80 FR 81553 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

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

Page Range		81553-81554
FR Document		2015-32877

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 81553-81554]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32877]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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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 NCI Technology Transfer Center on or before January 
29, 2016 will be considered.

ADDRESSES: Technology Transfer Center, National Cancer Institute, 9609 
Medical

[[Page 81554]]

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:
    Title of invention: Thalidomide/lenolidomide/pomalidomide analogs 
that inhibit inflammation, angiogenesis.
    Description of Technology: Thalidomide and its close analogs 
(lenalidomide and pomalidomide) are widely used to treat a variety of 
diseases, such as multiple myeloma and other cancers, as well as the 
symptoms of several inflammatory disorders. However, thalidomide is 
known for its teratogenic adverse effects when first introduced 
clinically in the 1950s, and is associated with drowsiness and 
peripheral neuropathy. Hence, there is intense interest to synthesize, 
identify and develop safer analogs. Researchers at the National 
Institute on Aging's Drug Design and Development Section synthesized 
novel thalidomide analogs that demonstrate clinical potential without 
being teratogenic, as initially evaluated in in vivo zebrafish and 
chicken embryo model systems and in cell culture. These new compounds 
differentially provide potent anti-angiogenesis and/or anti-
inflammatory action. The agents have potential for development of new 
cancer therapies and treatment of a number of neurological and systemic 
disorders involving chronic inflammation and elevated TNF-alpha levels.
    Potential Commercial Applications:

--Cancer therapeutics
--Inflammatory disorders such as Crohn's disease, sarcoidosis, graft-
versus-host disease, and rheumatoid arthritis
--Neuroinflammatory disorders (acute: Traumatic brain injury and 
stroke; chronic: Parkinson's disease, Alzheimer's disease, multiple 
sclerosis)
    Value Proposition:
--Non-teratogenic
--Potent
    Development Stage:
In Vitro/Discovery
    Inventor(s):
    Nigel H. Greig (NIA), Weiming Luo (NIA), David Tweedie (NIA), 
William Douglas Figg, Sr. (NCI), Neil Vargesson (Univ. Aberdeen, 
Scotland), and Shaunna Beedie (NCI & Univ. Aberdeen, Scotland)
    Intellectual Property:
HHS Reference No. E-208-2015/0-US-01
    U.S. Provisional Patent Application No. 62/235, 105, filed 
September 30, 2015, entitled ``Thalidomide/lenolidomide/pomalidomide 
analogs that inhibit inflammation, angiogenesis''
    Licensing and Collaborative/Co-Development Research Opportunity: 
The National Institute on Aging seeks collaborators to license or co-
develop novel thalidomide analogs that demonstrate clinical potential 
without being teratogenic.
    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].
    CFR Citation: 35 U.S.C. 209 and 37 CFR part 404

    Dated: December 22, 2015.
Thomas M. Stackhouse,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2015-32877 Filed 12-29-15; 8:45 am]
BILLING CODE 4140-01-P

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

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Document Created: 2015-12-30 03:16:05
Document Modified: 2015-12-30 03:16:05

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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.
FR Citation		80 FR 81553

80 FR 81553 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health