83_FR_35422 83 FR 35279 - Government-Owned Inventions; Availability for Licensing

83 FR 35279 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 143 (July 25, 2018)

Page Range35279-35280
FR Document2018-15907

The invention listed below is jointly owned by an agency of the U.S. Government with Vanderbilt University, University of Alabama and University of Pennsylvania and is available for licensing 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 83 Issue 143 (Wednesday, July 25, 2018) 
[Federal Register Volume 83, Number 143 (Wednesday, July 25, 2018)]
[Notices]
[Pages 35279-35280]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-15907]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is jointly owned by an agency of 
the U.S. Government with Vanderbilt University, University of Alabama 
and University of Pennsylvania and is available for licensing 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 application listed below may be obtained by 
communicating with Sury Vepa, Ph.D., J.D., Senior Licensing and 
Patenting Manager,

[[Page 35280]]

National Center for Advancing Translational Sciences, NIH, 9800 Medical 
Center Drive, Rockville, MD 20850, Phone: 301-827-7181, or email 
[email protected]. A signed Confidential Disclosure Agreement will be 
required to receive copies of unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Thiazole Based Inhibitors of Lactate Dehydrogenase (LDH) for the 
Treatment of Cancer

    Description of Technology: Agents that target enzymes involved in 
cancer cell metabolism offer an attractive therapeutic route in view of 
the potential to preferentially target cancer tissue over normal 
tissue. While normal tissue typically uses glycolysis as a major 
cellular metabolic path only when the oxygen supply is low, cancer 
tissue relies heavily on aerobic glycolysis regardless of the oxygen 
supply level. In addition, metabolic switching to a more glycolytic 
phenotype is a required step with inflammatory cells and other 
pathologies which require activated glycolysis in their metabolism. 
Lactate dehydrogenase (LDH) is involved in the final step of 
glycolysis, in which pyruvate is converted to lactate and the 
conversion of NADH to NAD+. There are two different genes of LDH, LDHA 
and LDHB, but both proteins (subunits) have the same active site and 
catalyze the conversion of pyruvate to lactate or lactate to pyruvate. 
In cancer patients, serum total lactate dehydrogenase (levels are often 
increased, and the gene for LDH, is up-regulated. LDH inhibition is 
expected to reduce the ability of the cell to effectively metabolize 
glucose and reduce tumor cell proliferation and tumor growth and other 
pathologies which involve a glycolytic metabolic switch. Thus, 
compounds that inhibit LDH activity have potential for the development 
of anti-cancer therapeutics. Previously developed LDH inhibitors have 
significant drawbacks, including poor potency and/or poor 
bioavailability, limiting their utility as therapeutics. The present 
technology provides novel 1 H-PYRAZOL-1 -YL-THIAZOLE based LDH 
inhibitors with improved potency, selectivity, and/or bioavailability 
for the treatment of cancer.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.
    Potential Commercial Applications:
     Novel therapeutics for cancer AND indications which depend 
on a metabolic switch to glycolysis (e.g., inflammation, autoimmune 
disease, etc.)
    Competitive Advantages:
     Novel LDH inhibitors with improved potency, selectivity, 
and/or bioavailability for the treatment of cancer.
    Development Stage:
     Optimized lactate dehydrogenase inhibitors are in pre-
clinical development.
    Inventors:
     David J. Maloney, Alex Gregory Waterson, Ganesha Rai 
Bantukallu, Kyle Ryan Brimacombe, Plamen Christov, Chi V. Dang, Victor 
M. Darley-Usmar, Matthew Hall, Xin Hu, Ajit Jadhav, Somnath Jana, 
Kwangho Kim, William J. Moore, Brian T. Mott, Leonard M. Neckers, Anton 
Simeonov, Gary Allen Sulikowski, Daniel Jason URBAN, and Shyh Ming 
Yang.
    Publications: This manuscript reports early compounds in the 
series: https://pubs.acs.org/doi/10.1021/acs.jmedchem.7b00941.
    Intellectual Property: 1. SMALL MOLECULE INHIBITORS OF LACTATE 
DEHYDROGENASE AND METHODS OF USE THERE OF, PCT/US2015/067895 filed on 
December 29, 2015 and published as WO 2016/109559 on July 7, 2016 (HHS 
Ref. No. E-244-2014), and
    2. 1 H-PYRAZOL-1 -YL-THIAZOLES AS INHIBITORS OF LACTATE 
DEHYDROGENASE AND METHODS OF USE THERE OF, PCP/US2017/040021 filed on 
June 29, 2017 and published as WO 2018/005807 on January 8, 2018 9HHS 
Ref. No. E-190-2016).
    Related Intellectual Property: HHS Reference Number E-293-2011.
    Licensing Contact: Sury Vepa, Ph.D., J.D., 301-827-7181; 
[email protected].

    Dated: July 5, 2018.
Lili Portilla,
Technology Development Coordinator, National Center for Advancing 
Translational Sciences.
[FR Doc. 2018-15907 Filed 7-24-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Notices 35279 SUMMARY: The Office for Human Comments received, including any Institutional Review Boards (IRBs), Research Protections (OHRP), Office of personal information, will be posted investigators, HHS funding agencies, the Assistant Secretary for Health is without change to http:// and others that may be responsible for announcing the availability of three www.regulations.gov. the review, conduct, or oversight of draft guidance documents titled, FOR FURTHER INFORMATION CONTACT: human subjects research conducted or ‘‘Scholarly and Journalistic Activities Irene Stith-Coleman, Ph.D., Office for supported by HHS. Deemed Not to be Research: 2018 Human Research Protections, 1101 The ‘‘Elimination of Institutional Requirements,’’ ‘‘When Continuing Wootton Parkway, Suite 200, Rockville, Review Board (IRB) Review of Research Review Is Not Required During the 6- MD 20852, 240–453–6900; email Applications and Proposals: 2018 Month Delay Period of July 19, 2018 Irene.Stith-Coleman@hhs.gov. Requirements’’ draft guidance provides through January 20, 2019: 2018 SUPPLEMENTARY INFORMATION: guidance on the elimination of the Requirements,’’ and ‘‘Elimination of requirement in the pre-2018 Institutional Review Board (IRB) Review I. Background Requirements (45 CFR 46.103(f)) that of Research Applications and Proposals: A. Overview each application or proposal for 2018 Requirements,’’ respectively. research undergo IRB review and OHRP, Office of the Assistant approval as part of the certification DATES:Submit written comments by Secretary for Health, is announcing the August 24, 2018. process. It is intended for Institutions, availability of three draft guidance IRBs, investigators, HHS funding ADDRESSES: Submit written requests for documents entitled ‘‘Scholarly and agencies, and others that may be single copies of the draft guidance Journalistic Activities Deemed Not to be responsible for the review, conduct, or documents titled ‘‘Scholarly and Research: 2018 Requirements,’’ ‘‘When oversight of nonexempt research Journalistic Activities Deemed Not to be Continuing Review Is Not Required involving human subjects conducted or Research: 2018 Requirements,’’ ‘‘When During the 6-Month Delay Period of July supported by HHS. Continuing Review Is Not Required 19, 2018 through January 20, 2019: 2018 During the 6-Month Delay Period of July Requirements,’’ and ‘‘Elimination of II. Electronic Access 19, 2018 through January 20, 2019: 2018 Institutional Review Board (IRB) Review Persons with access may obtain the Requirements,’’ and ‘‘Elimination of of Research Applications and Proposals: draft guidance documents on OHRP’s Institutional Review Board (IRB) Review 2018 Requirements.’’ The draft guidance website at https://www.hhs.gov/ohrp/ of Research Applications and Proposals: documents, when finalized, will regulations-and-policy/requests-for- 2018 Requirements,’’ respectively, to the represent OHRP’s current thinking on comments/index.html. Division of Policy and Assurances, these topics. OHRP obtained input from Dated: July 19, 2018. Office for Human Research Protections, HHS agencies and the Common Rule departments and agencies in developing Jerry Menikoff, 1101 Wootton Parkway, Suite 200, the draft guidance documents. Director, Office for Human Research Rockville, MD 20852. Send one self- Protections. addressed adhesive label to assist that The ‘‘Scholarly and Journalistic office in processing your request, or fax Activities Deemed Not to be Research: [FR Doc. 2018–15908 Filed 7–24–18; 8:45 am] your request to 240–453–6909. See the 2018 Requirements’’ draft guidance BILLING CODE 4150–36–P SUPPLEMENTARY INFORMATION section for explains how certain scholarly and information on electronic access to the journalistic activities that focus directly on the specific individuals about whom DEPARTMENT OF HEALTH AND draft guidance documents. the information is collected are deemed HUMAN SERVICES You may submit comments identified not to be research under the 2018 by docket ID number HHS–OS–OPHS– Requirements of the regulations for the National Institutes of Health 2018–0012 (Scholarly and Journalistic protection of human subjects (45 CFR Activities Deemed Not to be Research: Government-Owned Inventions; part 46), and consequently do not have 2018 Requirements), docket ID number Availability for Licensing to satisfy the requirements of those HHS–OS–OPHS–2018–0013 (When regulations. It is intended for IRB AGENCY: National Institutes of Health, Continuing Review Is Not Required administrators, IRB chairpersons, HHS. During the 6-Month Delay Period of July relevant institutional officials, and ACTION: Notice. 19, 2018 through January 20, 2019: 2018 investigators who may be concerned Requirements), and docket ID number about whether scholarly or journalistic SUMMARY: The invention listed below is HHS–OS–OPHS–2018–0014 activities need to satisfy the 2018 jointly owned by an agency of the U.S. (Elimination of Institutional Review Requirements of the regulations. Government with Vanderbilt University, Board (IRB) Review of Research The ‘‘When Continuing Review Is Not University of Alabama and University of Applications and Proposals: 2018 Required During the 6-Month Delay Pennsylvania and is available for Requirements), respectively, by one of Period of July 19, 2018 through January licensing to achieve expeditious the following methods: 20, 2019: 2018 Requirements’’ draft commercialization of results of • Federal eRulemaking Portal: http:// guidance provides information on the federally-funded research and www.regulations.gov. Enter the docket HHS regulations for the protection of development. Foreign patent ID number and click on ‘‘Search.’’ On human research subjects at 45 CFR part applications are filed on selected the next page, click the ‘‘Comment 46 related to the circumstances in which inventions to extend market coverage Now’’ action and follow the continuing review of research is not for companies and may also be available daltland on DSKBBV9HB2PROD with NOTICES instructions. required. In particular, this guidance for licensing. • Mail/Hand Delivery/Courier [For applies to research that transitions to FOR FURTHER INFORMATION CONTACT: Paper, Disk, or CD–ROM Submissions]: comply with the 2018 Requirements Licensing information and copies of the Irene Stith-Coleman, Ph.D., Office for during the 6-month delay period from U.S. patent application listed below Human Research Protections, 1101 July 19, 2018 through January 20, 2019. may be obtained by communicating Wootton Parkway, Suite 200, Rockville, This guidance only applies during the 6- with Sury Vepa, Ph.D., J.D., Senior MD 20852. month delay period. It is intended for Licensing and Patenting Manager, VerDate Sep<11>2014 18:50 Jul 24, 2018 Jkt 244001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\25JYN1.SGM 25JYN1

35280 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Notices National Center for Advancing metabolic switch to glycolysis (e.g., OMB review, in compliance with the Translational Sciences, NIH, 9800 inflammation, autoimmune disease, Paperwork Reduction Act (44 U.S.C. Medical Center Drive, Rockville, MD etc.) chapter 35). To request a copy of these 20850, Phone: 301–827–7181, or email Competitive Advantages: documents, call the SAMHSA Reports sury.vepa@nih.gov. A signed • Novel LDH inhibitors with Clearance Officer on (240) 276–1243. Confidential Disclosure Agreement will improved potency, selectivity, and/or be required to receive copies of bioavailability for the treatment of Project: Projects for Assistance in unpublished patent applications. cancer. Transition From Homelessness (PATH) Development Stage: Program Annual Report (OMB No. SUPPLEMENTARY INFORMATION: • Optimized lactate dehydrogenase 0930–0205)—Revision Technology description follows. inhibitors are in pre-clinical The Center for Mental Health Services Thiazole Based Inhibitors of Lactate development. Dehydrogenase (LDH) for the Treatment awards grants each fiscal year to each of Inventors: the states, the District of Columbia, the of Cancer • David J. Maloney, Alex Gregory Commonwealth of Puerto Rico, the Description of Technology: Agents Waterson, Ganesha Rai Bantukallu, Kyle Virgin Islands, Guam, American Samoa, that target enzymes involved in cancer Ryan Brimacombe, Plamen Christov, and the Commonwealth of the Northern cell metabolism offer an attractive Chi V. Dang, Victor M. Darley-Usmar, Mariana Islands from allotments therapeutic route in view of the Matthew Hall, Xin Hu, Ajit Jadhav, authorized under the PATH program potential to preferentially target cancer Somnath Jana, Kwangho Kim, William J. established by Public Law 101–645, 42 tissue over normal tissue. While normal Moore, Brian T. Mott, Leonard M. U.S.C. 290cc–21 et seq., the Stewart B. tissue typically uses glycolysis as a Neckers, Anton Simeonov, Gary Allen McKinney Homeless Assistance major cellular metabolic path only when Sulikowski, Daniel Jason URBAN, and Amendments Act of 1990 (section 521 et the oxygen supply is low, cancer tissue Shyh Ming Yang. seq. of the Public Health Service (PHS) relies heavily on aerobic glycolysis Publications: This manuscript reports regardless of the oxygen supply level. In Act) and the 21st Century Cures Act early compounds in the series: https:// addition, metabolic switching to a more (Pub. L. 114–255). Section 522 of the pubs.acs.org/doi/10.1021/ glycolytic phenotype is a required step PHS Act and the 21st Century Cures Act acs.jmedchem.7b00941. with inflammatory cells and other require that the grantee states and Intellectual Property: 1. SMALL pathologies which require activated territories must expend their payments MOLECULE INHIBITORS OF LACTATE glycolysis in their metabolism. Lactate under the Act solely for making grants DEHYDROGENASE AND METHODS dehydrogenase (LDH) is involved in the to political subdivisions of the state, and OF USE THERE OF, PCT/US2015/ final step of glycolysis, in which to nonprofit private entities (including 067895 filed on December 29, 2015 and pyruvate is converted to lactate and the community-based veterans’ published as WO 2016/109559 on July conversion of NADH to NAD+. There organizations and other community 7, 2016 (HHS Ref. No. E–244–2014), and are two different genes of LDH, LDHA organizations) for the purpose of 2. 1 H-PYRAZOL-1 -YL-THIAZOLES and LDHB, but both proteins (subunits) providing services specified in the Act. AS INHIBITORS OF LACTATE have the same active site and catalyze Available funding is allotted in DEHYDROGENASE AND METHODS the conversion of pyruvate to lactate or accordance with the formula provision OF USE THERE OF, PCP/US2017/ lactate to pyruvate. In cancer patients, of section 524 of the PHS Act. 040021 filed on June 29, 2017 and serum total lactate dehydrogenase published as WO 2018/005807 on This submission is for a revision of (levels are often increased, and the gene January 8, 2018 9HHS Ref. No. E–190– the current approval of the annual for LDH, is up-regulated. LDH inhibition 2016). grantee reporting requirements. Section is expected to reduce the ability of the Related Intellectual Property: HHS 528 of the PHS Act and the 21st Century cell to effectively metabolize glucose Reference Number E–293–2011. Cures Act specify that not later than and reduce tumor cell proliferation and Licensing Contact: Sury Vepa, Ph.D., January 31 of each fiscal year, a funded tumor growth and other pathologies J.D., 301–827–7181; sury.vepa@nih.gov. entity will prepare and submit a report which involve a glycolytic metabolic in such form and containing such Dated: July 5, 2018. switch. Thus, compounds that inhibit information as is determined necessary LDH activity have potential for the Lili Portilla, for securing a record and description of development of anti-cancer Technology Development Coordinator, the purposes for which amounts therapeutics. Previously developed LDH National Center for Advancing Translational Sciences. received under section 521 were inhibitors have significant drawbacks, expended during the preceding fiscal including poor potency and/or poor [FR Doc. 2018–15907 Filed 7–24–18; 8:45 am] year and of the recipients of such bioavailability, limiting their utility as BILLING CODE 4140–01–P amounts and determining whether such therapeutics. The present technology amounts were expended in accordance provides novel 1 H-PYRAZOL-1 -YL– with statutory provisions. THIAZOLE based LDH inhibitors with DEPARTMENT OF HEALTH AND HUMAN SERVICES The proposed changes to the PATH improved potency, selectivity, and/or Annual Report are as follows: bioavailability for the treatment of Substance Abuse and Mental Health cancer. Services Administration 1. Reporting on Contacts This technology is available for licensing for commercial development Agency Information Collection To ensure that all contacts made by daltland on DSKBBV9HB2PROD with NOTICES in accordance with 35 U.S.C. 209 and 37 Activities: Submission for OMB PATH providers are reflected in the CFR part 404, as well as for further Review; Comment Request report, a new question has been added development and evaluation under a that reports out on all contacts provided research collaboration. Periodically, the Substance Abuse and during the reporting period. The Potential Commercial Applications: Mental Health Services Administration previous PATH Annual Report only • Novel therapeutics for cancer AND (SAMHSA) will publish a summary of reported on contacts through the date of indications which depend on a information collection requests under enrollment. VerDate Sep<11>2014 18:50 Jul 24, 2018 Jkt 244001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\25JYN1.SGM 25JYN1


Document Created: 2018-07-25 00:44:11
Document Modified: 2018-07-25 00:44:11
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 application listed below may be obtained by communicating with Sury Vepa, Ph.D., J.D., Senior Licensing and Patenting Manager, National Center for Advancing Translational Sciences, NIH, 9800 Medical Center Drive, Rockville, MD 20850, Phone: 301-827-7181, or email [email protected] A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.
FR Citation83 FR 35279 
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