Government-Owned Inventions; Availability for Licensing, 43601-43603 [2012-18054]
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Federal Register / Vol. 77, No. 143 / Wednesday, July 25, 2012 / Notices
the number of registrants requesting to
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BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Risks and Benefits of Hydroxyethyl
Starch Solutions; Public Workshop
Food and Drug Administration,
HHS.
srobinson on DSK4SPTVN1PROD with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Risks and Benefits of
Hydroxyethyl Starch Solutions.’’ The
purpose of this public workshop is to
discuss new information on the risks
and benefits of FDA-approved
hydroxyethyl starch (HES) solutions.
The public workshop has been
planned in partnership with the
Department of Defense and the National
Heart, Lung and Blood Institute,
National Institutes of Health, and will
include presentations and panel
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HES
solutions are synthetic colloids
administered intravenously to patients
to maintain or expand plasma volume
when clinically indicated. Currently,
three such products are approved by
FDA. HES solutions are indicated for
the treatment of hypovolemia (low
blood volume) that may result from
trauma, sepsis, burns, or anaphylaxis.
These products are used in the
prehospital and hospital environment in
both military and civilian settings. This
public workshop will serve as a forum
for discussing new information on the
potential effects of HES solutions on
hemostasis and on the renal system.
The first day of the public workshop
will include presentations and panel
discussions on the following topics: (1)
The risks and benefits associated with
HES solutions in different clinical
settings and (2) the findings of two
recent major clinical studies conducted
on HES solutions.
The second day of the public
workshop will include a summary
discussion and presentations
concerning the overall safety profile of
HES solutions and a discussion of future
SUPPLEMENTARY INFORMATION:
[FR Doc. 2012–18095 Filed 7–24–12; 8:45 am]
AGENCY:
discussions with experts from academia,
regulated industry, government, and
other stakeholders.
Date and Time: The public workshop
will be held on September 6, 2012, from
8:00 a.m. to 5:30 p.m., and September 7,
2012, from 8:30 a.m. to 1:00 p.m.
Location: The public workshop will
be held at the Masur Auditorium,
National Institutes of Health, 10 Center
Dr., Bldg. 10, Clinical Center, Bethesda,
MD 20892.
Contact Person: Jennifer Scharpf,
Center for Biologics Evaluation and
Research (HFM–300), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
Phone: 301–827–6128, FAX: 301–827–
2843, email:
CBEROBRRWorkshops@fda.hhs.gov.
Registration: Mail, fax, or email your
registration information (including
name, title, firm or organization name,
address, telephone and fax numbers,
and email address) to Jennifer Scharpf
(see Contact Person) by August 15,
2012. There is no registration fee for the
public workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 7:00
a.m. If you need special
accommodations due to a disability,
please contact Jennifer Scharpf (see
Contact Person) at least 7 days in
advance.
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43601
clinical research for the evaluation of
HES solutions.
Transcripts: Please be advised that as
soon as possible after a transcript of the
public workshop is available, it will be
accessible at: https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
TranscriptsMinutes/default.htm.
Transcripts of the public workshop may
also be requested in writing from the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857.
Dated: July 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18110 Filed 7–24–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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.
SUMMARY:
Novel Analogues of the Asthma Drug
Fenoterol as Liver and Brain Cancer
Therapeutic Agents
Description of Technology: Available
for licensing are specific fenoterol
analogues, such as MNF, that inhibit the
growth of various types of cancers,
including brain, liver, colon, and lung
tumors. MNF acts as an agonist of the
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43602
Federal Register / Vol. 77, No. 143 / Wednesday, July 25, 2012 / Notices
GPRSS cannabinoid (CB) receptor and,
as such, represents one of the first
potential drugs directed at this target.
MNF crosses the blood brain barrier and
initial toxicity studies indicate that it
has few off-target effects. These new
analogues can be used to treat CB
receptor related disorders and diseases,
and in particular GRPSS-related
disorders and diseases, including brain
and liver cancers for which there are no
current effective treatments.
Potential Commercial Applications:
• A new class of compounds that can
be used to treat cannabinoid receptor
related disorders and diseases.
• Treatments for liver, brain, colon,
and lung cancers.
Competitive Advantages:
• Able to cross the blood:brain
barrier.
• Few side-effects.
• Broad range of therapeutic activity.
• Can be formulated for oral
administration.
Development Stage:
• Pre-clinical.
• In vitro data available.
• In vivo data available (animal).
Inventors: Irving Wainer, Michel
Bernier, Rajib Paul (all of NIA).
Publications:
1. Paul RK, et al. Cannabinoid
receptor activation correlates with the
pro-apoptotic action of the beta2adrenergic agonist (R,R’)-4’-methoxy-1naphthylfenoterol. J Pharmacol Exp
Ther., in press.
2. Paul RK, et al. Negative regulation
of GPR–55-mediated ligand uptake and
cellular motility by (R,R’)-4’-methoxy-1napthylfenoterol. Br J Pharmacol., in
preparation.
3. Paul RK, et al. The role of GPR55
and apoptotic signalling pathways in
(R,R’)-4’-methoxy-1-naphthyfenoterol.
Cancer Res., in preparation.
Intellectual Property: HHS Reference
No. E–139–2012/0—U.S. Provisional
Application No. 61/651,961 filed 25
May 2012.
Licensing Contact: Patrick McCue,
Ph.D.; 301–435–5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunities:
The IRP/NIA/LCI is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize (R,R’)-4’-methoxy-1naphthylfenoterol for the treatment of
brain, liver and colon carcinomas. For
collaboration opportunities, please
contact Nicole Guyton, Ph.D. at
darackn@mail.nih.gov.
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18:32 Jul 24, 2012
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High-Affinity Mouse Monoclonal
Antibodies to Glypican-3 (GPC3) for
Research Use
Description of Technology: Liver
cancer is the fifth most common cancer
in the world, with hepatocellular cancer
(HCC) representing the preponderance
of these liver cancers. As with many
cancers, positive prognosis for a patient
diagnosed with HCC correlates with the
early detection of the disease.
Unfortunately, HCC is usually detected
at a late stage in its development,
leading to poor prognosis for most
patients. As a result, there is great
interest and value in developing new
agents which can detect the presence of
HCC in a patient at an early stage.
Glypican-3 (GPC3) is a cell surface
heparan sulfate glycoprotein that is
expressed on the vast majority of HCC
cells. The correlation between GPC3
expression and HCC makes GPC3 an
attractive candidate for studying the
disease progression and treatment of
HCC. The presence, progression and
treatment of this disease can potentially
be monitored by tracking the level of
expression of GPC3 on cells. This can be
accomplished using monoclonal
antibodies which recognize only GPC3,
particularly the cell surface domain of
the protein. This invention concerns the
generation of several monoclonal
antibodies that are specific for the cell
surface domain of GPC3 (YP6, YP7,
YP8, YP9 and YP9.1), and which can be
used as research reagents for studying
the role of GPC3 in HCC.
Potential Commercial Applications:
Antibodies for use as research materials,
including:
• Detection of cells that express GPC3
for monitoring HCC disease progression
and treatment.
• Immunostaining for tumor imaging.
• ELISA and immunohistochemistry
applications.
• Any other antibody-related research
use, including immunoprecipitation,
western blot analysis, etc.
Competitive Advantages:
• Higher binding affinity
(subnanomolar levels) than
commercially available GPC3 antibodies
such as 1G12.
• Recognition of cells with low levels
of GPC3 expression.
• Able to bind to wild-type GPC3
(conjugated to heparan sulfate) better
than the GPC3 core protein (lacking
heparan sulfate).
Development Stage:
• Early-stage.
• In vitro data available.
Inventors: Mitchell Ho et al. (NCI).
Publications:
1. Ho M, Kim H. Glypican-3: a new
target for cancer immunotherapy. Eur J
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Cancer. 2011 Feb; 47(3):333–338. [PMID
21112773]
2. Ho M. Advances in liver cancer
antibody therapies: a focus on glypican3 and mesothelin. BioDrugs. 2011 Oct 1;
25(5):275–284. [PMID 21942912]
Intellectual Property: HHS Reference
No. E–136–2012/0—U.S. Provisional
Application No. 61/654,232 filed 01 Jun
2012.
Related Technology: HHS Reference
No. E–130–2011/0 — U.S. Provisional
Application No. 61/477,020 filed 19 Apr
2011; PCT Application No. PCT/
US2012/034186 filed 19 Apr 2012.
Licensing Contact: David A.
Lambertson, Ph.D.; 301–435–4632;
lambertsond@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 cancer diagnostics,
isolation of circulating tumor cells,
humanization and/or
immunoconjugates. For collaboration
opportunities, please contact John
Hewes, Ph.D. at hewesj@mail.nih.gov.
Self-Assembled Ferritin Nanoparticles
Expressing Hemagglutinin as an
Influenza Vaccine
Description of Technology: NIH
inventors at the Vaccine Research
Center have developed a novel
influenza virus hemagglutinin (HA)ferritin nanoparticle influenza vaccine
that is easily manufactured, potent, and
elicits broadly neutralizing influenza
antibodies against multiple strains of
influenza. This novel influenza
nanoparticle vaccine elicited two types
of broadly neutralizing, cross-protective
antibodies, one directed to the highly
conserved HA stem and a second
proximal to the conserved receptor
binding site (RBS) of the viral HA,
providing a new platform for universal
and seasonal influenza. In addition, HAferritin nanoparticles can be easily
produced from simple expression
vectors and without the production of
infectious virus in eggs, and will
facilitate influenza preparedness in the
face of emerging epidemics.
This technology exploits ferritin, a
ubiquitous iron storage protein, that
self-assembles into spherical
nanoparticles and could serve as a
scaffold to express a heterologous
protein, such as influenza HA, so it
mimics a physiologically relevant
trimeric viral spike. Immunization with
the HA-ferritin nanoparticle elicited
neutralizing antibody titers that were
>10-fold higher than a matched
inactivated vaccine. The immune sera
raised by HA-ferritin nanoparticles
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Federal Register / Vol. 77, No. 143 / Wednesday, July 25, 2012 / Notices
expressing a 1999 HA neutralized
seasonal H1N1 viruses from 1934 to
2007 and protected ferrets from an
unmatched 2007 H1N1 virus challenge.
This extended neutralization coverage is
partially explained by the presence of
both type of antibodies, antibodies
directed to the conserved HA stem and
against the RBS region. Finally, this
ferritin nanoparticle vaccine platform
has significant advantages in the ability
to utilize specific multimerized spikes
and it may be applicable to other viral
proteins.
Potential Commercial Applications:
The ferritin nanoparticles as a vaccine
platform can be used to deliver
vaccines, such as influenza vaccines,
with enhanced magnitude and breadth
of the neutralizing antibody responses.
This vaccine platform may be applicable
to other viral proteins.
Competitive Advantages:
• Forms an octahedron consisting of
24 subunits, allowing for greatly
increased presentation of heterologous
protein on the ferritin nanoparticles
surface, compared to other vaccine
platforms.
• In vivo data in multiple animal
models demonstrated induction of
broader and more potent antibody
responses.
• Vaccine stimulated broadly
neutralizing antibodies against the
highly conserved epitope on the HA
stem region and against the RBS, thus
targeting two independent sites of
vulnerability on HA.
• Multivalent influenza HA ferritin
vaccines have been tested in animal
models.
• Ferritin is extremely stable to
temperature ranges, pH, detergent and
other factors.
• Easily manufactured, will facilitate
influenza preparedness in the face of
emerging epidemics.
Development Status:
• Preclinical.
• In vitro data available.
• In vivo data available (animal).
Inventors: Gary Nabel, Masaru
Kanekiyo, Jeffrey C. Boyington, Patrick
McTamney (all of NIAID).
Publication: Kanekiyo M, et al. A SelfAssembling Influenza Nanoparticle
Vaccine Elicits Two Types of Broadly
Neutralizing and Cross-protective
Antibodies. Manuscript submitted.
Intellectual Property:
• HHS Reference No. E–293–2011/0
— U.S. Provisional Application No.
61/538,663 filed 23 Sep 2011.
• HHS Reference No. E–293–2011/1
— U.S. Provisional Application No.
61/661,209 filed 18 Jun 2012.
Licensing Contact: Cristina
Thalhammer-Reyero, Ph.D., M.B.A.;
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301–435–4507;
ThalhamC@mail.nih.gov.
Salen-Manganese Compounds for
Therapy of Viral Infections
Description of Technology: Salenmanganese compounds are synthetic,
stable, low toxicity, low cost agents that
may provide protection from immune
reaction-related oxidative cell damage
associated with many illnesses. In
particular, oxidative cell damage has
been associated with many viral
infections including influenza. This
invention demonstrates that treating
mice with salen-manganese compounds,
after lethal pandemic influenza virus
infection, significantly enhances
survival. Salen-manganese treatment
also reduces lung pathology and also
improved cellular recovery and repair.
Because oxidative damage is observed
in many viral infections, administration
of salen-manganese compounds may
have therapeutic relevance to a wide
range of viral infections, in addition
influenza. Existing viral therapeutics
merely target the infectious viral agent
and not the damage caused by the
immune system reaction related to
infection. Because, salen-manganese
treatments target the untapped
therapeutic space of infection-induced,
immune system-related pathology and
have favorable safety and cost profiles,
such therapies are ideal candidates for
development.
Potential Commercial Applications:
Viral therapeutics.
Competitive Advantages: Synthetic,
stable, low toxicity, low cost, untapped
therapeutic target space.
Development Stage:
• Early-stage.
• Pre-clinical.
• In vivo data available (animal).
Inventors: John Kash (NIAID), Jeffrey
Taubenberger (NIAID), Rodney Levine
(NHLBI), Susan Doctrow (Boston
University).
Publications:
1. Doctrow SR, et al. Salen Manganese
Complexes: Multifunctional Catalytic
Antioxidants Protective in Models for
Neurodegenerative Diseases of Aging.
In: Medicinal Inorganic Chemistry, ACS
Symposium Series, Vol. 903, Chapter
18, pp 319–347; August 25, 2005. [DOI:
10.1021/bk–2005–0903.ch018.]
2. Schwarz KB. Oxidative stress
during viral infection: a review. Free
Radic Biol Med. 1996; 21(5):641–9.
[PMID 8891667]
Intellectual Property: HHS Reference
No. E–281–2011/0—U.S. Provisional
Application No. 61/558,137 filed 10
Nov 2011.
Licensing Contact: Tedd Fenn, J.D.;
301–435–5031; Tedd.Fenn@nih.gov.
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43603
Collaborative Research Opportunity:
The NIAID Laboratory of Infectious
Diseases, Viral Pathogenesis and
Evolution Section, is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize this technology. For
collaboration opportunities, please
contact Maryann Puglielli at 301–594–
6656.
Dated: July 18, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–18054 Filed 7–24–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; 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: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel.
Date: September 25, 2012.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5635
Fishers Lane, Rockville, MD 20852,
(Telephone Conference Call).
Contact Person: Beata Buzas, Ph.D.,
Scientific Review Officer, National Institute
on Alcohol Abuse and Alcoholism, National
Institutes of Health, 5635 Fishers Lane, Room
2081, Rockville, MD 20852, 301–443–0800,
bbuzas@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
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]]>Agencies
[Federal Register Volume 77, Number 143 (Wednesday, July 25, 2012)]
[Notices]
[Pages 43601-43603]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18054]
-----------------------------------------------------------------------
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.
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.
Novel Analogues of the Asthma Drug Fenoterol as Liver and Brain Cancer
Therapeutic Agents
Description of Technology: Available for licensing are specific
fenoterol analogues, such as MNF, that inhibit the growth of various
types of cancers, including brain, liver, colon, and lung tumors. MNF
acts as an agonist of the
[[Page 43602]]
GPRSS cannabinoid (CB) receptor and, as such, represents one of the
first potential drugs directed at this target. MNF crosses the blood
brain barrier and initial toxicity studies indicate that it has few
off-target effects. These new analogues can be used to treat CB
receptor related disorders and diseases, and in particular GRPSS-
related disorders and diseases, including brain and liver cancers for
which there are no current effective treatments.
Potential Commercial Applications:
A new class of compounds that can be used to treat
cannabinoid receptor related disorders and diseases.
Treatments for liver, brain, colon, and lung cancers.
Competitive Advantages:
Able to cross the blood:brain barrier.
Few side-effects.
Broad range of therapeutic activity.
Can be formulated for oral administration.
Development Stage:
Pre-clinical.
In vitro data available.
In vivo data available (animal).
Inventors: Irving Wainer, Michel Bernier, Rajib Paul (all of NIA).
Publications:
1. Paul RK, et al. Cannabinoid receptor activation correlates with
the pro-apoptotic action of the beta2-adrenergic agonist (R,R')-4'-
methoxy-1-naphthylfenoterol. J Pharmacol Exp Ther., in press.
2. Paul RK, et al. Negative regulation of GPR-55-mediated ligand
uptake and cellular motility by (R,R')-4'-methoxy-1-napthylfenoterol.
Br J Pharmacol., in preparation.
3. Paul RK, et al. The role of GPR55 and apoptotic signalling
pathways in (R,R')-4'-methoxy-1-naphthyfenoterol. Cancer Res., in
preparation.
Intellectual Property: HHS Reference No. E-139-2012/0--U.S.
Provisional Application No. 61/651,961 filed 25 May 2012.
Licensing Contact: Patrick McCue, Ph.D.; 301-435-5560;
mccuepat@mail.nih.gov.
Collaborative Research Opportunities: The IRP/NIA/LCI is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
(R,R')-4'-methoxy-1-naphthylfenoterol for the treatment of brain, liver
and colon carcinomas. For collaboration opportunities, please contact
Nicole Guyton, Ph.D. at darackn@mail.nih.gov.
High-Affinity Mouse Monoclonal Antibodies to Glypican-3 (GPC3) for
Research Use
Description of Technology: Liver cancer is the fifth most common
cancer in the world, with hepatocellular cancer (HCC) representing the
preponderance of these liver cancers. As with many cancers, positive
prognosis for a patient diagnosed with HCC correlates with the early
detection of the disease. Unfortunately, HCC is usually detected at a
late stage in its development, leading to poor prognosis for most
patients. As a result, there is great interest and value in developing
new agents which can detect the presence of HCC in a patient at an
early stage.
Glypican-3 (GPC3) is a cell surface heparan sulfate glycoprotein
that is expressed on the vast majority of HCC cells. The correlation
between GPC3 expression and HCC makes GPC3 an attractive candidate for
studying the disease progression and treatment of HCC. The presence,
progression and treatment of this disease can potentially be monitored
by tracking the level of expression of GPC3 on cells. This can be
accomplished using monoclonal antibodies which recognize only GPC3,
particularly the cell surface domain of the protein. This invention
concerns the generation of several monoclonal antibodies that are
specific for the cell surface domain of GPC3 (YP6, YP7, YP8, YP9 and
YP9.1), and which can be used as research reagents for studying the
role of GPC3 in HCC.
Potential Commercial Applications: Antibodies for use as research
materials, including:
Detection of cells that express GPC3 for monitoring HCC
disease progression and treatment.
Immunostaining for tumor imaging.
ELISA and immunohistochemistry applications.
Any other antibody-related research use, including
immunoprecipitation, western blot analysis, etc.
Competitive Advantages:
Higher binding affinity (subnanomolar levels) than
commercially available GPC3 antibodies such as 1G12.
Recognition of cells with low levels of GPC3 expression.
Able to bind to wild-type GPC3 (conjugated to heparan
sulfate) better than the GPC3 core protein (lacking heparan sulfate).
Development Stage:
Early-stage.
In vitro data available.
Inventors: Mitchell Ho et al. (NCI).
Publications:
1. Ho M, Kim H. Glypican-3: a new target for cancer immunotherapy.
Eur J Cancer. 2011 Feb; 47(3):333-338. [PMID 21112773]
2. Ho M. Advances in liver cancer antibody therapies: a focus on
glypican-3 and mesothelin. BioDrugs. 2011 Oct 1; 25(5):275-284. [PMID
21942912]
Intellectual Property: HHS Reference No. E-136-2012/0--U.S.
Provisional Application No. 61/654,232 filed 01 Jun 2012.
Related Technology: HHS Reference No. E-130-2011/0 -- U.S.
Provisional Application No. 61/477,020 filed 19 Apr 2011; PCT
Application No. PCT/US2012/034186 filed 19 Apr 2012.
Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632;
lambertsond@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
cancer diagnostics, isolation of circulating tumor cells, humanization
and/or immunoconjugates. For collaboration opportunities, please
contact John Hewes, Ph.D. at hewesj@mail.nih.gov.
Self-Assembled Ferritin Nanoparticles Expressing Hemagglutinin as an
Influenza Vaccine
Description of Technology: NIH inventors at the Vaccine Research
Center have developed a novel influenza virus hemagglutinin (HA)-
ferritin nanoparticle influenza vaccine that is easily manufactured,
potent, and elicits broadly neutralizing influenza antibodies against
multiple strains of influenza. This novel influenza nanoparticle
vaccine elicited two types of broadly neutralizing, cross-protective
antibodies, one directed to the highly conserved HA stem and a second
proximal to the conserved receptor binding site (RBS) of the viral HA,
providing a new platform for universal and seasonal influenza. In
addition, HA-ferritin nanoparticles can be easily produced from simple
expression vectors and without the production of infectious virus in
eggs, and will facilitate influenza preparedness in the face of
emerging epidemics.
This technology exploits ferritin, a ubiquitous iron storage
protein, that self-assembles into spherical nanoparticles and could
serve as a scaffold to express a heterologous protein, such as
influenza HA, so it mimics a physiologically relevant trimeric viral
spike. Immunization with the HA-ferritin nanoparticle elicited
neutralizing antibody titers that were >10-fold higher than a matched
inactivated vaccine. The immune sera raised by HA-ferritin
nanoparticles
[[Page 43603]]
expressing a 1999 HA neutralized seasonal H1N1 viruses from 1934 to
2007 and protected ferrets from an unmatched 2007 H1N1 virus challenge.
This extended neutralization coverage is partially explained by the
presence of both type of antibodies, antibodies directed to the
conserved HA stem and against the RBS region. Finally, this ferritin
nanoparticle vaccine platform has significant advantages in the ability
to utilize specific multimerized spikes and it may be applicable to
other viral proteins.
Potential Commercial Applications: The ferritin nanoparticles as a
vaccine platform can be used to deliver vaccines, such as influenza
vaccines, with enhanced magnitude and breadth of the neutralizing
antibody responses. This vaccine platform may be applicable to other
viral proteins.
Competitive Advantages:
Forms an octahedron consisting of 24 subunits, allowing
for greatly increased presentation of heterologous protein on the
ferritin nanoparticles surface, compared to other vaccine platforms.
In vivo data in multiple animal models demonstrated
induction of broader and more potent antibody responses.
Vaccine stimulated broadly neutralizing antibodies against
the highly conserved epitope on the HA stem region and against the RBS,
thus targeting two independent sites of vulnerability on HA.
Multivalent influenza HA ferritin vaccines have been
tested in animal models.
Ferritin is extremely stable to temperature ranges, pH,
detergent and other factors.
Easily manufactured, will facilitate influenza
preparedness in the face of emerging epidemics.
Development Status:
Preclinical.
In vitro data available.
In vivo data available (animal).
Inventors: Gary Nabel, Masaru Kanekiyo, Jeffrey C. Boyington,
Patrick McTamney (all of NIAID).
Publication: Kanekiyo M, et al. A Self-Assembling Influenza
Nanoparticle Vaccine Elicits Two Types of Broadly Neutralizing and
Cross-protective Antibodies. Manuscript submitted.
Intellectual Property:
HHS Reference No. E-293-2011/0 -- U.S. Provisional
Application No. 61/538,663 filed 23 Sep 2011.
HHS Reference No. E-293-2011/1 -- U.S. Provisional
Application No. 61/661,209 filed 18 Jun 2012.
Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-
435-4507; ThalhamC@mail.nih.gov.
Salen-Manganese Compounds for Therapy of Viral Infections
Description of Technology: Salen-manganese compounds are synthetic,
stable, low toxicity, low cost agents that may provide protection from
immune reaction-related oxidative cell damage associated with many
illnesses. In particular, oxidative cell damage has been associated
with many viral infections including influenza. This invention
demonstrates that treating mice with salen-manganese compounds, after
lethal pandemic influenza virus infection, significantly enhances
survival. Salen-manganese treatment also reduces lung pathology and
also improved cellular recovery and repair. Because oxidative damage is
observed in many viral infections, administration of salen-manganese
compounds may have therapeutic relevance to a wide range of viral
infections, in addition influenza. Existing viral therapeutics merely
target the infectious viral agent and not the damage caused by the
immune system reaction related to infection. Because, salen-manganese
treatments target the untapped therapeutic space of infection-induced,
immune system-related pathology and have favorable safety and cost
profiles, such therapies are ideal candidates for development.
Potential Commercial Applications: Viral therapeutics.
Competitive Advantages: Synthetic, stable, low toxicity, low cost,
untapped therapeutic target space.
Development Stage:
Early-stage.
Pre-clinical.
In vivo data available (animal).
Inventors: John Kash (NIAID), Jeffrey Taubenberger (NIAID), Rodney
Levine (NHLBI), Susan Doctrow (Boston University).
Publications:
1. Doctrow SR, et al. Salen Manganese Complexes: Multifunctional
Catalytic Antioxidants Protective in Models for Neurodegenerative
Diseases of Aging. In: Medicinal Inorganic Chemistry, ACS Symposium
Series, Vol. 903, Chapter 18, pp 319-347; August 25, 2005. [DOI:
10.1021/bk-2005-0903.ch018.]
2. Schwarz KB. Oxidative stress during viral infection: a review.
Free Radic Biol Med. 1996; 21(5):641-9. [PMID 8891667]
Intellectual Property: HHS Reference No. E-281-2011/0--U.S.
Provisional Application No. 61/558,137 filed 10 Nov 2011.
Licensing Contact: Tedd Fenn, J.D.; 301-435-5031;
Tedd.Fenn@nih.gov.
Collaborative Research Opportunity: The NIAID Laboratory of
Infectious Diseases, Viral Pathogenesis and Evolution Section, is
seeking statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize
this technology. For collaboration opportunities, please contact
Maryann Puglielli at 301-594-6656.
Dated: July 18, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-18054 Filed 7-24-12; 8:45 am]
BILLING CODE 4140-01-P
