Government-Owned Inventions; Availability for Licensing, 24263-24265 [2015-10013]
Download as PDF
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices
2015. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by May 19, 2015.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Philip
Bautista at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 24, 2015.
Peter Lurie,
Associate Commissioner for Public Health
Strategy and Analysis.
[FR Doc. 2015–10022 Filed 4–29–15; 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.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:01 Apr 29, 2015
Jkt 235001
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.
A Novel T Cell Therapy Against
Patient-Specific Cancer Mutations
Description of Technology: This
invention is a novel T cell therapy
against cancer mutations that are patient
specific. Scientists at the National
Institutes of Health have developed a
method to identify T cells that
specifically recognize immunogenic
mutations expressed only by cancer
cells. Human cancers contain genetic
mutations that are unique to each
patient. Some of the mutated peptides
are immunogenic, can be recognized by
T cells, and therefore, may serve as
therapeutic targets. The inventors
identified cancer-specific mutations
from a patient with widely metastatic
cholangiocarcinoma by sequencing
tumor samples and comparing with
normal cells. Using tandem minigene
constructs encoding all of the mutations
expressed by a patient’s tumor, the
inventors identified T cells that
recognized the immunogenic mutations
from the same patient. These mutationreactive T cells have the potential to
eliminate the cancer cells while sparing
normal tissues since normal tissues do
not express the mutations. The
inventors expanded these mutationreactive T cells in vitro, and infused a
highly pure population of these T cells
back into the same patient. The patient
experienced tumor regression when she
was treated with this approach.
Potential Commercial Applications
• Personalized immunotherapy with
mutation-reactive T cells for mediating
tumor regression in patients with
immunogenic mutations.
• Mutation-reactive T cell therapy
especially beneficial for cancer patients
refractory to other therapies.
• A research tool to identify patientspecific immunogenic mutations in the
tumor.
Competitive Advantages
• This patient-specific therapy has
the potential application to most
epithelial cancers, which account for
about 90% of cancer deaths in the
United States.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
24263
• Personalized mutation-specific T
cells recognize mutations harboring
tumor cells only and spare normal
tissues. This therapy has no tissue
toxicities comparing to traditional
chemotherapy and radiotherapy.
• The infusion of a highly pure
population of these mutation-specific T
cells may maximize therapy and result
in regression of all target lesions.
Development Stage
• Early-stage
• In vitro data available
• In vivo data available (human)
• Ex vivo data available
Inventors: Eric Tran, Yong-Chen W.
Lu, Paul F. Robbins, Steven A.
Rosenberg (all of NCI).
Publications
1. Tran E, et al. Cancer immunotherapy
based on mutation-specific CD4+ T cells in
a patient with epithelial cancer. Science.
2014 May 9; 344(6184):641–5. [PMID
24812403]
2. Robbins P, et al. Mining exomic
sequencing data to identify mutated antigens
recognized by adoptively transferred tumorreactive T cells. Nat Med. 2013
Jun;19(6):747–52. [PMID 23644516]
3. Tran E, et al. T-cell therapy against
cancer mutations. Oncotarget. 2014 Jul
15;5(13):4579–80. [PMID 25046408]
Intellectual Property: HHS Reference
No. E–229–2014/0—PCT Application
No. PCT/US2014/058805 filed October
2, 2014.
Related Technology: HHS Reference
No. E–233–2014/0—PCT Application
No. PCT/US2014/058796 filed October
2, 2014.
Licensing Contact: Whitney A.
Hastings, Ph.D.; 301–451–7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute, Surgery
Branch, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize T-cell therapy against
cancer mutations. For collaboration
opportunities, please contact Steven A.
Rosenberg, M.D., Ph.D. at sar@nih.gov.
A Novel, Personalized T Cell Therapy:
T-Cell Receptor Engineered T Cells
Targeting Tumor Specific Mutations
Description of Technology: This
invention is a novel T cell therapy
against cancer mutations that are patient
specific. Scientists at the National
Institutes of Health have developed a
method to identify and generate T-cell
receptor (TCR) engineered T cells for
personalized cancer therapy. The TCR is
a complex of integral membrane
proteins that recognizes antigens and
activates T cells. Human cancers
E:\FR\FM\30APN1.SGM
30APN1
24264
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices
contain genetic mutations that are
unique in each patient. The inventors
found cancer-specific mutations by
sequencing tumors and comparing with
normal cells. Using tandem minigene
constructs encoding all of the patient’s
tumor mutations, they first identified T
cells that were reactive with the unique
mutated antigens expressed only in the
patient’s tumors. Next, they isolated the
mutation-reactive TCRs and engineered
peripheral blood T cells from the same
patient to express these mutationreactive TCRs. These personalized TCR
engineered T cells can be expanded and
infused back into the same patient with
the potential to induce tumor
regression.
Potential Commercial Applications
• Personalized immunotherapy to
treat primary and recurrent epithelial
cancer.
• A research tool to identify patientspecific immunogenic mutations in
tumors.
• A research tool to identify and
isolate mutation-specific T cell
receptors.
Competitive Advantages
• This patient-specific therapy has
the potential application to most
epithelial cancers, which account for
about 90% of cancer deaths in the
United States.
• Personalized TCR engineered T
cells target tumor cells and spare normal
tissues. This therapy has no tissue
toxicities comparing to traditional
chemotherapy and radiotherapy.
• The infusion of a highly pure
population of these T cells expressing
mutation-specific TCRs may maximize
therapy and result in regression of all
target lesions.
Development Stage
• Early-stage
• In vitro data available
• Ex vivo data available
Inventors: Eric Tran, Yong-Chen W.
Lu, Paul F. Robbins, Steven A.
Rosenberg (all of NCI).
mstockstill on DSK4VPTVN1PROD with NOTICES
Publications
1. Tran E, et al. Cancer immunotherapy
based on mutation-specific CD4+ T cells in
a patient with epithelial cancer. Science.
2014 May 9;344 (6184):641–5. [PMID
24812403].
2. Robbins P, et al. Mining exomic
sequencing data to identify mutated antigens
recognized by adoptively transferred tumorreactive T cells. Nat Med. 2013
Jun;19(6):747–52. [PMID 23644516].
3. Tran E, et al. T-cell therapy against
cancer mutations. Oncotarget. 2014 Jul
15;5(13):4579–80. [PMID 25046408].
4. Gros A, et al. PD–1 identifies the patientspecific CD8+ tumor-reactive repertoire
VerDate Sep<11>2014
17:01 Apr 29, 2015
Jkt 235001
infiltrating human tumors. J Clin Invest. 2014
May 1;124(5):2246–59. [PMID 24667641].
Intellectual Property: HHS Reference
No. E–233–2014/0—PCT Application
No. PCT/US2014/058796 filed October
2, 2014.
Related Technology: HHS Reference
No. E–229–2014/0—PCT Application
No. PCT/US2014/058805 filed October
2, 2014.
Licensing Contact: Whitney A.
Hastings, Ph.D.; 301–451–7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute, Surgery
Branch, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize TCRs reactive with
tumor associated antigens. For
collaboration opportunities, please
contact Steven A. Rosenberg, M.D.,
Ph.D. at sar@nih.gov.
Recombinant Paramyxoviruses
Expressing Optimized Heterologous
Antigens
Description of Technology: The
invention pertains to recombinant
paramyxoviruses that express one or
more heterologous antigens, such as the
human respiratory syncytial virus (RSV)
F protein, that have been optimized for
increased expression and
immunogenicity. The recombinant
constructs induce a bivalent immune
response to the paramyxovirus vectors
and the heterologous antigen. Potential
vectors include parainfluenza virus
(PIV) serotype 1 and 3, Sendai virus,
Newcastle disease virus, PIV2, and
PIV5. An exemplary modified
heterologous antigen includes the
ectodomain of RSV F protein linked to
the transmembrane and cytoplasmic
domains of the F protein from the PIV
vector, which results in efficient
incorporation into the vector particle.
The RSV F ectodomain can be
engineered to be stabilized in an
optimal conformation, such as the
highly immunogenic prefusion
conformation. Additionally, the
exemplary heterologous RSV F
ectodomain can include one or more
amino acid substitutions to modify
ectodomain expression, conformation,
phenotype, or stability.
Potential Commercial Applications
• RSV vaccine
• Paramyxovirus vaccines
• Prophylactic vaccines
Competitive Advantages
PO 00000
• Multi-valence
• Immunogenicity
Frm 00035
Fmt 4703
Sfmt 4703
Development Stage
• Early-stage
• In vitro data available
Inventors: Peter Collins, Bo Liang
Shirin Munir, Anne Schaap-Nutt,
Ursula Buchholz, Natalie Mackow, Peter
Kwong, Barney Graham, Jason McLellan
(all of NIAID).
Intellectual Property: HHS Reference
No. E–241–2014/0—US Provisional
Patent Application 62/105,667 filed
January 20, 2015.
Related Technologies: HHS Reference
No. E–081–2013/0–/5—US Patent
Application 14/207,372 filed March 12,
2014; International Patent Application
PCT/US2014/026714 filed March 13,
2014. Priority documents as follows:
(1) US Provisional Application 61/
780,910 filed March 13, 2013;
(2) US Provisional Application 61/
798,389 filed March 15, 2013;
(3) US Provisional Application 61/
857,613 filed July 23, 2013; and
(4) US Provisional Application 61/
863,909 filed August 9, 2013.
Licensing Contact: Peter A. Soukas;
301–435–4646; soukasp@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 Jenish Patel at jenish.patel@
nih.gov.
Adaptor for Suspending a Cryovial
Over a Centrifuge Tube
Description of Technology: The
invention pertains to a device and
system for expediting the thawing of
frozen specimens (e.g., cryopreserved
cells) contained in cryo-vials. An
adaptor support suspends cryo-vials
over a centrifuge tube containing culture
medium in an inverted position. The
adaptor has an elongated tubular body.
While relatively basic, the adaptor
dramatically expedites the process of
recovering viable cells from frozen
specimens. It reduces the labor time for
thawing from several minutes to a few
seconds. There is virtually no labor
involved and enables a single person to
load hundreds of samples within
minutes. The cells, once thawed, spend
essentially no time in liquid
cryopreservative, since they are diluted
instantly into growth medium contained
in the centrifuge tubes. This process
ensures the highest viability as well as
recovery from each specimen while
dramatically increasing throughput.
Importantly, the elimination of multiple
labor-intensive steps minimizes
variation in viability and yield.
E:\FR\FM\30APN1.SGM
30APN1
Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices
Potential Commercial Applications
• Sample preparation
• Cell culturing
Competitive Advantages
• High throughput
• Low labor
• Speed
• Reduced variability
Development Stage: Prototype.
Inventors: Mario Roederer, Margaret
Beddall, Pratip Chattopadhyay (all of
NIAID).
Intellectual Property: HHS Reference
No. E–080–2015/0—US Patent
Application No. 14/661,449 filed March
18, 2015.
Licensing Contact: Vince Contreras,
Ph.D.; 301–435–4711; contrerasv@
mail.nih.gov.
Collaborative Research Opportunity:
The National Institutes 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 Barry Buchbinder at
BBuchbinder@niaid.nih.gov or 240–
627–3678.
Dated: April 24, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–10013 Filed 4–29–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK4VPTVN1PROD with NOTICES
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following 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 material,
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: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel, NIBIB 2015–10 U01
Quantum Review.
VerDate Sep<11>2014
17:01 Apr 29, 2015
Jkt 235001
Date: June 23, 2015.
Time: 10 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, Suite 920, 6707 Democracy
Boulevard, Bethesda, MD 20892. (Virtual
Meeting).
Contact Person: Ruixia Zhou, Ph.D.,
Scientific Review Officer, 6707 Democracy
Boulevard, Suite 957, Bethesda, MD 20892,
301–496–4773, zhour@mail.nih.gov.
Dated: April 24, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–10006 Filed 4–29–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
24265
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Lyle Furr, Scientific
Review Officer, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 4227, MSC 9550, 6001
Executive Boulevard, Bethesda, MD 20892–
9550, (301) 435–1439, lf33c.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: April 24, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–10003 Filed 4–29–15; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of the following meetings.
The meetings 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
National Institutes of Health
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel, Novel
Treatment for Drug-Induced Respiratory
Depression (2239).
Date: May 12, 2015.
Time: 10 a.m. to 12 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Lyle Furr, Scientific
Review Officer, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 4227, MSC 9550, 6001
Executive Boulevard, Bethesda, MD 20892–
9550, (301) 435–1439, lf33c.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel, NIDA
Blending Initiative (2244).
Date: June 4, 2015.
Time: 10 a.m. to 12 p.m.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; 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 a meeting of the
National Advisory Child Health and
Human Development Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available. A
portion of this 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 for the review and
discussion of grant applications.
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.
Name of Committee: National Advisory
Child Health and Human Development
Council.
Date: June 4, 2015.
Open: June 4, 2015, 8:00 a.m. to 12:10 p.m.
Agenda: Report of the Director, NICHD;
Report of the Acting Director, Division of
Extramural Research, NICHD; Division of
Intramural Research, NICHD DIR
Reorganization and Discussion; NIH BRAIN
Initiative Update and New Business of the
Council.
Closed: June 4, 2015, 1:00 p.m. to
Adjournment.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\30APN1.SGM
30APN1
Agencies
[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Pages 24263-24265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10013]
-----------------------------------------------------------------------
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.
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.
A Novel T Cell Therapy Against Patient-Specific Cancer Mutations
Description of Technology: This invention is a novel T cell therapy
against cancer mutations that are patient specific. Scientists at the
National Institutes of Health have developed a method to identify T
cells that specifically recognize immunogenic mutations expressed only
by cancer cells. Human cancers contain genetic mutations that are
unique to each patient. Some of the mutated peptides are immunogenic,
can be recognized by T cells, and therefore, may serve as therapeutic
targets. The inventors identified cancer-specific mutations from a
patient with widely metastatic cholangiocarcinoma by sequencing tumor
samples and comparing with normal cells. Using tandem minigene
constructs encoding all of the mutations expressed by a patient's
tumor, the inventors identified T cells that recognized the immunogenic
mutations from the same patient. These mutation-reactive T cells have
the potential to eliminate the cancer cells while sparing normal
tissues since normal tissues do not express the mutations. The
inventors expanded these mutation-reactive T cells in vitro, and
infused a highly pure population of these T cells back into the same
patient. The patient experienced tumor regression when she was treated
with this approach.
Potential Commercial Applications
Personalized immunotherapy with mutation-reactive T cells
for mediating tumor regression in patients with immunogenic mutations.
Mutation-reactive T cell therapy especially beneficial for
cancer patients refractory to other therapies.
A research tool to identify patient-specific immunogenic
mutations in the tumor.
Competitive Advantages
This patient-specific therapy has the potential
application to most epithelial cancers, which account for about 90% of
cancer deaths in the United States.
Personalized mutation-specific T cells recognize mutations
harboring tumor cells only and spare normal tissues. This therapy has
no tissue toxicities comparing to traditional chemotherapy and
radiotherapy.
The infusion of a highly pure population of these
mutation-specific T cells may maximize therapy and result in regression
of all target lesions.
Development Stage
Early-stage
In vitro data available
In vivo data available (human)
Ex vivo data available
Inventors: Eric Tran, Yong-Chen W. Lu, Paul F. Robbins, Steven A.
Rosenberg (all of NCI).
Publications
1. Tran E, et al. Cancer immunotherapy based on mutation-
specific CD4+ T cells in a patient with epithelial cancer. Science.
2014 May 9; 344(6184):641-5. [PMID 24812403]
2. Robbins P, et al. Mining exomic sequencing data to identify
mutated antigens recognized by adoptively transferred tumor-reactive
T cells. Nat Med. 2013 Jun;19(6):747-52. [PMID 23644516]
3. Tran E, et al. T-cell therapy against cancer mutations.
Oncotarget. 2014 Jul 15;5(13):4579-80. [PMID 25046408]
Intellectual Property: HHS Reference No. E-229-2014/0--PCT
Application No. PCT/US2014/058805 filed October 2, 2014.
Related Technology: HHS Reference No. E-233-2014/0--PCT Application
No. PCT/US2014/058796 filed October 2, 2014.
Licensing Contact: Whitney A. Hastings, Ph.D.; 301-451-7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Surgery Branch, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize T-cell therapy against cancer mutations. For
collaboration opportunities, please contact Steven A. Rosenberg, M.D.,
Ph.D. at sar@nih.gov.
A Novel, Personalized T Cell Therapy: T-Cell Receptor Engineered T
Cells Targeting Tumor Specific Mutations
Description of Technology: This invention is a novel T cell therapy
against cancer mutations that are patient specific. Scientists at the
National Institutes of Health have developed a method to identify and
generate T-cell receptor (TCR) engineered T cells for personalized
cancer therapy. The TCR is a complex of integral membrane proteins that
recognizes antigens and activates T cells. Human cancers
[[Page 24264]]
contain genetic mutations that are unique in each patient. The
inventors found cancer-specific mutations by sequencing tumors and
comparing with normal cells. Using tandem minigene constructs encoding
all of the patient's tumor mutations, they first identified T cells
that were reactive with the unique mutated antigens expressed only in
the patient's tumors. Next, they isolated the mutation-reactive TCRs
and engineered peripheral blood T cells from the same patient to
express these mutation-reactive TCRs. These personalized TCR engineered
T cells can be expanded and infused back into the same patient with the
potential to induce tumor regression.
Potential Commercial Applications
Personalized immunotherapy to treat primary and recurrent
epithelial cancer.
A research tool to identify patient-specific immunogenic
mutations in tumors.
A research tool to identify and isolate mutation-specific
T cell receptors.
Competitive Advantages
This patient-specific therapy has the potential
application to most epithelial cancers, which account for about 90% of
cancer deaths in the United States.
Personalized TCR engineered T cells target tumor cells and
spare normal tissues. This therapy has no tissue toxicities comparing
to traditional chemotherapy and radiotherapy.
The infusion of a highly pure population of these T cells
expressing mutation-specific TCRs may maximize therapy and result in
regression of all target lesions.
Development Stage
Early-stage
In vitro data available
Ex vivo data available
Inventors: Eric Tran, Yong-Chen W. Lu, Paul F. Robbins, Steven A.
Rosenberg (all of NCI).
Publications
1. Tran E, et al. Cancer immunotherapy based on mutation-
specific CD4+ T cells in a patient with epithelial cancer. Science.
2014 May 9;344 (6184):641-5. [PMID 24812403].
2. Robbins P, et al. Mining exomic sequencing data to identify
mutated antigens recognized by adoptively transferred tumor-reactive
T cells. Nat Med. 2013 Jun;19(6):747-52. [PMID 23644516].
3. Tran E, et al. T-cell therapy against cancer mutations.
Oncotarget. 2014 Jul 15;5(13):4579-80. [PMID 25046408].
4. Gros A, et al. PD-1 identifies the patient-specific CD8+
tumor-reactive repertoire infiltrating human tumors. J Clin Invest.
2014 May 1;124(5):2246-59. [PMID 24667641].
Intellectual Property: HHS Reference No. E-233-2014/0--PCT
Application No. PCT/US2014/058796 filed October 2, 2014.
Related Technology: HHS Reference No. E-229-2014/0--PCT Application
No. PCT/US2014/058805 filed October 2, 2014.
Licensing Contact: Whitney A. Hastings, Ph.D.; 301-451-7337;
hastingw@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Surgery Branch, is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize TCRs reactive with tumor associated antigens.
For collaboration opportunities, please contact Steven A. Rosenberg,
M.D., Ph.D. at sar@nih.gov.
Recombinant Paramyxoviruses Expressing Optimized Heterologous Antigens
Description of Technology: The invention pertains to recombinant
paramyxoviruses that express one or more heterologous antigens, such as
the human respiratory syncytial virus (RSV) F protein, that have been
optimized for increased expression and immunogenicity. The recombinant
constructs induce a bivalent immune response to the paramyxovirus
vectors and the heterologous antigen. Potential vectors include
parainfluenza virus (PIV) serotype 1 and 3, Sendai virus, Newcastle
disease virus, PIV2, and PIV5. An exemplary modified heterologous
antigen includes the ectodomain of RSV F protein linked to the
transmembrane and cytoplasmic domains of the F protein from the PIV
vector, which results in efficient incorporation into the vector
particle. The RSV F ectodomain can be engineered to be stabilized in an
optimal conformation, such as the highly immunogenic prefusion
conformation. Additionally, the exemplary heterologous RSV F ectodomain
can include one or more amino acid substitutions to modify ectodomain
expression, conformation, phenotype, or stability.
Potential Commercial Applications
RSV vaccine
Paramyxovirus vaccines
Prophylactic vaccines
Competitive Advantages
Multi-valence
Immunogenicity
Development Stage
Early-stage
In vitro data available
Inventors: Peter Collins, Bo Liang Shirin Munir, Anne Schaap-Nutt,
Ursula Buchholz, Natalie Mackow, Peter Kwong, Barney Graham, Jason
McLellan (all of NIAID).
Intellectual Property: HHS Reference No. E-241-2014/0--US
Provisional Patent Application 62/105,667 filed January 20, 2015.
Related Technologies: HHS Reference No. E-081-2013/0-/5--US Patent
Application 14/207,372 filed March 12, 2014; International Patent
Application PCT/US2014/026714 filed March 13, 2014. Priority documents
as follows:
(1) US Provisional Application 61/780,910 filed March 13, 2013;
(2) US Provisional Application 61/798,389 filed March 15, 2013;
(3) US Provisional Application 61/857,613 filed July 23, 2013; and
(4) US Provisional Application 61/863,909 filed August 9, 2013.
Licensing Contact: Peter A. Soukas; 301-435-4646;
soukasp@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 Jenish Patel at jenish.patel@nih.gov.
Adaptor for Suspending a Cryovial Over a Centrifuge Tube
Description of Technology: The invention pertains to a device and
system for expediting the thawing of frozen specimens (e.g.,
cryopreserved cells) contained in cryo-vials. An adaptor support
suspends cryo-vials over a centrifuge tube containing culture medium in
an inverted position. The adaptor has an elongated tubular body. While
relatively basic, the adaptor dramatically expedites the process of
recovering viable cells from frozen specimens. It reduces the labor
time for thawing from several minutes to a few seconds. There is
virtually no labor involved and enables a single person to load
hundreds of samples within minutes. The cells, once thawed, spend
essentially no time in liquid cryopreservative, since they are diluted
instantly into growth medium contained in the centrifuge tubes. This
process ensures the highest viability as well as recovery from each
specimen while dramatically increasing throughput. Importantly, the
elimination of multiple labor-intensive steps minimizes variation in
viability and yield.
[[Page 24265]]
Potential Commercial Applications
Sample preparation
Cell culturing
Competitive Advantages
High throughput
Low labor
Speed
Reduced variability
Development Stage: Prototype.
Inventors: Mario Roederer, Margaret Beddall, Pratip Chattopadhyay
(all of NIAID).
Intellectual Property: HHS Reference No. E-080-2015/0--US Patent
Application No. 14/661,449 filed March 18, 2015.
Licensing Contact: Vince Contreras, Ph.D.; 301-435-4711;
contrerasv@mail.nih.gov.
Collaborative Research Opportunity: The National Institutes 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 Barry Buchbinder at
BBuchbinder@niaid.nih.gov or 240-627-3678.
Dated: April 24, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-10013 Filed 4-29-15; 8:45 am]
BILLING CODE 4140-01-P