80_FR_15847 80 FR 15790 - Government-Owned Inventions; Availability for Licensing

80 FR 15790 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 57 (March 25, 2015)

Page Range15790-15791
FR Document2015-06845

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.

Federal Register, Volume 80 Issue 57 (Wednesday, March 25, 2015) 
[Federal Register Volume 80, Number 57 (Wednesday, March 25, 2015)]
[Notices]
[Pages 15790-15791]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06845]


-----------------------------------------------------------------------

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.

Engineered Antibody Domains With Increased FcRn Binding and in vivo 
Half-Life

    Description of Technology: Monoclonal antibodies (mAbs) are a fast 
growing class of new therapeutic molecules. However, their large size 
remains a significant challenge, preventing them from targeting 
sterically restricted epitopes and efficiently penetrating into 
tissues. Smaller antibody fragments and engineered variants are under 
development to address this challenge, but to date their therapeutic 
applications have been limited due to rapid clearance and short half-
life which greatly decrease their efficacy in vivo.
    This technology describes two antibody constant domains or binders 
with increased FcRn binding and in vivo half-life. In addition, these 
binders are small in size (16kDa), very stable, and can be efficiently 
expressed in E. coli. As a result, the binders are particularly well 
suited as scaffolds for the generation of antibody libraries, from 
which a desired antigen binders could be developed into therapeutic 
products with much greater potency compared to existing mAbs. They 
could also be used as fusion partners to extend the half-life of 
candidate protein therapeutics.

Potential Commercial Applications

     Antibody scaffolds for library construction, and the 
generation of therapeutics against various diseases.
     Fusion partners to extend the half-life of candidate 
protein therapeutics.

Competitive Advantages

     Small (16kD) size for better tissue penetration, and in 
the case of fusion proteins, reduced steric hindrance for therapeutic 
activity.
     Superior stability compared to isolated CH2 domains and 
stability comparable to or higher than that of an isolated Fc fragment.
     Exhibit greatly enhanced FcRn binding abilities, including 
more potent transcytosis and longer in vivo half-life.
     Can be efficiently expressed in E. coli.

Development Stage

     Early-stage
     In vitro data available
     In vivo data available (animal)

    Inventors: Dimiter Dimitrov and Tianlei Ying (NCI).
    Intellectual Property: HHS Reference No. E-136-2014/0--US 
Provisional Application No. 62/022,810 filed July 10, 2014.
    Licensing Contact: Whitney Hastings, Ph.D.; 301-451-7337; 
[email protected].
    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 
Engineered Antibody Domains. For collaboration opportunities, please 
contact John D. Hewes, Ph.D. at [email protected] or 240-276-5515.

CXCR4 Reduction Leads to Enhancement of Engraftment of Hematopoietic 
Stem Cells

    Description of Technology: Methods of enhancing engraftment of 
donor hematopoietic stem cells (HSCs) by reducing expression or 
activity of

[[Page 15791]]

CXCR4 in HSCs is described. HSC are the only cells in the bone marrow 
that are both pluripotent and long lived. Bone marrow transplantation 
(BMT) using HSC is an increasingly common medical therapy for severe 
hematologic cancers and primary hematologic immunodeficiencies. 
However, for significant HSC engraftment to occur there must usually be 
pre-transplant conditioning with either irradiation or chemotherapy or 
both. The technology described herein shows that it is possible to 
replace HSC without the need for pre-transplant conditioning regimen. 
It is known that the chemokine receptor CXCR4 plays a critical role in 
HSC homing to the bone marrow and in HSC quiescence. The inventors have 
identified a patient in which one copy of CXCR4 had been deleted in a 
somatic mutation of an HSC and this cell had clonally repopulated the 
bone marrow. This led to experiments in mice where the inventors 
clearly demonstrated in a bone marrow transplantation model, that donor 
cells with a single copy of the Cxcr4 gene repopulate recipient mice 
much faster and last much longer than donor cells having two copies of 
the Cxcr4 gene. This technology which shows that HSCs with one copy of 
the CXCR4 gene have a durable selective advantage in bone marrow 
repopulation can solve the problem frequently encountered in gene 
therapy, i.e., the short-lived nature of gene-corrected cells, by 
utilizing recently discovered gene editing methods that can be used to 
delete one copy of CXCR4 gene in gene-corrected cells.

Potential Commercial Applications

     Improvement of engraftment in gene therapy protocols and 
in HSC transplantation.
     Improved bone marrow transplantation, enhancing the 
efficiency and durability of donor cell repopulation.

Competitive Advantages

     This technology potentially facilitates HSC 
transplantation without the need of radiation or chemotherapy 
conditioning.
     This technology may uniquely overcome a major hurdle 
limiting all gene therapy applications, namely the failure to correct 
the gene defect over a long time.

Development Stage

     Early-stage
     In vitro data available
     In vivo data available (animal)

    Inventors: Jiliang Gao, Philip M. Murphy, David H. McDermott, Marie 
Siwicki, Harry L. Malech, and Joy Liu (all of NIAID).
    Publication: McDermott DH, et al. Chromothriptic cure of WHIM 
syndrome. Cell. 2015 Feb 12;160(4):686-99. [PMID 25662009].
    Intellectual Property: HHS Reference No. E-173-2014/0--US Patent 
Application No. 62/026,138 filed July 18, 2014.
    Licensing Contact: Sury Vepa, Ph.D., J.D.; 301-435-5020; 
[email protected].

Development of GPR124 Wildtype and Knockout Brain Endothelial Reporter 
Cells

    Description of Technology: There is currently no effective way to 
block beta-catenin signaling specifically in brain endothelial cells. 
There is neither an effective way to block beta-catenin signaling 
stimulated by a particular Wnt family member such as WNT7. The reporter 
cells created by the NIH investigator from GPR124 knockout mice provide 
a unique and effective tool to screen for drugs that can specifically 
interfere with the Wnt7/GPR124 signaling pathway. Such drugs have 
potential for widespread therapeutic application in the treatment of 
cerebrovascular diseases, the third leading cause of death in the 
United States, and a variety of neurodegenerative disorders such as 
Alzheimer's disease, Parkinson disease, amyotrophic lateral sclerosis, 
multiple sclerosis, and others.
    Potential Commercial Applications: Research tools for drug 
screening.
    Competitive Advantages: The reporter cells are ideal for screening 
for drugs that specifically interfere with the Wnt7/GPR124 signaling 
pathway as the cells have no inherent low level Gpr124 expression.
    Development Stage: Prototype.
    Inventor: Brad St. Croix (NCI).
    Publication: Posokhova E, et al. GPR124 functions as a WNT7-
specific coactivator of canonical beta-catenin signaling. Cell Rep. 
2015 Jan 13;10 (2):123-30. [PMID 25558062].
    Intellectual Property: HHS Reference No. E-079-2015/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected].
    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 agents that antagonize or promote Gpr124 function. For 
collaboration opportunities, please contact John D. Hewes, Ph.D. at 
[email protected].

    Dated: March 20, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-06845 Filed 3-24-15; 8:45 am]
 BILLING CODE 4140-01-P

15790 Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices Obtaining Copies of Proposals: Period of Employment: April 10, 1951 This technology describes two Requesters may obtain a copy of the through December 31, 1979. antibody constant domains or binders information collection documents from with increased FcRn binding and in vivo John Howard, the General Services Administration, half-life. In addition, these binders are Regulatory Secretariat Division (MVCB), Director, National Institute for Occupational small in size (16kDa), very stable, and Safety and Health. 1800 F Street NW., Washington, DC can be efficiently expressed in E. coli. [FR Doc. 2015–06786 Filed 3–24–15; 8:45 am] 20405, telephone 202–501–4755. Please As a result, the binders are particularly cite OMB Control No. 9000–0054, BILLING CODE 4163–19–P well suited as scaffolds for the Submission for OMB Review; U.S.-Flag generation of antibody libraries, from Air Carriers Statement, in all which a desired antigen binders could DEPARTMENT OF HEALTH AND correspondence. be developed into therapeutic products HUMAN SERVICES Dated: March 19, 2015. with much greater potency compared to Edward Loeb, National Institutes of Health existing mAbs. They could also be used as fusion partners to extend the half-life Acting Director, Office of Government-wide Acquisition Policy, Office of Acquisition Government-Owned Inventions; of candidate protein therapeutics. Policy, Office of Government-wide Policy. Availability for Licensing Potential Commercial Applications [FR Doc. 2015–06818 Filed 3–24–15; 8:45 am] AGENCY: National Institutes of Health, • Antibody scaffolds for library BILLING CODE 6820–EP–P HHS. construction, and the generation of ACTION: Notice. therapeutics against various diseases. • Fusion partners to extend the half- SUMMARY: The inventions listed below life of candidate protein therapeutics. DEPARTMENT OF HEALTH AND are owned by an agency of the U.S. HUMAN SERVICES Competitive Advantages Government and are available for licensing in the U.S. in accordance with • Small (16kD) size for better tissue Decision To Evaluate a Petition To 35 U.S.C. 209 and 37 CFR part 404 to penetration, and in the case of fusion Designate a Class of Employees From achieve expeditious commercialization proteins, reduced steric hindrance for the Argonne National Laboratory-West of results of federally-funded research therapeutic activity. in Scoville, Idaho, To Be Included in • Superior stability compared to the Special Exposure Cohort and development. Foreign patent applications are filed on selected isolated CH2 domains and stability AGENCY: National Institute for inventions to extend market coverage comparable to or higher than that of an Occupational Safety and Health for companies and may also be available isolated Fc fragment. (NIOSH), Centers for Disease Control for licensing. • Exhibit greatly enhanced FcRn and Prevention, Department of Health binding abilities, including more potent FOR FURTHER INFORMATION CONTACT: and Human Services. transcytosis and longer in vivo half-life. Licensing information and copies of the • Can be efficiently expressed in E. ACTION: Notice. U.S. patent applications listed below coli. may be obtained by writing to the SUMMARY: NIOSH gives notice of a indicated licensing contact at the Office Development Stage decision to evaluate a petition to of Technology Transfer, National • Early-stage designate a class of employees from the Institutes of Health, 6011 Executive • In vitro data available Argonne National Laboratory-West in Boulevard, Suite 325, Rockville, • In vivo data available (animal) Scoville, Idaho, to be included in the Maryland 20852–3804; telephone: 301– Inventors: Dimiter Dimitrov and Special Exposure Cohort under the 496–7057; fax: 301–402–0220. A signed Tianlei Ying (NCI). Energy Employees Occupational Illness Confidential Disclosure Agreement will Intellectual Property: HHS Reference Compensation Program Act of 2000. be required to receive copies of the No. E–136–2014/0—US Provisional patent applications. Application No. 62/022,810 filed July FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: 10, 2014. Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, Technology descriptions follow. Licensing Contact: Whitney Hastings, National Institute for Occupational Engineered Antibody Domains With Ph.D.; 301–451–7337; hastingw@ Safety and Health, 1090 Tusculum Increased FcRn Binding and in vivo mail.nih.gov. Avenue, MS C–46, Cincinnati, OH Half-Life Collaborative Research Opportunity: 45226–1938, Telephone 877–222–7570. The National Cancer Institute is seeking Information requests can also be Description of Technology: statements of capability or interest from submitted by email to DCAS@CDC.GOV. Monoclonal antibodies (mAbs) are a fast parties interested in collaborative growing class of new therapeutic research to further develop, evaluate or SUPPLEMENTARY INFORMATION: molecules. However, their large size commercialize Engineered Antibody Authority: 42 CFR 83.9–83.12. remains a significant challenge, Domains. For collaboration preventing them from targeting opportunities, please contact John D. Pursuant to 42 CFR 83.12, the initial sterically restricted epitopes and Hewes, Ph.D. at john.hewes@nih.gov or proposed definition for the class being efficiently penetrating into tissues. 240–276–5515. evaluated, subject to revision as Smaller antibody fragments and rljohnson on DSK3VPTVN1PROD with NOTICES warranted by the evaluation, is as CXCR4 Reduction Leads to engineered variants are under follows: Enhancement of Engraftment of development to address this challenge, Facility: Argonne National but to date their therapeutic Hematopoietic Stem Cells Laboratory-West. applications have been limited due to Description of Technology: Methods Location: Scoville, Idaho. rapid clearance and short half-life of enhancing engraftment of donor Job Titles and/or Job Duties: All which greatly decrease their efficacy in hematopoietic stem cells (HSCs) by workers who worked in any location. vivo. reducing expression or activity of VerDate Sep<11>2014 15:26 Mar 24, 2015 Jkt 235001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\25MRN1.SGM 25MRN1

Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices 15791 CXCR4 in HSCs is described. HSC are Siwicki, Harry L. Malech, and Joy Liu contact John D. Hewes, Ph.D. at hewesj@ the only cells in the bone marrow that (all of NIAID). mail.nih.gov. are both pluripotent and long lived. Publication: McDermott DH, et al. Dated: March 20, 2015. Bone marrow transplantation (BMT) Chromothriptic cure of WHIM Richard U. Rodriguez, using HSC is an increasingly common syndrome. Cell. 2015 Feb Acting Director, Office of Technology medical therapy for severe hematologic 12;160(4):686–99. [PMID 25662009]. Transfer, National Institutes of Health. cancers and primary hematologic Intellectual Property: HHS Reference [FR Doc. 2015–06845 Filed 3–24–15; 8:45 am] immunodeficiencies. However, for No. E–173–2014/0—US Patent BILLING CODE 4140–01–P significant HSC engraftment to occur Application No. 62/026,138 filed July there must usually be pre-transplant 18, 2014. conditioning with either irradiation or Licensing Contact: Sury Vepa, Ph.D., DEPARTMENT OF HEALTH AND chemotherapy or both. The technology J.D.; 301–435–5020; vepas@ HUMAN SERVICES described herein shows that it is mail.nih.gov. possible to replace HSC without the Development of GPR124 Wildtype and Centers for Disease Control and need for pre-transplant conditioning Knockout Brain Endothelial Reporter Prevention regimen. It is known that the chemokine Cells [30Day–15–15IG] receptor CXCR4 plays a critical role in HSC homing to the bone marrow and in Description of Technology: There is currently no effective way to block beta- Agency Forms Undergoing Paperwork HSC quiescence. The inventors have Reduction Act Review identified a patient in which one copy catenin signaling specifically in brain of CXCR4 had been deleted in a somatic endothelial cells. There is neither an The Centers for Disease Control and mutation of an HSC and this cell had effective way to block beta-catenin Prevention (CDC) publishes a list of clonally repopulated the bone marrow. signaling stimulated by a particular Wnt information collection requests under This led to experiments in mice where family member such as WNT7. The review by the Office of Management and the inventors clearly demonstrated in a reporter cells created by the NIH Budget (OMB) in compliance with the bone marrow transplantation model, investigator from GPR124 knockout Paperwork Reduction Act (44 U.S.C. that donor cells with a single copy of mice provide a unique and effective tool Chapter 35). To request a copy of these the Cxcr4 gene repopulate recipient to screen for drugs that can specifically requests, call (404) 639–7570 or send an mice much faster and last much longer interfere with the Wnt7/GPR124 email to omb@cdc.gov. Send written than donor cells having two copies of signaling pathway. Such drugs have comments to CDC Desk Officer, Office of the Cxcr4 gene. This technology which potential for widespread therapeutic Management and Budget, Washington, shows that HSCs with one copy of the application in the treatment of DC or by fax to (202) 395–5806. Written CXCR4 gene have a durable selective cerebrovascular diseases, the third comments should be received within 30 advantage in bone marrow repopulation leading cause of death in the United days of this notice. can solve the problem frequently States, and a variety of neurodegenerative disorders such as Proposed Project encountered in gene therapy, i.e., the short-lived nature of gene-corrected Alzheimer’s disease, Parkinson disease, Public Health Associate Program cells, by utilizing recently discovered amyotrophic lateral sclerosis, multiple (PHAP) Alumni Assessment—New –- gene editing methods that can be used sclerosis, and others. Office for State, Tribal, Local, and to delete one copy of CXCR4 gene in Potential Commercial Applications: Territorial Support (OSTLTS), Centers gene-corrected cells. Research tools for drug screening. for Disease Control and Prevention Competitive Advantages: The reporter (CDC). Potential Commercial Applications cells are ideal for screening for drugs Background and Brief Description • Improvement of engraftment in that specifically interfere with the Wnt7/GPR124 signaling pathway as the The Centers for Disease Control and gene therapy protocols and in HSC Prevention (CDC) works to protect transplantation. cells have no inherent low level Gpr124 expression. America from health, safety and security • Improved bone marrow threats, both foreign and in the U.S. Development Stage: Prototype. transplantation, enhancing the Inventor: Brad St. Croix (NCI). CDC strives to fulfill this mission, in efficiency and durability of donor cell Publication: Posokhova E, et al. part, through a competent and capable repopulation. GPR124 functions as a WNT7-specific public health workforce. One Competitive Advantages coactivator of canonical beta-catenin mechanism to developing the public signaling. Cell Rep. 2015 Jan 13;10 health workforce is through training • This technology potentially (2):123–30. [PMID 25558062]. programs like the Public Health facilitates HSC transplantation without Intellectual Property: HHS Reference Associate Program (PHAP). the need of radiation or chemotherapy No. E–079–2015/0—Research Tool. The mission of the Public Health conditioning. Patent protection is not being pursued Associate Program (PHAP) is to train • This technology may uniquely for this technology. and provide experiential learning to overcome a major hurdle limiting all Licensing Contact: Betty B. Tong, early career professionals who gene therapy applications, namely the Ph.D.; 301–594–6565; tongb@ contribute to the public health failure to correct the gene defect over a mail.nih.gov. workforce. PHAP targets recent long time. Collaborative Research Opportunity: graduates with bachelors or masters rljohnson on DSK3VPTVN1PROD with NOTICES Development Stage The National Cancer Institute is seeking degrees who are beginning a career in statements of capability or interest from public health. Each year, a new cohort • Early-stage parties interested in collaborative of up to 200 associates is enrolled in the • In vitro data available research to further develop, evaluate, or program. • In vivo data available (animal) commercialize agents that antagonize or Associates are CDC employees who Inventors: Jiliang Gao, Philip M. promote Gpr124 function. For complete two-year assignments in a host Murphy, David H. McDermott, Marie collaboration opportunities, please site (i.e., a state, tribal, local, or VerDate Sep<11>2014 15:26 Mar 24, 2015 Jkt 235001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\25MRN1.SGM 25MRN1


Document Created: 2018-02-21 09:49:00
Document Modified: 2018-02-21 09:49:00
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactLicensing 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 Citation80 FR 15790 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR