[Federal Register Volume 80, Number 10 (Thursday, January 15, 2015)]
[Notices]
[Pages 2110-2112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00535]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the U.S. patent applications listed below may be obtained by writing to 
the indicated licensing contact at the Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to 
receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

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:
    <bullet> Early-stage
    <bullet> 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; 
<a href="/cdn-cgi/l/email-protection#590d3c3d3d773f3c373719373031773e362f"><span class="__cf_email__" data-cfemail="f2a6979696dc94979c9cb29c9b9adc959d84">[email protected]</span></a>.

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:
    <bullet> Superior therapeutic effect versus systemic 
administration.
    <bullet> 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; 
<a href="/cdn-cgi/l/email-protection#0652636262286063686846686f6e28616970"><span class="__cf_email__" data-cfemail="aafecfcece84cccfc4c4eac4c3c284cdc5dc">[email protected]</span></a>.
    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 <a href="/cdn-cgi/l/email-protection#7e1411161050161b091b0d3e10171650191108"><span class="__cf_email__" data-cfemail="a6ccc9cec888cec3d1c3d5e6c8cfce88c1c9d0">[email protected]</span></a>.

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:
    <bullet> Novel compounds with great inhibitory effect on select 
cancer cells, designed/synthesized as analogues to natural products 
that show striking anti-cancer properties.
    <bullet> Parent compounds are effective in in vivo cancer models.
    <bullet> Novel syntheses of the compounds of the invention are 
provided.
    <bullet> Bioavailability after oral administration in mouse model 
demonstrated, making it suitable for clinical usage.
    Development Stage:
    <bullet> Early-stage
    <bullet> In vitro data available
    <bullet> 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:
    <bullet> HHS Reference No. E-090-2014/0--U.S. Provisional Patent 
Application No. 61/936,285 filed February 5, 2014.
    <bullet> HHS Reference No. E-090-2014/1--U.S. Provisional Patent 
Application No. 62/018,381 filed June 27, 2014.
    Related Technologies:
    <bullet> HHS Reference No. E-064-2008/2-US-06--U.S. Patent No. 
8,410,292 issued April 2, 2013.

[[Page 2112]]

    <bullet> HHS Reference No. E-042-2012/0-US-06--U.S. Patent 
Application No. 14/370,140 filed July 1, 2014.
    <bullet> 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; 
<a href="/cdn-cgi/l/email-protection#ff899e8b97869e928cbf929e9693d1919697d1989089"><span class="__cf_email__" data-cfemail="3f495e4b57465e524c7f525e56531151565711585049">[email protected]</span></a>.
    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 <a href="/cdn-cgi/l/email-protection#f79d989f99d99f92809284b7999e9fd9909881"><span class="__cf_email__" data-cfemail="600a0f080e4e0805170513200e09084e070f16">[email protected]</span></a>.

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:
    <bullet> Early-stage
    <bullet> 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; 
<a href="/cdn-cgi/l/email-protection#fc9b8e99999299969d959199bc919d9590d2929594d29b938a"><span class="__cf_email__" data-cfemail="462134232328232c272f2b23062b272f2a68282f2e68212930">[email protected]</span></a>.
    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 <a href="/cdn-cgi/l/email-protection#ef9c968a8bc186828e82af898b8ec187879cc1888099"><span class="__cf_email__" data-cfemail="c9bab0acade7a0a4a8a489afada8e7a1a1bae7aea6bf">[email protected]</span></a>.

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:
    <bullet> Decreased hydrophobicity
    <bullet> Increased water solubility
    <bullet> Can be used at very long lengths
    <bullet> More stable and resistant to degradation than existing 
PNAs
    Development Stage:
    <bullet> Early-stage
    <bullet> 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:
    <bullet> HHS Reference No. E-308-2006/3--U.S. Application No. 13/
592,490 filed August 23, 2012.
    <bullet> 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; 
<a href="/cdn-cgi/l/email-protection#e98a81889b858c878cc784888d8d8691a9878081c78e869f"><span class="__cf_email__" data-cfemail="8deee5ecffe1e8e3e8a3e0ece9e9e2f5cde3e4e5a3eae2fb">[email protected]</span></a>.
    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 
<a href="/cdn-cgi/l/email-protection#410c2033263424332835246f0c282d2d2433012f28296f262e37"><span class="__cf_email__" data-cfemail="5c113d2e3b29392e3528397211353030392e1c323534723b332a">[email protected]</span></a> 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


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