Government-Owned Inventions; Availability for Licensing, 61877-61879 [2014-24403]
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tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices
sites after this document publishes in
the Federal Register.)
Requests for Oral Presentations: This
public workshop includes a public
comment session. During online
registration you may indicate if you
wish to speak during the public
comment session and which topics you
wish to address. FDA has included
general topics in this document. FDA
will do its best to accommodate requests
to make public comments. Following
the close of registration, FDA will
determine the amount of time allotted to
each speaker and will select and notify
participants by November 10, 2014. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Comments: FDA is holding this public
workshop to obtain input on insulin
bolus calculators. In order to permit the
widest possible opportunity to obtain
public comment, FDA is soliciting
either electronic or written comments
regarding the public workshop topics
that pertain to insulin bolus calculators.
The deadline for submitting comments
related to this public workshop is
December 11, 2014.
Regardless of attendance at the public
workshop, interested persons may
submit either electronic comments
regarding this document to https://
www.regulations.gov or written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. It is only
necessary to send one set of comments.
Please identify comments with the
docket number found in brackets in the
heading of this document. In addition,
when responding to specific questions
as outlined in section II of this
document, please identify the question
number you are addressing. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see Comments). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the
transcripts will also be available on the
Internet at https://www.fda.gov/
MedicalDevices/NewsEvents/
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WorkshopsConferences/default.htm
(select this public workshop from the
posted events list), approximately 45
days after the workshop.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is seeking to foster greater
stakeholder collaboration in the area of
diabetes device interoperability. To that
end, the Agency requests input from the
clinical community, academia,
government, industry, and other
stakeholders regarding usability
considerations for appropriate
information consumption (e.g.,
notifications, indicators, data, and
displays) based on user skill and
knowledge. The Agency also requests
input regarding the technical
considerations for calculator design and
use.
The first topic of discussion is the
interoperability between diabetes
devices. The Agency recognizes that the
diabetes community possesses an
interest in patients having greater
flexibility to pair device components,
e.g., continuous glucose meters with
insulin pumps from different
manufacturers. Pairing would allow
those devices to communicate with each
other and enable patients to interact
with a single interface platform.
Achieving this goal would improve data
tracking and access, thereby facilitating
more productive patient interactions
with their healthcare providers. In order
to realize the objective of effective
diabetes device interoperability,
developers and manufacturers should
discuss technical, safety, and regulatory
challenges that lay before this goal. A
forum that elicits opinions from
physicians and patients regarding their
desires and needs will help inform
those discussions. FDA is committed to
fostering a collaborative environment to
promote these interactions.
The second topic of discussion is
insulin bolus calculators. These devices
are intended to calculate insulin boluses
for patients who manage their diabetes
with insulin-intensive therapy. FDA
currently regulates insulin bolus
calculators as class II devices, often
clearing them in combination with
insulin pumps or blood glucose meters.
Devices that calculate insulin boluses
are increasingly available on the market,
including those devices that use novel
dosing algorithms and new user
interface formats. Although these
devices can benefit patient care, they
could also jeopardize patient safety
without proper regulation guarding
against the serious health consequences
of miscalculating insulin dosages. The
Agency will host a public dialogue
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61877
about insulin bolus calculators to help
realize the aim of ensuring continued
access to safe and effective
technological innovations, regardless of
interface format.
The public workshop will include
two sessions, one for each of the topics
noted previously. Each session will
include presentations from physicians,
FDA, and other experts in the field. A
panel discussion will follow the session
addressing insulin bolus calculators,
and the panel will address questions
from the audience. In addition, Agency
representatives will update the diabetes
community on relevant FDA news.
II. Topics for Discussion at the Public
Workshop
Among other topics, the workshop
will include discussion of the following
questions.
1. How can patients and providers be
confident that the insulin bolus values
obtained from the calculators are
accurate and appropriate for their use?
2. What information do patients and
providers need about how a particular
calculator works so that they may
appropriately use the calculator for
diabetes management?
3. How can FDA foster both
innovation and safety of insulin dose
calculators intended for use by
healthcare practitioners?
4. How can FDA foster both
innovation and safety of insulin dose
calculators intended for use by patients?
Dated: October 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–24451 Filed 10–14–14; 8:45 am]
BILLING CODE 4164–01–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 inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing 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.
SUMMARY:
E:\FR\FM\15OCN1.SGM
15OCN1
61878
Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUPPLEMENTARY INFORMATION:
Technology descriptions follow.
tkelley on DSK3SPTVN1PROD with NOTICES
The Use of Chimeric Antigen Receptor
To Control HIV Infection
Description of Technology: Chimeric
Antigen Receptors (CARs) are
engineered proteins expressed by
transduction on autologous CD8 T cells;
after adoptive transfer, they promote
targeted killing of specific cell types.
CARs are showing great promise for
treating cancer. The present invention
(CD4–CRD CAR) is a novel bifunctional
targeting motif for an anti-HIV CAR,
consisting of a region of human CD4
linked to a carbohydrate recognition
domain (CRD) from one of several
human C-type lectins known to interact
with high-mannose glycans on HIV
gp120. Compared to a ‘‘standard’’ CD4
CAR, the CD4–CRD CAR displays two
major enhancements: (1) Increased
potency for suppression of HIV–1
infection by selective killing of
productively infected cells, and (2)
complete absence of CD4-mediated
entry receptor activity that would
otherwise render the transduced CD8 T
cells susceptible to HIV infection.
Compared to antibody-based anti-HIV
CARs, the CD4–CRD CAR of the present
invention is predicted to have two major
advantages: (1) Lower escape potential,
due to the universality of HIV CD4dependence and high-mannose glycan
display on gp120, and (2) reduced
immunogenicity, since the all-human
CD4–CRD CAR sequences are devoid of
variable regions that would likely elicit
anti-idiotypic antibody responses
against scFv-based targeting motifs.
Potential Commercial Applications:
• Therapy for HIV infection
• Research on antiretroviral infection
Competitive Advantages: Enhanced
potency for HIV inhibition and does not
render transduced CD8T cells
susceptible to HIV infection.
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventors: Mustafa H. Ghanem, Bama
Dey, Edward Berger (all of NIAID)
Publications:
VerDate Sep<11>2014
18:00 Oct 14, 2014
Jkt 235001
1. Scholler J, et al. Decade-long safety
and function of retroviral-modified
chimeric antigen receptor T cells. Sci
Transl Med. 2012 May 2;4(132):132ra53.
[PMID 22553251]
2. Du T, et al. Bifunctional CD4–DC–
SIGN fusion proteins demonstrate
enhanced avidity to gp120 and inhibit
HIV–1 infection and dissemination.
Antimicrob Agents Chemother. 2012
Sep;56(9):4640–9. [PMID 22687513]
3. Lamers CH, et al. Immune
responses to transgene and retroviral
vector in patients treated with ex vivoengineered T cells. Blood. 2011 Jan
6;117(1):72–82. [PMID 20889925]
Intellectual Property: HHS Reference
No. E–212–2014/0—US Provisional
Application No. 62/040,398 filed 21
August 2014
Licensing Contact: John Stansberry,
Ph.D.; 301–435–5236; stansbej@
mail.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 this technology. For
collaboration opportunities, please
contact Chris Kornak at chris.kornak@
nih.gov.
Photo-Controlled Removal of Targets In
Vitro and In Vivo
Description of Technology: The
invention relates to a novel technology
for separation, isolation and removal of
target molecules or cells from a complex
mixture. The technology can be used for
both in vitro and in vivo applications.
It comprises a conjugate of a
biomolecule with specific binding
activity (e.g. antibody, hapten, protein,
nucleic acid) and the fluorescence dye
IR700. When the conjugate is allowed to
contact with a sample, it binds to the
target molecule in the sample to form a
biological complex. Upon exposure to
near infrared light (NIR) of
approximately 700 nm the biological
complex becomes hydrophobic due to
cleavage of a part of the fluorescent dye.
Such hydrophobic complex can
aggregate and readily be separated and
removed from the biological mixture.
The technology can be used in a broad
range of applications, such as
environmental or food (removal of
contaminants from samples), or in vivo
removal of toxins, pathogens or drugs
from a subject, where the latter may
provide a photo-controlled way to
control the pharmacokinetics of a drug
in vivo. The technology can also be
applied in the therapeutic field, for
example in cancer therapy, by killing
and removal of tumor cells in a subject
PO 00000
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Fmt 4703
Sfmt 4703
with the aid of wearable NIR device. In
such treatment, the aggregated target
cells may be removed from the subject
via the liver and/or spleen.
Potential Commercial Applications:
• Environmental or food (removal of
contaminants from samples)
• In vivo removal of toxins,
pathogens or drugs from a subject
• Cancer therapy
Competitive Advantages: Simple and
versatile way to separate and remove
molecules or cells from a complex
mixture.
Development Stage: Early-stage
Inventors: Hisataka Kobayashi, et al.
(NCI)
Intellectual Property: HHS Reference
No. E–209–2014/0—US Provisional
Application No. 62/034,990 filed 08
August 2014
Licensing Contact: Uri Reichman,
Ph.D., MBA; 301–435–4616; ur7a@
nih.gov
Collaborative Research Opportunity:
The National Cancer Institute is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize this technology. For
collaboration opportunities, please
contact John D. Hewes, Ph.D. at hewesj@
mail.nih.gov.
Human Monoclonal Antibodies Against
5T4 as Therapeutic Agents
Description of Technology: 5T4 is an
antigen expressed in a number of
carcinomas. Its expression is limited in
normal tissue, but is prevalent in
malignant tumors throughout their
development. This confined expression
makes it an attractive target for cancer
immunotherapy. 5T4 is often found in
colorectal, ovarian, and gastric tumors
and thus has been used as a prognostic
aid for these cancers. In addition, its
role in antibody-directed
immunotherapy for delivering response
modifiers to tumors has been studied
using murine monoclonal antibodies
(mAbs) and the cancer vaccine TroVax
(currently in clinical trials for multiple
solid tumors) targets 5T4.
The present invention describes the
identification and characterization of
two fully human mAbs (m1001 and
m1002) that bind to 5T4. Since the
mAbs are fully human, they could have
less immunogenicity and better safety
profiles than the existing mouse and
humanized antibodies. These mAbs
have the potential to be cancer
therapeutics as naked mAbs, Chimerica
Antigen Receptors (CARs) and/or
Antibody-Drug Conjugates (ADCs).
Potential Commercial Applications: A
mAb, CAR, or ADC therapeutic for the
E:\FR\FM\15OCN1.SGM
15OCN1
Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
treatment of various human cancers
expressing 5T4.
Competitive Advantages:
• The fully human antibodies may
have better drugability, especially less
immunogenicity and better safety.
• This antibodies could be used as
naked mAbs, CARs and/or as ADCs.
• The confined expression of 5T4
makes it an attractive target for cancer
immunotherapy.
• 5T4 mAbs could be used to treat
several solid tumor cancers.
Development Stage: In vitro data
available
Inventors: Dimiter Dimitrov, Tianlei
Ying, Yang Feng (all of NCI)
Intellectual Property: HHS Reference
No. E–158–2014/0—U.S. Provisional
Application No. 62/034,995 filed 08
August 2014
Licensing Contact: Whitney Hastings;
301–451–7337; hastingw@mail.nih.gov
Quantitative Multiplex Methods for
Rapid Detection and Identification of
Viral Nucleic Acids
Description of Technology: The
subject technologies are quantitative
multiplex loop mediated isothermal
amplification assays that can detect and
distinguish different viral pathogens,
including HIV, Hepatitis B Virus (HBV),
Hepatitis C Virus (HCV), Hepatitis E
Virus (HEV), Dengue Virus (DENV),
Chikungunya virus (CHIKV) and West
Nile Virus (WNV). The assay has the
advantage of distinguishing between
different genotypes of HCV. It has the
potential to detect other pathogens. A
quantitative multiplex variation of the
assay can detect and identify all seven
viruses using one reaction mixture. The
detection-reaction is performed on a
simple heat-source and viral
quantitation can be measured using a
simple fluorospectrophotometer. The
entire detection process using these
assays can be accomplished within 30 to
60 minutes in a doctor’s office,
laboratory setting, or in the field.
Detection limits of as little as 1–10
International Units (viral copies) are
possible with the use of fluorogenic
oligonucleotides. The assays
demonstrate very high specificity when
tested with human clinical samples.
Potential Commercial Applications:
Detection assays for viral pathogens
such as HIV, HBV, HCV, HEV, Dengue
Virus, Chikungunya, and West Nile
Virus.
Competitive Advantages:
• Assays can be completed within 30
to 60 minutes and in a doctor’s office,
laboratory setting, or in the field.
• Assays can be performed without
expensive instrumentation or
specialized technical operators.
VerDate Sep<11>2014
18:00 Oct 14, 2014
Jkt 235001
• Assays are highly specific and can
distinguish between different viruses
and between different genotypes of
viruses.
Development Stage:
• Early-stage
• In vitro data available
• In vivo data available (human)
Inventors: Dougbeh-Chris Nyan
(FDA), Deborah R. Taylor (FDA), Maria
Rios (FDA), Kevin L. Swinson (Morgan
State University), Laura E. Ulitzky
(FDA)
Publication: Nyan DC, et al. Rapid
Detection of Hepatitis B Virus in Blood
Plasma by a Specific and Sensitive
Loop-Mediated Isothermal
Amplification Assay. Clin Infect Dis.
2014 July 1;59(1):16–23. [PMID
24704724]
Intellectual Property: HHS Reference
No. E–135–2014/0—US Provisional
Patent Application No. 61/979,446 filed
14 April 2014
Licensing Contact: Kevin W. Chang,
Ph.D.; 301–435–5018; changke@
mail.nih.gov
Collaborative Research Opportunity:
The Food and Drug Administration,
Center for Biologics Evaluation and
Research, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize blood screening test and/
or diagnostic test for infectious diseases.
For collaboration opportunities, please
contact Nisha Narayan at
Nisha.Narayan@fda.hhs.gov or 240–
402–9770.
Dated: October 8, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–24403 Filed 10–14–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel,
October 27, 2014, 07:30 a.m. to October
28, 2014, 06:00 p.m., Doubletree Guest
Suites Santa Monica, 1707 Fourth
Street, Santa Monica, CA, 90401 which
was published in the Federal Register
on October 06, 2014, 79 FR 60175.
The meeting will start on October 27,
2014. The meeting time and location
remains the same.
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61879
The meeting is closed to the public.
Dated: October 7, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–24380 Filed 10–14–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of meetings of the Board of
Regents of the National Library of
Medicine.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Regents of
the National Library of Medicine; Extramural
Programs Subcommittee.
Date: February 10, 2015.
Closed: 7:45 a.m. to 8:45 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Library of Medicine,
Building 38, Billings Conference Room, 8600
Rockville Pike, Bethesda, MD 20892.
Contact Person: Donald A.B. Lindberg, MD,
Director, National Library of Medicine, 8600
Rockville Pike, Bethesda, MD 20892, 301–
496–6221, lindberg@mail.nih.gov.
Name of Committee: Board of Regents of
the National Library of Medicine;
Subcommittee on Outreach and Public
Information.
Date: February 10, 2015.
Open: 7:45 a.m. to 8:45 a.m.
Agenda: To review and discuss outreach
activities.
Place: National Library of Medicine,
Building 38, 2nd Floor, Conference Room B,
8600 Rockville Pike, Bethesda, MD 20892.
E:\FR\FM\15OCN1.SGM
15OCN1
]]>Agencies
[Federal Register Volume 79, Number 199 (Wednesday, October 15, 2014)]
[Notices]
[Pages 61877-61879]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24403]
-----------------------------------------------------------------------
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. 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.
[[Page 61878]]
FOR FURTHER INFORMATION CONTACT: Licensing information and copies of
the U.S. patent applications listed below may be obtained by writing to
the indicated licensing contact at the Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to
receive copies of the patent applications.
SUPPLEMENTARY INFORMATION: Technology descriptions follow.
The Use of Chimeric Antigen Receptor To Control HIV Infection
Description of Technology: Chimeric Antigen Receptors (CARs) are
engineered proteins expressed by transduction on autologous CD8 T
cells; after adoptive transfer, they promote targeted killing of
specific cell types. CARs are showing great promise for treating
cancer. The present invention (CD4-CRD CAR) is a novel bifunctional
targeting motif for an anti-HIV CAR, consisting of a region of human
CD4 linked to a carbohydrate recognition domain (CRD) from one of
several human C-type lectins known to interact with high-mannose
glycans on HIV gp120. Compared to a ``standard'' CD4 CAR, the CD4-CRD
CAR displays two major enhancements: (1) Increased potency for
suppression of HIV-1 infection by selective killing of productively
infected cells, and (2) complete absence of CD4-mediated entry receptor
activity that would otherwise render the transduced CD8 T cells
susceptible to HIV infection. Compared to antibody-based anti-HIV CARs,
the CD4-CRD CAR of the present invention is predicted to have two major
advantages: (1) Lower escape potential, due to the universality of HIV
CD4-dependence and high-mannose glycan display on gp120, and (2)
reduced immunogenicity, since the all-human CD4-CRD CAR sequences are
devoid of variable regions that would likely elicit anti-idiotypic
antibody responses against scFv-based targeting motifs.
Potential Commercial Applications:
Therapy for HIV infection
Research on antiretroviral infection
Competitive Advantages: Enhanced potency for HIV inhibition and
does not render transduced CD8T cells susceptible to HIV infection.
Development Stage:
In vitro data available
In vivo data available (animal)
Inventors: Mustafa H. Ghanem, Bama Dey, Edward Berger (all of
NIAID)
Publications:
1. Scholler J, et al. Decade-long safety and function of
retroviral-modified chimeric antigen receptor T cells. Sci Transl Med.
2012 May 2;4(132):132ra53. [PMID 22553251]
2. Du T, et al. Bifunctional CD4-DC-SIGN fusion proteins
demonstrate enhanced avidity to gp120 and inhibit HIV-1 infection and
dissemination. Antimicrob Agents Chemother. 2012 Sep;56(9):4640-9.
[PMID 22687513]
3. Lamers CH, et al. Immune responses to transgene and retroviral
vector in patients treated with ex vivo-engineered T cells. Blood. 2011
Jan 6;117(1):72-82. [PMID 20889925]
Intellectual Property: HHS Reference No. E-212-2014/0--US
Provisional Application No. 62/040,398 filed 21 August 2014
Licensing Contact: John Stansberry, Ph.D.; 301-435-5236;
stansbej@mail.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 this technology. For collaboration
opportunities, please contact Chris Kornak at chris.kornak@nih.gov.
Photo-Controlled Removal of Targets In Vitro and In Vivo
Description of Technology: The invention relates to a novel
technology for separation, isolation and removal of target molecules or
cells from a complex mixture. The technology can be used for both in
vitro and in vivo applications. It comprises a conjugate of a
biomolecule with specific binding activity (e.g. antibody, hapten,
protein, nucleic acid) and the fluorescence dye IR700. When the
conjugate is allowed to contact with a sample, it binds to the target
molecule in the sample to form a biological complex. Upon exposure to
near infrared light (NIR) of approximately 700 nm the biological
complex becomes hydrophobic due to cleavage of a part of the
fluorescent dye. Such hydrophobic complex can aggregate and readily be
separated and removed from the biological mixture. The technology can
be used in a broad range of applications, such as environmental or food
(removal of contaminants from samples), or in vivo removal of toxins,
pathogens or drugs from a subject, where the latter may provide a
photo-controlled way to control the pharmacokinetics of a drug in vivo.
The technology can also be applied in the therapeutic field, for
example in cancer therapy, by killing and removal of tumor cells in a
subject with the aid of wearable NIR device. In such treatment, the
aggregated target cells may be removed from the subject via the liver
and/or spleen.
Potential Commercial Applications:
Environmental or food (removal of contaminants from
samples)
In vivo removal of toxins, pathogens or drugs from a
subject
Cancer therapy
Competitive Advantages: Simple and versatile way to separate and
remove molecules or cells from a complex mixture.
Development Stage: Early-stage
Inventors: Hisataka Kobayashi, et al. (NCI)
Intellectual Property: HHS Reference No. E-209-2014/0--US
Provisional Application No. 62/034,990 filed 08 August 2014
Licensing Contact: Uri Reichman, Ph.D., MBA; 301-435-4616;
ur7a@nih.gov
Collaborative Research Opportunity: The National Cancer Institute
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate or commercialize
this technology. For collaboration opportunities, please contact John
D. Hewes, Ph.D. at hewesj@mail.nih.gov.
Human Monoclonal Antibodies Against 5T4 as Therapeutic Agents
Description of Technology: 5T4 is an antigen expressed in a number
of carcinomas. Its expression is limited in normal tissue, but is
prevalent in malignant tumors throughout their development. This
confined expression makes it an attractive target for cancer
immunotherapy. 5T4 is often found in colorectal, ovarian, and gastric
tumors and thus has been used as a prognostic aid for these cancers. In
addition, its role in antibody-directed immunotherapy for delivering
response modifiers to tumors has been studied using murine monoclonal
antibodies (mAbs) and the cancer vaccine TroVax (currently in clinical
trials for multiple solid tumors) targets 5T4.
The present invention describes the identification and
characterization of two fully human mAbs (m1001 and m1002) that bind to
5T4. Since the mAbs are fully human, they could have less
immunogenicity and better safety profiles than the existing mouse and
humanized antibodies. These mAbs have the potential to be cancer
therapeutics as naked mAbs, Chimerica Antigen Receptors (CARs) and/or
Antibody-Drug Conjugates (ADCs).
Potential Commercial Applications: A mAb, CAR, or ADC therapeutic
for the
[[Page 61879]]
treatment of various human cancers expressing 5T4.
Competitive Advantages:
The fully human antibodies may have better drugability,
especially less immunogenicity and better safety.
This antibodies could be used as naked mAbs, CARs and/or
as ADCs.
The confined expression of 5T4 makes it an attractive
target for cancer immunotherapy.
5T4 mAbs could be used to treat several solid tumor
cancers.
Development Stage: In vitro data available
Inventors: Dimiter Dimitrov, Tianlei Ying, Yang Feng (all of NCI)
Intellectual Property: HHS Reference No. E-158-2014/0--U.S.
Provisional Application No. 62/034,995 filed 08 August 2014
Licensing Contact: Whitney Hastings; 301-451-7337;
hastingw@mail.nih.gov
Quantitative Multiplex Methods for Rapid Detection and Identification
of Viral Nucleic Acids
Description of Technology: The subject technologies are
quantitative multiplex loop mediated isothermal amplification assays
that can detect and distinguish different viral pathogens, including
HIV, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Hepatitis E
Virus (HEV), Dengue Virus (DENV), Chikungunya virus (CHIKV) and West
Nile Virus (WNV). The assay has the advantage of distinguishing between
different genotypes of HCV. It has the potential to detect other
pathogens. A quantitative multiplex variation of the assay can detect
and identify all seven viruses using one reaction mixture. The
detection-reaction is performed on a simple heat-source and viral
quantitation can be measured using a simple fluorospectrophotometer.
The entire detection process using these assays can be accomplished
within 30 to 60 minutes in a doctor's office, laboratory setting, or in
the field. Detection limits of as little as 1-10 International Units
(viral copies) are possible with the use of fluorogenic
oligonucleotides. The assays demonstrate very high specificity when
tested with human clinical samples.
Potential Commercial Applications: Detection assays for viral
pathogens such as HIV, HBV, HCV, HEV, Dengue Virus, Chikungunya, and
West Nile Virus.
Competitive Advantages:
Assays can be completed within 30 to 60 minutes and in a
doctor's office, laboratory setting, or in the field.
Assays can be performed without expensive instrumentation
or specialized technical operators.
Assays are highly specific and can distinguish between
different viruses and between different genotypes of viruses.
Development Stage:
Early-stage
In vitro data available
In vivo data available (human)
Inventors: Dougbeh-Chris Nyan (FDA), Deborah R. Taylor (FDA), Maria
Rios (FDA), Kevin L. Swinson (Morgan State University), Laura E.
Ulitzky (FDA)
Publication: Nyan DC, et al. Rapid Detection of Hepatitis B Virus
in Blood Plasma by a Specific and Sensitive Loop-Mediated Isothermal
Amplification Assay. Clin Infect Dis. 2014 July 1;59(1):16-23. [PMID
24704724]
Intellectual Property: HHS Reference No. E-135-2014/0--US
Provisional Patent Application No. 61/979,446 filed 14 April 2014
Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018;
changke@mail.nih.gov
Collaborative Research Opportunity: The Food and Drug
Administration, Center for Biologics Evaluation and Research, is
seeking statements of capability or interest from parties interested in
collaborative research to further develop, evaluate or commercialize
blood screening test and/or diagnostic test for infectious diseases.
For collaboration opportunities, please contact Nisha Narayan at
Nisha.Narayan@fda.hhs.gov or 240-402-9770.
Dated: October 8, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-24403 Filed 10-14-14; 8:45 am]
BILLING CODE 4140-01-P
