80_FR_81802 80 FR 81552 - Government-Owned Inventions; Availability for Licensing and Co-Development

80 FR 81552 - Government-Owned Inventions; Availability for Licensing and Co-Development

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 250 (December 30, 2015)

Page Range81552-81553
FR Document2015-32878

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.

Federal Register, Volume 80 Issue 250 (Wednesday, December 30, 2015) 
[Federal Register Volume 80, Number 250 (Wednesday, December 30, 2015)]
[Notices]
[Pages 81552-81553]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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[[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

81552 Federal Register / Vol. 80, No. 250 / Wednesday, December 30, 2015 / Notices The meetings will be closed to the amended (5 U.S.C. App.), notice is DEPARTMENT OF HEALTH AND public in accordance with the hereby given of the following meetings. HUMAN SERVICES provisions set forth in sections The meetings will be closed to the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., National Institutes of Health public in accordance with the as amended. The grant applications and provisions set forth in sections the discussions could disclose National Center for Advancing 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Translational Sciences; Notice of confidential trade secrets or commercial as amended. The grant applications and Closed Meeting property such as patentable material, and personal information concerning the discussions could disclose confidential trade secrets or commercial Pursuant to section 10(d) of the individuals associated with the grant Federal Advisory Committee Act, as applications, the disclosure of which property such as patentable material, and personal information concerning amended (5 U.S.C. App.), notice is would constitute a clearly unwarranted hereby given of the following meeting. invasion of personal privacy. individuals associated with the grant applications, the disclosure of which The meeting will be closed to the Name of Committee: National Institute of public in accordance with the Allergy and Infectious Diseases Special would constitute a clearly unwarranted provisions set forth in sections Emphasis Panel; NIAID Peer Review Meeting. invasion of personal privacy. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Date: January 27, 2016. Name of Committee: National Institute of as amended. The contract proposals and Time: 11:00 a.m. to 7:00 p.m. Allergy and Infectious Diseases Special Agenda: To review and evaluate contract the discussions could disclose Emphasis Panel; NIAID Peer Review Meeting. confidential trade secrets or commercial proposals. Place: National Institutes of Health, Room Date: January 22, 2016. property such as patentable material, 8C100, 5601 Fishers Lane, Rockville, MD Time: 11:00 a.m. to 5:00 p.m. and personal information concerning 20892, (Telephone Conference Call). Agenda: To review and evaluate contract individuals associated with the contract Contact Person: Thomas F. Conway, Ph.D., proposals. proposals, the disclosure of which Scientific Review Officer, Scientific Review Place: National Institutes of Health, Room would constitute a clearly unwarranted Program, Division of Extramural Activities, 3C100, 5601 Fishers Lane, Rockville, MD invasion of personal privacy. Room 3G51, National Institutes of Health, 20892, (Telephone Conference Call). NIAID, 5601 Fishers Lane, MSC 9823, Name of Committee: National Center for Contact Person: Thomas F. Conway, Ph.D., Bethesda, MD 20892–9823, 240–507–9685, Advancing Translational Sciences Special Scientific Review Officer, Scientific Review Emphasis Panel; SBIR Review Meeting Topic thomas.conway@nih.gov. Program, Division of Extramural Activities, 14. Name of Committee: National Institute of Room 3G51, National Institutes of Health, Allergy and Infectious Diseases Special Date: February 5, 2016. NIAID, 5601 Fishers Lane, MSC 9823, Time: 8:00 a.m. to 5:00 p.m. Emphasis Panel; Investigator Initiated Bethesda, MD 20892–9823, 240–507–9685, Agenda: To review and evaluate contract Clinical Trials. thomas.conway@nih.gov. proposals. Date: January 27, 2016. Name of Committee: National Institute of Place: Bethesda North Marriott Hotel & Time: 1:00 p.m. to 3:00 p.m. Conference Center, 5701 Marinelli Road, Agenda: To review and evaluate grant Allergy and Infectious Diseases Special Bethesda, MD 20852. applications. Emphasis Panel; NIAID Investigator Initiated Contact Person: M. Lourdes Ponce, Ph.D., Place: National Institutes of Health, 5601 Clinical Trial Implementation Cooperative Scientific Review Officer, Office of Scientific Fishers Lane, Rockville, MD 20892, Agreement (U01). Review, National Center for Advancing (Telephone Conference Call). Date: January 22, 2016. Translational Sciences (NCATS), National Contact Person: Raymond R. Schleef, Time: 1:00 p.m. to 4:00 p.m. Institutes of Health, 6701 Democrary Blvd., Ph.D., Senior Scientific Review Officer, Democracy 1, Room 1073, Bethesda, MD Agenda: To review and evaluate grant Scientific Review Program, Division of 20892, 301–594–9459, lourdes.ponce@ Extramural Activities, Room 3E61, National applications. Place: National Institutes of Health, 5601 nih.gov. Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892–9823, Fishers Lane, Rockville, MD 20892, (Catalogue of Federal Domestic Assistance (240) 669–5019, schleefrr@niaid.nih.gov. (Telephone Conference Call). Program Nos. 93.859, Pharmacology, Contact Person: Zhuqing (Charlie) Li, Physiology, and Biological Chemistry (Catalogue of Federal Domestic Assistance Research; 93.350, B—Cooperative Program Nos. 93.855, Allergy, Immunology, Ph.D., Scientific Review Officer, Scientific Agreements; 93.859, Biomedical Research and Transplantation Research; 93.856, Review Program, Division of Extramural and Research Training, National Institutes of Microbiology and Infectious Diseases Activities, Room # 3G41B, National Institutes Health, HHS) Research, National Institutes of Health, HHS) of Health/NIAID, 5601 Fishers Lane, Dated: December 23, 2015. Dated: December 23, 2015. MSC9823, Bethesda, MD 20892–9823, (240) 669–5068, zhuqing.li@nih.gov. David Clary, Natasha M. Copeland, Program Analyst, Office of Federal Advisory Program Analyst, Office of Federal Advisory (Catalogue of Federal Domestic Assistance Committee Policy. Committee Policy. Program Nos. 93.855, Allergy, Immunology, [FR Doc. 2015–32765 Filed 12–29–15; 8:45 am] [FR Doc. 2015–32771 Filed 12–29–15; 8:45 am] and Transplantation Research; 93.856, BILLING CODE 4140–01–P BILLING CODE 4140–01–P Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: December 23, 2015. DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND HUMAN SERVICES Natasha M. Copeland, HUMAN SERVICES Program Analyst, Office of Federal Advisory mstockstill on DSK4VPTVN1PROD with NOTICES National Institutes of Health National Institutes of Health Committee Policy. [FR Doc. 2015–32767 Filed 12–29–15; 8:45 am] Government-Owned Inventions; National Institute of Allergy and BILLING CODE 4140–01–P Availability for Licensing and Co- Infectious Diseases; Notice of Closed Development Meetings AGENCY: National Institutes of Health. Pursuant to section 10(d) of the ACTION: Notice. Federal Advisory Committee Act, as VerDate Sep<11>2014 17:59 Dec 29, 2015 Jkt 238001 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 81553 SUMMARY: The invention listed below is advanced-stage disease, rapid disease —‘‘Identification of cell surface proteins owned by an agency of the U.S. progression, and poor survival. The as potential immunotherapy targets in Government and is available for correlation between FGFR4 expression 12 pediatric cancers.’’ Front Oncol. licensing and/or co-development in the and highly aggressive RMS makes 2012 Dec 17;2:194. doi: 10.3389/ U.S. in accordance with 35 U.S.C. 209 FGFR4 an attractive target for treatment fonc.2012.00194. eCollection 2012. and 37 CFR part 404 to achieve of RMS. By targeting FGFR4 Intellectual Property: expeditious commercialization of specifically, it may be possible to attack results of federally-funded research and the cancer cells while leaving healthy, HHS Reference No. E–264–2015/0–US– development. Foreign patent essential cells unaffected. This 01 applications are filed on selected invention concerns the generation of U.S. Provisional Patent Application inventions to extend market coverage several high-affinity monoclonal No. 62/221,045 filed September 20, for companies and may also be available antibodies which can be used to treat 2015 entitled ‘‘Monoclonal Antibodies for licensing and/or co-development. FGFR4-related diseases. In particular, Fibroblast Growth Factor Receptor 4 DATES: Only written comments and/or these antibodies have been used to (FGFR4) and Methods for Their Use’’ applications for a license which are generate antibody-drug conjugates [HHS Reference E–264–2015/0–US–01] received by the National Cancer (ADCs) and chimeric antigen receptors Licensing and Collaborative/Co- Institute, Technology Transfer Center on (CARs) which are capable of specifically Development Research Opportunity: or before January 29, 2016 will be targeting and killing diseased cells. The National Cancer Institute seeks considered. Potential Commercial Applications: partners to license or co-develop the development new antibody-based ADDRESSES: Invention Development and —Development of unconjugated therapies for metastatic Marketing Unit, Technology Transfer antibody therapeutics —Development of antibody-drug Rhabdomyosarcoma (RMS). Center, National Cancer Institute, 9609 Contact Information: Medical Center Drive, Mail Stop 9702, conjugates (ADCs) and recombinant Requests for copies of the patent Rockville, MD, 20850–9702, Tel. 240– immunotoxins (RITs) application or inquiries about licensing 276–5515 or email ncitechtransfer@ —Development of chimeric antigen and/or research collaboration and co- mail.nih.gov. receptors (CARs) and T Cell Receptors development opportunities should be (TCRs) FOR FURTHER INFORMATION CONTACT: sent to John D. Hewes, Ph.D., email: —Development of bispecific antibody Information on licensing and co- john.hewes@nih.gov. therapeutics development research collaborations, —Development of Diagnostic Agents for Dated: December 22, 2015. and copies of the U.S. patent detecting FGFR4-positive cancers Thomas M. Stackhouse, applications listed below may be Value Proposition: Associate Director, Technology Transfer obtained by contacting: Attn. Invention —High affinity and specificity of the Center, National Cancer Institute. Development and Marketing Unit, antibodies allows more selective [FR Doc. 2015–32878 Filed 12–29–15; 8:45 am] Technology Transfer Center, National targeting of cancer cells, reducing the BILLING CODE 4140–01–P Cancer Institute, 9609 Medical Center potential for side effects during Drive, Mail Stop 9702, Rockville, MD therapy 20850–9702, Tel. 240–276–5515 or —Multiple antibodies available DEPARTMENT OF HEALTH AND email ncitechtransfer@mail.nih.gov. A Development Stage: HUMAN SERVICES signed Confidential Disclosure Agreement may be required to receive In vitro/Discovery National Institutes of Health copies of the patent applications. Inventor(s): Government-Owned Inventions; SUPPLEMENTARY INFORMATION: Javed Khan, M.D. (NCI), S. Baskar Availability for Licensing Technology description follows. (NCI), R.J. Orientas (Lentigen Title of invention: Monoclonal Technology, Inc.) AGENCY: National Institutes of Health, Antibodies Fibroblast Growth Factor Publication(s): Public Health Service, HHS. Receptor 4 (FGFR4) and Methods for —‘‘Comprehensive genomic analysis of ACTION: Notice. Their Use. rhabdomyosarcoma reveals a Description of Technology: landscape of alterations affecting a SUMMARY: The invention listed below is Rhabdomyosarcoma (RMS) is the most common genetic axis in fusion- owned by an agency of the U.S. common soft tissue sarcoma in children positive and fusion-negative tumors.’’ Government and is available for and adolescents. Although current Cancer Discov. 2014 Feb;4(2):216–31. licensing and/or co-development in the treatments for primary disease are doi: 10.1158/2159–8290.CD–13–0639. U.S. in accordance with 35 U.S.C. 209 relatively successful, metastatic RMS is Epub 2014 Jan 23. and 37 CFR part 404 to achieve generally accompanied by a dismal —‘‘Targeting wild-type and expeditious commercialization of prognosis. Thus, the development new mutationally activated FGFR4 in results of federally-funded research and therapies for metastatic RMS provides a rhabdomyosarcoma with the inhibitor development. Foreign patent strong benefit to the advancement of ponatinib (AP24534)’’. PLoS One. applications are filed on selected public health. 2013 Oct 4;8(10):e76551. doi: inventions to extend market coverage Fibroblast Growth Factor Receptor 4 10.1371/journal.pone.0076551. for companies and may also be available for licensing and/or co-development. mstockstill on DSK4VPTVN1PROD with NOTICES (FGFR4) is a cell surface protein that is eCollection 2013 highly expressed in RMS, and other —‘‘Identification of FGFR4-activating DATES: Only written comments and/or cancers (including liver, lung, mutations in human applications for a license which are pancreatic, ovarian, and prostate rhabdomyosarcomas that promote received by the NCI Technology cancers). Researchers in the National metastasis in xenotransplanted Transfer Center on or before January 29, Cancer Institute’s Genetics-Branch models.’’ J Clin Invest. 2009 2016 will be considered. found that in RMS patients, high FGFR4 Nov;119(11):3395–407. doi: 10.1172/ ADDRESSES: Technology Transfer Center, expression is often associated with JCI39703. Epub 2009 Oct 5. National Cancer Institute, 9609 Medical VerDate Sep<11>2014 17:59 Dec 29, 2015 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1


Document Created: 2015-12-30 03:15:50
Document Modified: 2015-12-30 03:15:50
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.
DatesOnly 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.
ContactInformation 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 [email protected] A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.
FR Citation80 FR 81552 
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