Office of the Director; Notice of Charter Renewal, 27069 [2017-12143]
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Federal Register / Vol. 82, No. 112 / Tuesday, June 13, 2017 / Notices
exploiting cell surface proteases present
at high levels in tumors, they have
developed a tumor-targeted anthrax
based toxin that inactivates the blood
vessels within tumors. While in some
cases cancer cells are also killed by the
tumor-targeted toxin, the primary
mechanism of action is thought to be a
decrease in blood flow to the center of
tumors, causing cancer cell death and
tumor necrosis. Preliminary and ongoing studies have demonstrated that
the targeted toxins have antitumor
effects on melanomas, lung cancers and
colon cancer in mouse models, and on
feline and canine oral tumors.
Interestingly, this therapy does not
target a specific type of cancer cell,
rather it targets the vasculature in and
around tumors. Therefore, it has great
potential to treat a wide range of solid
tumors. Additionally, because few nonsurgical treatments are available to treat
many human and veterinary solid
tumors, this technology would fill an
unmet need in cancer therapy.
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
Therapeutic agent for a wide range of
human and veterinary solid tumors,
including:
• Melanomas
• Lung and colon cancers
• Oral squamous carcinomas
Competitive Advantages
• Proven effective in a variety of
models, including models of important
veterinary cancers.
• Agent is only active in tumor microenvironments, resulting in low toxicity
to healthy tissue.
• Cancer cells are not directly
targeted, so this agent can be used to
treat a broad spectrum of solid tumors
and resistance is unlikely to arise.
• Fills an unmet need in cancer
therapy, because few non-surgical
treatments exist.
nlaroche on DSK30NT082PROD with NOTICES
Development Stage
• in vitro data available
• in vivo data available (animal)
• prototype
Inventors: S. Leppla (NIAID); S.-H.
Liu (NIAID); T. Bugge (NIDCR); A.Wein
(NIAID); D. Peters (NIDCR); J. Liu
(NHLBI); K.-H.Chen (NIAID); H.
Birkedal-Hansen (NIDCR); S. NetzelArnett (NIDCR); D. Phillips (NIAID); C.
Leysath (NIAID); C. Bachran (NIAID)
VerDate Sep<11>2014
14:58 Jun 12, 2017
Jkt 241001
Publications
Chen KH, et al., Selection of anthrax
toxin protective antigen variants
that discriminate between the
cellular receptors tem8 and cmg2
and achieve targeting of tumor cells.
J Biol Chem. 2007 Mar 30; 282(13):
9834–9845 [PMID: 17251181
PMCID: PMC2530824]
Liu S, et al., Solid tumor therapy by
selectively targeting stromal
endothelial cells. Proc Natl Acad
Sci U S A. 2016 Jul 12; 113(28):
E4079–E4087 [PMID: 27357689
PMCID: PMC4948345]
Wein AN, et al., An anthrax toxin
variant with an improved activity in
tumor targeting. Sci Rep. 2015; 5:
16267 [PMID: 26584669 PMCID:
PMC4653645]
Peters DE, et al., Comparative toxicity
and efficacy of engineered anthrax
lethal toxin variants with broad
anti-tumor activities. Toxicol Appl
Pharmacol. 2014 Sep 1; 279(2):
220–229 [PMID: 24971906 PMCID:
PMC4137396]
Bachran C, et al., Cytolethal distending
toxin B as a cell-killing component
of tumor-targeted anthrax toxin
fusion proteins. Cell Death Dis.
2014 Jan; 5(1): e1003 [PMID:
24434511 PMCID: PMC4040664]
Wein AN, et al., Tumor therapy with a
urokinase plasminogen activatoractivated anthrax lethal toxin alone
and in combination with paclitaxel.
Invest New Drugs. 2013 Feb; 31(1):
206–212 [PMID: 22843210 PMCID:
PMC3757568]
Phillips DD, et al., Engineering Anthrax
Toxin Variants That Exclusively
Form Octamers and Their
Application to Targeting Tumors. J
Biol Chem. 2013 Mar 29; 288(13):
9058–9065 [PMID: 23393143
PMCID: PMC3610978]
Liu S, et al., Intermolecular
complementation achieves high
specificity tumor targeting by
anthrax toxin. Nat Biotechnol. 2005
Jun; 23(6): 725–730 [PMID:
15895075 PMCID: PMC2405912]
Intellectual Property
HHS E–256–2015—US Application Nos.
62/210,771, filed 27 Aug 2015; 62/
323,218, filed 15 Apr 2016; PCT App.
No. PCT/US16/48706, filed 25 Aug
2016.
HHS E–120–2013—US App. No. 14/
898,248, filed 14 Dec 2015; PCT App.
No. PCT/US2014/043131, filed 19 Jun
2014.
HHS E–246–2012—US App. No. 14/
423,408, filed 23 Feb 2015; PCT App.
No. PCT/US13/56205
HHS E–059–2004—US Patent No.
7,947,289, filed 09 Feb 2005.
PO 00000
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27069
HHS E–293–1999—US Patent Nos.
7,468,352, filed 22 Mar 2002;
8,791,074, filed 20 Oct 2008, and
9,403,872 filed 24 Jun 2014.
Licensing Contact: Dr. Natalie Greco,
301–761–7898; Natalie.Greco@nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize anthrax toxin-based
cancer therapeutics. For collaboration
opportunities, please contact Dr. Natalie
Greco, 301–761–7898; Natalie.Greco@
nih.gov.
Dated: June 1, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2017–12147 Filed 6–12–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of Charter
Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Advisory
Committee to the Director, National
Institutes of Health, was renewed for an
additional two-year period on May 31,
2017.
It is determined that the Advisory
Committee to the Director, National
Institutes of Health, is in the public
interest in connection with the
performance of duties imposed on the
National Institutes of Health by law, and
that these duties can best be performed
through the advice and counsel of this
group.
Inquiries may be directed to Jennifer
Spaeth, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or spaethj@od.nih.gov.
Dated: June 7, 2017.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–12143 Filed 6–12–17; 8:45 am]
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[Federal Register Volume 82, Number 112 (Tuesday, June 13, 2017)]
[Notices]
[Page 27069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12143]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of Charter Renewal
In accordance with Title 41 of the U.S. Code of Federal
Regulations, Section 102-3.65(a), notice is hereby given that the
Charter for the Advisory Committee to the Director, National Institutes
of Health, was renewed for an additional two-year period on May 31,
2017.
It is determined that the Advisory Committee to the Director,
National Institutes of Health, is in the public interest in connection
with the performance of duties imposed on the National Institutes of
Health by law, and that these duties can best be performed through the
advice and counsel of this group.
Inquiries may be directed to Jennifer Spaeth, Director, Office of
Federal Advisory Committee Policy, Office of the Director, National
Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda,
Maryland 20892 (Mail code 4875), Telephone (301) 496-2123, or
spaethj@od.nih.gov.
Dated: June 7, 2017.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-12143 Filed 6-12-17; 8:45 am]
BILLING CODE 4140-01-P
