Government-Owned Inventions; Availability for Licensing, 62915-62916 [2016-21905]
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Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: September 7, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–21894 Filed 9–12–16; 8:45 am]
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Closed Meetings
Lhorne on DSK30JT082PROD with NOTICES
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The meetings will be closed to the
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as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
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would constitute a clearly unwarranted
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Dissemination and Implementation Research
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(Virtual Meeting).
Contact Person: Jan Li, MD, Ph.D.,
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(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
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93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: September 7, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–21893 Filed 9–12–16; 8:45 am]
BILLING CODE 4140–01–P
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62915
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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 codevelopment 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 ncitechtransfer@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Title of invention: A SNP-based blood
test for predicting breast cancer survival
and determining treatment strategies.
Keywords: SNP Single Nucleotide
Polymorphism Array Probe Breast
Cancer.
SUMMARY:
Description of Technology
Metastasis is a primary cause of
patient morbidity and mortality in solid
tumors. Although recent advances in
genomic technologies have provided
major insights into tumor etiology, there
is a significant lack of knowledge
regarding the factors that contribute to
metastasis.
Through studying the metastatic
susceptibility of tumors, researchers at
NCI’s Laboratory of Cancer Biology and
Genetics have discovered a select panel
of single nucleotide polymorphisms
(SNPs) and a method for predicting
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62916
Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices
breast cancer patient’s survival. In this
array, SNPs are analyzed from a
patient’s genomic DNA (gDNA); the
result can be used to predict whether a
patient is likely to respond to current
breast cancer treatment strategies. This
invention can reassure newly diagnosed
patients that they have a high
probability of responding to treatment
and can also identify those patients that
require alternative, more aggressive
therapeutic strategies. Importantly, this
invention has several advantages over
the currently-offered gene expressionbased breast cancer prognostic tests.
Since this array can be completed
following routine blood draw, rather
than through a tumor biopsy, the
samples are more stable, the process is
quicker, simpler, less-invasive, and
more cost-effective than current
methods.
Lhorne on DSK30JT082PROD with NOTICES
Potential Commercial Applications
• Identification of patients with
higher susceptibility to tumor
progression (i.e., metastasis).
• Prediction of breast cancer survival
(less than 10 years, for example) using
array and methods.
• Personalization of patient
treatment.
Value Proposition: Since the array
processes DNA from blood rather than
tissue from a standard biopsy or
resection of a primary tumor, it is faster,
simpler, more stable, more costefficient, and less-invasive because
gDNA is more stable than tumor mRNA.
Development Stage: Pre-clinical (in
vivo validation).
Inventor(s): Kent W. Hunter, Ph.D.
(NCI), Howard H. Yang, Ph.D. (NCI),
Maxwell P. Lee, Ph.D. (NCI).
Intellectual Property: HHS Reference
No. E–082–2015/0–US–01
US Provisional Application 62/
297,557 (HHS Reference No. E–082–
2015/0–US–01) filed February 19, 2016
entitled ‘‘SNP-Based Assay to Predict
Breast Cancer Survival’’.
Collaboration Opportunity:
Researchers at the NCI seek licensing
and/or co-development research
collaborations for methods that provide
significant improvements in examining
additional SNPs for improved
prognostics, and to evaluate whether the
SNP signature is associated with overall
cancer incidence or effective treatment
strategies.
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 hewesj@
mail.nih.gov.
VerDate Sep<11>2014
15:27 Sep 12, 2016
Jkt 238001
Dated: September 5, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology
Transfer Center, National Cancer Institute.
[FR Doc. 2016–21905 Filed 9–12–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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 codevelopment 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 ncitechtransfer@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Title of invention: Immunotoxins with
Increased Stability for Cancer Therapy.
Keywords: Recombinant
Immunotoxin, RIT, Antibody,
Mesothelin, Mesothelioma.
SUMMARY:
Description of Technology
Recombinant immunotoxins (RITs)
are fusions of an antibody-based
targeting moiety and a toxin.
Pseudomonas exotoxin A (PE) is a
bacterial toxin that has been used in
several RITs evaluated in clinical
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trials.1 2 Once the Fv portion of the
immunotoxin binds to its target
receptor, the immunotoxin is
internalized by endocytosis. Following
internalization, Furin cleavage is
critically important for proper cytosolic
shuttling of the immunotoxin. Early PEcontaining RITs were effective, but also
had issues of off-target toxicity.
To mitigate off-target toxicity of PE,
the inventors removed specific
sequences of domain II, and connected
the Fv domain to domain III (PE24) by
a furin linker peptide. These PE24–RITs
are very active and better tolerated by
mice. However, the PE24-containing
RITs could potentially be cleaved and
inactivated before internalization by cell
surface furin or other proteases in the
bloodstream or the tumor
microenvironment, due to the absence
of a key disulfide bond (lost after
removal of domain II sequences).
Researchers at the National Cancer
Institute’s Laboratory of Molecular
Biology (NCI LMB) developed and
isolated several de-immunized, low
toxicity, PE24-based RITs with a longer
serum half-life. This was enabled by
using a disulfide bond to protect the
furin cleavage sequence (FCS).
Collectively, the new RITs are
designated ‘‘DS–PE24’’ immunotoxins.
The goal of the disulfide bond is to
protect the RIT from cleavage-based
deactivation before internalization. The
most active of these new RITs has longer
serum half-life than an RIT without the
disulfide bond, has the same anti-tumor
activity, while remaining less cytotoxic
in vitro. Currently, the inventors are
working with mouse models to further
develop the DS–PE24 RITs towards
developing an anti-mesothelin RIT for
treatment of mesothelin-expressing
cancers, such as mesothelioma.
Potential Commercial Applications
• A more stable cancer therapeutic for
currently used PE-coupled RITs, for
example, anti-mesothelin PE-based
immunotoxins.
Value Proposition
• Protection of the FCS by a disulfide
bond results in more stable RIT, which
can lead to fewer off-target effects.
Development Stage: In-vivo.
Inventor(s): Ira Pastan M.D. (NCI), et
al.
Intellectual Property: United States
Provisional Patent Application 62/
323,668 (NIH Reference E–157–2016/0–
US–01), entitled ‘‘New, More Stable
1 Fitzgerald DJ, Kreitman R, et al. Int J Med
Microbiol. 2004;293:577–582.
2 Sampson JH, Akabani G, Archer GE, et al. J
Neurooncol. 2003;65(1):27–35.
E:\FR\FM\13SEN1.SGM
13SEN1
]]>Agencies
[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Notices]
[Pages 62915-62916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21905]
-----------------------------------------------------------------------
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 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
ncitechtransfer@mail.nih.gov. A signed Confidential Disclosure
Agreement may be required to receive copies of the patent applications.
SUPPLEMENTARY INFORMATION: Technology description follows.
Title of invention: A SNP-based blood test for predicting breast
cancer survival and determining treatment strategies.
Keywords: SNP Single Nucleotide Polymorphism Array Probe Breast
Cancer.
Description of Technology
Metastasis is a primary cause of patient morbidity and mortality in
solid tumors. Although recent advances in genomic technologies have
provided major insights into tumor etiology, there is a significant
lack of knowledge regarding the factors that contribute to metastasis.
Through studying the metastatic susceptibility of tumors,
researchers at NCI's Laboratory of Cancer Biology and Genetics have
discovered a select panel of single nucleotide polymorphisms (SNPs) and
a method for predicting
[[Page 62916]]
breast cancer patient's survival. In this array, SNPs are analyzed from
a patient's genomic DNA (gDNA); the result can be used to predict
whether a patient is likely to respond to current breast cancer
treatment strategies. This invention can reassure newly diagnosed
patients that they have a high probability of responding to treatment
and can also identify those patients that require alternative, more
aggressive therapeutic strategies. Importantly, this invention has
several advantages over the currently-offered gene expression-based
breast cancer prognostic tests. Since this array can be completed
following routine blood draw, rather than through a tumor biopsy, the
samples are more stable, the process is quicker, simpler, less-
invasive, and more cost-effective than current methods.
Potential Commercial Applications
Identification of patients with higher susceptibility to
tumor progression (i.e., metastasis).
Prediction of breast cancer survival (less than 10 years,
for example) using array and methods.
Personalization of patient treatment.
Value Proposition: Since the array processes DNA from blood rather
than tissue from a standard biopsy or resection of a primary tumor, it
is faster, simpler, more stable, more cost-efficient, and less-invasive
because gDNA is more stable than tumor mRNA.
Development Stage: Pre-clinical (in vivo validation).
Inventor(s): Kent W. Hunter, Ph.D. (NCI), Howard H. Yang, Ph.D.
(NCI), Maxwell P. Lee, Ph.D. (NCI).
Intellectual Property: HHS Reference No. E-082-2015/0-US-01
US Provisional Application 62/297,557 (HHS Reference No. E-082-
2015/0-US-01) filed February 19, 2016 entitled ``SNP-Based Assay to
Predict Breast Cancer Survival''.
Collaboration Opportunity: Researchers at the NCI seek licensing
and/or co-development research collaborations for methods that provide
significant improvements in examining additional SNPs for improved
prognostics, and to evaluate whether the SNP signature is associated
with overall cancer incidence or effective treatment strategies.
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
hewesj@mail.nih.gov.
Dated: September 5, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National
Cancer Institute.
[FR Doc. 2016-21905 Filed 9-12-16; 8:45 am]
BILLING CODE 4140-01-P
