80_FR_24346 80 FR 24263 - Government-Owned Inventions; Availability for Licensing

80 FR 24263 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 83 (April 30, 2015)

Page Range24263-24265
FR Document2015-10013

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.

Federal Register, Volume 80 Issue 83 (Thursday, April 30, 2015)
[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Pages 24263-24265]
From the Federal Register Online  [www.thefederalregister.org]
[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; 
[email protected].
    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 [email protected].

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; 
[email protected].
    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 [email protected].

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; 
[email protected].
    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 [email protected].

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; 
[email protected].
    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 
[email protected] 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



                                                                                Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices                                             24263

                                                  2015. Time allotted for each                            U.S. patent applications listed below                    • Personalized mutation-specific T
                                                  presentation may be limited. If the                     may be obtained by writing to the                     cells recognize mutations harboring
                                                  number of registrants requesting to                     indicated licensing contact at the Office             tumor cells only and spare normal
                                                  speak is greater than can be reasonably                 of Technology Transfer, National                      tissues. This therapy has no tissue
                                                  accommodated during the scheduled                       Institutes of Health, 6011 Executive                  toxicities comparing to traditional
                                                  open public hearing session, FDA may                    Boulevard, Suite 325, Rockville,                      chemotherapy and radiotherapy.
                                                  conduct a lottery to determine the                      Maryland 20852–3804; telephone: 301–                     • The infusion of a highly pure
                                                  speakers for the scheduled open public                  496–7057; fax: 301–402–0220. A signed                 population of these mutation-specific T
                                                  hearing session. The contact person will                Confidential Disclosure Agreement will                cells may maximize therapy and result
                                                  notify interested persons regarding their               be required to receive copies of the                  in regression of all target lesions.
                                                  request to speak by May 19, 2015.                       patent applications.
                                                                                                                                                                Development Stage
                                                    Persons attending FDA’s advisory                      SUPPLEMENTARY INFORMATION:
                                                  committee meetings are advised that the                 Technology descriptions follow.                         • Early-stage
                                                  Agency is not responsible for providing                                                                         • In vitro data available
                                                  access to electrical outlets.                           A Novel T Cell Therapy Against                          • In vivo data available (human)
                                                    FDA welcomes the attendance of the                    Patient-Specific Cancer Mutations                       • Ex vivo data available
                                                  public at its advisory committee                           Description of Technology: This                      Inventors: Eric Tran, Yong-Chen W.
                                                  meetings and will make every effort to                  invention is a novel T cell therapy                   Lu, Paul F. Robbins, Steven A.
                                                  accommodate persons with physical                       against cancer mutations that are patient             Rosenberg (all of NCI).
                                                  disabilities or special needs. If you                   specific. Scientists at the National                  Publications
                                                  require special accommodations due to                   Institutes of Health have developed a
                                                                                                          method to identify T cells that                         1. Tran E, et al. Cancer immunotherapy
                                                  a disability, please contact Philip                                                                           based on mutation-specific CD4+ T cells in
                                                  Bautista at least 7 days in advance of the              specifically recognize immunogenic                    a patient with epithelial cancer. Science.
                                                  meeting.                                                mutations expressed only by cancer                    2014 May 9; 344(6184):641–5. [PMID
                                                    FDA is committed to the orderly                       cells. Human cancers contain genetic                  24812403]
                                                  conduct of its advisory committee                       mutations that are unique to each                       2. Robbins P, et al. Mining exomic
                                                  meetings. Please visit our Web site at                  patient. Some of the mutated peptides                 sequencing data to identify mutated antigens
                                                  http://www.fda.gov/Advisory                             are immunogenic, can be recognized by                 recognized by adoptively transferred tumor-
                                                  Committees/AboutAdvisoryCommittees/                     T cells, and therefore, may serve as                  reactive T cells. Nat Med. 2013
                                                  ucm111462.htm for procedures on                         therapeutic targets. The inventors                    Jun;19(6):747–52. [PMID 23644516]
                                                  public conduct during advisory                          identified cancer-specific mutations                    3. Tran E, et al. T-cell therapy against
                                                                                                                                                                cancer mutations. Oncotarget. 2014 Jul
                                                  committee meetings.                                     from a patient with widely metastatic                 15;5(13):4579–80. [PMID 25046408]
                                                    Notice of this meeting is given under                 cholangiocarcinoma by sequencing
                                                  the Federal Advisory Committee Act (5                   tumor samples and comparing with                         Intellectual Property: HHS Reference
                                                  U.S.C. app. 2).                                         normal cells. Using tandem minigene                   No. E–229–2014/0—PCT Application
                                                                                                          constructs encoding all of the mutations              No. PCT/US2014/058805 filed October
                                                    Dated: April 24, 2015.
                                                                                                          expressed by a patient’s tumor, the                   2, 2014.
                                                  Peter Lurie,                                                                                                     Related Technology: HHS Reference
                                                                                                          inventors identified T cells that
                                                  Associate Commissioner for Public Health                                                                      No. E–233–2014/0—PCT Application
                                                  Strategy and Analysis.                                  recognized the immunogenic mutations
                                                                                                          from the same patient. These mutation-                No. PCT/US2014/058796 filed October
                                                  [FR Doc. 2015–10022 Filed 4–29–15; 8:45 am]                                                                   2, 2014.
                                                                                                          reactive T cells have the potential to
                                                  BILLING CODE 4164–01–P
                                                                                                          eliminate the cancer cells while sparing                 Licensing Contact: Whitney A.
                                                                                                          normal tissues since normal tissues do                Hastings, Ph.D.; 301–451–7337;
                                                                                                          not express the mutations. The                        hastingw@mail.nih.gov.
                                                  DEPARTMENT OF HEALTH AND                                                                                         Collaborative Research Opportunity:
                                                  HUMAN SERVICES                                          inventors expanded these mutation-
                                                                                                          reactive T cells in vitro, and infused a              The National Cancer Institute, Surgery
                                                                                                          highly pure population of these T cells               Branch, is seeking statements of
                                                  National Institutes of Health                                                                                 capability or interest from parties
                                                                                                          back into the same patient. The patient
                                                  Government-Owned Inventions;                            experienced tumor regression when she                 interested in collaborative research to
                                                  Availability for Licensing                              was treated with this approach.                       further develop, evaluate or
                                                                                                                                                                commercialize T-cell therapy against
                                                  AGENCY:    National Institutes of Health,               Potential Commercial Applications                     cancer mutations. For collaboration
                                                  HHS.                                                      • Personalized immunotherapy with                   opportunities, please contact Steven A.
                                                  ACTION:   Notice.                                       mutation-reactive T cells for mediating               Rosenberg, M.D., Ph.D. at sar@nih.gov.
                                                                                                          tumor regression in patients with                     A Novel, Personalized T Cell Therapy:
                                                  SUMMARY:   The inventions listed below
                                                                                                          immunogenic mutations.                                T-Cell Receptor Engineered T Cells
                                                  are owned by an agency of the U.S.                        • Mutation-reactive T cell therapy
                                                  Government and are available for                                                                              Targeting Tumor Specific Mutations
                                                                                                          especially beneficial for cancer patients
                                                  licensing in the U.S. in accordance with                refractory to other therapies.                          Description of Technology: This
                                                  35 U.S.C. 209 and 37 CFR part 404 to                      • A research tool to identify patient-              invention is a novel T cell therapy
                                                  achieve expeditious commercialization                   specific immunogenic mutations in the                 against cancer mutations that are patient
                                                  of results of federally-funded research
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                                                                          tumor.                                                specific. Scientists at the National
                                                  and development. Foreign patent                                                                               Institutes of Health have developed a
                                                  applications are filed on selected                      Competitive Advantages                                method to identify and generate T-cell
                                                  inventions to extend market coverage                      • This patient-specific therapy has                 receptor (TCR) engineered T cells for
                                                  for companies and may also be available                 the potential application to most                     personalized cancer therapy. The TCR is
                                                  for licensing.                                          epithelial cancers, which account for                 a complex of integral membrane
                                                  FOR FURTHER INFORMATION CONTACT:                        about 90% of cancer deaths in the                     proteins that recognizes antigens and
                                                  Licensing information and copies of the                 United States.                                        activates T cells. Human cancers


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                                                  24264                         Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices

                                                  contain genetic mutations that are                      infiltrating human tumors. J Clin Invest. 2014         Development Stage
                                                  unique in each patient. The inventors                   May 1;124(5):2246–59. [PMID 24667641].
                                                                                                                                                                    • Early-stage
                                                  found cancer-specific mutations by                         Intellectual Property: HHS Reference                   • In vitro data available
                                                  sequencing tumors and comparing with                    No. E–233–2014/0—PCT Application                          Inventors: Peter Collins, Bo Liang
                                                  normal cells. Using tandem minigene                     No. PCT/US2014/058796 filed October                    Shirin Munir, Anne Schaap-Nutt,
                                                  constructs encoding all of the patient’s                2, 2014.                                               Ursula Buchholz, Natalie Mackow, Peter
                                                  tumor mutations, they first identified T                   Related Technology: HHS Reference                   Kwong, Barney Graham, Jason McLellan
                                                  cells that were reactive with the unique                No. E–229–2014/0—PCT Application                       (all of NIAID).
                                                  mutated antigens expressed only in the                  No. PCT/US2014/058805 filed October                       Intellectual Property: HHS Reference
                                                  patient’s tumors. Next, they isolated the               2, 2014.                                               No. E–241–2014/0—US Provisional
                                                  mutation-reactive TCRs and engineered                      Licensing Contact: Whitney A.                       Patent Application 62/105,667 filed
                                                  peripheral blood T cells from the same                  Hastings, Ph.D.; 301–451–7337;                         January 20, 2015.
                                                  patient to express these mutation-                      hastingw@mail.nih.gov.                                    Related Technologies: HHS Reference
                                                  reactive TCRs. These personalized TCR                      Collaborative Research Opportunity:                 No. E–081–2013/0–/5—US Patent
                                                  engineered T cells can be expanded and                  The National Cancer Institute, Surgery                 Application 14/207,372 filed March 12,
                                                  infused back into the same patient with                 Branch, is seeking statements of                       2014; International Patent Application
                                                  the potential to induce tumor                           capability or interest from parties                    PCT/US2014/026714 filed March 13,
                                                  regression.                                             interested in collaborative research to                2014. Priority documents as follows:
                                                                                                                                                                    (1) US Provisional Application 61/
                                                  Potential Commercial Applications                       further develop, evaluate or
                                                                                                                                                                 780,910 filed March 13, 2013;
                                                                                                          commercialize TCRs reactive with
                                                     • Personalized immunotherapy to                                                                                (2) US Provisional Application 61/
                                                                                                          tumor associated antigens. For                         798,389 filed March 15, 2013;
                                                  treat primary and recurrent epithelial
                                                                                                          collaboration opportunities, please                       (3) US Provisional Application 61/
                                                  cancer.
                                                     • A research tool to identify patient-               contact Steven A. Rosenberg, M.D.,                     857,613 filed July 23, 2013; and
                                                  specific immunogenic mutations in                       Ph.D. at sar@nih.gov.                                     (4) US Provisional Application 61/
                                                  tumors.                                                 Recombinant Paramyxoviruses                            863,909 filed August 9, 2013.
                                                     • A research tool to identify and                    Expressing Optimized Heterologous                         Licensing Contact: Peter A. Soukas;
                                                  isolate mutation-specific T cell                        Antigens                                               301–435–4646; soukasp@mail.nih.gov.
                                                  receptors.                                                                                                        Collaborative Research Opportunity:
                                                                                                            Description of Technology: The                       The National Institute of Allergy and
                                                  Competitive Advantages                                  invention pertains to recombinant                      Infectious Diseases is seeking statements
                                                     • This patient-specific therapy has                  paramyxoviruses that express one or                    of capability or interest from parties
                                                  the potential application to most                       more heterologous antigens, such as the                interested in collaborative research to
                                                  epithelial cancers, which account for                   human respiratory syncytial virus (RSV)                further develop, evaluate or
                                                  about 90% of cancer deaths in the                       F protein, that have been optimized for                commercialize this technology. For
                                                  United States.                                          increased expression and                               collaboration opportunities, please
                                                     • Personalized TCR engineered T                      immunogenicity. The recombinant                        contact Jenish Patel at jenish.patel@
                                                  cells target tumor cells and spare normal               constructs induce a bivalent immune                    nih.gov.
                                                  tissues. This therapy has no tissue                     response to the paramyxovirus vectors
                                                                                                          and the heterologous antigen. Potential                Adaptor for Suspending a Cryovial
                                                  toxicities comparing to traditional
                                                                                                          vectors include parainfluenza virus                    Over a Centrifuge Tube
                                                  chemotherapy and radiotherapy.
                                                     • The infusion of a highly pure                      (PIV) serotype 1 and 3, Sendai virus,                     Description of Technology: The
                                                  population of these T cells expressing                  Newcastle disease virus, PIV2, and                     invention pertains to a device and
                                                  mutation-specific TCRs may maximize                     PIV5. An exemplary modified                            system for expediting the thawing of
                                                  therapy and result in regression of all                 heterologous antigen includes the                      frozen specimens (e.g., cryopreserved
                                                  target lesions.                                         ectodomain of RSV F protein linked to                  cells) contained in cryo-vials. An
                                                                                                          the transmembrane and cytoplasmic                      adaptor support suspends cryo-vials
                                                  Development Stage                                                                                              over a centrifuge tube containing culture
                                                                                                          domains of the F protein from the PIV
                                                    • Early-stage                                         vector, which results in efficient                     medium in an inverted position. The
                                                    • In vitro data available                             incorporation into the vector particle.                adaptor has an elongated tubular body.
                                                    • Ex vivo data available                              The RSV F ectodomain can be                            While relatively basic, the adaptor
                                                    Inventors: Eric Tran, Yong-Chen W.                    engineered to be stabilized in an                      dramatically expedites the process of
                                                  Lu, Paul F. Robbins, Steven A.                          optimal conformation, such as the                      recovering viable cells from frozen
                                                  Rosenberg (all of NCI).                                 highly immunogenic prefusion                           specimens. It reduces the labor time for
                                                  Publications                                            conformation. Additionally, the                        thawing from several minutes to a few
                                                                                                          exemplary heterologous RSV F                           seconds. There is virtually no labor
                                                    1. Tran E, et al. Cancer immunotherapy
                                                  based on mutation-specific CD4+ T cells in              ectodomain can include one or more                     involved and enables a single person to
                                                  a patient with epithelial cancer. Science.              amino acid substitutions to modify                     load hundreds of samples within
                                                  2014 May 9;344 (6184):641–5. [PMID                      ectodomain expression, conformation,                   minutes. The cells, once thawed, spend
                                                  24812403].                                              phenotype, or stability.                               essentially no time in liquid
                                                    2. Robbins P, et al. Mining exomic                                                                           cryopreservative, since they are diluted
                                                                                                          Potential Commercial Applications
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  sequencing data to identify mutated antigens                                                                   instantly into growth medium contained
                                                  recognized by adoptively transferred tumor-                   • RSV vaccine                                    in the centrifuge tubes. This process
                                                  reactive T cells. Nat Med. 2013                               • Paramyxovirus vaccines                         ensures the highest viability as well as
                                                  Jun;19(6):747–52. [PMID 23644516].
                                                    3. Tran E, et al. T-cell therapy against
                                                                                                                • Prophylactic vaccines                          recovery from each specimen while
                                                  cancer mutations. Oncotarget. 2014 Jul                                                                         dramatically increasing throughput.
                                                                                                          Competitive Advantages
                                                  15;5(13):4579–80. [PMID 25046408].                                                                             Importantly, the elimination of multiple
                                                    4. Gros A, et al. PD–1 identifies the patient-              • Multi-valence                                  labor-intensive steps minimizes
                                                  specific CD8+ tumor-reactive repertoire                       • Immunogenicity                                 variation in viability and yield.


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                                                                                Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices                                                 24265

                                                  Potential Commercial Applications                         Date: June 23, 2015.                                  Agenda: To review and evaluate contract
                                                                                                            Time: 10 a.m. to 3:30 p.m.                          proposals.
                                                    • Sample preparation                                    Agenda: To review and evaluate grant                  Place: National Institutes of Health,
                                                    • Cell culturing                                      applications.                                         Neuroscience Center, 6001 Executive
                                                  Competitive Advantages                                    Place: National Institutes of Health, Two           Boulevard, Rockville, MD 20852, (Telephone
                                                                                                          Democracy Plaza, Suite 920, 6707 Democracy            Conference Call).
                                                    • High throughput                                     Boulevard, Bethesda, MD 20892. (Virtual                 Contact Person: Lyle Furr, Scientific
                                                    • Low labor                                           Meeting).                                             Review Officer, Office of Extramural Affairs,
                                                    • Speed                                                 Contact Person: Ruixia Zhou, Ph.D.,                 National Institute on Drug Abuse, NIH,
                                                    • Reduced variability                                 Scientific Review Officer, 6707 Democracy             DHHS, Room 4227, MSC 9550, 6001
                                                    Development Stage: Prototype.                         Boulevard, Suite 957, Bethesda, MD 20892,             Executive Boulevard, Bethesda, MD 20892–
                                                    Inventors: Mario Roederer, Margaret                   301–496–4773, zhour@mail.nih.gov.                     9550, (301) 435–1439, lf33c.nih.gov.
                                                  Beddall, Pratip Chattopadhyay (all of                     Dated: April 24, 2015.                              (Catalogue of Federal Domestic Assistance
                                                  NIAID).                                                 David Clary,                                          Program Nos.: 93.279, Drug Abuse and
                                                    Intellectual Property: HHS Reference                  Program Analyst, Office of Federal Advisory           Addiction Research Programs, National
                                                  No. E–080–2015/0—US Patent                              Committee Policy.                                     Institutes of Health, HHS)
                                                  Application No. 14/661,449 filed March                  [FR Doc. 2015–10006 Filed 4–29–15; 8:45 am]             Dated: April 24, 2015.
                                                  18, 2015.
                                                    Licensing Contact: Vince Contreras,
                                                                                                          BILLING CODE 4140–01–P                                Michelle Trout,
                                                  Ph.D.; 301–435–4711; contrerasv@                                                                              Program Analyst, Office of Federal Advisory
                                                  mail.nih.gov.                                                                                                 Committee Policy.
                                                                                                          DEPARTMENT OF HEALTH AND                              [FR Doc. 2015–10003 Filed 4–29–15; 8:45 am]
                                                    Collaborative Research Opportunity:                   HUMAN SERVICES
                                                  The National Institutes of Allergy and                                                                        BILLING CODE 4140–01–P
                                                  Infectious Diseases is seeking statements               National Institutes of Health
                                                  of capability or interest from parties
                                                  interested in collaborative research to                 National Institute on Drug Abuse;                     DEPARTMENT OF HEALTH AND
                                                  further develop, evaluate or                            Notice of Closed Meetings                             HUMAN SERVICES
                                                  commercialize this technology. For
                                                                                                            Pursuant to section 10(d) of the                    National Institutes of Health
                                                  collaboration opportunities, please
                                                                                                          Federal Advisory Committee Act, as
                                                  contact Barry Buchbinder at                                                                                   Eunice Kennedy Shriver National
                                                                                                          amended (5 U.S.C. App), notice is
                                                  BBuchbinder@niaid.nih.gov or 240–                                                                             Institute of Child Health and Human
                                                                                                          hereby given of the following meetings.
                                                  627–3678.                                                 The meetings will be closed to the                  Development; Notice of Meeting
                                                    Dated: April 24, 2015.                                public in accordance with the
                                                  Richard U. Rodriguez,                                   provisions set forth in sections                         Pursuant to section 10(d) of the
                                                  Acting Director, Office of Technology                   552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            Federal Advisory Committee Act, as
                                                  Transfer, National Institutes of Health.                as amended. The contract proposals and                amended (5 U.S.C. App.), notice is
                                                  [FR Doc. 2015–10013 Filed 4–29–15; 8:45 am]             the discussions could disclose                        hereby given of a meeting of the
                                                  BILLING CODE 4140–01–P                                  confidential trade secrets or commercial              National Advisory Child Health and
                                                                                                          property such as patentable material,                 Human Development Council.
                                                                                                          and personal information concerning                      The meeting will be open to the
                                                  DEPARTMENT OF HEALTH AND                                individuals associated with the contract              public as indicated below, with
                                                  HUMAN SERVICES                                          proposals, the disclosure of which                    attendance limited to space available. A
                                                                                                          would constitute a clearly unwarranted                portion of this meeting will be closed to
                                                  National Institutes of Health                           invasion of personal privacy.                         the public in accordance with the
                                                                                                            Name of Committee: National Institute on            provisions set forth in sections
                                                  National Institute of Biomedical
                                                                                                          Drug Abuse Special Emphasis Panel, Novel              552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                  Imaging and Bioengineering; Notice of
                                                                                                          Treatment for Drug-Induced Respiratory                as amended for the review and
                                                  Closed Meeting                                          Depression (2239).                                    discussion of grant applications.
                                                    Pursuant to section 10(d) of the                        Date: May 12, 2015.                                 Individuals who plan to attend and
                                                  Federal Advisory Committee Act, as                        Time: 10 a.m. to 12 p.m.                            need special assistance, such as sign
                                                                                                            Agenda: To review and evaluate contract
                                                  amended (5 U.S.C. App.), notice is                                                                            language interpretation or other
                                                                                                          proposals.
                                                  hereby given of the following meeting.                    Place: National Institutes of Health,               reasonable accommodations, should
                                                    The meeting will be closed to the                     Neuroscience Center, 6001 Executive                   notify the contact person listed below in
                                                  public in accordance with the                           Boulevard, Rockville, MD 20852, (Telephone            advance of the meeting.
                                                  provisions set forth in sections                        Conference Call).                                       Name of Committee: National Advisory
                                                  552b(c)(4) and 552b(c)(6), title 5 U.S.C.,                Contact Person: Lyle Furr, Scientific               Child Health and Human Development
                                                  as amended. The grant applications and                  Review Officer, Office of Extramural Affairs,         Council.
                                                  the discussions could disclose                          National Institute on Drug Abuse, NIH,                  Date: June 4, 2015.
                                                  confidential trade secrets or commercial                DHHS, Room 4227, MSC 9550, 6001                         Open: June 4, 2015, 8:00 a.m. to 12:10 p.m.
                                                  property such as patentable material,                   Executive Boulevard, Bethesda, MD 20892–                Agenda: Report of the Director, NICHD;
                                                                                                          9550, (301) 435–1439, lf33c.nih.gov.                  Report of the Acting Director, Division of
                                                  and personal information concerning
                                                                                                            This notice is being published less than 15         Extramural Research, NICHD; Division of
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  individuals associated with the grant
                                                                                                          days prior to the meeting due to the timing           Intramural Research, NICHD DIR
                                                  applications, the disclosure of which                   limitations imposed by the review and                 Reorganization and Discussion; NIH BRAIN
                                                  would constitute a clearly unwarranted                  funding cycle.                                        Initiative Update and New Business of the
                                                  invasion of personal privacy.                             Name of Committee: National Institute on            Council.
                                                    Name of Committee: National Institute of              Drug Abuse Special Emphasis Panel, NIDA                 Closed: June 4, 2015, 1:00 p.m. to
                                                  Biomedical Imaging and Bioengineering                   Blending Initiative (2244).                           Adjournment.
                                                  Special Emphasis Panel, NIBIB 2015–10 U01                 Date: June 4, 2015.                                   Agenda: To review and evaluate grant
                                                  Quantum Review.                                           Time: 10 a.m. to 12 p.m.                            applications.



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Document Created: 2018-02-21 10:14:39
Document Modified: 2018-02-21 10:14:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactLicensing 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.
FR Citation80 FR 24263 

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