Government-Owned Inventions; Availability for Licensing and Co-Development, 81552-81553 [2015-32878]

Download as PDF 81552 Federal Register / Vol. 80, No. 250 / Wednesday, December 30, 2015 / Notices 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 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 Allergy and Infectious Diseases Special Emphasis Panel; NIAID Peer Review Meeting. Date: January 27, 2016. Time: 11:00 a.m. to 7:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Room 8C100, 5601 Fishers Lane, Rockville, MD 20892, (Telephone Conference Call). Contact Person: Thomas F. Conway, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3G51, National Institutes of Health, NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892–9823, 240–507–9685, thomas.conway@nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Investigator Initiated Clinical Trials. Date: January 27, 2016. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892, (Telephone Conference Call). Contact Person: Raymond R. Schleef, Ph.D., Senior Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3E61, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892–9823, (240) 669–5019, schleefrr@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: December 23, 2015. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–32771 Filed 12–29–15; 8:45 am] BILLING CODE 4140–01–P Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Peer Review Meeting. Date: January 22, 2016. Time: 11:00 a.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Room 3C100, 5601 Fishers Lane, Rockville, MD 20892, (Telephone Conference Call). Contact Person: Thomas F. Conway, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3G51, National Institutes of Health, NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892–9823, 240–507–9685, thomas.conway@nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Investigator Initiated Clinical Trial Implementation Cooperative Agreement (U01). Date: January 22, 2016. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892, (Telephone Conference Call). Contact Person: Zhuqing (Charlie) Li, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room # 3G41B, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC9823, Bethesda, MD 20892–9823, (240) 669–5068, zhuqing.li@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; 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 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. Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel; SBIR Review Meeting Topic 14. Date: February 5, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: M. Lourdes Ponce, Ph.D., Scientific Review Officer, Office of Scientific Review, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, 6701 Democrary Blvd., Democracy 1, Room 1073, Bethesda, MD 20892, 301–594–9459, lourdes.ponce@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: December 23, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–32765 Filed 12–29–15; 8:45 am] BILLING CODE 4140–01–P Dated: December 23, 2015. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2015–32767 Filed 12–29–15; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES 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 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. Government-Owned Inventions; Availability for Licensing and CoDevelopment BILLING CODE 4140–01–P 17:59 Dec 29, 2015 Jkt 238001 National Institutes of Health. Notice. AGENCY: Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Sep<11>2014 National Institutes of Health ACTION: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1 Federal Register / Vol. 80, No. 250 / Wednesday, December 30, 2015 / Notices The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute, Technology Transfer Center on or before January 29, 2016 will be considered. SUMMARY: Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850–9702, Tel. 240– 276–5515 or email ncitechtransfer@ mail.nih.gov. ADDRESSES: mstockstill on DSK4VPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Information on licensing and codevelopment research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD 20850–9702, Tel. 240–276–5515 or email ncitechtransfer@mail.nih.gov. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. Title of invention: Monoclonal Antibodies Fibroblast Growth Factor Receptor 4 (FGFR4) and Methods for Their Use. Description of Technology: Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma in children and adolescents. Although current treatments for primary disease are relatively successful, metastatic RMS is generally accompanied by a dismal prognosis. Thus, the development new therapies for metastatic RMS provides a strong benefit to the advancement of public health. Fibroblast Growth Factor Receptor 4 (FGFR4) is a cell surface protein that is highly expressed in RMS, and other cancers (including liver, lung, pancreatic, ovarian, and prostate cancers). Researchers in the National Cancer Institute’s Genetics-Branch found that in RMS patients, high FGFR4 expression is often associated with VerDate Sep<11>2014 17:59 Dec 29, 2015 Jkt 238001 advanced-stage disease, rapid disease progression, and poor survival. The correlation between FGFR4 expression and highly aggressive RMS makes FGFR4 an attractive target for treatment of RMS. By targeting FGFR4 specifically, it may be possible to attack the cancer cells while leaving healthy, essential cells unaffected. This invention concerns the generation of several high-affinity monoclonal antibodies which can be used to treat FGFR4-related diseases. In particular, these antibodies have been used to generate antibody-drug conjugates (ADCs) and chimeric antigen receptors (CARs) which are capable of specifically targeting and killing diseased cells. Potential Commercial Applications: —Development of unconjugated antibody therapeutics —Development of antibody-drug conjugates (ADCs) and recombinant immunotoxins (RITs) —Development of chimeric antigen receptors (CARs) and T Cell Receptors (TCRs) —Development of bispecific antibody therapeutics —Development of Diagnostic Agents for detecting FGFR4-positive cancers Value Proposition: —High affinity and specificity of the antibodies allows more selective targeting of cancer cells, reducing the potential for side effects during therapy —Multiple antibodies available Development Stage: In vitro/Discovery Inventor(s): Javed Khan, M.D. (NCI), S. Baskar (NCI), R.J. Orientas (Lentigen Technology, Inc.) Publication(s): —‘‘Comprehensive genomic analysis of rhabdomyosarcoma reveals a landscape of alterations affecting a common genetic axis in fusionpositive and fusion-negative tumors.’’ Cancer Discov. 2014 Feb;4(2):216–31. doi: 10.1158/2159–8290.CD–13–0639. Epub 2014 Jan 23. —‘‘Targeting wild-type and mutationally activated FGFR4 in rhabdomyosarcoma with the inhibitor ponatinib (AP24534)’’. PLoS One. 2013 Oct 4;8(10):e76551. doi: 10.1371/journal.pone.0076551. eCollection 2013 —‘‘Identification of FGFR4-activating mutations in human rhabdomyosarcomas that promote metastasis in xenotransplanted models.’’ J Clin Invest. 2009 Nov;119(11):3395–407. doi: 10.1172/ JCI39703. Epub 2009 Oct 5. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 81553 —‘‘Identification of cell surface proteins as potential immunotherapy targets in 12 pediatric cancers.’’ Front Oncol. 2012 Dec 17;2:194. doi: 10.3389/ fonc.2012.00194. eCollection 2012. Intellectual Property: HHS Reference No. E–264–2015/0–US– 01 U.S. Provisional Patent Application No. 62/221,045 filed September 20, 2015 entitled ‘‘Monoclonal Antibodies Fibroblast Growth Factor Receptor 4 (FGFR4) and Methods for Their Use’’ [HHS Reference E–264–2015/0–US–01] Licensing and Collaborative/CoDevelopment Research Opportunity: The National Cancer Institute seeks partners to license or co-develop the development new antibody-based therapies for metastatic Rhabdomyosarcoma (RMS). Contact Information: Requests for copies of the patent application or inquiries about licensing and/or research collaboration and codevelopment opportunities should be sent to John D. Hewes, Ph.D., email: john.hewes@nih.gov. Dated: December 22, 2015. Thomas M. Stackhouse, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2015–32878 Filed 12–29–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development. DATES: Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before January 29, 2016 will be considered. ADDRESSES: Technology Transfer Center, National Cancer Institute, 9609 Medical SUMMARY: E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 80, Number 250 (Wednesday, December 30, 2015)]
[Notices]
[Pages 81552-81553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32878]


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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing and Co-
Development

AGENCY: National Institutes of Health.

ACTION: Notice.

-----------------------------------------------------------------------

[[Page 81553]]

SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing and/or co-development in the 
U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve 
expeditious commercialization of results of federally-funded research 
and development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing and/or co-development.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute, Technology Transfer 
Center on or before January 29, 2016 will be considered.

ADDRESSES: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD, 20850-9702, Tel. 240-276-5515 or email 
ncitechtransfer@mail.nih.gov.

FOR FURTHER INFORMATION CONTACT: Information on licensing and co-
development research collaborations, and copies of the U.S. patent 
applications listed below may be obtained by contacting: Attn. 
Invention Development and Marketing Unit, Technology Transfer Center, 
National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, 
Rockville, MD 20850-9702, Tel. 240-276-5515 or email 
ncitechtransfer@mail.nih.gov. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of invention: Monoclonal Antibodies Fibroblast Growth Factor 
Receptor 4 (FGFR4) and Methods for Their Use.
    Description of Technology: Rhabdomyosarcoma (RMS) is the most 
common soft tissue sarcoma in children and adolescents. Although 
current treatments for primary disease are relatively successful, 
metastatic RMS is generally accompanied by a dismal prognosis. Thus, 
the development new therapies for metastatic RMS provides a strong 
benefit to the advancement of public health.
    Fibroblast Growth Factor Receptor 4 (FGFR4) is a cell surface 
protein that is highly expressed in RMS, and other cancers (including 
liver, lung, pancreatic, ovarian, and prostate cancers). Researchers in 
the National Cancer Institute's Genetics-Branch found that in RMS 
patients, high FGFR4 expression is often associated with advanced-stage 
disease, rapid disease progression, and poor survival. The correlation 
between FGFR4 expression and highly aggressive RMS makes FGFR4 an 
attractive target for treatment of RMS. By targeting FGFR4 
specifically, it may be possible to attack the cancer cells while 
leaving healthy, essential cells unaffected. This invention concerns 
the generation of several high-affinity monoclonal antibodies which can 
be used to treat FGFR4-related diseases. In particular, these 
antibodies have been used to generate antibody-drug conjugates (ADCs) 
and chimeric antigen receptors (CARs) which are capable of specifically 
targeting and killing diseased cells.

    Potential Commercial Applications:

--Development of unconjugated antibody therapeutics
--Development of antibody-drug conjugates (ADCs) and recombinant 
immunotoxins (RITs)
--Development of chimeric antigen receptors (CARs) and T Cell Receptors 
(TCRs)
--Development of bispecific antibody therapeutics
--Development of Diagnostic Agents for detecting FGFR4-positive cancers

    Value Proposition:

--High affinity and specificity of the antibodies allows more selective 
targeting of cancer cells, reducing the potential for side effects 
during therapy
--Multiple antibodies available

    Development Stage:
In vitro/Discovery
    Inventor(s):
    Javed Khan, M.D. (NCI), S. Baskar (NCI), R.J. Orientas (Lentigen 
Technology, Inc.)
    Publication(s):

--``Comprehensive genomic analysis of rhabdomyosarcoma reveals a 
landscape of alterations affecting a common genetic axis in fusion-
positive and fusion-negative tumors.'' Cancer Discov. 2014 
Feb;4(2):216-31. doi: 10.1158/2159-8290.CD-13-0639. Epub 2014 Jan 23.
--``Targeting wild-type and mutationally activated FGFR4 in 
rhabdomyosarcoma with the inhibitor ponatinib (AP24534)''. PLoS One. 
2013 Oct 4;8(10):e76551. doi: 10.1371/journal.pone.0076551. eCollection 
2013
--``Identification of FGFR4-activating mutations in human 
rhabdomyosarcomas that promote metastasis in xenotransplanted models.'' 
J Clin Invest. 2009 Nov;119(11):3395-407. doi: 10.1172/JCI39703. Epub 
2009 Oct 5.
--``Identification of cell surface proteins as potential immunotherapy 
targets in 12 pediatric cancers.'' Front Oncol. 2012 Dec 17;2:194. doi: 
10.3389/fonc.2012.00194. eCollection 2012.

    Intellectual Property:
HHS Reference No. E-264-2015/0-US-01
    U.S. Provisional Patent Application No. 62/221,045 filed September 
20, 2015 entitled ``Monoclonal Antibodies Fibroblast Growth Factor 
Receptor 4 (FGFR4) and Methods for Their Use'' [HHS Reference E-264-
2015/0-US-01]
    Licensing and Collaborative/Co-Development Research Opportunity:
    The National Cancer Institute seeks partners to license or co-
develop the development new antibody-based therapies for metastatic 
Rhabdomyosarcoma (RMS).
    Contact Information:
    Requests for copies of the patent application or inquiries about 
licensing and/or research collaboration and co-development 
opportunities should be sent to John D. Hewes, Ph.D., email: 
john.hewes@nih.gov.

    Dated: December 22, 2015.
Thomas M. Stackhouse,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2015-32878 Filed 12-29-15; 8:45 am]
 BILLING CODE 4140-01-P

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