80 FR 57380 - Government-Owned Inventions; Availability for Licensing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 184 (September 23, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 184 (September 23, 2015)
| Page Range | 57380-57383 | |
| FR Document | 2015-24137 |
[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)] [Notices] [Pages 57380-57383] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24137] ----------------------------------------------------------------------- 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. A Novel Rapid Point-of-Care Diagnostic Method for Infectious and Autoimmune Diseases Description of Technology: Rapid point-of-care, antibody-based testing is not available for the diagnosis of autoimmune and most infectious diseases. For detecting autoantibodies associated with most autoimmune conditions, fluid-phase immunoprecipitation assays are required. However, these assays usually involve radioactivity and are not feasible for point-of-care applications. The subject invention describes methods of using neodymium magnet for diagnosis of infectious and autoimmune diseases including lupus, Sj[ouml]gren's syndrome, type I diabetes, HIV and Lyme disease. The assay takes 3.5 minutes, is highly efficient, and has low background. Potential Commercial ApplicationsA rapid assay for point-of-care diagnosis of infectious and autoimmune diseases. Applications to different assay platforms, such as a portable, commercially available hand-held luminometer or an automated, high-throughput device. Competitive Advantages Highly efficient, rapid, and easy to perform. Low background signals. Development Stage Early-stage In vitro data available Prototype. Inventor: Peter D. Burbelo (NIDCR) Publications 1. Burbelo PD, et al. Luciferase immunoprecipitation systems for measuring antibodies in autoimmune and infectious diseases. Transl Res. 2015 Feb; 165(2):325-335. [PMID 25241936] 2. Burbelo PD, et al. New autoantibody detection technologies yield novel insights into autoimmune disease. Curr Opin Rheumatol. 2014 Nov; 26(6):717-723. [PMID 25203116] 3. Burbelo PD, et al. Searching for biomarkers: humoral response profiling with luciferase immunoprecipitation systems. Expert Rev Proteomics. 2011 Jun; 8(3):309-316. [PMID 21679112] 4. Burbelo PD, et al. Antibody profiling by luciferase immunoprecipitation systems (LIPS). J Vis Exp. 2009 Oct 7; (32). [PMID 19812534] Intellectual Property: HHS Reference No. E-190-2015/0--US Provisional Application No. 62/212,973 filed 01 Oct 2015. Related Technologies E-036-2010 family: PCT/US2011/027888, US 8,926,989, issued. US 14/562,068 and EP 11730770.1, pending. E-281-2010: US 13/882,850, allowed. E-063-2009: US 8,951,723, issued. Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5606; [email protected]. Collaborative Research Opportunity: The National Institute of Dental and Craniofacial Research is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize using neodymium magnet for rapid diagnosis. For collaboration opportunities, please contact David Bradley, Ph.D. at [email protected]. A Mobile Health Platform Description of Technology: The NIH inventors have developed a mobile health technology to monitor and predict a user's psychological status and to deliver an automated intervention when needed. The technology uses smartphones to monitor the user's location and ask questions about psychological status throughout the day. Continuously collected ambulatory psychological data are fused with data on location and responses to questions. The mobile data are combined with geospatial risk maps to quantify exposure to risk and predict a future psychological state. The future predictions are used to warn the user when he or she is at especially high risk of experiencing a negative event that might lead to an unwanted outcome (e.g., lapse to drug use in a recovering addict). An internally developed mobile app is now being deployed to deliver an intervention in the context of drug addiction. The inventors are also seeking to test the technology for other health applications. Potential Commercial Applications Real time behavior monitoring Therapeutic delivery of an intervention via a mobile device Competitive Advantages Mobile device Real time Exposure to risk Development Stage: Prototype Inventors: Kenzie L. Preston, David H. Epstein, Matthew Tyburski, Massoud Vahabzadeh (all of NIDA) Publications 1. Epstein DH, et al. Real-time tracking of neighborhood surroundings and mood in urban drug misusers: Application of a new method to study behavior in its geographical context. Drug Alcohol Depend. 2014 Jan 1;134:22-9. [PMID 24332365] 2. Kennedy AP, et al. Continuous in-the-field measurement of heart rate: Correlates of drug use, craving, stress and mood in polydrug users. Drug Alcohol Depend. 2015 June 1;151:159-66. [PMID 25920802] Intellectual Property: HHS Reference No. E-049-2015/0--US Provisional Application No. 62/186, 983 filed 30 June 2015 Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; [email protected] Collaborative Research Opportunity: The National Institute on Drug Abuse is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize [[Page 57381]] mhealth system to analyze and intervene. For collaboration opportunities, please contact Vio Conley at [email protected]. Detection and Discrimination of Classical and Atypical L-Type BSE Strains by RT-QuIC Description of Technology: Statutory surveillance of bovine spongiform encephalopathy (BSE) indicates that cattle are susceptible to both classical (C-BSE) and atypical forms of BSE. Atypical forms of BSE appear to be sporadic and thus may never be eradicated. A major challenge is the lack of sufficiently practical and sensitive tests for routine BSE detection and strain discrimination. The RT-QuIC test, which is based on prion-seeded fibrillization of recombinant prion protein (rPrP Sen ), is known to be highly specific and sensitive for detection of multiple human and animal prion diseases, but not BSE. This application claims methods for distinguishing whether a sheep, cow or goat has atypical L-bovine spongiform encephalopathy prion or classical bovine spongiform encephalopathy. Potential Commercial ApplicationsDetection and distinguishing of both BSE forms Rapid detection and discrimination of BSE forms Competitive Advantages Orders of magnitude more sensitive than ELISA tests Eliminates need for multi-phase analyses of samples Can be applied to large scale testing of multiple samples Development Stage In vitro data available In vivo data available (animal) Prototype Inventors: Byron W. Caughey (NIAID), Christina D. Orr[uacute] (NIAID), Alessandra Favolez (EM), Cristina Casalone (EM), Maria Mazza (EM), Cristiano Corona (EM) Publications 1. Orr[uacute] CD, et al. Detection and discrimination of classical and atypical L-type bovine spongiform encephalopathy by real-time quaking-induced conversion. J Clin Microbiol. 2015 Apr;53(4):1115-20. [PMID 25609728] 2. Orr[uacute] CD, et al. Correction: Bank Vole Prion Protein As an Apparently Universal Substrate for RT-QuIC-Based Detection and Discrimination of Prion Strains. PLoS Pathog. 2015 Aug 18;11(8):e1005117. [PMID 26284358] 3. Orr[uacute] CD, et al. Bank Vole Prion Protein As an Apparently Universal Substrate for RT-QuIC-Based Detection and Discrimination of Prion Strains. PLoS Pathog. 2015 Jun 18;11(6):e1004983. [PMID 26086786] Intellectual Property: HHS Reference E-048-2015/0--US Provisional Application No. 62/092,645 filed 16 Dec 2014 Licensing Contact: Peter A. Soukas; 301-435-4646; [email protected] Lenalidomide Analogs for the Treatment of Neurodegenerative Disorders and Cancer Description of Technology: Inflammatory processes associated with the over-production of tumor necrosis-alpha (TNF-alpha), a potent activator of the immune system accompany numerous neurodegenerative diseases. TNF-alpha has been validated as a drug target with the development of the inhibitors Enbrel and Remicade (fusion antibodies) as prescription medications. Both, however, are large macromolecules that require direct injection and have limited brain access. The classical drug, thalidomide is being increasingly used in the clinical management of a wide spectrum of immunologically-mediated and infectious diseases, and cancers. The NIA inventors developed and assessed novel thio analogs of lenalidomide (Celegene's Revlimid and an analog of thalidomide) as immunomodulatory agents, with the potential to reduce chronic systemic and central nervous system inflammation. These compounds were synthesized and evaluated for their TNF-alpha inhibitory activity. This invention was extended from the inventors' prior work to develop potent compounds to reduce neuroinflammation as a treatment strategy for neurodegenerative disorders. The current studies focus the compounds activity in classical models of neurodegeneration as well as cancer. Potential Commercial Applications Treatment for blood disorders (myelodysplastic syndrome), cancer (multiple myeloma), inflammatory processes and erythema Immunomodulatory agents Reduce chronic systemic and central nervous system inflammation Competitive Advantages Effective smaller molecular weight compound that can enter brain among current agents Experimental therapeutic to reduce inflammation systematically and within the brain Effective in reducing proinflammatory cytokines than existing agents Development Stage In vitro data available In vivo data available (animal) Prototype Inventors: Nigel H. Greig, Weiming Luo, David Tweedie, Harold W. Holloway, Qian-sheng Yu (all of NIA) Publication: Luo W, et al. Design, synthesis and biological assessment of novel N-substituted 3-(phthalimidin-2-yl)-2,6- dioxopiperidines and 3-substituted 2,6-dioxopiperidines for TNF-alpha inhibitory activity. Bioorg Med Chem. 2011 Jul 1;19(13):3965-3972. [PMID 21658960] Intellectual Property: HHS Reference No. E-045-2012/0-- US Patent No. 8,927,725 issued 06 Jan 2015 US Patent No. 9,084,783 issued 21 Jul 2015 US Patent Application No. 14/746,512 filed 22 Jun 2015 Related Technologies: HHS Reference No. E-189-2003/0-- US Patent No. 7,973,057 issued 05 Jul 2011 US Patent No. 8,546,430 issued 01 Oct 2013 US Patent Application No. 13/648,625 filed 10 Oct 2012 US Patent Application No. 14/314,124 filed 25 Jun 2014 and related international patents/patent applications Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; [email protected] Novel Regulatory B Cells for Treatment of Cancer and Autoimmune Disease Description of Technology: The manner by which cancers evade the immune response is not well-understood. What is known is that the manner is an active process that regulates immune responses employing at least two types of suppressive cells, myeloid-derived suppressive cells and regulatory T cells (Tregs), a key subset of CD4\+\ T cells that controls peripheral tolerance to self- and allo-antigens. Tregs are considered to play a key role in the escape of cancer cells from anti-tumor effector T cells. Cancer cells have been found to directly activate resting B cells to form suppressive regulatory B cells (tBregs) and utilize them to evade immune surveillance and mediate metastasis. tBregs directly inhibit CD4\+\ and CD8\+\ T cell activity in a cell contact-dependent manner, induce FoxP3\+\ T cell activity, and promote Treg-dependent metastasis. Researchers from the National Institute on Aging (NIA), NIH, have developed methods for the generation of tBregs, and for using tBregs to produce [[Page 57382]] Tregs, and methods that inactivate or deplete tBregs. These methods have significant therapeutic value in the combat with cancer immune escape and metastasis, and in the control of harmful autoimmune diseases. Potential Commercial Applications: Production of cellular cancer vaccines Treatments for immune-mediated disorders Treatments for cancer Treatments for chronic viral infections Development Stage: Early-stage In vitro data available In vivo data available (animal) In situ data available Ex vivo data available Inventors: Bira Arya and Purevdorj Olkhanud (NIA) Intellectual Property: HHS Reference No. E-101-2010/0--US Patent Application No. 13/577,226 filed 03 Aug 2012 Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; [email protected] Collaborative Research Opportunity: The National Institute on Aging, Laboratory of Molecular Biology and Immunology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the utilization of regulatory B cells to control autoimmune diseases and strategies that inactivate tBregs to control cancer immune escape. Please contact Nicole Darack, Ph.D. at 240-276-5493 or [email protected] for more information. Immunogenic Tumor-associated Antigen SPANX-B for Selective Cancer Immunotherapy Description of Technology: Researchers at the National Institute on Aging (NIA) have characterized a novel tumor-associated antigen, SPANX- B, which is naturally immunogenic and is expressed in a variety of human malignancies, including melanoma and lung, colon, renal, ovarian and breast carcinomas. In melanoma specifically, SPANX-B expression is associated with advanced and metastatic disease. Moreover, the researchers have found several agonist epitope peptides from SPANX-B which can be used to activate the immune system to eradicate tumors utilizing T cells. SPANX-B peptides have significant clinical and immunotherapeutic potential for the development of cancer diagnostic assays and potent protective and/or therapeutic vaccines to combat a wide-range of cancers. Potential Commercial Applications: In vitro diagnostic assays for highly-metastatic melanomas or other cancers Therapeutic monoclonal antibodies Cancer vaccine development Competitive Advantages: Immunogenic: SPANX-B peptides are naturally able to elicit immune response. Expressed in a wide-range of cancers. Use of epitope peptides facilitates the activation of cells of the more therapeutically effective branch of the immune system. Small epitope peptides: Can be more easily manufactured in contrast to recombinant proteins. Development Stage: In vitro data available In vivo data available (animal) Publication: Almanzar G, et al. Sperm-derived SPANX-B is a clinically relevant tumor antigen that is expressed in human tumors and readily recognized by human CD4+ and CD8+ T cells. Clin Cancer Res. 2009 Mar 15;15(6):1954-63. [PMID 19276289] Inventors: Bira Arya (NIA) and Vladimir Larionov (NCI) Intellectual Property: HHS Reference No. E-089-2009/0-- US Patent No. 8,664,183 issued 04 Mar 2014 US Patent Application No. 14/155,230 filed 14 Jan 2014 Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; [email protected] Collaborative Research Opportunity: The National Institute on Aging, Laboratory of Molecular Biology and Immunology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the use of SPANX-B-based therapeutic approaches to combat cancers. Please contact Nicole Darack, Ph.D. at 240-276-5493 or [email protected] for more information. Method for the Diagnosis and Prognosis of Age-Related Cardiovascular Disorders Description of Technology: NIH investigators have discovered a method for the diagnosis and prognosis of cardiovascular aging. Current methodologies include the measurement of patient lipid profiles or expression of up to two proteins. In contrast, this technology utilizes the expression levels of a panel of proteins not previously known to be related to cardiovascular aging and may prove to be a more accurate diagnostic or prognostic of cardiovascular aging than currently available tests or it may improve the accuracy of currently available tests when used in concert. The technology relates to methods for determining susceptibility to having an extremely common age-associated vascular disorder. It also describes the subsequent use of these proteins as markers for disease. While the underlying cellular and molecular mechanisms of age-related vascular disease remain largely undefined, the expression levels of the genes described in this technology have been empirically determined to differ between healthy and age-inflamed arterial tissue. Further, this technology includes a companion mass spectroscopic-based methodology for reproducible quantification of specific expression levels of interest. Potential Commercial Applications: Diagnosis of age-related vascular disorder. Inventors: Mingyi Wang et al. (NIA) Intellectual Property: HHS Reference No. E-219-2008/0--US Patent Application No. 13/202,319 filed 18 Aug 2011 Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; [email protected] Collaborative Research Opportunity: The National Institute on Aging, Laboratory of Cardiovascular Science, Cardiac Biology Section-- Vascular Group, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize idea of how to assess and retard accelerated arterial aging and its attendant risks for atherosclerosis and hypertension. Please contact Vio Conley at 240-276-5531 or [email protected] for more information. A Novel and Efficient Technology for Targeted Delivery of siRNA Description of Technology: The biological phenomenon of RNA interference (RNAi) has much promise for developing therapeutics to a variety of diseases. However, development of RNAi therapies remains mainly in preclinical stages largely because of difficulties in delivering small inhibitory RNAs (siRNA) and short hairpin RNAs (shRNA) into target cells. Although viral vector-based siRNA delivery systems have been widely used, their specificity and safety remains significant issue. Without a [[Page 57383]] solution to this delivery problem, RNAi cannot fulfill its therapeutic promise. Investigators at the National Institutes of Health have developed novel compositions and methods for delivering inhibitory oligonucleotides to cells in a targeted and efficient manner. The compositions and methods are based on utilizing a cell surface receptor targeting ligand, such as cytokine or chemokine, and a domain that binds an inhibitory oligonucleotide, to efficiently deliver the inhibitory oligonucleotide to the cell that expresses the cell surface receptor targeting ligand. Chemokine receptors are differentially expressed on various cells, including tumors; hence this technology allows targeting siRNA to aberrant cells. Gene silencing can also be achieved in variety of immune cells by targeting cytokine receptors. This technology has great potential for developing into a safe and effective means of delivering therapeutic siRNAs. Potential Commercial Applications Treatment of cancers and autoimmune diseases by delivery of siRNA to tumor cells or various aberrantly functioning immune cells. This technology can be used to boost vaccine responses against cancers and chronic infectious diseases. Targeted delivery of fluorochrome-labeled RNA both in vitro and in vivo for diagnostic purposes, for example, to trace or localize various cells and to determine tumor metastasis and aberrant proliferation or homing of immune cells. Competitive Advantages Simple method for linking siRNA to polypeptides to create non-covalent or covalent complexes In vivo targeted delivery of inhibitory RNAs into cells rather than systemically Delivery of multiple inhibitory RNAs to target multiple genes Long-term repression of target gene expression through RNAi phenomenon Development Stage In vitro data available In vivo data available (animal) In situ data available Inventors: Bira Arya, Purevdorj Olkhanud, Juan Espinoza (all of NIA) Intellectual Property: HHS Reference No. E-051-2008/0-- US Patent No. 8,703,921 issued 22 Apr 2014 US Patent Application No. 14/220,726 filed 20 Mar 2014 Various international patents/patent applications Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; [email protected] Collaborative Research Opportunity: The National Institute on Aging, Laboratory of Molecular Biology and Immunology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize chemokine-based siRNA/shRNA technology for treatment of cancers and autoimmune diseases, i.e. to control expression of immunomodulatory cytokines and other factors that facilitate tumor escape, activity of regulatory T cells or Th2 type of cells. This technology can be also utilized to boost vaccine responses against cancers and chronic infectious diseases. Please contact John D. Hewes, Ph.D. at 240-276- 5515 or [email protected] for more information. Dated: September 17, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015-24137 Filed 9-22-15; 8:45 am] BILLING CODE 4140-01-P
![57380 Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices
Dated: September 16, 2015. minutes, is highly efficient, and has low A Mobile Health Platform
Walter J. Koroshetz, background. Description of Technology: The NIH
Director, National Institute of Neurological Potential Commercial Applications inventors have developed a mobile
Disorders and Stroke, National Institutes of health technology to monitor and
Health. • A rapid assay for point-of-care
predict a user’s psychological status and
[FR Doc. 2015–24117 Filed 9–22–15; 8:45 am] diagnosis of infectious and autoimmune
to deliver an automated intervention
BILLING CODE 4140–01–P diseases.
when needed. The technology uses
• Applications to different assay
smartphones to monitor the user’s
platforms, such as a portable,
location and ask questions about
DEPARTMENT OF HEALTH AND commercially available hand-held
psychological status throughout the day.
HUMAN SERVICES luminometer or an automated, high-
Continuously collected ambulatory
throughput device.
National Institutes of Health psychological data are fused with data
Competitive Advantages on location and responses to questions.
Government-Owned Inventions; • Highly efficient, rapid, and easy to The mobile data are combined with
Availability for Licensing perform. geospatial risk maps to quantify
• Low background signals. exposure to risk and predict a future
AGENCY: National Institutes of Health, psychological state. The future
HHS. Development Stage predictions are used to warn the user
ACTION: Notice. • Early-stage when he or she is at especially high risk
SUMMARY: The inventions listed below • In vitro data available of experiencing a negative event that
are owned by an agency of the U.S. • Prototype. might lead to an unwanted outcome
Inventor: Peter D. Burbelo (NIDCR) (e.g., lapse to drug use in a recovering
Government and are available for addict).
licensing in the U.S. in accordance with Publications An internally developed mobile app
35 U.S.C. 209 and 37 CFR part 404 to is now being deployed to deliver an
achieve expeditious commercialization 1. Burbelo PD, et al. Luciferase
immunoprecipitation systems for measuring intervention in the context of drug
of results of federally-funded research addiction. The inventors are also
antibodies in autoimmune and infectious
and development. Foreign patent diseases. Transl Res. 2015 Feb; 165(2):325– seeking to test the technology for other
applications are filed on selected 335. [PMID 25241936] health applications.
inventions to extend market coverage 2. Burbelo PD, et al. New autoantibody
for companies and may also be available detection technologies yield novel insights Potential Commercial Applications
for licensing. into autoimmune disease. Curr Opin • Real time behavior monitoring
FOR FURTHER INFORMATION CONTACT: Rheumatol. 2014 Nov; 26(6):717–723. [PMID • Therapeutic delivery of an
25203116] intervention via a mobile device
Licensing information and copies of the
3. Burbelo PD, et al. Searching for
U.S. patent applications listed below biomarkers: humoral response profiling with Competitive Advantages
may be obtained by writing to the luciferase immunoprecipitation systems.
indicated licensing contact at the Office Expert Rev Proteomics. 2011 Jun; 8(3):309– • Mobile device
of Technology Transfer, National 316. [PMID 21679112] • Real time
Institutes of Health, 6011 Executive 4. Burbelo PD, et al. Antibody profiling by • Exposure to risk
Boulevard, Suite 325, Rockville, luciferase immunoprecipitation systems Development Stage: Prototype
Maryland 20852–3804; telephone: 301– (LIPS). J Vis Exp. 2009 Oct 7; (32). [PMID Inventors: Kenzie L. Preston, David H.
496–7057; fax: 301–402–0220. A signed 19812534] Epstein, Matthew Tyburski, Massoud
Confidential Disclosure Agreement will Intellectual Property: HHS Reference Vahabzadeh (all of NIDA)
be required to receive copies of the No. E–190–2015/0—US Provisional Publications
patent applications. Application No. 62/212,973 filed 01 Oct
2015. 1. Epstein DH, et al. Real-time tracking of
SUPPLEMENTARY INFORMATION:
neighborhood surroundings and mood in
Technology descriptions follow. Related Technologies urban drug misusers: Application of a new
A Novel Rapid Point-of-Care Diagnostic method to study behavior in its geographical
• E–036–2010 family: PCT/US2011/ context. Drug Alcohol Depend. 2014 Jan
Method for Infectious and Autoimmune 027888, US 8,926,989, issued. US 14/ 1;134:22–9. [PMID 24332365]
Diseases 562,068 and EP 11730770.1, pending. 2. Kennedy AP, et al. Continuous in-the-
Description of Technology: Rapid • E–281–2010: US 13/882,850, field measurement of heart rate: Correlates of
point-of-care, antibody-based testing is allowed. drug use, craving, stress and mood in
not available for the diagnosis of • E–063–2009: US 8,951,723, issued. polydrug users. Drug Alcohol Depend. 2015
autoimmune and most infectious Licensing Contact: Sally Hu, Ph.D., June 1;151:159–66. [PMID 25920802]
diseases. For detecting autoantibodies M.B.A.; 301–435–5606; hus@ Intellectual Property: HHS Reference
associated with most autoimmune mail.nih.gov. No. E–049–2015/0—US Provisional
conditions, fluid-phase Collaborative Research Opportunity: Application No. 62/186, 983 filed 30
immunoprecipitation assays are The National Institute of Dental and June 2015
required. However, these assays usually Craniofacial Research is seeking Licensing Contact: Betty B. Tong,
mstockstill on DSK4VPTVN1PROD with NOTICES
involve radioactivity and are not statements of capability or interest from Ph.D.; 301–594–6565; tongb@
feasible for point-of-care applications. parties interested in collaborative mail.nih.gov
The subject invention describes research to further develop, evaluate or Collaborative Research Opportunity:
methods of using neodymium magnet commercialize using neodymium The National Institute on Drug Abuse is
for diagnosis of infectious and magnet for rapid diagnosis. For seeking statements of capability or
autoimmune diseases including lupus, collaboration opportunities, please interest from parties interested in
Sjögren’s syndrome, type I diabetes, HIV contact David Bradley, Ph.D. at collaborative research to further
and Lyme disease. The assay takes 3.5 bradleyda@nidcr.nih.gov. develop, evaluate or commercialize
VerDate Sep<11>2014 18:00 Sep 22, 2015 Jkt 235001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1](https://thefederalregister.org/doc/80_FR_57564/page/1.svg)
![Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices 57381
mhealth system to analyze and QuIC-Based Detection and Discrimination of Development Stage
intervene. For collaboration Prion Strains. PLoS Pathog. 2015 Jun
18;11(6):e1004983. [PMID 26086786] • In vitro data available
opportunities, please contact Vio Conley • In vivo data available (animal)
at conleyv@mail.nih.gov. Intellectual Property: HHS Reference • Prototype
Detection and Discrimination of E–048–2015/0—US Provisional Inventors: Nigel H. Greig, Weiming
Classical and Atypical L-Type BSE Application No. 62/092,645 filed 16 Dec Luo, David Tweedie, Harold W.
Strains by RT-QuIC 2014 Holloway, Qian-sheng Yu (all of NIA)
Licensing Contact: Peter A. Soukas; Publication: Luo W, et al. Design,
Description of Technology: Statutory 301–435–4646; ps193c@nih.gov
surveillance of bovine spongiform synthesis and biological assessment of
encephalopathy (BSE) indicates that Lenalidomide Analogs for the novel N-substituted 3-(phthalimidin-2-
cattle are susceptible to both classical Treatment of Neurodegenerative yl)-2,6-dioxopiperidines and 3-
(C–BSE) and atypical forms of BSE. Disorders and Cancer substituted 2,6-dioxopiperidines for
Atypical forms of BSE appear to be TNF-alpha inhibitory activity. Bioorg
Description of Technology: Med Chem. 2011 Jul 1;19(13):3965–
sporadic and thus may never be Inflammatory processes associated with
eradicated. A major challenge is the lack 3972. [PMID 21658960]
the over-production of tumor necrosis- Intellectual Property: HHS Reference
of sufficiently practical and sensitive alpha (TNF-alpha), a potent activator of
tests for routine BSE detection and No. E–045–2012/0—
the immune system accompany • US Patent No. 8,927,725 issued 06
strain discrimination. The RT-QuIC test, numerous neurodegenerative diseases.
which is based on prion-seeded Jan 2015
TNF-alpha has been validated as a drug • US Patent No. 9,084,783 issued 21
fibrillization of recombinant prion target with the development of the
protein (rPrPSen), is known to be highly Jul 2015
inhibitors Enbrel and Remicade (fusion • US Patent Application No. 14/
specific and sensitive for detection of antibodies) as prescription medications. 746,512 filed 22 Jun 2015
multiple human and animal prion Both, however, are large Related Technologies: HHS Reference
diseases, but not BSE. This application macromolecules that require direct No. E–189–2003/0—
claims methods for distinguishing injection and have limited brain access. • US Patent No. 7,973,057 issued 05
whether a sheep, cow or goat has The classical drug, thalidomide is being Jul 2011
atypical L-bovine spongiform increasingly used in the clinical • US Patent No. 8,546,430 issued 01
encephalopathy prion or classical management of a wide spectrum of Oct 2013
bovine spongiform encephalopathy. immunologically-mediated and • US Patent Application No. 13/
Potential Commercial Applications infectious diseases, and cancers. The 648,625 filed 10 Oct 2012
• Detection and distinguishing of
NIA inventors developed and assessed • US Patent Application No. 14/
novel thio analogs of lenalidomide 314,124 filed 25 Jun 2014
both BSE forms
• Rapid detection and discrimination
(Celegene’s Revlimid and an analog of • and related international patents/
thalidomide) as immunomodulatory patent applications
of BSE forms agents, with the potential to reduce Licensing Contact: Betty B. Tong,
Competitive Advantages chronic systemic and central nervous Ph.D.; 301–594–6565; tongb@
system inflammation. These compounds mail.nih.gov
• Orders of magnitude more sensitive
were synthesized and evaluated for their
than ELISA tests Novel Regulatory B Cells for Treatment
TNF-alpha inhibitory activity. This
• Eliminates need for multi-phase of Cancer and Autoimmune Disease
invention was extended from the
analyses of samples
• Can be applied to large scale testing inventors’ prior work to develop potent Description of Technology: The
of multiple samples compounds to reduce manner by which cancers evade the
neuroinflammation as a treatment immune response is not well-
Development Stage strategy for neurodegenerative understood. What is known is that the
• In vitro data available disorders. The current studies focus the manner is an active process that
• In vivo data available (animal) compounds activity in classical models regulates immune responses employing
• Prototype of neurodegeneration as well as cancer. at least two types of suppressive cells,
Inventors: Byron W. Caughey (NIAID), Potential Commercial Applications myeloid-derived suppressive cells and
Christina D. Orrú (NIAID), Alessandra regulatory T cells (Tregs), a key subset
• Treatment for blood disorders of CD4+ T cells that controls peripheral
Favolez (EM), Cristina Casalone (EM),
(myelodysplastic syndrome), cancer tolerance to self- and allo-antigens.
Maria Mazza (EM), Cristiano Corona
(multiple myeloma), inflammatory Tregs are considered to play a key role
(EM)
processes and erythema in the escape of cancer cells from anti-
Publications • Immunomodulatory agents tumor effector T cells.
1. Orrú CD, et al. Detection and • Reduce chronic systemic and Cancer cells have been found to
discrimination of classical and atypical L- central nervous system inflammation directly activate resting B cells to form
type bovine spongiform encephalopathy by suppressive regulatory B cells (tBregs)
Competitive Advantages
real-time quaking-induced conversion. J Clin and utilize them to evade immune
Microbiol. 2015 Apr;53(4):1115–20. [PMID • Effective smaller molecular weight surveillance and mediate metastasis.
25609728] compound that can enter brain among
mstockstill on DSK4VPTVN1PROD with NOTICES
tBregs directly inhibit CD4+ and CD8+ T
2. Orrú CD, et al. Correction: Bank Vole current agents cell activity in a cell contact-dependent
Prion Protein As an Apparently Universal • Experimental therapeutic to reduce manner, induce FoxP3+ T cell activity,
Substrate for RT-QuIC-Based Detection and
Discrimination of Prion Strains. PLoS Pathog.
inflammation systematically and within and promote Treg-dependent metastasis.
2015 Aug 18;11(8):e1005117. [PMID the brain Researchers from the National
26284358] • Effective in reducing Institute on Aging (NIA), NIH, have
3. Orrú CD, et al. Bank Vole Prion Protein proinflammatory cytokines than existing developed methods for the generation of
As an Apparently Universal Substrate for RT- agents tBregs, and for using tBregs to produce
VerDate Sep<11>2014 18:00 Sep 22, 2015 Jkt 235001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1](https://thefederalregister.org/doc/80_FR_57564/page/2.svg)
![57382 Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices
Tregs, and methods that inactivate or and potent protective and/or therapeutic of a panel of proteins not previously
deplete tBregs. These methods have vaccines to combat a wide-range of known to be related to cardiovascular
significant therapeutic value in the cancers. aging and may prove to be a more
combat with cancer immune escape and accurate diagnostic or prognostic of
Potential Commercial Applications:
metastasis, and in the control of harmful cardiovascular aging than currently
autoimmune diseases. • In vitro diagnostic assays for highly- available tests or it may improve the
metastatic melanomas or other cancers accuracy of currently available tests
Potential Commercial Applications: • Therapeutic monoclonal antibodies when used in concert.
• Production of cellular cancer • Cancer vaccine development The technology relates to methods for
vaccines Competitive Advantages: determining susceptibility to having an
• Treatments for immune-mediated extremely common age-associated
disorders • Immunogenic: SPANX–B peptides vascular disorder. It also describes the
• Treatments for cancer are naturally able to elicit immune subsequent use of these proteins as
• Treatments for chronic viral response. markers for disease. While the
infections • Expressed in a wide-range of underlying cellular and molecular
cancers. mechanisms of age-related vascular
Development Stage: • Use of epitope peptides facilitates
disease remain largely undefined, the
• Early-stage the activation of cells of the more
expression levels of the genes described
• In vitro data available therapeutically effective branch of the
• In vivo data available (animal) in this technology have been
immune system.
• In situ data available empirically determined to differ
• Small epitope peptides: Can be
• Ex vivo data available between healthy and age-inflamed
more easily manufactured in contrast to
arterial tissue. Further, this technology
Inventors: Bira Arya and Purevdorj recombinant proteins.
includes a companion mass
Olkhanud (NIA)
Intellectual Property: HHS Reference Development Stage: spectroscopic-based methodology for
No. E–101–2010/0—US Patent • In vitro data available reproducible quantification of specific
Application No. 13/577,226 filed 03 • In vivo data available (animal) expression levels of interest.
Aug 2012 Publication: Almanzar G, et al. Potential Commercial Applications:
Licensing Contact: Betty B. Tong, Sperm-derived SPANX–B is a clinically Diagnosis of age-related vascular
Ph.D.; 301–594–6565; tongb@ relevant tumor antigen that is expressed disorder.
mail.nih.gov in human tumors and readily Inventors: Mingyi Wang et al. (NIA)
Collaborative Research Opportunity: recognized by human CD4+ and CD8+ T Intellectual Property: HHS Reference
The National Institute on Aging, cells. Clin Cancer Res. 2009 Mar No. E–219–2008/0—US Patent
Laboratory of Molecular Biology and 15;15(6):1954–63. [PMID 19276289] Application No. 13/202,319 filed 18
Immunology, is seeking statements of Inventors: Bira Arya (NIA) and Aug 2011
capability or interest from parties Vladimir Larionov (NCI) Licensing Contact: Betty B. Tong,
interested in collaborative research to Intellectual Property: HHS Reference Ph.D.; 301–594–6565; tongb@
further develop, evaluate, or No. E–089–2009/0— mail.nih.gov
commercialize the utilization of • US Patent No. 8,664,183 issued 04 Collaborative Research Opportunity:
regulatory B cells to control Mar 2014 The National Institute on Aging,
autoimmune diseases and strategies that • US Patent Application No. 14/ Laboratory of Cardiovascular Science,
inactivate tBregs to control cancer 155,230 filed 14 Jan 2014 Cardiac Biology Section—Vascular
immune escape. Please contact Nicole Licensing Contact: Betty B. Tong, Group, is seeking statements of
Darack, Ph.D. at 240–276–5493 or Ph.D.; 301–594–6565; tongb@ capability or interest from parties
darackn@mail.nih.gov for more mail.nih.gov interested in collaborative research to
information. Collaborative Research Opportunity: further develop, evaluate, or
The National Institute on Aging, commercialize idea of how to assess and
Immunogenic Tumor-associated retard accelerated arterial aging and its
Laboratory of Molecular Biology and
Antigen SPANX–B for Selective Cancer attendant risks for atherosclerosis and
Immunology, is seeking statements of
Immunotherapy hypertension. Please contact Vio Conley
capability or interest from parties
Description of Technology: interested in collaborative research to at 240–276–5531 or conleyv@
Researchers at the National Institute on further develop, evaluate, or mail.nih.gov for more information.
Aging (NIA) have characterized a novel commercialize the use of SPANX–B-
tumor-associated antigen, SPANX–B, A Novel and Efficient Technology for
based therapeutic approaches to combat Targeted Delivery of siRNA
which is naturally immunogenic and is cancers. Please contact Nicole Darack,
expressed in a variety of human Ph.D. at 240–276–5493 or darackn@ Description of Technology: The
malignancies, including melanoma and mail.nih.gov for more information. biological phenomenon of RNA
lung, colon, renal, ovarian and breast interference (RNAi) has much promise
carcinomas. In melanoma specifically, Method for the Diagnosis and Prognosis for developing therapeutics to a variety
SPANX–B expression is associated with of Age-Related Cardiovascular of diseases. However, development of
advanced and metastatic disease. Disorders RNAi therapies remains mainly in
mstockstill on DSK4VPTVN1PROD with NOTICES
Moreover, the researchers have found Description of Technology: NIH preclinical stages largely because of
several agonist epitope peptides from investigators have discovered a method difficulties in delivering small
SPANX–B which can be used to activate for the diagnosis and prognosis of inhibitory RNAs (siRNA) and short
the immune system to eradicate tumors cardiovascular aging. Current hairpin RNAs (shRNA) into target cells.
utilizing T cells. SPANX–B peptides methodologies include the measurement Although viral vector-based siRNA
have significant clinical and of patient lipid profiles or expression of delivery systems have been widely
immunotherapeutic potential for the up to two proteins. In contrast, this used, their specificity and safety
development of cancer diagnostic assays technology utilizes the expression levels remains significant issue. Without a
VerDate Sep<11>2014 18:00 Sep 22, 2015 Jkt 235001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1](https://thefederalregister.org/doc/80_FR_57564/page/3.svg)
![Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices 57383
solution to this delivery problem, RNAi Collaborative Research Opportunity: Name of Committee: Center for Scientific
cannot fulfill its therapeutic promise. The National Institute on Aging, Review Special Emphasis Panel;
Investigators at the National Institutes Laboratory of Molecular Biology and Fellowships: Cell Biology, Developmental
of Health have developed novel Biology, and Bioengineering.
Immunology, is seeking statements of
Date: October 29–30, 2015.
compositions and methods for capability or interest from parties Time: 8:00 a.m. to 6:00 p.m.
delivering inhibitory oligonucleotides to interested in collaborative research to Agenda: To review and evaluate grant
cells in a targeted and efficient manner. further develop, evaluate, or applications.
The compositions and methods are commercialize chemokine-based siRNA/ Place: Hyatt Regency Bethesda, One
based on utilizing a cell surface receptor shRNA technology for treatment of Bethesda Metro Center, 7400 Wisconsin
targeting ligand, such as cytokine or cancers and autoimmune diseases, i.e. Avenue, Bethesda, MD 20814.
chemokine, and a domain that binds an to control expression of Contact Person: Raj K. Krishnaraju, Ph.D.,
inhibitory oligonucleotide, to efficiently immunomodulatory cytokines and other Scientific Review Officer, Center for
deliver the inhibitory oligonucleotide to Scientific Review, National Institutes of
factors that facilitate tumor escape, Health, 6701 Rockledge Drive, Room 6190,
the cell that expresses the cell surface activity of regulatory T cells or Th2 type Bethesda, MD 20892, 301–435–1047,
receptor targeting ligand. Chemokine of cells. This technology can be also kkrishna@csr.nih.gov.
receptors are differentially expressed on utilized to boost vaccine responses Name of Committee: Molecular, Cellular
various cells, including tumors; hence against cancers and chronic infectious and Developmental Neuroscience Integrated
this technology allows targeting siRNA diseases. Please contact John D. Hewes, Review Group; Cellular and Molecular
to aberrant cells. Gene silencing can also Ph.D. at 240–276–5515 or john.hewes@ Biology of Glia Study Section.
be achieved in variety of immune cells nih.gov for more information. Date: October 29–30, 2015.
by targeting cytokine receptors. This Time: 8:00 a.m. to 2:00 p.m.
Dated: September 17, 2015.
technology has great potential for Agenda: To review and evaluate grant
developing into a safe and effective Richard U. Rodriguez, applications.
means of delivering therapeutic siRNAs. Acting Director, Office of Technology Place: Hilton McLean Tysons Corner, 7920
Transfer, National Institutes of Health. Jones Branch Drive, McLean, VA 22102.
Potential Commercial Applications [FR Doc. 2015–24137 Filed 9–22–15; 8:45 am] Contact Person: Linda MacArthur, Ph.D.,
• Treatment of cancers and BILLING CODE 4140–01–P
Scientific Review Officer, Center for
autoimmune diseases by delivery of Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4187,
siRNA to tumor cells or various Bethesda, MD 20892, 301–537–9986,
aberrantly functioning immune cells. DEPARTMENT OF HEALTH AND macarthurlh@csr.nih.gov.
• This technology can be used to HUMAN SERVICES
Name of Committee: Oncology 1-Basic
boost vaccine responses against cancers Translational Integrated Review Group;
and chronic infectious diseases. National Institutes of Health
Tumor Progression and Metastasis Study
• Targeted delivery of fluorochrome- Section.
labeled RNA both in vitro and in vivo for Center for Scientific Review; Notice of
Date: October 29–30, 2015.
diagnostic purposes, for example, to Closed Meetings Time: 8:00 a.m. to 6:00 p.m.
trace or localize various cells and to Pursuant to section 10(d) of the Agenda: To review and evaluate grant
determine tumor metastasis and Federal Advisory Committee Act, as applications.
aberrant proliferation or homing of Place: Embassy Suites, DC Convention
amended (5 U.S.C. App.), notice is Center, 900 10 Street, Washington, DC 20001.
immune cells. hereby given of the following meetings. Contact Person: Rolf Jakobi, Ph.D.,
Competitive Advantages The meetings will be closed to the Scientific Review Officer, Center for
public in accordance with the Scientific Review, National Institutes of
• Simple method for linking siRNA to provisions set forth in sections Health, 6701 Rockledge Drive, Room 6187,
polypeptides to create non-covalent or 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., MSC 7806, Bethesda, MD 20892, 301–495–
covalent complexes as amended. The grant applications and 1718, jakobir@mail.nih.gov.
• In vivo targeted delivery of
the discussions could disclose Name of Committee: Center for Scientific
inhibitory RNAs into cells rather than Review Special Emphasis Panel; Topics in
confidential trade secrets or commercial
systemically Bacterial Pathogenesis.
• Delivery of multiple inhibitory property such as patentable material,
and personal information concerning Date: October 29–30, 2015.
RNAs to target multiple genes Time: 8:00 a.m. to 6:00 p.m.
• Long-term repression of target gene individuals associated with the grant
Agenda: To review and evaluate grant
expression through RNAi phenomenon applications, the disclosure of which applications.
would constitute a clearly unwarranted Place: The Warwick Allerton Hotel, 701
Development Stage invasion of personal privacy. North Michigan Avenue, Chicago, IL 60611.
• In vitro data available Name of Committee: Center for Scientific Contact Person: Richard G. Kostriken,
• In vivo data available (animal) Review Special Emphasis Panel; Member Ph.D., Scientific Review Officer, Center for
• In situ data available Conflict: Bioengineering Sciences Scientific Review, National Institutes of
Inventors: Bira Arya, Purevdorj Biocomputational and Modeling. Health, 6701 Rockledge Drive, Room 3192,
Date: October 28, 2015. MSC 7808, Bethesda, MD 20892, 240–519–
Olkhanud, Juan Espinoza (all of NIA)
Time: 2:00 p.m. to 4:30 p.m. 7808, kostrikr@csr.nih.gov.
Intellectual Property: HHS Reference
No. E–051–2008/0— Agenda: To review and evaluate grant Name of Committee: Center for Scientific
• US Patent No. 8,703,921 issued 22 applications. Review Special Emphasis Panel;
Place: National Institutes of Health, 6701 Fellowships: Biophysical, Physiological,
mstockstill on DSK4VPTVN1PROD with NOTICES
Apr 2014
Rockledge Drive, Bethesda, MD 20892, Pharmacological and Bioengineering
• US Patent Application No. 14/ (Telephone Conference Call). Neuroscience.
220,726 filed 20 Mar 2014 Contact Person: Joseph Thomas Peterson, Date: October 29–30, 2015.
• Various international patents/patent Ph.D., Scientific Review Officer, Center for Time: 8:00 a.m. to 5:00 p.m.
applications Scientific Review, National Institutes of Agenda: To review and evaluate grant
Licensing Contact: Betty B. Tong, Health, 6701 Rockledge Drive, Room 4118, applications.
Ph.D.; 301–594–6565; tongb@ MSC 7814, Bethesda, MD 20892, 301–408– Place: The Westin Georgetown, 2350 M St.
mail.nih.gov 9694, petersonjt@csr.nih.gov. NW., Washington, DC 20037.
VerDate Sep<11>2014 18:00 Sep 22, 2015 Jkt 235001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1](https://thefederalregister.org/doc/80_FR_57564/page/4.svg)
Document Created: 2015-12-15 09:45:06
Document Modified: 2015-12-15 09:45:06
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 80 FR 57380 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR