Government-Owned Inventions; Availability for Licensing, 42718 [2016-15442]

Download as PDF 42718 Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Department of Health and Human Services. ACTION: Notice. AGENCY: 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. FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892–2479; telephone: 301–402–5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information. SUPPLEMENTARY INFORMATION: Technology description follows. mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: Long Acting Therapeutic Conjugates With Evans Blue This invention is a platform technology that pertains to the advantages of conjugating therapeutics to Evans Blue thus providing long lasting pharmacokinetic profiles by complexing with albumin. Notably, albumin bound therapeutic- or prodrugEvans Blue conjugates provide a complex with a total molecular size above 60 kDa thus eliminating the risk for renal clearance. Interestingly, since albumin also crosses the blood-brain barrier and since all circulating Evans Blue is bound to albumin, Evans Blue bound therapeutics or prodrugs can also cross the blood-brain barrier. By way for example but not limitation, Evans Blue can be conjugated to insulin, GLP-1, exendin-4, exendin (9-39), octreotide, bombesin, RGD peptide (arginylglycylaspartic acid), vascular endothelial growth factor (VEGF), interferon (IFN), tumor necrosis factor (TNF), asparaginase, or adenosine deaminase, exenatide, dipeptidyl peptidase-4 inhibitors, neuropilin, epidermal growth factor, islet neogenesis associated protein, alpha-1 antitrypsin, anti-inflammatory agents, glulisine, glucagons, local cytokines, modulators of cytokines, anti-apoptotic VerDate Sep<11>2014 20:01 Jun 29, 2016 Jkt 238001 molecules, aptamers, asparaginase, adenosine deaminase, interferon a2a, interferon a2b, granulocyte colony stimulating factor, growth hormone receptor antagonists, doxorubicin, paclitaxel, gemcitabine, camptothecin, and temozolomide. Evans Blue conjugates according to this invention can additionally include radionuclides like 18F, 76Br, 124I, 125I, or 131I, or 117mSn for tracking or use in diagnostics. Potential Commercial Applications: —Diabetes therapeutics —Cancer therapeutics —CNS therapeutics —Pharmacokinetic/distribution studies Competitive Advantages: —long pharmacokinetic profile —no renal clearance of circulating drug Development Stage: • Early stage Inventors: Xiaoyuan Chen, Lixin Lang, Gang NIU (all of NIBIB). Intellectual Property: HHS Reference No. E–143–2015/0; U.S. Provisional Patent Application 62/182,694 filed June 22, 2015; International Patent Application PCT/US2016/38475 filed June 21, 2016. Licensing Contact: Michael Shmilovich, Esq, CLP; 301–435–5019; shmilovm@mail.nih.gov. Dated: June 23, 2016. Michael Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development. [FR Doc. 2016–15442 Filed 6–29–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Request for Data and Information on Technologies Used for Identifying Potential Developmental Toxicants The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on approaches and/or technologies currently used for identifying potential developmental toxicants. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the potential of chemicals to induce adverse effects in offspring. DATES: Receipt of information: Deadline is August 15, 2016. SUMMARY: PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 Data and information should be submitted electronically to niceatm@niehs.nih.gov. FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; email: warren.casey@nih.gov; telephone: (919) 316–4729. SUPPLEMENTARY INFORMATION: Background: NICEATM, which fosters the evaluation and promotion of alternative test methods for regulatory use, is supporting efforts to develop, validate, and implement alternative approaches for identifying potential developmental toxicants. The goal of these alternative approaches is to replace, reduce, or refine the use of animals in testing. Testing a chemical’s potential to cause developmental toxicity is required by multiple regulatory agencies and may require the use of large numbers of animals. Request for Information: NICEATM requests available data and information on approaches and/or technologies currently used to identify potential developmental toxicants. Respondents should provide information on any activities relevant to the development or validation of alternatives to in vivo developmental toxicity test methods currently required by regulatory agencies, including data from nonanimal chemical tests for developmental hazard potential. NICEATM also requests any available data resulting from in vivo developmental studies, ethical human or animal studies, or accidental human exposures, using the same chemicals. Respondents to this request for information should include their name, affiliation (if applicable), mailing address, telephone, email, and sponsoring organization (if any) with their communications. The deadline for receipt of the requested information is August 15, 2016. Responses to this notice will be posted at: https:// ntp.niehs.nih.gov/go/dev-nonanimal. Persons submitting responses will be identified on the Web page by name and affiliation or sponsoring organization, if applicable. Responses to this request are voluntary. No proprietary, classified, confidential, or sensitive information should be included in responses. This request for information is for planning purposes only and is not a solicitation for applications or an obligation on the part of the U.S. Government to provide support for any ideas identified in response to the request. Please note that the U.S. Government will not pay for the preparation of any information submitted or for its use of that information. ADDRESSES: E:\FR\FM\30JNN1.SGM 30JNN1

Agencies

[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Page 42718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15442]



[[Page 42718]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Department of Health and Human 
Services.

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.

FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained 
by emailing the indicated licensing contact at the National Heart, 
Lung, and Blood, Office of Technology Transfer and Development Office 
of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, 
MD 20892-2479; telephone: 301-402-5579. A signed Confidential 
Disclosure Agreement may be required to receive any unpublished 
information.

SUPPLEMENTARY INFORMATION: Technology description follows.

Long Acting Therapeutic Conjugates With Evans Blue

    This invention is a platform technology that pertains to the 
advantages of conjugating therapeutics to Evans Blue thus providing 
long lasting pharmacokinetic profiles by complexing with albumin. 
Notably, albumin bound therapeutic- or prodrug-Evans Blue conjugates 
provide a complex with a total molecular size above 60 kDa thus 
eliminating the risk for renal clearance. Interestingly, since albumin 
also crosses the blood-brain barrier and since all circulating Evans 
Blue is bound to albumin, Evans Blue bound therapeutics or prodrugs can 
also cross the blood-brain barrier. By way for example but not 
limitation, Evans Blue can be conjugated to insulin, GLP-1, exendin-4, 
exendin (9-39), octreotide, bombesin, RGD peptide 
(arginylglycylaspartic acid), vascular endothelial growth factor 
(VEGF), interferon (IFN), tumor necrosis factor (TNF), asparaginase, or 
adenosine deaminase, exenatide, dipeptidyl peptidase-4 inhibitors, 
neuropilin, epidermal growth factor, islet neogenesis associated 
protein, alpha-1 antitrypsin, anti-inflammatory agents, glulisine, 
glucagons, local cytokines, modulators of cytokines, anti-apoptotic 
molecules, aptamers, asparaginase, adenosine deaminase, interferon 
[alpha]2a, interferon [alpha]2b, granulocyte colony stimulating factor, 
growth hormone receptor antagonists, doxorubicin, paclitaxel, 
gemcitabine, camptothecin, and temozolomide. Evans Blue conjugates 
according to this invention can additionally include radionuclides like 
\18\F, \76\Br, \124\I, \125\I, or \131\I, or \117m\Sn for tracking or 
use in diagnostics.
    Potential Commercial Applications:
--Diabetes therapeutics
--Cancer therapeutics
--CNS therapeutics
--Pharmacokinetic/distribution studies
    Competitive Advantages:
--long pharmacokinetic profile
--no renal clearance of circulating drug
    Development Stage:
 Early stage
    Inventors: Xiaoyuan Chen, Lixin Lang, Gang NIU (all of NIBIB).
    Intellectual Property: HHS Reference No. E-143-2015/0; U.S. 
Provisional Patent Application 62/182,694 filed June 22, 2015; 
International Patent Application PCT/US2016/38475 filed June 21, 2016.
    Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; 
shmilovm@mail.nih.gov.

    Dated: June 23, 2016.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2016-15442 Filed 6-29-16; 8:45 am]
 BILLING CODE 4140-01-P
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