Government-Owned Inventions; Availability for Licensing, 35756-35758 [2014-14650]
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Federal Register / Vol. 79, No. 121 / Tuesday, June 24, 2014 / Notices
pharmacologically active small
molecules sensitized cisplatin-resistant
non-small cell lung cancer (NSCLC)
cells to DNA crosslinking agent(77).
Thus, USP1 inhibitors hold promise in
combination therapy with the existing
anti-cancer drugs to improve the
efficacy and lower the toxic effect of the
existing drugs.
More recently we have developed
small molecules that target the USP1/
UAF1 DUB complex(1). These
compounds were identified via a highthroughput screen and subjected to
medicinal chemistry optimization,
leading to one of the most potent and
selective DUB inhibitors reported to
date. Moreover, the inhibitors act
synergistically with cisplatin, a DNA
damaging anti-cancer drug, to overcome
chemoresistance and enhance
cytotoxicity. These results suggest the
inhibitors may also improve the efficacy
and potency of other commonly
prescribed chemotherapeutic agents that
are known to induce DNA damage.
Furthermore the USP1/UAF1 small
molecule inhibitors also hold promise
in the single-agent therapy.
Under the CRADA, the chemical
series will be further characterized and
optimized to address specific aspects of
this target product profile. The CRADA
scope will also include studies beyond
candidate selection including all aspects
of preclinical studies such as toxicity
studies, xenograft studies and chemistry
GMP scale up of selected compounds
and manufacture of control leading to a
successful investigational new drug
(IND) application. Collaborators should
have experience in pre-clinical
development of small molecules with a
focus on cancer and a track record of
successful submission of IND
applications to the FDA.
The full CRADA proposal should
include a capability statement with a
detailed description of (1) collaborator’s
expertise in the areas of modulation of
small molecule physicochemical and
pharmacokinetic properties; (2)
expertise in formulation of small
molecules and ability to manufacture
sufficient quantities of chemical
compounds according to FDA
guidelines and under Good
Manufacturing Practice (GMP); (3)
expertise with oncology and/or other
diseases which may benefit from USP1/
UAF1 inhibition; (4) expertise in
regulatory affairs, particularly at the IND
filing and early clinical trial stages; (5)
collaborator’s ability to support, directly
or through contract mechanisms, and
ability, upon the successful completion
of relevant milestones, to support the
ongoing pharmacokinetics and
biological studies, long term toxicity
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studies, process chemistry and other
pre-clinical development studies
needed to obtain regulatory approval of
a given molecule so as to ensure a high
probability of eventual successful
commercialization; (6) collaborator’s
ability to provide adequate funding to
support some of the project’s preclinical studies.
Publications
1. Liang, Q., Dexheimer, T. S., Zhang, P.,
Rosenthal, A. S., Villamil, M. A., You, C.,
Zhang, Q., Chen, J., Ott, C. A., Sun, H.,
Luci, D. K., Yuan, B., Simeonov, A.,
Jadhav, A., Xiao, H., Wang, Y., Maloney,
D. J., and Zhuang, Z. (2014) A selective
USP1–UAF1 inhibitor links
deubiquitination to DNA damage
responses, Nature chemical biology 10,
298–304.
2. Singhal, S., Taylor, M. C., and Baker, R.
T. (2008) Deubiquitylating enzymes and
disease, BMC Biochem 9 Suppl 1, S3.
3. Reyes-Turcu, F. E., Ventii, K. H., and
Wilkinson, K. D. (2009) Regulation and
cellular roles of ubiquitin-specific
deubiquitinating enzymes, Annu Rev
Biochem 78, 363–397.
4. Hussain, S., Zhang, Y., and Galardy, P. J.
(2009) DUBs and cancer: the role of
deubiquitinating enzymes as oncogenes,
non-oncogenes and tumor suppressors,
Cell Cycle 8, 1688–1697.
5. Oestergaard, V. H., Langevin, F., Kuiken,
H. J., Pace, P., Niedzwiedz, W., Simpson,
L. J., Ohzeki, M., Takata, M., Sale, J. E.,
and Patel, K. J. (2007) Deubiquitination
of FANCD2 is required for DNA
crosslink repair, Mol Cell 28, 798–809.
6. Kim, J. M., Parmar, K., Huang, M.,
Weinstock, D. M., Ruit, C. A., Kutok, J.
L., and D’Andrea, A. D. (2009)
Inactivation of murine Usp1 results in
genomic instability and a Fanconi
anemia phenotype, Dev Cell 16, 314–320.
7. Chen, J., Dexheimer, T. S., Ai, Y., Liang,
Q., Villamil, M. A., Inglese, J., Maloney,
D. J., Jadhav, A., Simeonov, A., and
Zhuang, Z. (2011) Selective and CellActive Inhibitors of the USP1/UAF1
Deubiquitinase Complex Reverse
Cisplatin Resistance in Non-small Cell
Lung Cancer Cells, Chemistry & biology
18, 1390–1400.
Patent Status
US Provisional Patent Application No.
61/747,052 entitled ‘‘Inhibitors of the
USP/UAF1 Deubiquitinase Complexes
and Uses Thereof’’ filed December 28,
2012; Inventors: Thomas Dexheimer
(NCATS), Ajit Jadhav (NCATS), Qin
Liang (University of Delaware), David
Maloney (NCATS), Andrew Rosenthal
(NCATS), Anton Simeonov (NCATS),
Zhihao Zhuang (University of
Delaware) NIH Ref. No.: E–043–2013/
0–US–01.
PCT Application No. PCT/US2013/
077804 entitled, ‘‘Inhibitors of the
USP/UAF1 Deubiquitinase Complexes
and Uses Thereof’’ filed December 26,
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2013 Inventors: Thomas Dexheimer
(NCATS), Ajit Jadhav (NCATS), Qin
Liang (University of Delaware), Diane
Luci (NCATS), David Maloney
(NCATS), Andrew Rosenthal
(NCATS), Anton Simeonov (NCATS),
Zhihao Zhuang (University of
Delaware) NIH Ref. No.: E–043–2013/
0–PCT–02.
Dated: June 12, 2014.
Christopher P. Austin,
Director, National Center for Advancing
Translational Sciences, National Institutes of
Health.
[FR Doc. 2014–14719 Filed 6–23–14; 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.
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.
SUMMARY:
AMA1–RON2 Complex-Based Vaccine
Against Malaria
Description of Technology: This
technology relates to a malaria vaccine
composed of a protein complex of
Apical Membrane Antigen (AMA1) and
rhoptry neck protein 2 (RON2) with an
adjuvant. AMA1 is a crucial component
of the Plasmodium invasion machinery
and is a leading candidate for
antimalarial vaccine development.
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AMA1-based vaccines have shown
ability to block red cell invasion in in
vitro assays, but protection has so far
not translated to in vivo human
infections. NIAID investigators have
demonstrated that interaction between
AMA1 and RON2 (or peptide thereof) is
essential for malaria parasites to
successfully enter human red blood
cells (RBCs). Vaccination with uncomplexed AMA1 and RON2 did not
protect against lethal malaria. However,
vaccination with a pre-formed AMA1–
RON2 complex, highlighted in this
technology, produced antibodies that
protected against lethal malaria in an in
vivo mouse model (P. yoelli) and
blocked the entry of human malaria
parasites into RBCs in vitro.
Additionally, the inhibitory antibody
response induced by the AMA1–RON2
complex was greater than AMA1 alone
or when AMA1 and RON2 proteins
were administered in a un-complexed
form.
Immunization using the AMA1–RON2
complex of this technology represents a
candidate for an effective malaria
vaccine against multiple Plasmodium
species.
Potential Commercial Applications:
Malaria vaccine.
Competitive Advantages: Lower-cost
malarial prevention for developing/
developed countries.
Development Stage:
• Early-stage.
• In vitro data available.
• In vivo data available (animal).
Inventors: Prakash Srinivasan and
Louis Miller (NIAID).
Publications:
1. Srinivasan P, et al. Binding of
Plasmodium merozoite proteins RON2
and AMA1 triggers commitment to
invasion. Proc Natl Acad Sci U S A.
2011 Aug 9;108(32):13275–80. [PMID
21788485].
2. Srinivasan P, et al. Disrupting
malaria parasite AMA1–RON2
interaction with a small molecule
prevents erythrocyte invasion. Nat
Commun. 2013;4:2261. [PMID
23907321].
Intellectual Property: HHS Reference
No. E–066–2013/0—U.S. Provisional
Application No. 61/841,479 filed 01 Jul
2013.
Licensing Contact: Edward (Tedd)
Fenn; 424–297–0336;
Tedd.fenn@nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize MA1–RON2 vaccine by
providing well established human
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adjuvants and clinical trial funding. For
collaboration opportunities, please
contact Mala Dutta, Ph.D. at 240–627–
3684 or mala.dutta@nih.gov.
A Novel Therapeutic Technology for
Treating Glioblastoma Multiforme and
Other Cancers
Description of Technology:
Glioblastoma Multiforme (GBM) is the
most common and devastating form of
brain cancer. Despite existing
conventional therapies, including an
initial surgical resection followed by
chemotherapy and radiation, GBM is
currently incurable with a median
survival of approximate 15 months and
a two-year survival of 30%.
This invention discloses a novel
therapeutic technology to treat GBM by
using induced electric fields that are
applied to the brain tissue via an array
of coils placed over the scalp. The
device of the invention consists of a
portable current generator with a
customized coil array. It has been
shown to reduce pain for patients and
be easy to use.
Potential Commercial Applications:
• Treatment of patients with
Glioblastoma Multiforme (GBM).
• Clinical research device for
Glioblastoma Multiforme.
• Possible application to other
cancers.
• Research tool to study mechanisms
of electric field effects on mitosis and
other cell and tissue processes.
• May be useful in improving
effectiveness and enhancing delivery of
adjuvant therapies.
Competitive Advantages:
• Portable.
• Painless.
• Easy to operate.
• No scalp burns that occur when
using current electrodes.
Development Stage:
• Early-stage.
• Prototype.
Inventor: Peter J. Basser (NICHD).
Publications:
1. Silva S, et al. Elucidating the
mechanisms and loci of neuronal
excitation by transcranial magnetic
stimulation using a finite element model
of a cortical sulcus. Clin Neurophysiol.
2008 Oct;119(10):2405–13. [PMID
18783986].
2. Salvador R, el al. Determining
which mechanisms lead to activation in
the motor cortex: A modeling study of
transcranial magnetic stimulation using
realistic stimulus waveforms and sulcal
geometry. Clin Neurophysiol. 2011
Apr;122(4):748–58. [PMID 21035390].
3. Miranda PC, et al. Tissue
heterogeneity as a mechanism for
localized neural stimulation by applied
PO 00000
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electric fields. Phys Med Biol. 2007 Sep
21;52(18):5603–17. [PMID 17804884].
4. Miranda PC, et al. The electric field
induced in the brain by magnetic
stimulation: A 3–D finite-element
analysis of the effect of tissue
heterogeneity and anisotropy. IEEE
Trans Biomed Eng. 2003
Sep;50(9):1074–85. [PMID 12943275].
5. Basser PJ. Focal magnetic
stimulation of an axon. IEEE Trans
Biomed Eng. 1994 Jun;41(6):601–6.
[PMID 7927380]
6. Miranda PC, et al. Modeling the
current distribution during transcranial
direct current stimulation. Clin
Neurophysiol. 2006 Jul;117(7):1623–9.
[PMID 16762592].
Intellectual Property: HHS Reference
No. E–187–2012/0—US Patent
Application No. 61/954,494 filed 17
March 2014.
Licensing Contact: John Stansberry,
Ph.D.; 301–435–5236;
stansbej@mail.nih.gov.
Collaborative Research Opportunity:
The Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, Program on Pediatric
Imaging and Tissue Sciences, Section on
Tissue Biophysics and Biomimetics, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate or commercialize
technology that uses a.c. current
electrodes to try to kill GBM cells. For
collaboration opportunities, please
contact Alan Hubbs, Ph.D. at
hubbsa@mail.nih.gov.
Broadly Neutralizing Human Anti-HIV
Monoclonal Antibody 10E8 and Related
Antibodies Capable of Neutralizing
Most HIV–1 Strains
Description of Technology: The uses
for human anti-HIV monoclonal
antibody 10E8 and its variants include
passive immunization, therapeutic
vaccination, and the development of
vaccine immunogens. 10E8 is one of the
most potent HIV-neutralizing antibodies
isolated and it neutralizes up to 98% of
diverse HIV–1 strains. 10E8 is specific
to the membrane-proximal external
region (MPER) of the HIV envelope
protein gp41 and 10E8 is orthogonal to
other anti-HIV antibodies. In
combination with other antibodies 10E8
may provide an antibody response that
neutralizes nearly all strains of HIV–1.
Additionally, 10E8 effectively induces
antibody-dependent cellular
cytotoxicity (ADCC) indicating its
potential use for therapeutic vaccine
strategies. Further, 10E8 is a tool for
immunogen design and validation of
immunogen structure.
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NIAID is currently developing certain
embodiments of 10E8 for clinical use.
Therefore, for some fields of use, NIH
will evaluate a license applicant’s
capabilities and experience in
advancing similar technologies through
the regulatory process. This technology
is not eligible for the NIH’s start-up
license program.
Potential Commercial Applications:
• Passive protection to prevent HIV
infection.
• Passive protection to prevent
mother-to-infant HIV transmission.
• Topical microbicide to prevent HIV
infection.
• Gene-based vectors for anti-gp41
antibody expression.
• Therapeutic for the elimination of
HIV infected cells that are actively
producing virus.
Competitive Advantages:
• One of the most potent Human
broadly-neutralizing anti HIV antibodies
isolated to date.
• Broad reactivity and high affinity to
most HIV–1 strains.
• Activity is highly complementary to
existing broadly neutralizing antibodies,
such as CD4 binding site antibodies.
• Not auto-reactive.
Development Stage:
• In vitro data available.
• In vivo data available (animal).
Inventors: Mark Connors, Jinghe
Huang, Leo Laub, John Mascola, Gary
Nabel, Peter Kwong, Baoshan Zhang,
Rebecca Rudicell, Ivelin Geogiev,
Yongping Yang, Jiang Zhu, and Giled
Oflek.
Publication: Huang J, et al. Broad and
potent neutralization of HIV–1 by a
gp41-specific human antibody. Nature.
2012 Nov 15;491(7424):406–12. [PMID
23151583].
Intellectual Property: HHS Reference
Nos. E–253–2011/0,1,2,3—Neutralizing
gp41 antibodies and their use.
• US Provisional Patent Application
Nos. 61/556,660 filed 07 Nov 2011; 61/
672,708 filed 17 Jul 2012; and 61/
698,480 filed 07 Sep 2012.
• PCT Patent Application No. PCT/
US2012/063958 (Publication No. WO/
2013/070776) filed 07 Nov 2012; and
corresponding applications filed in BR,
CN, EP, IN, RU, US, and ZA.
Licensing Contact: Cristina
Thalhammer-Reyero, Ph.D., MBA; +1
301–435–4507; thalhamc@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize 10E8-related vaccines or
immunotherapies. For collaboration
opportunities, please contact Bill
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Ronnenberg at +1 240–627–3726 or
wronnenberg@niaid.nih.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 18, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
National Institutes of Health
[FR Doc. 2014–14650 Filed 6–23–14; 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 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 Brain
Imaging in Alzheimer’s Disease.
Date: June 27, 2014.
Time: 11:00 a.m. to 12:00 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: Samuel C Edwards, Ph.D.,
IRG CHIEF, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5210, MSC 7846, Bethesda, MD
20892, (301) 435–1246,
edwardss@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.
(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: June 18, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–14646 Filed 6–23–14; 8:45 am]
BILLING CODE 4140–01–P
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National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
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 of
Arthritis and Musculoskeletal and Skin
Diseases, Special Emphasis Panel, NIAMS
Clinical Study Applications.
Date: July 16, 2014.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Democracy Boulevard, Suite 800, Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: Helen Lin, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute of Arthritis,
Musculoskeletal and Skin Diseases, NIH,
6701 Democracy Boulevard, Suite 800,
Bethesda, MD 20892, 301–594–4952,
linh1@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: June 18, 2014.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–14647 Filed 6–23–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; 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
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]]>Agencies
[Federal Register Volume 79, Number 121 (Tuesday, June 24, 2014)]
[Notices]
[Pages 35756-35758]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14650]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, 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. 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.
AMA1-RON2 Complex-Based Vaccine Against Malaria
Description of Technology: This technology relates to a malaria
vaccine composed of a protein complex of Apical Membrane Antigen (AMA1)
and rhoptry neck protein 2 (RON2) with an adjuvant. AMA1 is a crucial
component of the Plasmodium invasion machinery and is a leading
candidate for antimalarial vaccine development.
[[Page 35757]]
AMA1-based vaccines have shown ability to block red cell invasion in in
vitro assays, but protection has so far not translated to in vivo human
infections. NIAID investigators have demonstrated that interaction
between AMA1 and RON2 (or peptide thereof) is essential for malaria
parasites to successfully enter human red blood cells (RBCs).
Vaccination with un-complexed AMA1 and RON2 did not protect against
lethal malaria. However, vaccination with a pre-formed AMA1-RON2
complex, highlighted in this technology, produced antibodies that
protected against lethal malaria in an in vivo mouse model (P. yoelli)
and blocked the entry of human malaria parasites into RBCs in vitro.
Additionally, the inhibitory antibody response induced by the AMA1-RON2
complex was greater than AMA1 alone or when AMA1 and RON2 proteins were
administered in a un-complexed form.
Immunization using the AMA1-RON2 complex of this technology
represents a candidate for an effective malaria vaccine against
multiple Plasmodium species.
Potential Commercial Applications: Malaria vaccine.
Competitive Advantages: Lower-cost malarial prevention for
developing/developed countries.
Development Stage:
Early-stage.
In vitro data available.
In vivo data available (animal).
Inventors: Prakash Srinivasan and Louis Miller (NIAID).
Publications:
1. Srinivasan P, et al. Binding of Plasmodium merozoite proteins
RON2 and AMA1 triggers commitment to invasion. Proc Natl Acad Sci U S
A. 2011 Aug 9;108(32):13275-80. [PMID 21788485].
2. Srinivasan P, et al. Disrupting malaria parasite AMA1-RON2
interaction with a small molecule prevents erythrocyte invasion. Nat
Commun. 2013;4:2261. [PMID 23907321].
Intellectual Property: HHS Reference No. E-066-2013/0--U.S.
Provisional Application No. 61/841,479 filed 01 Jul 2013.
Licensing Contact: Edward (Tedd) Fenn; 424-297-0336;
Tedd.fenn@nih.gov.
Collaborative Research Opportunity: The National Institute of
Allergy and Infectious Diseases is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize MA1-RON2 vaccine by providing well
established human adjuvants and clinical trial funding. For
collaboration opportunities, please contact Mala Dutta, Ph.D. at 240-
627-3684 or mala.dutta@nih.gov.
A Novel Therapeutic Technology for Treating Glioblastoma Multiforme and
Other Cancers
Description of Technology: Glioblastoma Multiforme (GBM) is the
most common and devastating form of brain cancer. Despite existing
conventional therapies, including an initial surgical resection
followed by chemotherapy and radiation, GBM is currently incurable with
a median survival of approximate 15 months and a two-year survival of
30%.
This invention discloses a novel therapeutic technology to treat
GBM by using induced electric fields that are applied to the brain
tissue via an array of coils placed over the scalp. The device of the
invention consists of a portable current generator with a customized
coil array. It has been shown to reduce pain for patients and be easy
to use.
Potential Commercial Applications:
Treatment of patients with Glioblastoma Multiforme (GBM).
Clinical research device for Glioblastoma Multiforme.
Possible application to other cancers.
Research tool to study mechanisms of electric field
effects on mitosis and other cell and tissue processes.
May be useful in improving effectiveness and enhancing
delivery of adjuvant therapies.
Competitive Advantages:
Portable.
Painless.
Easy to operate.
No scalp burns that occur when using current electrodes.
Development Stage:
Early-stage.
Prototype.
Inventor: Peter J. Basser (NICHD).
Publications:
1. Silva S, et al. Elucidating the mechanisms and loci of neuronal
excitation by transcranial magnetic stimulation using a finite element
model of a cortical sulcus. Clin Neurophysiol. 2008 Oct;119(10):2405-
13. [PMID 18783986].
2. Salvador R, el al. Determining which mechanisms lead to
activation in the motor cortex: A modeling study of transcranial
magnetic stimulation using realistic stimulus waveforms and sulcal
geometry. Clin Neurophysiol. 2011 Apr;122(4):748-58. [PMID 21035390].
3. Miranda PC, et al. Tissue heterogeneity as a mechanism for
localized neural stimulation by applied electric fields. Phys Med Biol.
2007 Sep 21;52(18):5603-17. [PMID 17804884].
4. Miranda PC, et al. The electric field induced in the brain by
magnetic stimulation: A 3-D finite-element analysis of the effect of
tissue heterogeneity and anisotropy. IEEE Trans Biomed Eng. 2003
Sep;50(9):1074-85. [PMID 12943275].
5. Basser PJ. Focal magnetic stimulation of an axon. IEEE Trans
Biomed Eng. 1994 Jun;41(6):601-6. [PMID 7927380]
6. Miranda PC, et al. Modeling the current distribution during
transcranial direct current stimulation. Clin Neurophysiol. 2006
Jul;117(7):1623-9. [PMID 16762592].
Intellectual Property: HHS Reference No. E-187-2012/0--US Patent
Application No. 61/954,494 filed 17 March 2014.
Licensing Contact: John Stansberry, Ph.D.; 301-435-5236;
stansbej@mail.nih.gov.
Collaborative Research Opportunity: The Eunice Kennedy Shriver
National Institute of Child Health and Human Development, Program on
Pediatric Imaging and Tissue Sciences, Section on Tissue Biophysics and
Biomimetics, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize technology that uses a.c. current electrodes
to try to kill GBM cells. For collaboration opportunities, please
contact Alan Hubbs, Ph.D. at hubbsa@mail.nih.gov.
Broadly Neutralizing Human Anti-HIV Monoclonal Antibody 10E8 and
Related Antibodies Capable of Neutralizing Most HIV-1 Strains
Description of Technology: The uses for human anti-HIV monoclonal
antibody 10E8 and its variants include passive immunization,
therapeutic vaccination, and the development of vaccine immunogens.
10E8 is one of the most potent HIV-neutralizing antibodies isolated and
it neutralizes up to 98% of diverse HIV-1 strains. 10E8 is specific to
the membrane-proximal external region (MPER) of the HIV envelope
protein gp41 and 10E8 is orthogonal to other anti-HIV antibodies. In
combination with other antibodies 10E8 may provide an antibody response
that neutralizes nearly all strains of HIV-1. Additionally, 10E8
effectively induces antibody-dependent cellular cytotoxicity (ADCC)
indicating its potential use for therapeutic vaccine strategies.
Further, 10E8 is a tool for immunogen design and validation of
immunogen structure.
[[Page 35758]]
NIAID is currently developing certain embodiments of 10E8 for
clinical use. Therefore, for some fields of use, NIH will evaluate a
license applicant's capabilities and experience in advancing similar
technologies through the regulatory process. This technology is not
eligible for the NIH's start-up license program.
Potential Commercial Applications:
Passive protection to prevent HIV infection.
Passive protection to prevent mother-to-infant HIV
transmission.
Topical microbicide to prevent HIV infection.
Gene-based vectors for anti-gp41 antibody expression.
Therapeutic for the elimination of HIV infected cells that
are actively producing virus.
Competitive Advantages:
One of the most potent Human broadly-neutralizing anti HIV
antibodies isolated to date.
Broad reactivity and high affinity to most HIV-1 strains.
Activity is highly complementary to existing broadly
neutralizing antibodies, such as CD4 binding site antibodies.
Not auto-reactive.
Development Stage:
In vitro data available.
In vivo data available (animal).
Inventors: Mark Connors, Jinghe Huang, Leo Laub, John Mascola, Gary
Nabel, Peter Kwong, Baoshan Zhang, Rebecca Rudicell, Ivelin Geogiev,
Yongping Yang, Jiang Zhu, and Giled Oflek.
Publication: Huang J, et al. Broad and potent neutralization of
HIV-1 by a gp41-specific human antibody. Nature. 2012 Nov
15;491(7424):406-12. [PMID 23151583].
Intellectual Property: HHS Reference Nos. E-253-2011/0,1,2,3--
Neutralizing gp41 antibodies and their use.
US Provisional Patent Application Nos. 61/556,660 filed 07
Nov 2011; 61/672,708 filed 17 Jul 2012; and 61/698,480 filed 07 Sep
2012.
PCT Patent Application No. PCT/US2012/063958 (Publication
No. WO/2013/070776) filed 07 Nov 2012; and corresponding applications
filed in BR, CN, EP, IN, RU, US, and ZA.
Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., MBA; +1 301-
435-4507; thalhamc@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Allergy and Infectious Diseases is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize 10E8-related vaccines or
immunotherapies. For collaboration opportunities, please contact Bill
Ronnenberg at +1 240-627-3726 or wronnenberg@niaid.nih.gov.
Dated: June 18, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-14650 Filed 6-23-14; 8:45 am]
BILLING CODE 4140-01-P
