81 FR 62913 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 177 (September 13, 2016)

Page Range		62913-62914
FR Document		2016-21904

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development 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 and/or co-development.

Federal Register, Volume 81 Issue 177 (Tuesday, September 13, 2016)

[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Notices]
[Pages 62913-62914]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21904]


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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 owned by an agency of the U.S. 
Government and is available for licensing and/or co-development 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 and/or co-development.

ADDRESSES: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD, 20850-9702.

FOR FURTHER INFORMATION CONTACT: Information on licensing and co-
development research collaborations, and copies of the U.S. patent 
applications listed below may be obtained by contacting: Attn. 
Invention Development and Marketing Unit, Technology Transfer Center, 
National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, 
Rockville, MD, 20850-9702, Tel. 240-276-5515 or email 
[email protected]. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of invention: Analogues of Withanolide E Sensitize Cancer 
Cells to Apoptosis.
    Keywords: TRAIL, TLR3, apoptosis, immunotherapy, tumor necrosis 
factor, TNF.
    Description of Technology: The tumor necrosis factor (TNF)-related 
apoptosis-inducing ligand (TRAIL) protein has been a target of interest 
in cancer therapy because it plays a large role in inducing cell 
apoptosis in cancer cells but not in normal cells. Although TRAIL has 
been reported to successfully target certain tumor cells which are 
resistant to traditional chemotherapy or radiation, TRAIL resistance 
has also been widely observed. Similarly, Toll-like receptor (TLR) 3 
ligands such as poly I:C have also been reported to promote apoptosis 
in certain cancer cells, though the apoptotic signaling in most cancer 
cells was weak and was only significant following longer term 
incubations. Thus, there is a need to develop compounds that can 
sensitize cancer cells to apoptosis inducing ligands, such as poly I:C 
and TRAIL.
    In collaboration with the University of Arizona, NCI investigators 
have discovered a series of compounds in the withanolide family that 
synergistically enhance the response of cancer cells to treatment with 
an apoptosis-inducing ligand. The compounds each show a 4- to 10-fold 
increase in potency compared to withanolide E alone in promoting death 
ligand-mediated cancer cell death. One biotinylated analogue in 
particular is at least 15-fold more potent than withanolide E in 
promoting apoptosis in human melanoma cells when used in combination 
with either poly I:C or TRAIL. A selection of active compounds were 
tested in murine xenograft models of human melanoma and showed 
decreased tumor growth and tumor regression.

Potential Commercial Applications

     Potential therapeutic for the treatment of cancer either 
alone or in combination with an apoptosis inducing agent such as TRAIL 
receptor or TLR 3 agonists by directly promoting tumor cell apoptosis.
     Possible indirect enhancement of cancer immunotherapy due 
to release of cancer cell antigens in the presence of the powerful 
immune-adjuvant effects of TLR3 agonists.

Value Proposition

     Withanolide E derivatives enhance the anti-cancer activity 
of known apoptosis inducing ligands such as TRAIL or poly I:C and may 
be used to enhance efficacy of TRAIL receptor or poly I:C agonists that 
are currently under development.
    Development Stage: Pre-clinical (in vivo validation).
    Inventor(s): Thomas Sayers (NCI), Alan Brooks (NCI), Curtis Henrich 
(NCI), Poonam Tewary (NCI), James McMahon (NCI), Leslie Gunatilaka 
(University of Arizona), Ya-ming Xu (University of Arizona), and E.M. 
Kithsiri Wijeratne (University of Arizona).
    Intellectual Property: US Provisional Application No. 62/292,974, 
entitled ``Method of Sensitizing Cancer Cells to The Cytotoxic Effects 
of Apoptosis Inducing Ligands in Cancer Treatment,'' filed February 9, 
2016.

Publications

    1. Tewary P., Gunatilaka A.A. and Sayers T.J. (2016) Using natural 
products to promote caspase-8-

[[Page 62914]]

dependent cancer cell death. Cancer Immunol Immunother. doi:10.1007/
s00262-016-1855-0.
    Related Technologies: US Patent 9,238,069 (HHS Ref. No. E-050-2010) 
entitled ``Use of withanolides to sensitize cancer cells to the 
cytotoxic effects of Apo2L/TRAIL'' issued January 19, 2016.
    Collaboration Opportunity: Researchers at the NCI seek licensing 
and/or co-development research collaborations for development of 
withanolide E analogues for the treatment of cancer.
    Contact Information: Requests for copies of the patent application 
or inquiries about licensing, research collaborations, and co-
development opportunities should be sent to John D. Hewes, Ph.D., 
email: [email protected].

    Dated: September 6, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-21904 Filed 9-12-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices 62913

amended (5 U.S.C. App.), notice is DEPARTMENT OF HEALTH AND most cancer cells was weak and was
hereby given of the following meetings. HUMAN SERVICES only significant following longer term
The meetings will be closed to the incubations. Thus, there is a need to
National Institutes of Health develop compounds that can sensitize
public in accordance with the
provisions set forth in sections cancer cells to apoptosis inducing
Government-Owned Inventions; ligands, such as poly I:C and TRAIL.
552b(c)(4) and 552b(c)(6), title 5 U.S.C., Availability for Licensing In collaboration with the University of
as amended. The grant applications and Arizona, NCI investigators have
the discussions could disclose AGENCY: National Institutes of Health,
HHS. discovered a series of compounds in the
confidential trade secrets or commercial withanolide family that synergistically
property such as patentable material, ACTION: Notice.
enhance the response of cancer cells to
and personal information concerning SUMMARY: The invention listed below is treatment with an apoptosis-inducing
individuals associated with the grant owned by an agency of the U.S. ligand. The compounds each show a 4-
applications, the disclosure of which Government and is available for to 10-fold increase in potency compared
would constitute a clearly unwarranted licensing and/or co-development in the to withanolide E alone in promoting
invasion of personal privacy. U.S. in accordance with 35 U.S.C. 209 death ligand-mediated cancer cell death.
Name of Committee: National Institute of and 37 CFR part 404 to achieve One biotinylated analogue in particular
Diabetes and Digestive and Kidney Diseases expeditious commercialization of is at least 15-fold more potent than
Special Emphasis Panel; Cell Replacement results of federally-funded research and withanolide E in promoting apoptosis in
Technology for Type 1 Diabetes (SBIR). development. Foreign patent human melanoma cells when used in
Date: October 4, 2016. applications are filed on selected combination with either poly I:C or
Time: 12:00 p.m. to 4:00 p.m. inventions to extend market coverage TRAIL. A selection of active compounds
Agenda: To review and evaluate grant for companies and may also be available were tested in murine xenograft models
applications. for licensing and/or co-development. of human melanoma and showed
Place: National Institutes of Health, Two ADDRESSES: Invention Development and decreased tumor growth and tumor
Democracy Plaza, 6707 Democracy Marketing Unit, Technology Transfer regression.
Boulevard, Bethesda, MD 20892 (Telephone Center, National Cancer Institute, 9609 Potential Commercial Applications
Conference Call). Medical Center Drive, Mail Stop 9702,
Contact Person: Thomas A. Tatham, Ph.D., Rockville, MD, 20850–9702. • Potential therapeutic for the
Scientific Review Officer, Review Branch, treatment of cancer either alone or in
FOR FURTHER INFORMATION CONTACT:
DEA, NIDDK, National Institutes of Health, combination with an apoptosis inducing
Information on licensing and co-
Room 7021, 6707 Democracy Boulevard, agent such as TRAIL receptor or TLR 3
development research collaborations,
Bethesda, MD 20892–5452, (301) 594–3993, agonists by directly promoting tumor
and copies of the U.S. patent
tathamt@mail.nih.gov. cell apoptosis.
applications listed below may be • Possible indirect enhancement of
Name of Committee: National Institute of obtained by contacting: Attn. Invention
Diabetes and Digestive and Kidney Diseases cancer immunotherapy due to release of
Development and Marketing Unit, cancer cell antigens in the presence of
Special Emphasis Panel; NIDDK Ancillary Technology Transfer Center, National
Studies (R01). the powerful immune-adjuvant effects
Cancer Institute, 9609 Medical Center of TLR3 agonists.
Date: October 27, 2016. Drive, Mail Stop 9702, Rockville, MD,
Time: 11:00 a.m. to 12:00 p.m. 20850–9702, Tel. 240–276–5515 or Value Proposition
Agenda: To review and evaluate grant email ncitechtransfer@mail.nih.gov. A
applications. • Withanolide E derivatives enhance
signed Confidential Disclosure the anti-cancer activity of known
Place: National Institutes of Health, Two Agreement may be required to receive
Democracy Plaza, 6707 Democracy apoptosis inducing ligands such as
copies of the patent applications. TRAIL or poly I:C and may be used to
Boulevard, Bethesda, MD 20892 (Telephone
SUPPLEMENTARY INFORMATION: enhance efficacy of TRAIL receptor or
Conference Call).
Contact Person: Jason D. Hoffert, Ph.D.,
Technology description follows. poly I:C agonists that are currently
Title of invention: Analogues of under development.
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Withanolide E Sensitize Cancer Cells to Development Stage: Pre-clinical (in
Room 7343, 6707 Democracy Boulevard,
Apoptosis. vivo validation).
Keywords: TRAIL, TLR3, apoptosis, Inventor(s): Thomas Sayers (NCI),
Bethesda, MD 20817, 301–496–9010,
immunotherapy, tumor necrosis factor, Alan Brooks (NCI), Curtis Henrich
hoffertj@niddk.nih.gov.
TNF. (NCI), Poonam Tewary (NCI), James
(Catalogue of Federal Domestic Assistance Description of Technology: The tumor McMahon (NCI), Leslie Gunatilaka
Program Nos. 93.847, Diabetes, necrosis factor (TNF)-related apoptosis-
Endocrinology and Metabolic Research;
(University of Arizona), Ya-ming Xu
inducing ligand (TRAIL) protein has (University of Arizona), and E.M.
93.848, Digestive Diseases and Nutrition been a target of interest in cancer
Research; 93.849, Kidney Diseases, Urology
Kithsiri Wijeratne (University of
therapy because it plays a large role in Arizona).
and Hematology Research, National Institutes inducing cell apoptosis in cancer cells
of Health, HHS)
Intellectual Property: US Provisional
but not in normal cells. Although TRAIL Application No. 62/292,974, entitled
Dated: September 7, 2016. has been reported to successfully target ‘‘Method of Sensitizing Cancer Cells to
David Clary, certain tumor cells which are resistant The Cytotoxic Effects of Apoptosis
Lhorne on DSK30JT082PROD with NOTICES

Program Analyst, Office of Federal Advisory to traditional chemotherapy or Inducing Ligands in Cancer Treatment,’’
Committee Policy. radiation, TRAIL resistance has also filed February 9, 2016.
[FR Doc. 2016–21895 Filed 9–12–16; 8:45 am]
been widely observed. Similarly, Toll-
like receptor (TLR) 3 ligands such as Publications
BILLING CODE 4140–01–P
poly I:C have also been reported to 1. Tewary P., Gunatilaka A.A. and
promote apoptosis in certain cancer Sayers T.J. (2016) Using natural
cells, though the apoptotic signaling in products to promote caspase-8-

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62914 Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices

dependent cancer cell death. Cancer Bethesda, MD 20852, 301–443–1225, Health Sciences, 530 Davis Drive, Room
Immunol Immunother. doi:10.1007/ aschulte@mail.nih.gov. 3171, P.O. Box 12233, MD EC–30, Research
s00262–016–1855–0. (Catalogue of Federal Domestic Assistance Triangle Park, NC 27709, (919) 541–0670,
Program No. 93.242, Mental Health Research worth@niehs.nih.gov.
Related Technologies: US Patent
Grants, National Institutes of Health, HHS) (Catalogue of Federal Domestic Assistance
9,238,069 (HHS Ref. No. E–050–2010) Program Nos. 93.115, Biometry and Risk
entitled ‘‘Use of withanolides to Dated: September 7, 2016.
Estimation—Health Risks from
sensitize cancer cells to the cytotoxic Carolyn A. Baum, Environmental Exposures; 93.142, NIEHS
effects of Apo2L/TRAIL’’ issued January Program Analyst, Office of Federal Advisory Hazardous Waste Worker Health and Safety
19, 2016. Committee Policy. Training; 93.143, NIEHS Superfund
Collaboration Opportunity: [FR Doc. 2016–21897 Filed 9–12–16; 8:45 am] Hazardous Substances—Basic Research and
Researchers at the NCI seek licensing BILLING CODE 4140–01–P
Education; 93.894, Resources and Manpower
Development in the Environmental Health
and/or co-development research Sciences; 93.113, Biological Response to
collaborations for development of Environmental Health Hazards; 93.114,
withanolide E analogues for the DEPARTMENT OF HEALTH AND Applied Toxicological Research and Testing,
treatment of cancer. HUMAN SERVICES National Institutes of Health, HHS)
Contact Information: Requests for Dated: September 7, 2016.
National Institutes of Health
copies of the patent application or Carolyn Baum,
inquiries about licensing, research National Institute of Environmental Program Analyst, Office of Federal Advisory
collaborations, and co-development Health Sciences; Notice of Closed Committee Policy.
opportunities should be sent to John D. Meetings [FR Doc. 2016–21896 Filed 9–12–16; 8:45 am]
Hewes, Ph.D., email: john.hewes@
nih.gov. Pursuant to section 10(d) of the BILLING CODE 4140–01–P

Federal Advisory Committee Act, as
Dated: September 6, 2016.
amended (5 U.S.C. App.), notice is
John D. Hewes, hereby given of the following meetings. DEPARTMENT OF HEALTH AND
Technology Transfer Specialist, Technology The meetings will be closed to the HUMAN SERVICES
Transfer Center, National Cancer Institute. public in accordance with the
[FR Doc. 2016–21904 Filed 9–12–16; 8:45 am] National Institutes of Health
provisions set forth in sections
BILLING CODE 4140–01–P 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Eunice Kennedy Shriver National
as amended. The grant applications and Institute of Child Health & Human
the discussions could disclose Development; Notice of Closed
DEPARTMENT OF HEALTH AND confidential trade secrets or commercial Meeting
HUMAN SERVICES property such as patentable material,
and personal information concerning Pursuant to section 10(d) of the
National Institutes of Health Federal Advisory Committee Act, as
individuals associated with the grant
applications, the disclosure of which amended (5 U.S.C. App.), notice is
National Institute of Mental Health; hereby given of the following meeting.
Notice of Closed Meeting would constitute a clearly unwarranted
invasion of personal privacy. The meeting will be closed to the
Pursuant to section 10(d) of the public in accordance with the
Name of Committee: National Institute of provisions set forth in sections
Federal Advisory Committee Act, as Environmental Health Sciences Special
amended (5 U.S.C. App.), notice is Emphasis Panel; Superfund Hazardous 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
hereby given of the following meeting. Substance Research and Training Program. as amended. The grant applications and
Date: September 27–29, 2016. the discussions could disclose
The meeting will be closed to the
Time: 8:30 a.m. to 6:00 p.m. confidential trade secrets or commercial
public in accordance with the
Agenda: To review and evaluate grant property such as patentable material,
provisions set forth in sections applications. and personal information concerning
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Place: Sheraton Imperial Hotel and individuals associated with the grant
as amended. The grant applications and Convention Center, 4700 Emperor Blvd., applications, the disclosure of which
the discussions could disclose Durham, NC 27703.
would constitute a clearly unwarranted
confidential trade secrets or commercial Contact Person: Linda K. Bass, Ph.D.,
Scientific Review Officer, Scientific Review invasion of personal privacy.
property such as patentable material,
and personal information concerning Branch, Division of Extramural Research and Name of Committee: National Institute of
individuals associated with the grant Training, Nat. Institute Environmental Health Child Health and Human Development Initial
Sciences, 530 Davis Drive, Room 3074, P.O. Review Group; Health, Behavior, and Context
applications, the disclosure of which Box 12233, MD EC–30, Research Triangle Subcommittee.
would constitute a clearly unwarranted Park, NC 27709, (919) 541–1307, bass@ Date: October 14, 2016.
invasion of personal privacy. niehs.nih.gov. Time: 8:00 a.m. to 5:00 p.m.
Name of Committee: National Institute of Name of Committee: National Institute of Agenda: To review and evaluate grant
Mental Health Initial Review Group; Mental Environmental Health Sciences Special applications.
Health Services Research Committee. Emphasis Panel; Superfund Hazardous Place: Embassy Suites at the Chevy Chase
Date: October 7, 2016. Substance Research and Training Program. Pavilion, 4300 Military Road NW.,
Time: 8:00 a.m. to 2:00 p.m. Date: September 29, 2016. Washington, DC 20015.
Agenda: To review and evaluate grant Time: 1:30 p.m. to 4:30 p.m. Contact Person: Priscah Mujuru, DRPH,
applications. Agenda: To review and evaluate grant MPH, Scientific Review Officer, Scientific
Lhorne on DSK30JT082PROD with NOTICES

Place: Hotel Monaco, 700 F Street NW., applications. Review Branch, Eunice Kennedy Shriver
Washington, DC 20001. Place: Sheraton Imperial Center, One National Institute of Child Health and
Contact Person: Aileen Schulte, Ph.D., Europa Drive, Chapel Hill, NC 27517. Human Development, NIH, 6710B Bethesda
Scientific Review Officer, Division of Contact Person: Leroy Worth, Ph.D., Drive, 2221A, Bethesda, MD 20892, 301–
Extramural Activities, National Institute of Scientific Review Officer, Scientific Review 435–6908, mujurup@mail.nih.gov.
Mental Health, NIH, Neuroscience Center, Branch, Division of Extramural Research and (Catalogue of Federal Domestic Assistance
6001 Executive Blvd., Room 6136, MSC 9606, Training, Nat. Institute of Environmental Program Nos. 93.864, Population Research;

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Document Created: 2018-02-09 13:16:37
Document Modified: 2018-02-09 13:16:37

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		Information on licensing and co- development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850-9702, Tel. 240-276-5515 or email [email protected] A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.
FR Citation		81 FR 62913

81 FR 62913 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 177 (September 13, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health