Government-Owned Inventions; Availability for Licensing, 73087-73090 [2014-28748]
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Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices
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[FR Doc. 2014–28750 Filed 12–8–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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. 209 and 37 CFR part 404 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.
SUMMARY:
[FR Doc. 2014–28702 Filed 12–8–14; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
rljohnson on DSK3VPTVN1PROD with NOTICES
National Institutes of Health
Office of the Director Notice of Charter
Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Board of
Regents of the National Library of
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SUPPLEMENTARY INFORMATION:
Technology descriptions follow.
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Vaccine for Protection Against
Shigella sonnei Disease
Description of Technology:
Shigellosis is a global human health
problem. Transmission usually occurs
by contaminated food and water or
through person-to-person contact. The
bacterium is highly infectious by the
oral route, and ingestion of as few as 10
organisms can cause an infection in
volunteers. An estimated 200 million
people worldwide suffer from
shigellosis, with more than 650,000
associated deaths annually. A recent
CDC estimate indicates the occurrence
of over 440,000 annual shigellosis cases
in the United States alone,
approximately eighty percent (80%) of
which are caused by Shigella sonnei.
Shigella sonnei is more active in
developed countries. Shigella infections
are typically treated with a course of
antibiotics. However, due to the
emergence of multidrug resistant
Shigella strains, a safe and effective
vaccine is highly desirable. No vaccines
against Shigella infection currently
exist. Immunity to Shigellae is mediated
largely by immune responses directed
against the serotype specific Opolysaccharide. Claimed in the
invention are compositions and
methods for inducing an
immunoprotective response against S.
sonnei. Specifically, an attenuated
bacteria capable of expressing an S.
sonnei antigen comprised of the S.
sonnei form I O-polysaccharide
expressed from the S. sonnei rfb/rfc
gene cluster is claimed. The inventors
have shown that the claimed vaccine
compositions showed one hundred
percent (100%) protection against
parenteral challenge with virulent S.
sonnei in mice.
Potential Commercial Applications:
• Shigella/Typhoid vaccine for
travelers, military
• Shigella/Typhoid vaccine for
developing countries
• Shigella/Typhoid diagnostics
Competitive Advantages:
• Low cost of production
• Temperature stable formulation
• Safety/efficacy of Ty21a established
in humans
Development Stage: In vivo data
available (animal)
Inventors: Dennis J. Kopecko (FDA),
De Qi Xu (NIDCR), John O. Cisar
(NICHD)
Publication: Kopecko DJ, et al.
Molecular cloning and characterization
of genes for Shigella sonnei form I O
polysaccharide: proposed biosynthetic
pathway and stable expression in a live
salmonella vaccine vector. Infect
Immun. 2002 Aug;70(8):4414–23.
[PMID: 12117952]
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Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices
Intellectual Property: HHS Reference
No. E–210–2001/0 –
• US Patent No. 7,541,043 issued 02
Jun 2009
• US Patent No. 8,071,084 issued 06
Dec 2011
• US Patent No. 8,337,832 issued 25
Dec 2012
• US Patent Application No. 13/
686,299 filed 27 Nov 2012
Licensing Contact: Peter A. Soukas;
301–435–4646; soukasp@mail/nih.gov
rljohnson on DSK3VPTVN1PROD with NOTICES
Live Oral Shigella dysenteriae
Vaccine
Description of Technology: This
application claims a Salmonella typhi
Ty21a construct comprising a Shigella
dysenteriae O-specific polysaccharide
(O-Ps) inserted into the Salmonella
typhi Ty21a chromosome, where
heterologous Shigella dysenteriae
serotype 1 O-antigen is stably expressed
together with homologous Salmonella
typhi O-antigen. The constructs of this
invention elicit immune protection
against virulent Shigella dysenteriae
challenge, as well as Salmonella typhi
challenge. Also claimed in this
application are methods of making the
constructs of this invention and
methods for inducing an immune
response.
Shigella cause millions of cases of
dysentery every year, which result in
about seven hundred thousand deaths
worldwide. Shigella dysenteriae
serotype 1, one of about forty serotypes
of Shigella, causes a more severe disease
with a much higher mortality rate than
other serotypes. There are no licensed
vaccines available for protection against
Shigella. The fact that many isolates
exhibit multiple antibiotic resistance
complicates the management of
dysentery infections.
Potential Commercial Applications:
• One component of a multivalent
anti-shigellosis vaccine under
development.
• Shigella vaccines, therapeutics and
diagnostics.
Competitive Advantages:
• Vector is well-characterized.
• Simple manufacturing process.
• Potential low-cost vaccine.
• Oral vaccine—avoids need for
needles.
• Temperature-stable formulation
allows for vaccine distribution without
refrigeration.
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventors: Dennis J. Kopecko and De
Qi Xu (FDA/CBER)
Publication: Xu DQ, et al. Core-linked
LPS expression of Shigella dysenteriae
serotype 1 O-antigen in live Salmonella
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typhi vaccine vector Ty21a: Preclinical
evidence of immunogenicity and
protection. Vaccine. 2007 Aug
14;25(33):6167–75. [PMID 17629369]
Intellectual Property: HHS Reference
No. E–214–2004/0 • US Patent No. 8,071,113 issued 06
Dec 2011
• US Patent No. 8,337,831 issued 25
Dec 2012
• US Patent No. 8,790,635 issued 29
Jul 2014
• US Patent Application No. 14/
145,104 filed 31 Dec 2013 (allowed)
• Various international patent
applications pending
Licensing Contact: Peter A. Soukas;
301–435–4646; soukasp@mail.nih.gov
Oral Shigellosis Vaccine
Description of Technology: This
application claims a Salmonella typhi
Ty21a construct comprising a Shigella
sonnei O-antigen biosynthetic gene
region inserted into the Salmonella
typhi Ty21a chromosome, where
heterologous Shigella sonnei form 1 Oantigen is stably expressed together with
homologous Salmonella typhi Oantigen. The constructs of this invention
elicit immune protection against
virulent Shigella sonnei challenge, as
well as Salmonella Typhi challenge.
Also claimed in this application are
methods of recombineering a large
antigenic gene region into a bacterial
chromosome.
Bacillary dysentery and enteric fevers
continue to be important causes of
morbidity in both developed and
developing nations. Shigella cause
greater than one hundred and fifty
million cases of dysentery and enteric
fever occurs in greater than twentyseven million people annually.
Currently, there is no licensed vaccine
to prevent the occurrence of shigellosis.
Increasing multiple resistance in
Shigella commonly thwarts local
therapies.
Potential Commercial Applications:
• One component of a multivalent
Shigellosis vaccine under development
• Research tool
Competitive Advantages:
• Low cost production
• Lower cost vaccine
• Oral vaccine—no needles required
• Temperature-stable manufacturing
process—avoids need for refrigeration
during vaccine distribution
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventors: Dennis J. Kopecko and
Madushini N. Dharmasena (FDA/CBER)
Publication: Dharmasena MN, et al.
Stable expression of Shigella sonnei
form I O-polysaccharide genes
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recombineered into the chromosome of
live Salmonella oral vaccine vector
Ty21a. Int J Med Microbiol. 2013
Apr;303(3):105–13. [PMID 23474241]
Intellectual Property: HHS Reference
No. E–168–2012/0 • US Provisional Application No. 61/
701,939 filed 17 Sep 2012
• PCT Application No. PCT/US2013/
059980 filed 16 Sep 2013, which
published as WO 2014/043637 on 20
Mar 2014
Licensing Contact: Peter A. Soukas;
301–435–4646; soukasp@mail.nih.gov
Acid-Resistant, Attenuated Microbial
Vector for Improved Oral Delivery of
Multiple Targeted Antigens
Description of Technology: Ty21a, the
licensed oral live, attenuated bacterial
vaccine for Salmonella typhi (the
causative agent of typhoid fever), has
been engineered to stably express a
variety of target LPS
(lipopolysaccharides) and protein
antigens to protect against shigellosis,
anthrax, and plague. Ty21a induces
mucosal, humoral, and cellular
immunity and can be utilized as a
multivalent vaccine vector that is
inexpensive to produce. Salmonella
species encode inducible acid tolerance,
but this genus does not survive well
below pH 4. Shigella and
enterohemorrhagic E. coli isolates have
more effective acid resistance systems
than Salmonella and can survive an
extreme acid challenge of pH 1–2 (the
acidity of the human stomach when
full).
This application claims an engineered
Ty21a vector that can survive a very low
pH for two to three hours (i.e., normal
transit time through a full stomach),
allowing for a final delivery format for
Ty21a as a rapidly dissolvable wafer,
instead of the large bullet-size entericcoated capsule, which small children
cannot swallow. This formulation
enhances the ability of the
immunogenic composition and/or
vaccine to stimulate immune responses
sublingually and throughout the
intestinal tract.
Potential Commercial Applications:
• Shigella vaccines
• Biodefense vaccines
• Diagnostics
Competitive Advantages:
• Ease of manufacture
• Inexpensive to manufacture
• Ease of administration
• Known live attenuated bacterial
vector
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventors: Madushini N. Dharmasena
and Dennis J. Kopecko (FDA/CBER)
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Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices
rljohnson on DSK3VPTVN1PROD with NOTICES
Intellectual Property: HHS Reference
No. E–535–2013/0 • US Provisional Application No. 61/
862,815 filed 06 Aug 2013
• PCT Application No. PCT/US2014/
049933 filed 06 Aug 2014
Licensing Contact: Peter A. Soukas;
301–435–4646; soukasp@mail.nih.gov
Attenuated Salmonella as a Delivery
System for siRNA-Based Tumor
Therapy
Description of Technology: This
technology comprises live, attenuated
Salmonella strains as a delivery system
for small interfering double-stranded
RNA (siRNA)-based tumor therapy. The
inventors’ data provide the first
convincing evidence that Salmonella
can be used for delivering plasmidbased siRNAs into tumors growing in
vivo. Claimed in the related patent
application are methods of inhibiting
the growth or reducing the volume of
solid cancer tumors using the si-RNA
constructs directed against genes that
promote tumor survival and cancer cell
growth. The Stat3-siRNAs carried by an
attenuated S. typhimurium described in
the application exhibit tumor
suppressive effects not only on the
growth of the primary tumor but also on
the development of metastases,
suggesting that an appropriate
attenuated S. typhimurium combined
with the RNA interference (RNAi)
approach may offer a clinically feasible
method for cancer therapy.
Potential Commercial Applications:
• Development of live attenuated
bacterial cancer vaccines, cancer
therapeutics and diagnostics.
• Developing/developed world
vaccine.
Competitive Advantages:
• Low cost of production
• Vaccine vector safety/efficacy in
humans established
Development Status: In vivo data
available (animal)
Inventors: Dennis J. Kopecko (FDA),
De Qi Xu (FDA), Ling Zhang (Jilin
University), Xuejian Zhao (Jilin
University), Jiadi Hu (University of
Maryland)
Publications:
1. Zhang L, et al. Intratumoral
delivery and suppression of prostate
tumor growth by attenuated Salmonella
enterica serovar typhimurium carrying
plasmid-based small interfering RNAs.
Cancer Res. 2007 Jun 15;67(12):5859–64.
[PMID 17575154]
2. Zhang L, et al. Effects of plasmidbased Stat3-specific short hairpin RNA
and GRIM–19 on PC–3M tumor cell
growth. Clin Cancer Res. 2008 Jan
15;14(2):559–68. [PMID 18223232]
Intellectual Property: HHS Reference
No. E–278–2007/0 -
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• PCT Application No. PCT/US2007/
074272 filed 27 Jul 2007, which
published as WO 2008/091375 on 31 Jul
2008
• U.S. Patent Application No. 12/
374,916 filed 23 Jan 2009
• International Application No.
200610017045.5 filed in China 27 Jul
2006
Licensing Contact: Peter A. Soukas;
301–435–4616; soukasp@mail.nih.gov
DNA Promoters and Anthrax Vaccines
Description of Technology: Currently,
the only licensed vaccine against
anthrax in the United States is AVA
BioThrax®, which, although efficacious,
suffers from several limitations. This
vaccine requires six injectable doses
over 18 months to stimulate protective
immunity, requires a cold chain for
storage, and in many cases has been
associated with adverse effects.
This application claims a modified B.
anthracis protective antigen (PA) gene
for optimal expression and stability,
linked it to an inducible promoter for
maximal expression in the host, and
fused to the secretion signal of the
Escherichia coli alpha-hemolysin
protein (HlyA) on a low-copy-number
plasmid. This plasmid was introduced
into the licensed typhoid vaccine strain,
Salmonella enterica serovar Typhi
strain Ty21a, and was found to be
genetically stable. Immunization of mice
with three vaccine doses elicited a
strong PA-specific serum
immunoglobulin G response with a
geometric mean titer of 30,000 (range,
5,800 to 157,000) and lethal-toxinneutralizing titers greater than 16,000.
Vaccinated mice demonstrated 100%
protection against a lethal intranasal
challenge with aerosolized spores of B.
anthracis 7702.
Potential Commercial Applications:
Anthrax vaccines, therapeutics and
diagnostics.
Competitive Advantages:
• Vector is well-characterized.
• Simple manufacturing process.
• Potential low-cost vaccine.
• Oral vaccine—avoids needles and
can be administered rapidly during
emergencies.
• Temperature-stable manufacturing
allows for vaccine distribution without
refrigeration.
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventors: Dennis J. Kopecko, Siba
Bhattacharyya, Milan Blake (all of FDA/
CBER)
Publication: Osorio M, et al. Anthrax
protective antigen delivered by
Salmonella enterica serovar Typhi
Ty21a protects mice from a lethal
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anthrax spore challenge. Infect Immun.
2009 Apr;77(4):1475–82. [PMID
19179420]
Intellectual Property: HHS Reference
No. E–344–2003/1 • U.S. Patent No. 7,758,855 issued 20
Jul 2010
• U.S. Patent No. 8,247,225 issued 21
Aug 2012
• U.S. Patent No. 8,709,813 issued 29
Apr 2014
• U.S. Patent Application No. 14/
185,353 filed 20 Feb 2014
• Various international patents issued
Licensing Contact: Peter A. Soukas;
301–435–4646; soukasp@mail.nih.gov
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:
• In vitro data available
• In vivo data available (animal)
Inventors: Dennis J. Kopecko, Manuel
A. Osorio, Monica R. Foote (all of FDA/
CBER)
Intellectual Property: HHS Reference
No. E–105–2011/0 • U.S. Provisional Application No.
61/650,676 filed 23 May 2012
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Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices
• PCT Application No. PCT/US2013/
042240 filed 22 May 2013, which
published as WO 2013/177291 on 28
Nov 2013
Related Technologies: HHS Reference
No. E–344–2003/1• U.S. Patent No. 7,758,855 issued 20
Jul 2010
• U.S. Patent No. 8,247,225 issued 21
Aug 2012
• U.S. Patent No. 8,709,813 issued 29
Apr 2014
• U.S. Patent Application No. 14/
185,353 filed 20 Feb 2014
• Various international patents issued
Licensing Contact: Peter A. Soukas;
301–435–4616; soukasp@mail.nih.gov
Dated: December 3, 2014.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2014–28748 Filed 12–8–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
rljohnson on DSK3VPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Program
Project: AIDS and AIDS Related Research.
Date: December 15, 2014.
Time: 10:30 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Jose H Guerrier, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1137, guerriej@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
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Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: AIDS and AIDS Related Research.
Date: December 15, 2014.
Time: 2:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Mary Clare Walker, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5208,
MSC 7852, Bethesda, MD 20892, (301) 435–
1165, walkermc@csr.nih.gov.
This notice is being published less than 15
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Name of Committee: Center for Scientific
Review Special Emphasis Panel; Special
Topics in HIV/AIDS Behavioral Research.
Date: December 18, 2014.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Mark P Rubert, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1775, rubertm@csr.nih.gov.
This notice is being published less than 15
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Name of Committee: Center for Scientific
Review Special Emphasis Panel; Pathologies
in the Nervous System.
Date: December 18, 2014.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Peter B Guthrie, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4142,
MSC 7850, Bethesda, MD 20892, (301) 435–
1239, guthriep@csr.nih.gov.
This notice is being published less than 15
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(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: December 3, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–28752 Filed 12–8–14; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Special
Topic: Small Business Innovative
Immunology Research.
Date: December 18, 2014.
Time: 3:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Andrea Keane-Myers, BS,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4218,
Bethesda, MD 20892, 301–435–1221,
andrea.keane-myers@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: December 3, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–28747 Filed 12–8–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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[Federal Register Volume 79, Number 236 (Tuesday, December 9, 2014)]
[Notices]
[Pages 73087-73090]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28748]
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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, 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. 209 and 37 CFR part 404 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.
SUPPLEMENTARY INFORMATION: Technology descriptions follow.
Vaccine for Protection Against Shigella sonnei Disease
Description of Technology: Shigellosis is a global human health
problem. Transmission usually occurs by contaminated food and water or
through person-to-person contact. The bacterium is highly infectious by
the oral route, and ingestion of as few as 10 organisms can cause an
infection in volunteers. An estimated 200 million people worldwide
suffer from shigellosis, with more than 650,000 associated deaths
annually. A recent CDC estimate indicates the occurrence of over
440,000 annual shigellosis cases in the United States alone,
approximately eighty percent (80%) of which are caused by Shigella
sonnei. Shigella sonnei is more active in developed countries. Shigella
infections are typically treated with a course of antibiotics. However,
due to the emergence of multidrug resistant Shigella strains, a safe
and effective vaccine is highly desirable. No vaccines against Shigella
infection currently exist. Immunity to Shigellae is mediated largely by
immune responses directed against the serotype specific O-
polysaccharide. Claimed in the invention are compositions and methods
for inducing an immunoprotective response against S. sonnei.
Specifically, an attenuated bacteria capable of expressing an S. sonnei
antigen comprised of the S. sonnei form I O-polysaccharide expressed
from the S. sonnei rfb/rfc gene cluster is claimed. The inventors have
shown that the claimed vaccine compositions showed one hundred percent
(100%) protection against parenteral challenge with virulent S. sonnei
in mice.
Potential Commercial Applications:
Shigella/Typhoid vaccine for travelers, military
Shigella/Typhoid vaccine for developing countries
Shigella/Typhoid diagnostics
Competitive Advantages:
Low cost of production
Temperature stable formulation
Safety/efficacy of Ty21a established in humans
Development Stage: In vivo data available (animal)
Inventors: Dennis J. Kopecko (FDA), De Qi Xu (NIDCR), John O. Cisar
(NICHD)
Publication: Kopecko DJ, et al. Molecular cloning and
characterization of genes for Shigella sonnei form I O polysaccharide:
proposed biosynthetic pathway and stable expression in a live
salmonella vaccine vector. Infect Immun. 2002 Aug;70(8):4414-23. [PMID:
12117952]
[[Page 73088]]
Intellectual Property: HHS Reference No. E-210-2001/0 -
US Patent No. 7,541,043 issued 02 Jun 2009
US Patent No. 8,071,084 issued 06 Dec 2011
US Patent No. 8,337,832 issued 25 Dec 2012
US Patent Application No. 13/686,299 filed 27 Nov 2012
Licensing Contact: Peter A. Soukas; 301-435-4646; soukasp@mail/
nih.gov
Live Oral Shigella dysenteriae Vaccine
Description of Technology: This application claims a Salmonella
typhi Ty21a construct comprising a Shigella dysenteriae O-specific
polysaccharide (O-Ps) inserted into the Salmonella typhi Ty21a
chromosome, where heterologous Shigella dysenteriae serotype 1 O-
antigen is stably expressed together with homologous Salmonella typhi
O-antigen. The constructs of this invention elicit immune protection
against virulent Shigella dysenteriae challenge, as well as Salmonella
typhi challenge. Also claimed in this application are methods of making
the constructs of this invention and methods for inducing an immune
response.
Shigella cause millions of cases of dysentery every year, which
result in about seven hundred thousand deaths worldwide. Shigella
dysenteriae serotype 1, one of about forty serotypes of Shigella,
causes a more severe disease with a much higher mortality rate than
other serotypes. There are no licensed vaccines available for
protection against Shigella. The fact that many isolates exhibit
multiple antibiotic resistance complicates the management of dysentery
infections.
Potential Commercial Applications:
One component of a multivalent anti-shigellosis vaccine
under development.
Shigella vaccines, therapeutics and diagnostics.
Competitive Advantages:
Vector is well-characterized.
Simple manufacturing process.
Potential low-cost vaccine.
Oral vaccine--avoids need for needles.
Temperature-stable formulation allows for vaccine
distribution without refrigeration.
Development Stage:
In vitro data available
In vivo data available (animal)
Inventors: Dennis J. Kopecko and De Qi Xu (FDA/CBER)
Publication: Xu DQ, et al. Core-linked LPS expression of Shigella
dysenteriae serotype 1 O-antigen in live Salmonella typhi vaccine
vector Ty21a: Preclinical evidence of immunogenicity and protection.
Vaccine. 2007 Aug 14;25(33):6167-75. [PMID 17629369]
Intellectual Property: HHS Reference No. E-214-2004/0 -
US Patent No. 8,071,113 issued 06 Dec 2011
US Patent No. 8,337,831 issued 25 Dec 2012
US Patent No. 8,790,635 issued 29 Jul 2014
US Patent Application No. 14/145,104 filed 31 Dec 2013
(allowed)
Various international patent applications pending
Licensing Contact: Peter A. Soukas; 301-435-4646;
nih.gov">soukasp@mail.nih.gov
Oral Shigellosis Vaccine
Description of Technology: This application claims a Salmonella
typhi Ty21a construct comprising a Shigella sonnei O-antigen
biosynthetic gene region inserted into the Salmonella typhi Ty21a
chromosome, where heterologous Shigella sonnei form 1 O-antigen is
stably expressed together with homologous Salmonella typhi O-antigen.
The constructs of this invention elicit immune protection against
virulent Shigella sonnei challenge, as well as Salmonella Typhi
challenge. Also claimed in this application are methods of
recombineering a large antigenic gene region into a bacterial
chromosome.
Bacillary dysentery and enteric fevers continue to be important
causes of morbidity in both developed and developing nations. Shigella
cause greater than one hundred and fifty million cases of dysentery and
enteric fever occurs in greater than twenty-seven million people
annually. Currently, there is no licensed vaccine to prevent the
occurrence of shigellosis. Increasing multiple resistance in Shigella
commonly thwarts local therapies.
Potential Commercial Applications:
One component of a multivalent Shigellosis vaccine under
development
Research tool
Competitive Advantages:
Low cost production
Lower cost vaccine
Oral vaccine--no needles required
Temperature-stable manufacturing process--avoids need for
refrigeration during vaccine distribution
Development Stage:
In vitro data available
In vivo data available (animal)
Inventors: Dennis J. Kopecko and Madushini N. Dharmasena (FDA/CBER)
Publication: Dharmasena MN, et al. Stable expression of Shigella
sonnei form I O-polysaccharide genes recombineered into the chromosome
of live Salmonella oral vaccine vector Ty21a. Int J Med Microbiol. 2013
Apr;303(3):105-13. [PMID 23474241]
Intellectual Property: HHS Reference No. E-168-2012/0 -
US Provisional Application No. 61/701,939 filed 17 Sep
2012
PCT Application No. PCT/US2013/059980 filed 16 Sep 2013,
which published as WO 2014/043637 on 20 Mar 2014
Licensing Contact: Peter A. Soukas; 301-435-4646;
nih.gov">soukasp@mail.nih.gov
Acid-Resistant, Attenuated Microbial Vector for Improved Oral Delivery
of Multiple Targeted Antigens
Description of Technology: Ty21a, the licensed oral live,
attenuated bacterial vaccine for Salmonella typhi (the causative agent
of typhoid fever), has been engineered to stably express a variety of
target LPS (lipopolysaccharides) and protein antigens to protect
against shigellosis, anthrax, and plague. Ty21a induces mucosal,
humoral, and cellular immunity and can be utilized as a multivalent
vaccine vector that is inexpensive to produce. Salmonella species
encode inducible acid tolerance, but this genus does not survive well
below pH 4. Shigella and enterohemorrhagic E. coli isolates have more
effective acid resistance systems than Salmonella and can survive an
extreme acid challenge of pH 1-2 (the acidity of the human stomach when
full).
This application claims an engineered Ty21a vector that can survive
a very low pH for two to three hours (i.e., normal transit time through
a full stomach), allowing for a final delivery format for Ty21a as a
rapidly dissolvable wafer, instead of the large bullet-size enteric-
coated capsule, which small children cannot swallow. This formulation
enhances the ability of the immunogenic composition and/or vaccine to
stimulate immune responses sublingually and throughout the intestinal
tract.
Potential Commercial Applications:
Shigella vaccines
Biodefense vaccines
Diagnostics
Competitive Advantages:
Ease of manufacture
Inexpensive to manufacture
Ease of administration
Known live attenuated bacterial vector
Development Stage:
In vitro data available
In vivo data available (animal)
Inventors: Madushini N. Dharmasena and Dennis J. Kopecko (FDA/CBER)
[[Page 73089]]
Intellectual Property: HHS Reference No. E-535-2013/0 -
US Provisional Application No. 61/862,815 filed 06 Aug
2013
PCT Application No. PCT/US2014/049933 filed 06 Aug 2014
Licensing Contact: Peter A. Soukas; 301-435-4646;
nih.gov">soukasp@mail.nih.gov
Attenuated Salmonella as a Delivery System for siRNA-Based Tumor
Therapy
Description of Technology: This technology comprises live,
attenuated Salmonella strains as a delivery system for small
interfering double-stranded RNA (siRNA)-based tumor therapy. The
inventors' data provide the first convincing evidence that Salmonella
can be used for delivering plasmid-based siRNAs into tumors growing in
vivo. Claimed in the related patent application are methods of
inhibiting the growth or reducing the volume of solid cancer tumors
using the si-RNA constructs directed against genes that promote tumor
survival and cancer cell growth. The Stat3-siRNAs carried by an
attenuated S. typhimurium described in the application exhibit tumor
suppressive effects not only on the growth of the primary tumor but
also on the development of metastases, suggesting that an appropriate
attenuated S. typhimurium combined with the RNA interference (RNAi)
approach may offer a clinically feasible method for cancer therapy.
Potential Commercial Applications:
Development of live attenuated bacterial cancer vaccines,
cancer therapeutics and diagnostics.
Developing/developed world vaccine.
Competitive Advantages:
Low cost of production
Vaccine vector safety/efficacy in humans established
Development Status: In vivo data available (animal)
Inventors: Dennis J. Kopecko (FDA), De Qi Xu (FDA), Ling Zhang
(Jilin University), Xuejian Zhao (Jilin University), Jiadi Hu
(University of Maryland)
Publications:
1. Zhang L, et al. Intratumoral delivery and suppression of
prostate tumor growth by attenuated Salmonella enterica serovar
typhimurium carrying plasmid-based small interfering RNAs. Cancer Res.
2007 Jun 15;67(12):5859-64. [PMID 17575154]
2. Zhang L, et al. Effects of plasmid-based Stat3-specific short
hairpin RNA and GRIM-19 on PC-3M tumor cell growth. Clin Cancer Res.
2008 Jan 15;14(2):559-68. [PMID 18223232]
Intellectual Property: HHS Reference No. E-278-2007/0 -
PCT Application No. PCT/US2007/074272 filed 27 Jul 2007,
which published as WO 2008/091375 on 31 Jul 2008
U.S. Patent Application No. 12/374,916 filed 23 Jan 2009
International Application No. 200610017045.5 filed in
China 27 Jul 2006
Licensing Contact: Peter A. Soukas; 301-435-4616;
nih.gov">soukasp@mail.nih.gov
DNA Promoters and Anthrax Vaccines
Description of Technology: Currently, the only licensed vaccine
against anthrax in the United States is AVA BioThrax[supreg], which,
although efficacious, suffers from several limitations. This vaccine
requires six injectable doses over 18 months to stimulate protective
immunity, requires a cold chain for storage, and in many cases has been
associated with adverse effects.
This application claims a modified B. anthracis protective antigen
(PA) gene for optimal expression and stability, linked it to an
inducible promoter for maximal expression in the host, and fused to the
secretion signal of the Escherichia coli alpha-hemolysin protein (HlyA)
on a low-copy-number plasmid. This plasmid was introduced into the
licensed typhoid vaccine strain, Salmonella enterica serovar Typhi
strain Ty21a, and was found to be genetically stable. Immunization of
mice with three vaccine doses elicited a strong PA-specific serum
immunoglobulin G response with a geometric mean titer of 30,000 (range,
5,800 to 157,000) and lethal-toxin-neutralizing titers greater than
16,000. Vaccinated mice demonstrated 100% protection against a lethal
intranasal challenge with aerosolized spores of B. anthracis 7702.
Potential Commercial Applications: Anthrax vaccines, therapeutics
and diagnostics.
Competitive Advantages:
Vector is well-characterized.
Simple manufacturing process.
Potential low-cost vaccine.
Oral vaccine--avoids needles and can be administered
rapidly during emergencies.
Temperature-stable manufacturing allows for vaccine
distribution without refrigeration.
Development Stage:
In vitro data available
In vivo data available (animal)
Inventors: Dennis J. Kopecko, Siba Bhattacharyya, Milan Blake (all
of FDA/CBER)
Publication: Osorio M, et al. Anthrax protective antigen delivered
by Salmonella enterica serovar Typhi Ty21a protects mice from a lethal
anthrax spore challenge. Infect Immun. 2009 Apr;77(4):1475-82. [PMID
19179420]
Intellectual Property: HHS Reference No. E-344-2003/1 -
U.S. Patent No. 7,758,855 issued 20 Jul 2010
U.S. Patent No. 8,247,225 issued 21 Aug 2012
U.S. Patent No. 8,709,813 issued 29 Apr 2014
U.S. Patent Application No. 14/185,353 filed 20 Feb 2014
Various international patents issued
Licensing Contact: Peter A. Soukas; 301-435-4646;
nih.gov">soukasp@mail.nih.gov
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:
In vitro data available
In vivo data available (animal)
Inventors: Dennis J. Kopecko, Manuel A. Osorio, Monica R. Foote
(all of FDA/CBER)
Intellectual Property: HHS Reference No. E-105-2011/0 -
U.S. Provisional Application No. 61/650,676 filed 23 May
2012
[[Page 73090]]
PCT Application No. PCT/US2013/042240 filed 22 May 2013,
which published as WO 2013/177291 on 28 Nov 2013
Related Technologies: HHS Reference No. E-344-2003/1-
U.S. Patent No. 7,758,855 issued 20 Jul 2010
U.S. Patent No. 8,247,225 issued 21 Aug 2012
U.S. Patent No. 8,709,813 issued 29 Apr 2014
U.S. Patent Application No. 14/185,353 filed 20 Feb 2014
Various international patents issued
Licensing Contact: Peter A. Soukas; 301-435-4616;
nih.gov">soukasp@mail.nih.gov
Dated: December 3, 2014.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2014-28748 Filed 12-8-14; 8:45 am]
BILLING CODE 4140-01-P
