83 FR 38707 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 152 (August 7, 2018)

Page Range		38707-38707
FR Document		2018-16839

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.

Federal Register, Volume 83 Issue 152 (Tuesday, August 7, 2018)

[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Page 38707]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16839]


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

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.

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Disclosure Agreement may be required to receive any unpublished 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: This notice is in accordance with 35 U.S.C. 
209 and 37 CFR part 404 to achieve commercialization of results of 
federally-funded research and development.
    Technology description follows.

Neuroendocrine Tumor Evans Blue Containing Radiotherapeutics

    The invention pertains to a radiotherapeutic against neuroendocrine 
tumors that express somatostatin receptor. Radionuclide therapies 
directed against tumors that express somatostatin receptors (SSTRs) 
have proven effective for the treatment of advanced, low- to 
intermediate-grade neuroendocrine tumors. The subject radiotherapeutic 
covered by the subject patent estate includes a somatostatin (SST) 
peptide derivative like octreotate (TATE), conjugated to an Evans Blue 
(EB) analog, and further chelated via DOTA to therapeutic 
radionuclide\177\Lu, a beta emitter. The EB analog reversibly binds to 
circulating serum albumin and improves the pharmacokinetics of SST 
peptide derivatives and reduce peptide-receptor radionuclide therapy 
toxicity. EB analog conjugated to octreotate (EB-DOTATATE) has been 
shown by the inventors to provide reversible albumin binding in vivo 
and extended half-life in circulation. When EB-TATE is slowly released 
into the tumor microenvironment, tumor uptake and internalization into 
SSTR positive tumors resulted in delivery of radioactive particles and 
tumor cell killing. EB-TATE displayed significantly more favorable 
pharmacokinetics than TATE alone by achieving higher tumor to non-tumor 
penetration as evidenced by positron emission tomography.
    Potential Commercial Applications:

 Cancer therapeutics
 Higher stability/Lower toxicity

    Development Stage:

 Early stage

    Inventors: Xiaoyuan Chen and Orit Jacobson Weiss (both of NIBIB).
    Intellectual Property: HHS Reference No. E-150-2016-1; 
International Patent Application PCT/US2017/031696.
    Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; 
[email protected].

    Dated: July 20, 2018.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2018-16839 Filed 8-6-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38707

Program (CICP) to provide benefits to Place: Bethesda Marriott, 5151 Pooks Hill (EB) analog, and further chelated via
certain individuals or estates of Rd., Bethesda, MD 20814. DOTA to therapeutic radionuclide177Lu,
individuals who sustain a covered Contact Person: Alicja L. Markowska, a beta emitter. The EB analog reversibly
Ph.D., DSC, National Institute on Aging,
serious physical injury as the direct National Institutes of Health, Gateway
binds to circulating serum albumin and
result of the administration or use of the Building 2C212, 7201 Wisconsin Avenue, improves the pharmacokinetics of SST
Covered Countermeasures, and benefits Bethesda, MD 20892, 301–496–9666, peptide derivatives and reduce peptide-
to certain survivors of individuals who markowsa@nia.nih.gov. receptor radionuclide therapy toxicity.
die as a direct result of the (Catalogue of Federal Domestic Assistance EB analog conjugated to octreotate (EB–
administration or use of the Covered Program Nos. 93.866, Aging Research, DOTATATE) has been shown by the
Countermeasures. The causal National Institutes of Health, HHS) inventors to provide reversible albumin
connection between the countermeasure Dated: August 1, 2018. binding in vivo and extended half-life in
and the serious physical injury must be Melanie J. Pantoja, circulation. When EB–TATE is slowly
supported by compelling, reliable, valid, released into the tumor
Program Analyst, Office of Federal Advisory
medical and scientific evidence in order Committee Policy. microenvironment, tumor uptake and
for the individual to be considered for internalization into SSTR positive
[FR Doc. 2018–16787 Filed 8–6–18; 8:45 am]
compensation. The CICP is tumors resulted in delivery of
BILLING CODE 4140–01–P
administered by the Health Resources radioactive particles and tumor cell
and Services Administration, within the killing. EB–TATE displayed
Department of Health and Human DEPARTMENT OF HEALTH AND significantly more favorable
Services. Information about the CICP is HUMAN SERVICES pharmacokinetics than TATE alone by
available at the toll-free number 1–855– achieving higher tumor to non-tumor
266–2427 or http://www.hrsa.gov/cicp/. National Institutes of Health penetration as evidenced by positron
emission tomography.
XV. Amendments
Government-Owned Inventions; Potential Commercial Applications:
42 U.S.C. 247d–6d(b)(4) Availability for Licensing • Cancer therapeutics
Amendments to this Declaration will AGENCY: National Institutes of Health, • Higher stability/Lower toxicity
be published in the Federal Register. HHS. Development Stage:
Authority: 42 U.S.C. 247d–6d. ACTION: Notice. • Early stage
Dated: August 1, 2018. SUMMARY: The inventions listed below Inventors: Xiaoyuan Chen and Orit
Alex M. Azar II are owned by an agency of the U.S. Jacobson Weiss (both of NIBIB).
Secretary, Department of Health and Human Government and are available for Intellectual Property: HHS Reference
Services. licensing in the U.S. No. E–150–2016–1; International Patent
Application PCT/US2017/031696.
[FR Doc. 2018–16856 Filed 8–6–18; 8:45 am] FOR FURTHER INFORMATION CONTACT:
Licensing Contact: Michael
BILLING CODE P Licensing information may be obtained
Shmilovich, Esq, CLP; 301–435–5019;
by emailing the indicated licensing
shmilovm@mail.nih.gov.
contact at the National Heart, Lung, and
DEPARTMENT OF HEALTH AND Blood, Office of Technology Transfer Dated: July 20, 2018.
HUMAN SERVICES and Development Office of Technology Michael Shmilovich,
Transfer, 31 Center Drive Room 4A29, Senior Licensing and Patenting Manager,
National Institutes of Health MSC2479, Bethesda, MD 20892–2479; National Heart, Lung, and Blood Institute,
telephone: 301–402–5579. A signed Office of Technology Transfer and
National Institute on Aging; Notice of Development.
Closed Meeting Confidential Disclosure Agreement may
be required to receive any unpublished [FR Doc. 2018–16839 Filed 8–6–18; 8:45 am]
Pursuant to section 10(d) of the information. BILLING CODE 4140–01–P

Federal Advisory Committee Act, as SUPPLEMENTARY INFORMATION: This
amended, notice is hereby given of the notice is in accordance with 35 U.S.C.
following meeting. 209 and 37 CFR part 404 to achieve DEPARTMENT OF HEALTH AND
The meeting will be closed to the commercialization of results of HUMAN SERVICES
public in accordance with the federally-funded research and National Institutes of Health
provisions set forth in sections development.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Technology description follows. Prospective Grant of Exclusive Patent
as amended. The grant applications and Neuroendocrine Tumor Evans Blue License: Treatment of Type I Diabetes
the discussions could disclose Containing Radiotherapeutics and its Comorbidities
confidential trade secrets or commercial
property such as patentable material, The invention pertains to a AGENCY: National Institutes of Health,
and personal information concerning radiotherapeutic against neuroendocrine HHS.
individuals associated with the grant tumors that express somatostatin ACTION: Notice.
applications, the disclosure of which receptor. Radionuclide therapies
would constitute a clearly unwarranted directed against tumors that express SUMMARY: The National Heart, Lung and
invasion of personal privacy. somatostatin receptors (SSTRs) have Blood Institute (NHLBI), National
daltland on DSKBBV9HB2PROD with NOTICES

proven effective for the treatment of Institutes of Health, Department of
Name of Committee: National Institute on advanced, low- to intermediate-grade Health and Human Services, is
Aging Initial Review Group; Clinical Aging
Review Committee NIA–C.
neuroendocrine tumors. The subject contemplating the grant of an exclusive
Date: September 27–28, 2018. radiotherapeutic covered by the subject patent License to Inversago Pharma,
Time: 3:00 p.m. to 2:00 p.m. patent estate includes a somatostatin Inc., located in Montreal, Quebec,
Agenda: To review and evaluate grant (SST) peptide derivative like octreotate Canada, to practice the inventions
applications. (TATE), conjugated to an Evans Blue embodied in the patent applications

VerDate Sep<11>2014 16:54 Aug 06, 2018 Jkt 244001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1

Document Created: 2018-11-06 10:39:08
Document Modified: 2018-11-06 10:39:08

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		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.
FR Citation		83 FR 38707

83 FR 38707 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 152 (August 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health