Government-Owned Inventions; Availability for Licensing, 2110-2112 [2015-00535]
Download as PDF
2110
Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; The NIH/NCATS
GRDRSM Program: Global Rare
Diseases Patient Registry Data
Repository (GRDR)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on July 17, 2014,
page 44185 and allowed 60-days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Center for Advancing Translational
Sciences (NCATS), National Institutes of
Health, may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
SUMMARY:
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project
contact: Dr. Yaffa Rubinstein, Director of
Patient Resources for Clinical and
Translational Research at the Office of
Rare Diseases Research (ORDR),
NCATS, NIH, Suite 1004, 6701
Democracy Boulevard, Bethesda, MD
20892–4874, or call non-toll-free
number (301) 402–4338 or Email your
request, including your address to:
yaffa.rubinstein@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: NIH/NCATS
GRDRSM Program: Global Rare Diseases
Patient Registry Data (GRDR), The
National Center for Advancing
Translational Sciences (NCATS),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The NIH created the GRDR
program https://grdr.ncats.nih.gov an
informatics system and central data
repository, housed at the NCATS/NIH
Center to support and accelerate
research in the cause, diagnosis, and
treatment of rare diseases. The GRDR
program collects a wide range of data
types, including phenotypic and clinical
information, as well as medical images,
derived from individuals who
participate in rare disease patient
registries, regardless of the source of
funding. The GRDR program provides
the infrastructure to store, search across,
retrieve, and analyze these varied types
of data. This valuable information will
help NIH understand and evaluate the
use of repositories/datasets in the
research community. The GRDR
program will support: (1) Mapping data
to standards; (2) increased visibility for
participating registries; (3) opportunity
for cross-disease research; (4) better and
faster rare disease clinical research.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
334.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Type of
respondent
Request for Open access ..................................
Request for Controlled access ..........................
Request to Submit .............................................
Individuals ........................
Individuals ........................
Individuals ........................
Dated: January 9, 2015.
Pamela McInnes,
Deputy Director, NCATS, NIH.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
National Institutes of Health
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–00554 Filed 1–14–15; 8:45 am]
rljohnson on DSK3VPTVN1PROD with NOTICES
BILLING CODE 4140–01–P
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
SUMMARY:
VerDate Sep<11>2014
14:13 Jan 14, 2015
Jkt 235001
Number of
respondents
2000
1000
100
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
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
1
Average
burden
per response
(in hours)
Total annual
burden hours
2/60
15/60
10/60
67
250
17
be required to receive copies of the
patent applications.
SUPPLEMENTARY INFORMATION:
Technology descriptions follow.
Highly Sensitive Tethered-Bead
Immune Sandwich Assay
Description of Technology: This
technology is a highly sensitive
tethered-bead immune sandwich assay.
Analyte molecules are captured between
two antibodies, a capture antibody and
a detection antibody. The capture
antibody on a micron-size bead binds
analyte from a sample fluid. The beadcaptured analyte is then exposed to a
‘‘detection’’ antibody that binds to the
bead-captured analyte, forming a
‘‘sandwich’’. The sandwiched analytebead complex then connects to a
flexible polymer (such as DNA)
E:\FR\FM\15JAN1.SGM
15JAN1
Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Notices
rljohnson on DSK3VPTVN1PROD with NOTICES
anchored on a solid surface to form
tethered particles. Binding the analytebead complex to a flexible polymer
forms tethered particles and may be
done, for example, by streptavidin
biotin. Motion of the tethered beads
easily identifies bound analyte. The
tethered beads are quantified using lowmagnification light microscopy. Prior
enhanced sensitivity tethered bead
technologies require expensive and
cumbersome detection equipment. This
assay is inherently single molecule, low
background, and works with simple
inexpensive imaging formats, but is
automatable and potentially adaptable
to portable technologies. A prototype
design using prostate specific antigen
(PSA) shows detection sensitivity of
∼.03ng/ml, compared with normal PSA
sensitivity of ∼< 4ng/ml. Design
refinements further improve
sensitivities.
Potential Commercial Applications:
Diagnostics and research.
Competitive Advantages: Highly
sensitive single molecule adaptable
format, specific, low background,
inexpensive, simple to use, automatable
for image analysis.
Development Stage:
• Early-stage
• Prototype
Inventors: Jonathan Silver (NHLBI),
Zhenyu Li (George Washington Univ.),
Keir Neuman (NHLBI).
Publication: Silver J, et al. Tetheredbead, immune sandwich assay. Biosens
Bioelectron. 2015 Jan 15;63:117–23.
[PMID 25064819].
Intellectual Property: HHS Reference
No. E–188–2014/0—U.S. Provisional
Application No. 62/015,122 filed June
20, 2014.
Licensing Contact: Edward (Tedd)
Fenn; 424–297–0336; Tedd.fenn@
nih.gov.
Polyketal Nanoparticle Delivery of CpG
Oligodeoxynucleotide for Treatment of
Lung Cancer
Description of Technology: This
technology delivers
oligodexoynucleotide locally to lung
tumors using polyketal nanoparticles.
CpG ODNs (oligonucleotides with CpG
motifs) stimulate anti-tumor immune
cells via Toll-like receptor 9 and show
promise as cancer therapeutics in
preclinical and clinical trials. However,
previous systemic CpG ODN treatments
of lung tumors progressed only to Phase
3 trials. Local CpG ODN delivery
appears to have superior antitumor
effect compared to earlier systemic
treatments. Adsorbing CpG ODNs onto
biodegradable polyketal (CpG–NP)
creates 1–3 micron nanoparticles that
can reach distal alveoli by inhalation.
VerDate Sep<11>2014
14:13 Jan 14, 2015
Jkt 235001
This localized treatment improves
uptake and persistence in the tumor
microenvironment, resulting in
decreased immunosuppressive T-Cells
and increased macrophages. In vivo data
indicate this therapy reduces tumor
growth and enhances survival rate in
lung cancer. Mice treated with CpG–NP
had fewer and smaller tumor nodules
(reduced by >90%). In Lewis lung
carcinoma model, CpG–NP therapy
significantly improved the survival;
80% of CpG–NP-treated mice survived
(some for >1 yr). CpG–NP represents a
promising potential lung cancer
therapy.
Potential Commercial Applications:
Therapeutic or combination therapy for
lung cancer treatment.
Competitive Advantages:
• Superior therapeutic effect versus
systemic administration.
• CpG ODN treatments have well
studied safety profile in phase 1–3
clinical trials.
Development Stage: In vivo data
available (animal).
Inventors: Dennis Klinman and
Takashi Sato (NCI).
Publication: Klinman D, et al.
Synthetic oligonucleotides as
modulators of inflammation. J Leukoc
Biol. Oct 2008; 84(4): 958–64. [PMID
18430787].
Intellectual Property: HHS Reference
No. E–159–2014/0—U.S. Provisional
Application No. 62/024,657 filed July
15, 2014.
Licensing Contact: Edward (Tedd)
Fenn; 424–297–0336; Tedd.fenn@
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 optimizing delivery of
immunostimulatory CpG
oligonucleotides to patients with lung
cancer. For collaboration opportunities,
please contact John D. Hewes, Ph.D. at
john.hewes@nih.gov.
Aza-Englerin Analogues—Novel
Natural Product-Based NitrogenContaining Anti-Cancer Agents
Description of Technology: Available
for licensing are synthetic compounds
developed as novel cancer therapeutics.
Scientists at the National Institutes of
Health and University of Hawaii have
designed and synthesized novel azaenglerin analogues that have shown
great inhibitory effects on cancer cell
growth. Englerin A is a natural
compound from the African plant
Phyllanthus engleri that displays potent
and selective anti-cancer properties in
several cancer types and has been found
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
2111
to be active in several mouse xenograft
experiments with human tumor cells
when injected intraperitoneally. The
invention provides compositions,
methods of synthesis and methods of
using the aza-derivatives of englerin for
cancer treatment. These englerin
analogues show significant
bioavailability after oral administration
in mice, making them attractive as
cancer therapeutics.
Potential Commercial Applications:
Potential therapeutics for cancer,
particularly kidney cancer, Ewing’s
sarcoma, and other cancers with a
glycolytic phenotype. Potential in
diabetes and HIV infection.
Competitive Advantages:
• Novel compounds with great
inhibitory effect on select cancer cells,
designed/synthesized as analogues to
natural products that show striking anticancer properties.
• Parent compounds are effective in
in vivo cancer models.
• Novel syntheses of the compounds
of the invention are provided.
• Bioavailability after oral
administration in mouse model
demonstrated, making it suitable for
clinical usage.
Development Stage:
• Early-stage
• In vitro data available
• In vivo data available (animal)
Inventors: John A Beutler (NCI),
Douglas Figg (NCI), William Chain
(Univ. of Hawaii-Manoa).
Publications:
1. Ratnayake R, et al. Englerin A, a
selective inhibitor of renal cancer cell
growth, from Phyllanthus engleri. Org
Lett. 2009 Jan 1;11(1):57–60. [PMID
19061394].
2. Li Z, et al. A brief synthesis of
(-)-englerin A. J Am Chem Soc. 2011
May 4;133(17):6553–6. [PMID
21476574].
3. Akee R, et al. Chlorinated englerins
with selective inhibition of renal cancer
cell growth. J Nat Prod. 2012 Mar
23;75(3):459–63. [PMID 22280462].
4. Sourbier C, et al. Englerin A
stimulates PKC theta to inhibit insulin
signaling while simultaneously
activating HSF1: A case of
pharmacologically induced synthetic
lethality. Cancer Cell 23 (2):228–237,
2013. [PMID 23352416].
Intellectual Property:
• HHS Reference No. E–090–2014/
0—U.S. Provisional Patent Application
No. 61/936,285 filed February 5, 2014.
• HHS Reference No. E–090–2014/
1—U.S. Provisional Patent Application
No. 62/018,381 filed June 27, 2014.
Related Technologies:
• HHS Reference No. E–064–2008/2–
US–06—U.S. Patent No. 8,410,292
issued April 2, 2013.
E:\FR\FM\15JAN1.SGM
15JAN1
2112
Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Notices
rljohnson on DSK3VPTVN1PROD with NOTICES
• HHS Reference No. E–042–2012/0–
US–06—U.S. Patent Application No. 14/
370,140 filed July 1, 2014.
• HHS Reference No. E–201–2012/0–
PCT–02—PCT Application No. PCT/
US2013/069796 filed November 13,
2013, which published as WO 2014/
078350 on May 22, 2014.
Licensing Contact: Surekha Vathyam,
Ph.D.; 301–435–4076; vathyams@
mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute,
Molecular Targets Development
Program, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize aza-englerin analogues as
cancer inhibitors. For collaboration
opportunities, please contact John D.
Hewes, Ph.D. at john.hewes@nih.gov.
Nicotine Conjugate Treatment for
Parkinson’s Disease
Description of Technology: It has been
known since 1959 that tobacco use has
protective effects against Parkinson’s
disease. However, efforts to turn that
knowledge into a safe and effective
treatment, divorced from tobacco use,
have had little success. An inventor at
FDA now has in vitro evidence that
nicotine promotes a protein clearance
system, thereby halting Parkinson’s
disease progression. In addition to using
nicotine as the treatment, the inventor
has created a coated conjugate of
nicotine and nanoceria. This conjugate
not only harnesses the power of nicotine
but also takes advantage of the antioxidant effect of the nanoceria to reduce
the oxidant environment, which is also
a major mechanism of neuronal damage
in Parkinson’s disease.
Potential Commercial Applications:
Treatment for Parkinson’s disease.
Competitive Advantages: Improved
mechanism to use nicotine as a
treatment.
Development Stage:
• Early-stage
• In vitro data available
Inventor: Syed Z. Imam (FDA).
Intellectual Property: HHS Reference
No. E–016–2014/0—U.S. Provisional
Application No. 62/010,033 filed June
10, 2014.
Licensing Contact: Jaime M. Greene,
M.S.; 301–435–5559; greenejaime@
mail.nih.gov.
Collaborative Research Opportunity:
The FDA National Center for
Toxicological Research, Division of
Neurotoxicology, is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize A Nicotine-NanoCeria
VerDate Sep<11>2014
14:13 Jan 14, 2015
Jkt 235001
Conjugate named NIC–NANO for
treatment of Parkinson’s disease. For
collaboration opportunities, please
contact Syed Z Imam at syed.imam@
fda.hhs.gov.
cGAP–PNA Multivalent Ligand Display
at the Nanoscale
Description of Technology: Scientists
at the NIH are developing new types of
peptide nucleic acids (PNAs) that
maintain aqueous solubility at longer
lengths. This new type of PNA is called
‘‘cGAP–PNA’’ because it contains a
sequence complementary to the L–PNA
sequence, which is a PNA with one or
more gamma-sidechains that displays a
ligand. The investigators have
synthesized cGAP–PNAs that are 60
nucleobases long that can support the
assembly of 5 complementary L–PNAs
(each with 12 nucleobases) that bear
specific ligands. This platform can
replace more traditional multivalent
scaffolds, such as dendrimers and gold
nanoparticles.
Potential Commercial Applications:
Multivalent ligand display.
Competitive Advantages:
• Decreased hydrophobicity
• Increased water solubility
• Can be used at very long lengths
• More stable and resistant to
degradation than existing PNAs
Development Stage:
• Early-stage
• In vitro data available
Inventors: Daniel H. Appella, Andrew
V. Dix, Ethan A. Englund, Kara M.
George Rosenker (all of NIDDK).
Publication: Dix A, et al.
Programmable nanoscaffolds that
control ligand display to a G-proteincoupled receptor in membranes to allow
dissection of multivalent effects. J Am
Chem Soc. 2014 Sep 3;136(35):12296–
303. [PMID 25116377].
Intellectual Property: HHS Reference
No. E–761–2013/0—U.S. Provisional
Application No. 61/929,893 filed
January 21, 2014.
Related Technologies:
• HHS Reference No. E–308–2006/
3—U.S. Application No. 13/592,490
filed August 23, 2012.
• HHS Reference No. E–129–2010/
0—EP Application No. 11721899.0 filed
May 11, 2011; U.S. Application No. 13/
697,123 filed November 9, 2012.
Licensing Contact: Charlene S.
Maddox, Ph.D.; 301–435–4689;
charlene.maddox@nih.gov.
Collaborative Research Opportunity:
The National Institute of Diabetes and
Digestive and Kidney Diseases is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate or commercialize this
PO 00000
Frm 00021
Fmt 4703
Sfmt 9990
technology. For collaboration
opportunities, please contact Marguerite
Miller at Marguerite.Miller@nih.gov or
301–496–9003.
Dated: January 9, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–00535 Filed 1–14–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
Closure Devices for Transcaval Access to the
Abdominal Aorta.
Date: February 6, 2015.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7185, Bethesda, MD
20892, (Telephone Conference Call).
Contact Person: Kristen Page, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7185, Bethesda, MD 20892, 301–435–0725,
kristen.page@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: January 8, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–00497 Filed 1–14–15; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\15JAN1.SGM
15JAN1
Agencies
[Federal Register Volume 80, Number 10 (Thursday, January 15, 2015)]
[Notices]
[Pages 2110-2112]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00535]
-----------------------------------------------------------------------
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.
Highly Sensitive Tethered-Bead Immune Sandwich Assay
Description of Technology: This technology is a highly sensitive
tethered-bead immune sandwich assay. Analyte molecules are captured
between two antibodies, a capture antibody and a detection antibody.
The capture antibody on a micron-size bead binds analyte from a sample
fluid. The bead-captured analyte is then exposed to a ``detection''
antibody that binds to the bead-captured analyte, forming a
``sandwich''. The sandwiched analyte-bead complex then connects to a
flexible polymer (such as DNA)
[[Page 2111]]
anchored on a solid surface to form tethered particles. Binding the
analyte-bead complex to a flexible polymer forms tethered particles and
may be done, for example, by streptavidin biotin. Motion of the
tethered beads easily identifies bound analyte. The tethered beads are
quantified using low-magnification light microscopy. Prior enhanced
sensitivity tethered bead technologies require expensive and cumbersome
detection equipment. This assay is inherently single molecule, low
background, and works with simple inexpensive imaging formats, but is
automatable and potentially adaptable to portable technologies. A
prototype design using prostate specific antigen (PSA) shows detection
sensitivity of ~.03ng/ml, compared with normal PSA sensitivity of ~<
4ng/ml. Design refinements further improve sensitivities.
Potential Commercial Applications: Diagnostics and research.
Competitive Advantages: Highly sensitive single molecule adaptable
format, specific, low background, inexpensive, simple to use,
automatable for image analysis.
Development Stage:
Early-stage
Prototype
Inventors: Jonathan Silver (NHLBI), Zhenyu Li (George Washington
Univ.), Keir Neuman (NHLBI).
Publication: Silver J, et al. Tethered-bead, immune sandwich assay.
Biosens Bioelectron. 2015 Jan 15;63:117-23. [PMID 25064819].
Intellectual Property: HHS Reference No. E-188-2014/0--U.S.
Provisional Application No. 62/015,122 filed June 20, 2014.
Licensing Contact: Edward (Tedd) Fenn; 424-297-0336;
Tedd.fenn@nih.gov.
Polyketal Nanoparticle Delivery of CpG Oligodeoxynucleotide for
Treatment of Lung Cancer
Description of Technology: This technology delivers
oligodexoynucleotide locally to lung tumors using polyketal
nanoparticles. CpG ODNs (oligonucleotides with CpG motifs) stimulate
anti-tumor immune cells via Toll-like receptor 9 and show promise as
cancer therapeutics in preclinical and clinical trials. However,
previous systemic CpG ODN treatments of lung tumors progressed only to
Phase 3 trials. Local CpG ODN delivery appears to have superior
antitumor effect compared to earlier systemic treatments. Adsorbing CpG
ODNs onto biodegradable polyketal (CpG-NP) creates 1-3 micron
nanoparticles that can reach distal alveoli by inhalation. This
localized treatment improves uptake and persistence in the tumor
microenvironment, resulting in decreased immunosuppressive T-Cells and
increased macrophages. In vivo data indicate this therapy reduces tumor
growth and enhances survival rate in lung cancer. Mice treated with
CpG-NP had fewer and smaller tumor nodules (reduced by >90%). In Lewis
lung carcinoma model, CpG-NP therapy significantly improved the
survival; 80% of CpG-NP-treated mice survived (some for >1 yr). CpG-NP
represents a promising potential lung cancer therapy.
Potential Commercial Applications: Therapeutic or combination
therapy for lung cancer treatment.
Competitive Advantages:
Superior therapeutic effect versus systemic
administration.
CpG ODN treatments have well studied safety profile in
phase 1-3 clinical trials.
Development Stage: In vivo data available (animal).
Inventors: Dennis Klinman and Takashi Sato (NCI).
Publication: Klinman D, et al. Synthetic oligonucleotides as
modulators of inflammation. J Leukoc Biol. Oct 2008; 84(4): 958-64.
[PMID 18430787].
Intellectual Property: HHS Reference No. E-159-2014/0--U.S.
Provisional Application No. 62/024,657 filed July 15, 2014.
Licensing Contact: Edward (Tedd) Fenn; 424-297-0336;
Tedd.fenn@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
optimizing delivery of immunostimulatory CpG oligonucleotides to
patients with lung cancer. For collaboration opportunities, please
contact John D. Hewes, Ph.D. at john.hewes@nih.gov.
Aza-Englerin Analogues--Novel Natural Product-Based Nitrogen-Containing
Anti-Cancer Agents
Description of Technology: Available for licensing are synthetic
compounds developed as novel cancer therapeutics. Scientists at the
National Institutes of Health and University of Hawaii have designed
and synthesized novel aza-englerin analogues that have shown great
inhibitory effects on cancer cell growth. Englerin A is a natural
compound from the African plant Phyllanthus engleri that displays
potent and selective anti-cancer properties in several cancer types and
has been found to be active in several mouse xenograft experiments with
human tumor cells when injected intraperitoneally. The invention
provides compositions, methods of synthesis and methods of using the
aza-derivatives of englerin for cancer treatment. These englerin
analogues show significant bioavailability after oral administration in
mice, making them attractive as cancer therapeutics.
Potential Commercial Applications: Potential therapeutics for
cancer, particularly kidney cancer, Ewing's sarcoma, and other cancers
with a glycolytic phenotype. Potential in diabetes and HIV infection.
Competitive Advantages:
Novel compounds with great inhibitory effect on select
cancer cells, designed/synthesized as analogues to natural products
that show striking anti-cancer properties.
Parent compounds are effective in in vivo cancer models.
Novel syntheses of the compounds of the invention are
provided.
Bioavailability after oral administration in mouse model
demonstrated, making it suitable for clinical usage.
Development Stage:
Early-stage
In vitro data available
In vivo data available (animal)
Inventors: John A Beutler (NCI), Douglas Figg (NCI), William Chain
(Univ. of Hawaii-Manoa).
Publications:
1. Ratnayake R, et al. Englerin A, a selective inhibitor of renal
cancer cell growth, from Phyllanthus engleri. Org Lett. 2009 Jan
1;11(1):57-60. [PMID 19061394].
2. Li Z, et al. A brief synthesis of (-)-englerin A. J Am Chem Soc.
2011 May 4;133(17):6553-6. [PMID 21476574].
3. Akee R, et al. Chlorinated englerins with selective inhibition
of renal cancer cell growth. J Nat Prod. 2012 Mar 23;75(3):459-63.
[PMID 22280462].
4. Sourbier C, et al. Englerin A stimulates PKC theta to inhibit
insulin signaling while simultaneously activating HSF1: A case of
pharmacologically induced synthetic lethality. Cancer Cell 23 (2):228-
237, 2013. [PMID 23352416].
Intellectual Property:
HHS Reference No. E-090-2014/0--U.S. Provisional Patent
Application No. 61/936,285 filed February 5, 2014.
HHS Reference No. E-090-2014/1--U.S. Provisional Patent
Application No. 62/018,381 filed June 27, 2014.
Related Technologies:
HHS Reference No. E-064-2008/2-US-06--U.S. Patent No.
8,410,292 issued April 2, 2013.
[[Page 2112]]
HHS Reference No. E-042-2012/0-US-06--U.S. Patent
Application No. 14/370,140 filed July 1, 2014.
HHS Reference No. E-201-2012/0-PCT-02--PCT Application No.
PCT/US2013/069796 filed November 13, 2013, which published as WO 2014/
078350 on May 22, 2014.
Licensing Contact: Surekha Vathyam, Ph.D.; 301-435-4076;
vathyams@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Molecular Targets Development Program, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize aza-englerin
analogues as cancer inhibitors. For collaboration opportunities, please
contact John D. Hewes, Ph.D. at john.hewes@nih.gov.
Nicotine Conjugate Treatment for Parkinson's Disease
Description of Technology: It has been known since 1959 that
tobacco use has protective effects against Parkinson's disease.
However, efforts to turn that knowledge into a safe and effective
treatment, divorced from tobacco use, have had little success. An
inventor at FDA now has in vitro evidence that nicotine promotes a
protein clearance system, thereby halting Parkinson's disease
progression. In addition to using nicotine as the treatment, the
inventor has created a coated conjugate of nicotine and nanoceria. This
conjugate not only harnesses the power of nicotine but also takes
advantage of the anti-oxidant effect of the nanoceria to reduce the
oxidant environment, which is also a major mechanism of neuronal damage
in Parkinson's disease.
Potential Commercial Applications: Treatment for Parkinson's
disease.
Competitive Advantages: Improved mechanism to use nicotine as a
treatment.
Development Stage:
Early-stage
In vitro data available
Inventor: Syed Z. Imam (FDA).
Intellectual Property: HHS Reference No. E-016-2014/0--U.S.
Provisional Application No. 62/010,033 filed June 10, 2014.
Licensing Contact: Jaime M. Greene, M.S.; 301-435-5559;
greenejaime@mail.nih.gov.
Collaborative Research Opportunity: The FDA National Center for
Toxicological Research, Division of Neurotoxicology, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize A
Nicotine-NanoCeria Conjugate named NIC-NANO for treatment of
Parkinson's disease. For collaboration opportunities, please contact
Syed Z Imam at syed.imam@fda.hhs.gov.
cGAP-PNA Multivalent Ligand Display at the Nanoscale
Description of Technology: Scientists at the NIH are developing new
types of peptide nucleic acids (PNAs) that maintain aqueous solubility
at longer lengths. This new type of PNA is called ``cGAP-PNA'' because
it contains a sequence complementary to the L-PNA sequence, which is a
PNA with one or more gamma-sidechains that displays a ligand. The
investigators have synthesized cGAP-PNAs that are 60 nucleobases long
that can support the assembly of 5 complementary L-PNAs (each with 12
nucleobases) that bear specific ligands. This platform can replace more
traditional multivalent scaffolds, such as dendrimers and gold
nanoparticles.
Potential Commercial Applications: Multivalent ligand display.
Competitive Advantages:
Decreased hydrophobicity
Increased water solubility
Can be used at very long lengths
More stable and resistant to degradation than existing
PNAs
Development Stage:
Early-stage
In vitro data available
Inventors: Daniel H. Appella, Andrew V. Dix, Ethan A. Englund, Kara
M. George Rosenker (all of NIDDK).
Publication: Dix A, et al. Programmable nanoscaffolds that control
ligand display to a G-protein-coupled receptor in membranes to allow
dissection of multivalent effects. J Am Chem Soc. 2014 Sep
3;136(35):12296-303. [PMID 25116377].
Intellectual Property: HHS Reference No. E-761-2013/0--U.S.
Provisional Application No. 61/929,893 filed January 21, 2014.
Related Technologies:
HHS Reference No. E-308-2006/3--U.S. Application No. 13/
592,490 filed August 23, 2012.
HHS Reference No. E-129-2010/0--EP Application No.
11721899.0 filed May 11, 2011; U.S. Application No. 13/697,123 filed
November 9, 2012.
Licensing Contact: Charlene S. Maddox, Ph.D.; 301-435-4689;
charlene.maddox@nih.gov.
Collaborative Research Opportunity: The National Institute of
Diabetes and Digestive and Kidney Diseases 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 Marguerite Miller at
Marguerite.Miller@nih.gov or 301-496-9003.
Dated: January 9, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-00535 Filed 1-14-15; 8:45 am]
BILLING CODE 4140-01-P