 
JC Virus. For collaboration opportunities, please contact Melissa 
Maderia at [email protected] or 301-451-3943.

Cross-Reactive Dengue Fully Human Monoclonal Antibodies

    Description of Technology: Among the arthropod-borne flaviviruses, 
the four dengue virus serotypes, dengue type 1 virus (DENV-1), dengue 
type 2 virus (DENV-2), dengue type 3 virus (DENV-

[[Page 3441]]

3), and dengue type 4 virus (DENV-4) are most important in terms of 
human morbidity and geographic distribution. Dengue viruses cause 
dengue outbreaks and major epidemics in most tropical and subtropical 
areas where Aedes albopictus and Aedes aegypti mosquitoes are abundant.
    A safe and effective vaccine against dengue is currently not 
available. Passive immunization with monoclonal antibodies from non-
human primates or humans represents a possible alternative to vaccines 
for prevention of illness caused by dengue virus. This invention claims 
fully human monoclonal antibodies that bind and neutralize dengue type 
1, 2, 3 and 4 viruses. It also claims fragments of such antibodies and 
nucleic acids encoding the antibodies of the invention as well as 
prophylactic, therapeutic and diagnostic methods employing the 
antibodies and nucleic acids of the invention.
    Potential Commercial Applications:
     Prophylaxis/therapy against dengue serotypes 1, 2, 3, and 
4.
     Dengue diagnostics.
    Competitive Advantages:
     Antibodies are cross-reactive with all four serotypes of 
dengue.
     Antibodies are fully human.
    Development Stage:
     Pre-clinical.
     In vitro data.
    Inventors: Dimiter S. Dimitrov and Zhongyu Zhu (NCI).
    Intellectual Property: HHS Reference No. E-273-2011/0--US 
Application No. 61/646,638 filed 14 May 2012.
    Related Technologies: HHS Reference No. E-066-2003/5--US Patent 
7,622,133 issued 24 Nov 2009; US Application No. 12/607,035 filed 27 
Oct 2009.
    Licensing Contact: Peter A. Soukas; 301-435-4646; 
[email protected].
    Collaborative Research Opportunity: The NCI/CCR/NP is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate or commercialize 
Cross-Reactive Dengue Fully Human Monoclonal A. For collaboration 
opportunities, please contact John Hewes, Ph.D. at [email protected].

Typhoid-Plague Bivalent Vaccine

    Description of Technology: Yersinia pestis (Y. pestis) bacteria is 
the causative agent of plague, typically transmitted from animals to 
humans by the bite of an infected flea. Y. pestis infection of the 
lungs leads to pneumonic plague, which is highly contagious and 
generally fatal. Y. pestis is a potential bioterrorist threat agent for 
which no vaccine yet exists.
    This invention claims the generation and development of a candidate 
oral vaccine against plague. The vaccine consists of a synthetic gene 
construct that expresses a Y. pestis F1-V fusion antigen linked to a 
secretion signal, resulting in the production of large amounts of the 
F1-V antigen. The F1-V synthetic gene fusion is housed within Ty21a, an 
attenuated typhoid fever strain that is licensed for human use as a 
live oral bacterial vaccine. Ty21a serves as a carrier to deliver the 
F1-V fusion antigens of the plague bacteria; the combined F1-V fusion 
in the Ty21a carrier has been shown to stimulate a robust immune 
response in mice. The possibility of combining the oral plague vaccine 
of this invention with FDA's candidate oral anthrax vaccine exists and 
would result in an easy-to-administer oral delivery system to 
streamline administration of the vaccine to large numbers of recipients 
in emergency situations.
    Potential Commercial Applications: Plague vaccines, therapeutics 
and diagnostics.
    Competitive Advantages:
     Vector is well-characterized.
     Simple manufacturing process.
     Potential low-cost vaccine.
    Development Stage:
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Dennis J. Kopecko, Manuel A. Osorio, Monica R. Foote 
(FDA/CBER).
    Intellectual Property: HHS Reference No. E-105-2011/0--US 
Application No. 61/650,676 filed 23 May 2012.
    Related Technologies: HHS Reference No. E-344-2003/1--US Patent 
7,758,855 issued 20 Jul 2010; US Patent 8,247,225 issued 21 Aug 2012.
    Licensing Contact: Peter A. Soukas; 301-435-4616; 
[email protected].
    Collaborative Research Opportunity: The FDA Center for Biologics 
Evaluation and Research, Lab of Enteric and Sexually Transmitted 
Diseases, is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate or 
commercialize oral plague vaccine. For collaboration opportunities, 
please contact Dennis Kopecko at [email protected].

    Dated: January 10, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-00737 Filed 1-15-13; 8:45 am]
BILLING CODE 4140-01-P