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
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