[Federal Register: February 21, 2008 (Volume 73, Number 35)]
[Notices]
[Page 9578-9580]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21fe08-72]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 9579]]
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.
Development of Antigenic Chimeric St. Louis Encephalitis Virus/Dengue
Virus Type Four Recombinant Viruses (SLEV/DEN4) as Vaccine Candidates
for the Prevention of Disease Caused by SLEV
Description of Invention: St. Louis Encephalitis Virus (SLEV) is a
mosquito-borne flavivirus that is endemic in the Americas and causes
sporadic outbreaks of disease in humans. SLEV is a member of the
Japanese encephalitis virus serocomplex and is closely related to West
Nile Virus (WNV). St. Louis encephalitis is found throughout North,
Central, and South America, and the Caribbean, but is a major public
health problem mainly in the United States. Prior to the outbreak of
West Nile virus in 1999, St. Louis encephalitis was the most common
human disease caused by mosquitoes in the United States. Since 1964,
there have been about 4,440 confirmed cases of St. Louis encephalitis,
with an average of 130 cases per year. Up to 3,000 cases have been
reported during epidemics in some years. Many more infections occur
without symptoms and go undiagnosed. At present, a vaccine or FDA-
approved antiviral therapy is not available.
The inventors have previously developed a WNV/Dengue4Delta30
antigenic chimeric virus as a live attenuated virus vaccine candidate
that contains the WNV premembrane and envelope (prM and E) proteins on
a dengue virus type 4 (DEN4) genetic background with a thirty
nucleotide deletion (Delta30) in the DEN4 3'-UTR. Using a similar
strategy, the inventors have generated an antigenic chimeric virus,
SLE/DEN4Delta30. Preclinical testing results indicate that
chimerization of SLE with DEN4Delta30 decreased neuroinvasiveness in
mice, did not affect neurovirulence in mice, and appeared to
overattenuate the virus for non-human primates. Modifications of the
SLE/DEN4Delta30 vaccine candidate are underway to improve its
immunogenicity.
This application claims live attenuated chimeric SLE/DEN4Delta30
vaccine compositions and bivalent WNV/SLE/DEN4Delta30 vaccine
compositions. Also claimed are methods of treating or preventing SLEV
infection in a mammalian host, methods of producing a subunit vaccine
composition, isolated polynucleotides comprising a nucleotide sequence
encoding a SLEV immunogen, methods for detecting SLEV infection in a
biological sample and infectious chimeric SLEV.
Application: Immunization against SLEV or SLEV and WNV.
Development Status: Live attenuated vaccine candidates are
currently being developed and preclinical studies in mice and monkeys
are in progress. Suitable vaccine candidates will then be evaluated in
clinical studies.
Inventors: Stephen S. Whitehead, Joseph Blaney, Alexander Pletnev,
Brian R. Murphy (NIAID).
Patent Status: U.S. Provisional Application No. 60/934,730 filed 14
Jun 2007 (HHS Reference No. E-240-2007/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Collaborative Research Opportunity: The NIAID Laboratory of
Infectious Diseases is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate, or commercialize live attenuated virus vaccine candidates for
St. Louis encephalitis virus. Please contact Dr. Whitehead at 301-496-
7692 for more information.
Methods of Glycosylation and Bioconjugation
Description of Technology: Eukaryotic cells express several classes
of oligosaccharides attached to proteins or lipids. Animal glycans can
be N-linked via beta-GlcNAc to Asn (N-glycans), O-linked via -GalNAc to
Ser/Thr (O-glycans), or can connect the carboxyl end of a protein to a
phosphatidylinositol unit (GPI-anchors) via a common core glycan
structure. Beta (1,4)-galactosyltransferase I catalyzes the transfer of
galactose from the donor, UDP-galactose, to an acceptor, N-
acetylglucosamine, to form a galactose-beta (1,4)-N-acetylglucosamine
bond, and allows galactose to be linked to an N-acetylglucosamine that
may itself be linked to a variety of other molecules. Examples of these
molecules include other sugars and proteins. The reaction can be used
to make many types of molecules having great biological significance.
For example, galactose-beta (1,4)-N-acetylglucosamine linkages are
important for many recognition events that control how cells interact
with each other in the body, and how cells interact with pathogens. In
addition, numerous other linkages of this type are also very important
for cellular recognition and binding events as well as cellular
interactions with pathogens, such as viruses. Therefore, methods to
synthesize these types of bonds have many applications in research and
medicine to develop pharmaceutical agents and improved vaccines that
can be used to treat disease.
The invention provides in vitro folding method for a polypeptidyl-
alpha-N-acetylgalactosaminyltransferase (pp-GalNAc-T) that transfers
GalNAc to Ser/Thr residue on a protein. The application claims that
this in vitro-folded recombinant ppGalNAc-T enzyme transfers modified
sugar with a chemical handle to a specific site in the designed C-
terminal polypeptide tag fused to a protein. The invention provides
methods for engineering a glycoprotein from a biological substrate, and
methods for glycosylating a biological substrate for use in
glycoconjugation. Also included in the invention are diagnostic and
therapeutic uses.
Application: Enzymes and methods are provided that can be used to
promote the chemical linkage of biologically important molecules that
have previously been difficult to link.
Developmental Status: Enzymes have been synthesized and
characterization studies have been performed.
Inventors: Pradman Qasba and Boopathy Ramakrishnan (NCI/SAIC).
Patent Status: U.S. Provisional Application No. 60/930,294 filed 14
May 2007 (HHS Reference No. E-204-2007/0-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 National Cancer Institute
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate, or
commercialize this technology. Please contact John D. Hewes, Ph.D. at
301-435-3121 or hewesj@mail.nih.gov for more information.
Chlamydia Vaccine
Description of Invention: Chlamydia trachomatis is an obligate
intracellular bacterial pathogen that colonizes and infects
oculogenital mucosal surfaces. The organism exists as multiple
serovariants that infect millions of people worldwide. Ocular
infections cause trachoma, a chronic follicular conjunctivitis that
results in scarring and blindness. The World Health Organization
estimates that 300-500 million people are afflicted by
[[Page 9580]]
trachoma, making it the most prevalent form of infectious preventable
blindness. Urogenital infections are the leading cause of bacterial
sexually transmitted disease in both industrialized and developing
nations. Moreover, sexually transmitted diseases are risk factors for
infertility, the transmission of HIV, and human papilloma virus-induced
cervical neoplasia. Control of C. trachomatis infections is an
important public health goal. Unexpectedly, however, aggressive
infection control measures based on early detection and antibiotic
treatment have resulted in an increase in infection rates, most likely
by interfering with natural immunity, a concept suggested by studies
performed in experimental infection models. Effective management of
chlamydial disease will likely require the development of an
efficacious vaccine.
This technology claims vaccine compositions that comprise an
immunologically effective amount of PmpD protein from C. trachomatis.
Also claimed in the application are methods of immunizing individuals
against C. trachomatis. PmpD is an antigenically stable pan-
neutralizing target that, in theory, would provide protection against
all human strains, thus allowing the development of a univalent vaccine
that is efficacious against both blinding trachoma and sexually
transmitted disease.
Application: Prophylactics against C. trachomatis.
Developmental Status: Preclinical studies have been performed.
Inventors: Harlan Caldwell and Deborah Crane (NIAID).
Publication: DD Crane et al. Chlamydia trachomatis polymorphic
membrane protein D is a species-common pan-neutralizing antigen. Proc
Natl Acad Sci USA. 2006 Feb 7;103(6):1894-1899.
Patent Status: PCT Patent Application No. PCT/US2007/001213 filed
16 Jan 2007, which published as WO 2007/082105 on 19 Jul 2007 (HHS
Reference No. E-031-2006/0-PCT-02).
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 NIAID Laboratory of
Intracellular Parasites is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate, or commercialize PmpD vaccine development. Please contact
Harlan D. Caldwell, at hcaldwell@niaid.nih.gov or 406-363-9333 for more
information.
Dated: February 11, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-3164 Filed 2-20-08; 8:45 am]
BILLING CODE 4140-01-P