80 FR 46309 - Government-Owned Inventions; Availability for Licensing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 149 (August 4, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 149 (August 4, 2015)
| Page Range | 46309-46311 | |
| FR Document | 2015-19082 |
[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)] [Notices] [Pages 46309-46311] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-19082] ----------------------------------------------------------------------- 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. Interferon Alpha Hybrids Description of Technology: Available for licensing are hybrid interferon alpha (INF-alpha) polypeptides constructed by combinations of INFalpha21b and INFalpha2c, and mutants of these hybrids. These hybrid constructs have resulted in novel IFNs that either combine different biological properties from the parent proteins or have significantly different biological activity from both the parents in anti-proliferative, anti-viral, or competitive binding properties. For instance, the hybrid designated HY-3 has higher anti-proliferative activity in Daudi, WISH, and primary human lymphocyte cells exhibiting approximately 6 times higher anti-proliferative activity than either parent IFN. These IFN hybrids provide a powerful tool for studying the structure-function relationship of these molecules. The engineered IFN- alpha proteins may have important new therapeutic applications and may provide greater insights into understanding of the clinical activities of existing IFN-alphas. Also available for licensing are hybrid INF-alpha nucleic acids encoding the hybrid polypeptides as well as cells, vectors, pharmaceutical compositions with these nucleic acid sequences. Potential Commercial ApplicationsAnti-viral and cancer therapeutics Research tool to study IFN-alpha functions Competitive Advantages Ease of manufacture Strong anti-viral activity Development Stage: In vitro data available. Inventors: Kathryn C. Zoon (NIAID), Joseph B. Bekisz (NIAID), Mark P. Hayes (FDA), Renqiu Hu (FDA). Publications 1. Hu R, et al. Protein engineering of interferon alphas. Methods Mol Med. 2005;116:69-80. [PMID 16000855] 2. Hu R, et al. Human IFN-alpha protein engineering: the amino acid residues at positions 86 and 90 are important for antiproliferative activity. J Immunol. 2001 Aug 1;167(3):1482-9. [PMID 11466368] 3. Hu R, et al. Divergence of binding, signaling, and biological responses to recombinant human hybrid IFN. J Immunol. 1999 Jul 15;163(2):854-60. [PMID 10395679] Intellectual Property: HHS Reference No. E-068-1998/0-- US Patent No. 6,685,933 issued 03 Feb 2004 US Patent No. 7,235,232 issued 26 Jun 2007 Licensing Contact: Peter Soukas; 301-435-4646; ps193c@nih.gov. Novel Treatment for Anemia and Polycythemia: AVPR1B Molecules Modulating Erythropoiesis Description of Technology: Anemia can be caused by chronic diseases, chemotherapy, or radiation. Erythropoietin is commonly used to stimulate red blood cell production for anemia treatment, but it takes about a week to manifest its clinical effect. The [[Page 46310]] subject invention describes the arginine vasopressin receptor 1B (AVPR1B) stimulatory molecules that can be used to stimulate hematopoietic stem cell proliferation. Preliminary results from animal studies suggest that the number of red blood cells and their precursors significantly increased on day 2 following AVP administration, an onset time much faster than erythropoietin. The AVPR1B stimulatory molecules can be used to jumpstart the system and erythropoietin can be used to sustain the effect. In addition, the AVPR1B inhibitory molecules can be used to suppress hematopoietic stem cell proliferation to treat polycythemia (overproduction of red blood cells). Potential Commercial Applications Treatment of anemia caused by chronic diseases, chemotherapy, or radiation. Anemia patients who do not respond to erythropoietin. Polycythemia treatment. Competitive Advantages: AVPR1B stimulatory molecules act faster than the commonly used erythropoietin for anemia treatment. Development Stage Early-stage In vivo data available (animal) Inventors: Eva Mezey and Miklos Krepuska (NIDCR); Balazs Mayer and Krisztian Nemeth (Semmelweis University Medical School) Intellectual Property: HHS Reference No. E-619-2013/0-- US Application No. 61/885,258 filed October 01, 2013 (E-619- 2013/0-US-01) PCT Application No. PCT/US2014/058613 filed October 01, 2014 (E-619-2013/0-PCT-02) Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5605; hus@mail.nih.gov. 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 treatment for anemia and polycythemia. For collaboration opportunities, please contact David Bradley, Ph.D. at bradleyda@nidcr.nih.gov. Modified AAV5 Vectors for Enhanced Transduction and Reduced Antibody Neutralization Description of Technology: Adeno-associated viruses (AAVs) are small nonpathogenic viruses and can integrate into the cellular genome. AAV vectors are among the most frequently used viral vectors for gene therapy because AAV vectors can infect both dividing and non-dividing cells, and can establish long-term transgene expression. Two major issues in gene therapy are the ability to efficiently transduce the target cells and to evade the immune response to vectors. The subject invention describes a mutated AAV serotype 5 by modifying sialic acid binding regions which mediate viral entry into host cells. Preliminary results from animal studies suggest that this modification can increase transduction by 3-4 folds in salivary glands and muscle, and can significantly decrease the potential of being neutralized by preexisting antibodies compared to the wild type. Thus, the modified AAV5 vectors seem to be optimal for gene therapy. Potential Commercial Applications: Genetically engineered AAV5 vectors for gene therapy. Competitive Advantages Enhanced transduction activity. Reduced the potential for being neutralized by preexisting antibodies. Development Stage Early-stage In vivo data available (animal) Inventors: John Chiorini and Sandra Afione-Wainer (NIDCR); Mavis Agbandje-Mckenna and Sujata Halder (University of Florida). Publications 1. Afione S, et al. Identification and mutagenesis of the adeno- associated virus 5 sialic acid binding region. J Virol. 2015 Feb; 89(3): 1660-72. [PMID 25410855] 2. Chiorini J, et al. AAV4 Vector and the uses thereof. U.S. Patent 6,468,524, issued on October 22, 2002. 3. Chiorini J, et al. AAV5 Vector and the uses thereof. U.S. Patent 7,479,554, issued January 20, 2009, and U.S. Patent 6.984,517, issued on January 10, 2006. 4. Chiorini J, et al. AAV5 Vector for transducing brain cells and lung cells. U.S. Patent 6,855,314, issued on February 15, 2005. Intellectual Property: HHS Reference No. E-097-2015/0--US Application No. 62/143,524 filed April 6, 2015. Related Technologies E-175-2015: US 62/160,552. E-736-2013: PCT/US14/59825. E-142-2011 family: PCT/US12/34268, CA, EP and US. E-087-2011 family: PCT/US12/33556, EP and US. E-232-2011: US 14/428,929. E-194-2010: US 8,808,684. E-179-2005: US 8,283,151. E-227-2004: US 7,407,801. E-329-2003 family: US 8,137,960, US 8,685,722. E-105-2003: US 8,927,269. E-308-2001: US 7,419,817. E-071-2000: US 6,468,524. E-127-1998 family: US 6,984,517, AU, CA, EP, and JP. Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5606; hus@mail.nih.gov. 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 modified AAV5 vector for gene therapy. For collaboration opportunities, please contact David Bradley, Ph.D. at bradleyda@nidcr.nih.gov. A Novel Adeno-Associated Virus for Gene Therapy Description of Technology: Adeno-associated viruses (AAVs) are small nonpathogenic viruses and can integrate into the cellular genome. AAV vectors are among the most frequently used viral vectors for gene therapy because AAV vectors can infect both dividing and non-dividing cells, and can establish long-term transgene expression. The subject invention describes a novel AAV termed ``44-9.'' AAV44-9 based vectors have high gene transfer activity in a number of cell types, including salivary gland cells, liver cells, and different types of neurons (e.g., cells of the cortex, olfactory bulb, and brain stem, and Purkinje cells of the cerebellum). These vectors can deliver heterologous genes to particular target cells through site-specific administration. Preliminary results from animal studies suggest that AAV44-9 vectors can efficiently deliver genes of interest, and the protein products of the delivered genes can be detected in bloodstream and at the local tissues. Therefore, these vectors are suitable for gene therapy for cells/tissues that are not efficiently targeted by other vectors. Potential Commercial Applications: AAV44-9 can be used as a delivery vector in gene therapy. Competitive Advantages High gene transfer activity in a number of cell types including salivary gland cells, liver cells, and different types of neurons (e.g., cells of the cortex, olfactory bulb, and brain stem, and Purkinje cells of the cerebellum). As a gene transfer vector for cells that are not efficiently targeted by other vector. [[Page 46311]] Development Stage In vitro data available In vivo data available (animal) Inventors: John Chiorini and Giovanni Pasquale (NIDCR). Publication: Schmidt M, et al. Identification and characterization of novel adeno-associated virus isolates in ATCC virus stocks. J Virol. 2006 May; 80 (10): 5082-5098. [PMID 16641301] Intellectual Property: HHS Reference No. E-175-2015/0--US Application No. 62/160,552 filed May 12, 2015. Related Technologies E-097-2015: US 62/143,524. E-736-2013: PCT/US14/59825. E-142-2011 family: PCT/US12/34268, CA, EP and US. E-087-2011 family: PCT/US12/33556, EP and US. E-232-2011: US 14/428,929. E-194-2010: US 8,808,684. E-179-2005: US 8,283,151. E-227-2004: US 7,407,801. E-329-2003 family: US 8,137,960, US 8,685,722. E-105-2003: US 8,927,269. E-308-2001: US 7,419,817. E-071-2000: US 6,468,524. E-127-1998 family: US 6,984,517, AU, CA, EP, and JP. Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5606; hus@mail.nih.gov. 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 AAV44-9 vector for gene therapy. For collaboration opportunities, please contact David Bradley, Ph.D. at bradleyda@nidcr.nih.gov. WNT1-Induced Secreted Protein-1 Knockout Mouse Model Description of Technology: WNT1-induced secreted protein-1 (WISP1) is expressed at high levels in osteoblasts and their precursors. WIPS1 plays an important role in various aspects of bone formation. Scientists at the NIH generated Wisp1-deficient (Wisp1-/-) mice. Deletion of Wisp1 resulted in a decrease in bone mineral density, total bone volume, bone thickness, and biomechanical strength. Wisp1 knockout mouse model can be used to study the molecular mechanisms of bone turnover and patho/physiology of tissues that express WISP1. Potential Commercial Applications To study the molecular mechanisms of bone formation and osteodifferentiation. To study the patho/physiology of tissues that express WISP1, including cartilage during osteoarthritis, healing skin, and other soft tissues including lung, pancreas, and heart. Development Stage: In vivo data available (animal). Inventors: Marian F. Young, Mitsuaki Ono, Azusa Maeda (all of NIDCR). Publication: Maeda A, et al. WNT1-induced secreted protein-1 (WISP1), a novel regulator of bone turnover and Wnt signaling. J Bio Chem. 2015 May 29;290(22):14004-18. [PMID 25864198] Intellectual Property: HHS Reference No. E-234-2015/0--Research Tool. Patent protection is not being pursued for this technology. Licensing Contact: Sally Hu, Ph.D., M.B.A.; 301-435-5606; hus@mail.nih.gov 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 WNT1-Induced Secreted Protein-1 Knockout Mouse Model. For collaboration opportunities, please contact David Bradley, Ph.D. at bradleyda@nidcr.nih.gov. Dated: July 30, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015-19082 Filed 8-3-15; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices 46309
Place: National Institutes of Health, any additional information for the meeting binding properties. For instance, the
Building 31, 31 Center Drive, Conference will be posted when available. hybrid designated HY–3 has higher anti-
Room 10, Bethesda, MD 20892. (Catalogue of Federal Domestic Assistance proliferative activity in Daudi, WISH,
Contact Person: Brent B. Stanfield, Ph.D., Program Nos. 93.847, Diabetes,
Director, Division of Extramural Activities,
and primary human lymphocyte cells
Endocrinology and Metabolic Research;
National Institutes of Diabetes And Digestive exhibiting approximately 6 times higher
93.848, Digestive Diseases and Nutrition
and Kidney Diseases, 6707 Democracy Blvd. Research; 93.849, Kidney Diseases, Urology anti-proliferative activity than either
Room 715, MSC 5452, Bethesda, MD 20892, and Hematology Research, National Institutes parent IFN. These IFN hybrids provide
(301) 594–8843, stanfibr@niddk.nih.gov. of Health, HHS) a powerful tool for studying the
Name of Committee: National Diabetes and Dated: July 29, 2015. structure-function relationship of these
Digestive and Kidney Diseases Advisory molecules. The engineered IFN-alpha
Council; Kidney, Urologic and Hematologic David Clary,
proteins may have important new
Diseases Subcommittee. Program Analyst, Office of Federal Advisory
Committee Policy.
therapeutic applications and may
Date: September 9, 2015. provide greater insights into
Open: 1:00 p.m. to 3:00 p.m. [FR Doc. 2015–19024 Filed 8–3–15; 8:45 am]
Agenda: To review the Division’s scientific understanding of the clinical activities
BILLING CODE 4140–01–P
and planning activities. of existing IFN-alphas.
Place: National Institutes of Health, Also available for licensing are hybrid
Building 31, 31 Center Drive, Conference INF-alpha nucleic acids encoding the
DEPARTMENT OF HEALTH AND
Room 7, Bethesda, MD 20892. hybrid polypeptides as well as cells,
Closed: 3:00 p.m. to 3:30 p.m. HUMAN SERVICES
vectors, pharmaceutical compositions
Agenda: To review and evaluate grant with these nucleic acid sequences.
applications. National Institutes of Health
Place: National Institutes of Health, Potential Commercial Applications
Building 31, 31 Center Drive, Conference Government-Owned Inventions;
Room 7, Bethesda, MD 20892. Availability for Licensing • Anti-viral and cancer therapeutics
Contact Person: Brent B. Stanfield, Ph.D., • Research tool to study IFN-alpha
AGENCY: National Institutes of Health, functions
Director, Division of Extramural Activities,
HHS.
National Institutes of Diabetes And Digestive
ACTION: Notice. Competitive Advantages
and Kidney Diseases, 6707 Democracy Blvd.
Room 715, MSC 5452, Bethesda, MD 20892, • Ease of manufacture
SUMMARY: The inventions listed below
(301) 594–8843, stanfibr@niddk.nih.gov. • Strong anti-viral activity
are owned by an agency of the U.S.
Name of Committee: National Diabetes and Development Stage: In vitro data
Digestive and Kidney Diseases Advisory Government and are available for
licensing in the U.S. in accordance with available.
Council; Digestive Diseases and Nutrition
35 U.S.C. 209 and 37 CFR part 404 to Inventors: Kathryn C. Zoon (NIAID),
Subcommittee.
Date: September 9, 2015. achieve expeditious commercialization Joseph B. Bekisz (NIAID), Mark P. Hayes
Open: 1:00 p.m. to 3:00 p.m. of results of federally-funded research (FDA), Renqiu Hu (FDA).
Agenda: To review the Division’s scientific and development. Foreign patent Publications
and planning activities. applications are filed on selected
Place: National Institutes of Health, inventions to extend market coverage 1. Hu R, et al. Protein engineering of
Building 31, 31 Center Drive, Conference interferon alphas. Methods Mol Med.
for companies and may also be available
Room 6, Bethesda, MD 20892. 2005;116:69–80. [PMID 16000855]
Closed: 3:00 p.m. to 3:30 p.m. for licensing. 2. Hu R, et al. Human IFN-alpha protein
Agenda: To review and evaluate grant FOR FURTHER INFORMATION CONTACT: engineering: the amino acid residues at
applications. Licensing information and copies of the positions 86 and 90 are important for
Place: National Institutes of Health, U.S. patent applications listed below antiproliferative activity. J Immunol.
Building 31, 31 Center Drive, Conference may be obtained by writing to the 2001 Aug 1;167(3):1482–9. [PMID
Room 6, Bethesda, MD 20892. indicated licensing contact at the Office 11466368]
Contact Person: Brent B. Stanfield, Ph.D., 3. Hu R, et al. Divergence of binding,
of Technology Transfer, National
Director, Division Of Extramural Activities, signaling, and biological responses to
National Institutes of Diabetes And Digestive Institutes of Health, 6011 Executive
recombinant human hybrid IFN. J
and Kidney Diseases, 6707 Democracy Blvd. Boulevard, Suite 325, Rockville, Immunol. 1999 Jul 15;163(2):854–60.
Room 715, MSC 5452, Bethesda, MD 20892 Maryland 20852–3804; telephone: 301– [PMID 10395679]
(301) 594–8843, stanfibr@niddk.nih.gov. 496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will Intellectual Property: HHS Reference
Any interested person may file written
comments with the committee by forwarding be required to receive copies of the No. E–068–1998/0—
the statement to the Contact Person listed on patent applications. • US Patent No. 6,685,933 issued 03
this notice. The statement should include the SUPPLEMENTARY INFORMATION: Feb 2004
name, address, telephone number and when
Technology descriptions follow. • US Patent No. 7,235,232 issued 26 Jun
applicable, the business or professional 2007
affiliation of the interested person. Interferon Alpha Hybrids
In the interest of security, NIH has Licensing Contact: Peter Soukas; 301–
instituted stringent procedures for entrance Description of Technology: Available 435–4646; ps193c@nih.gov.
onto the NIH campus. All visitor vehicles, for licensing are hybrid interferon alpha
(INF-alpha) polypeptides constructed by Novel Treatment for Anemia and
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on combinations of INFalpha21b and Polycythemia: AVPR1B Molecules
campus. Visitors will be asked to show one INFalpha2c, and mutants of these Modulating Erythropoiesis
form of identification (for example, a
tkelley on DSK3SPTVN1PROD with NOTICES
hybrids. These hybrid constructs have Description of Technology: Anemia
government-issued photo ID, driver’s license, resulted in novel IFNs that either can be caused by chronic diseases,
or passport) and to state the purpose of their
visit.
combine different biological properties chemotherapy, or radiation.
Information is also available on the from the parent proteins or have Erythropoietin is commonly used to
Institute’s/Center’s home page: significantly different biological activity stimulate red blood cell production for
www.niddk.nih.gov/fund/divisions/DEA/ from both the parents in anti- anemia treatment, but it takes about a
Council/coundesc.htm., where an agenda and proliferative, anti-viral, or competitive week to manifest its clinical effect. The
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![46310 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices
subject invention describes the arginine are among the most frequently used • E–227–2004: US 7,407,801.
vasopressin receptor 1B (AVPR1B) viral vectors for gene therapy because • E–329–2003 family: US 8,137,960,
stimulatory molecules that can be used AAV vectors can infect both dividing US 8,685,722.
to stimulate hematopoietic stem cell and non-dividing cells, and can • E–105–2003: US 8,927,269.
proliferation. Preliminary results from establish long-term transgene • E–308–2001: US 7,419,817.
animal studies suggest that the number expression. Two major issues in gene • E–071–2000: US 6,468,524.
of red blood cells and their precursors therapy are the ability to efficiently • E–127–1998 family: US 6,984,517,
significantly increased on day 2 transduce the target cells and to evade AU, CA, EP, and JP.
following AVP administration, an onset the immune response to vectors. The Licensing Contact: Sally Hu, Ph.D.,
time much faster than erythropoietin. subject invention describes a mutated M.B.A.; 301–435–5606; hus@
The AVPR1B stimulatory molecules can AAV serotype 5 by modifying sialic acid mail.nih.gov.
be used to jumpstart the system and binding regions which mediate viral Collaborative Research Opportunity:
erythropoietin can be used to sustain entry into host cells. Preliminary results The National Institute of Dental and
the effect. In addition, the AVPR1B from animal studies suggest that this Craniofacial Research is seeking
inhibitory molecules can be used to modification can increase transduction statements of capability or interest from
suppress hematopoietic stem cell by 3–4 folds in salivary glands and parties interested in collaborative
proliferation to treat polycythemia muscle, and can significantly decrease research to further develop, evaluate or
(overproduction of red blood cells). the potential of being neutralized by commercialize modified AAV5 vector
preexisting antibodies compared to the for gene therapy. For collaboration
Potential Commercial Applications opportunities, please contact David
wild type. Thus, the modified AAV5
• Treatment of anemia caused by vectors seem to be optimal for gene Bradley, Ph.D. at bradleyda@
chronic diseases, chemotherapy, or therapy. nidcr.nih.gov.
radiation. Potential Commercial Applications: A Novel Adeno-Associated Virus for
• Anemia patients who do not Genetically engineered AAV5 vectors Gene Therapy
respond to erythropoietin. for gene therapy.
• Polycythemia treatment. Description of Technology: Adeno-
Competitive Advantages: AVPR1B Competitive Advantages associated viruses (AAVs) are small
stimulatory molecules act faster than the • Enhanced transduction activity. nonpathogenic viruses and can integrate
commonly used erythropoietin for • Reduced the potential for being into the cellular genome. AAV vectors
anemia treatment. neutralized by preexisting antibodies. are among the most frequently used
viral vectors for gene therapy because
Development Stage Development Stage AAV vectors can infect both dividing
• Early-stage • Early-stage and non-dividing cells, and can
• In vivo data available (animal) • In vivo data available (animal) establish long-term transgene
Inventors: John Chiorini and Sandra expression. The subject invention
Inventors: Eva Mezey and Miklos
Afione-Wainer (NIDCR); Mavis describes a novel AAV termed ‘‘44–9.’’
Krepuska (NIDCR); Balazs Mayer and
Agbandje-Mckenna and Sujata Halder AAV44–9 based vectors have high gene
Krisztian Nemeth (Semmelweis
(University of Florida). transfer activity in a number of cell
University Medical School)
types, including salivary gland cells,
Intellectual Property: HHS Reference Publications liver cells, and different types of
No. E–619–2013/0—
1. Afione S, et al. Identification and neurons (e.g., cells of the cortex,
• US Application No. 61/885,258 filed olfactory bulb, and brain stem, and
mutagenesis of the adeno-associated
October 01, 2013 (E–619–2013/0–US– virus 5 sialic acid binding region. J Virol. Purkinje cells of the cerebellum). These
01) 2015 Feb; 89(3): 1660–72. [PMID vectors can deliver heterologous genes
• PCT Application No. PCT/US2014/ 25410855] to particular target cells through site-
058613 filed October 01, 2014 (E– 2. Chiorini J, et al. AAV4 Vector and the uses specific administration. Preliminary
619–2013/0–PCT–02) thereof. U.S. Patent 6,468,524, issued on results from animal studies suggest that
Licensing Contact: Sally Hu, Ph.D., October 22, 2002.
3. Chiorini J, et al. AAV5 Vector and the uses
AAV44–9 vectors can efficiently deliver
M.B.A.; 301–435–5605; hus@ genes of interest, and the protein
thereof. U.S. Patent 7,479,554, issued
mail.nih.gov. January 20, 2009, and U.S. Patent products of the delivered genes can be
Collaborative Research Opportunity: 6.984,517, issued on January 10, 2006. detected in bloodstream and at the local
The National Institute of Dental and 4. Chiorini J, et al. AAV5 Vector for tissues. Therefore, these vectors are
Craniofacial Research is seeking transducing brain cells and lung cells. suitable for gene therapy for cells/
statements of capability or interest from U.S. Patent 6,855,314, issued on tissues that are not efficiently targeted
parties interested in collaborative February 15, 2005. by other vectors.
research to further develop, evaluate or Intellectual Property: HHS Reference Potential Commercial Applications:
commercialize treatment for anemia and No. E–097–2015/0—US Application No. AAV44–9 can be used as a delivery
polycythemia. For collaboration 62/143,524 filed April 6, 2015. vector in gene therapy.
opportunities, please contact David
Bradley, Ph.D. at bradleyda@ Related Technologies Competitive Advantages
nidcr.nih.gov. • E–175–2015: US 62/160,552. • High gene transfer activity in a
Modified AAV5 Vectors for Enhanced • E–736–2013: PCT/US14/59825. number of cell types including salivary
tkelley on DSK3SPTVN1PROD with NOTICES
• E–142–2011 family: PCT/US12/ gland cells, liver cells, and different
Transduction and Reduced Antibody
34268, CA, EP and US. types of neurons (e.g., cells of the
Neutralization
• E–087–2011 family: PCT/US12/ cortex, olfactory bulb, and brain stem,
Description of Technology: Adeno- 33556, EP and US. and Purkinje cells of the cerebellum).
associated viruses (AAVs) are small • E–232–2011: US 14/428,929. • As a gene transfer vector for cells
nonpathogenic viruses and can integrate • E–194–2010: US 8,808,684. that are not efficiently targeted by other
into the cellular genome. AAV vectors • E–179–2005: US 8,283,151. vector.
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![Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices 46311
Development Stage • To study the patho/physiology of Emphasis Panel; Review of U24 Applications
tissues that express WISP1, including for Parkinson’s Disease Repositories.
• In vitro data available Date: August 11, 2015.
• In vivo data available (animal) cartilage during osteoarthritis, healing
Time: 9:00 a.m. to 1:00 p.m.
skin, and other soft tissues including
Inventors: John Chiorini and Giovanni Agenda: To review and evaluate grant
lung, pancreas, and heart. applications.
Pasquale (NIDCR).
Publication: Schmidt M, et al. Development Stage: In vivo data Place: National Institutes of Health,
Identification and characterization of available (animal). Neuroscience Center, 6001 Executive
novel adeno-associated virus isolates in Inventors: Marian F. Young, Mitsuaki Boulevard, Rockville, MD 20852, (Telephone
Ono, Azusa Maeda (all of NIDCR). Conference Call).
ATCC virus stocks. J Virol. 2006 May; Contact Person: Joel A. Saydoff, Ph.D.,
80 (10): 5082–5098. [PMID 16641301] Publication: Maeda A, et al. WNT1-
Scientific Review Officer, Scientific Review
Intellectual Property: HHS Reference induced secreted protein-1 (WISP1), a Branch, Division of Extramural Research,
No. E–175–2015/0—US Application No. novel regulator of bone turnover and NINDS/NIH/DHHS/Neuroscience Center,
62/160,552 filed May 12, 2015. Wnt signaling. J Bio Chem. 2015 May 6001 Executive Boulevard, Suite 3205, MSC
29;290(22):14004–18. [PMID 25864198] 9529, Bethesda, MD 20892–9529, 301–435–
Related Technologies Intellectual Property: HHS Reference 9223, joel.saydoff@nih.gov.
• E–097–2015: US 62/143,524. No. E–234–2015/0—Research Tool. Name of Committee: National Institute of
• E–736–2013: PCT/US14/59825. Patent protection is not being pursued Neurological Disorders and Stroke Special
• E–142–2011 family: PCT/US12/ for this technology. Emphasis Panel; Review of U01 Applications
34268, CA, EP and US. Licensing Contact: Sally Hu, Ph.D., for Parkinson’s Disease Biomarker Program.
• E–087–2011 family: PCT/US12/ M.B.A.; 301–435–5606; hus@
Date: August 12, 2015.
33556, EP and US. Time: 8:00 a.m. to 12:00 p.m.
mail.nih.gov Agenda: To review and evaluate grant
• E–232–2011: US 14/428,929. Collaborative Research Opportunity: applications.
• E–194–2010: US 8,808,684. The National Institute of Dental and Place: National Institutes of Health,
• E–179–2005: US 8,283,151. Craniofacial Research is seeking Neuroscience Center, 6001 Executive
• E–227–2004: US 7,407,801. statements of capability or interest from Boulevard, Rockville, MD 20852, (Telephone
• E–329–2003 family: US 8,137,960, Conference Call).
parties interested in collaborative
US 8,685,722. Contact Person: Joel A. Saydoff, Ph.D.,
research to further develop, evaluate or
• E–105–2003: US 8,927,269. Scientific Review Officer, Scientific Review
• E–308–2001: US 7,419,817. commercialize WNT1-Induced Secreted Branch, Division of Extramural Research,
• E–071–2000: US 6,468,524. Protein-1 Knockout Mouse Model. For NINDS/NIH/DHHS/Neuroscience Center,
• E–127–1998 family: US 6,984,517, collaboration opportunities, please 6001 Executive Boulevard, Suite 3205, MSC
AU, CA, EP, and JP. contact David Bradley, Ph.D. at 9529, Bethesda, MD 20892–9529, 301–435–
Licensing Contact: Sally Hu, Ph.D., bradleyda@nidcr.nih.gov. 9223.
M.B.A.; 301–435–5606; hus@ Dated: July 30, 2015. (Catalogue of Federal Domestic Assistance
mail.nih.gov. Program Nos. 93.853, Clinical Research
Richard U. Rodriguez,
Related to Neurological Disorders; 93.854,
Collaborative Research Opportunity: Acting Director, Office of Technology Biological Basis Research in the
The National Institute of Dental and Transfer, National Institutes of Health. Neurosciences, National Institutes of Health,
Craniofacial Research is seeking [FR Doc. 2015–19082 Filed 8–3–15; 8:45 am] HHS)
statements of capability or interest from BILLING CODE 4140–01–P Dated: July 29, 2015.
parties interested in collaborative
research to further develop, evaluate or Carolyn Baum,
commercialize AAV44–9 vector for gene Program Analyst, Office of Federal Advisory
DEPARTMENT OF HEALTH AND Committee Policy.
therapy. For collaboration HUMAN SERVICES
opportunities, please contact David [FR Doc. 2015–19032 Filed 8–3–15; 8:45 am]
Bradley, Ph.D. at bradleyda@ National Institutes of Health BILLING CODE 4140–01–P
nidcr.nih.gov.
National Institute of Neurological
WNT1-Induced Secreted Protein-1 Disorders and Stroke: Notice of Closed DEPARTMENT OF HEALTH AND
Knockout Mouse Model Meetings HUMAN SERVICES
Description of Technology: WNT1-
induced secreted protein-1 (WISP1) is Pursuant to section 10(d) of the National Institutes of Health
expressed at high levels in osteoblasts Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is Center for Scientific Review: Notice of
and their precursors. WIPS1 plays an Closed Meeting
important role in various aspects of hereby given of the following meetings.
bone formation. Scientists at the NIH The meetings will be closed to the Pursuant to section 10(d) of the
generated Wisp1-deficient (Wisp1-/-) public in accordance with the Federal Advisory Committee Act, as
mice. Deletion of Wisp1 resulted in a provisions set forth in sections amended (5 U.S.C. App.), notice is
decrease in bone mineral density, total 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., hereby given of the following meeting.
bone volume, bone thickness, and as amended. The grant applications and The meeting will be closed to the
biomechanical strength. Wisp1 the discussions could disclose public in accordance with the
knockout mouse model can be used to confidential trade secrets or commercial provisions set forth in sections
study the molecular mechanisms of property such as patentable material, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
and personal information concerning
tkelley on DSK3SPTVN1PROD with NOTICES
bone turnover and patho/physiology of as amended. The grant applications and
tissues that express WISP1. individuals associated with the grant the discussions could disclose
applications, the disclosure of which confidential trade secrets or commercial
Potential Commercial Applications would constitute a clearly unwarranted property such as patentable material,
• To study the molecular mechanisms invasion of personal privacy. and personal information concerning
of bone formation and Name of Committee: National Institute of individuals associated with the grant
osteodifferentiation. Neurological Disorders and Stroke Special applications, the disclosure of which
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| Collection | Federal Register | |
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| 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. | |
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