[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.

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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 
[email protected].

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 
[email protected]. 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: 
[email protected].

    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