[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85980-85981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28624]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing and 
Collaboration

AGENCY: National Institutes of Health, 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 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.

ADDRESSES: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD 20850-9702.

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: Genetically Engineered Mouse-Derived Allograft 
for Use in Preclinical Studies of Metastatic Melanoma Therapies.
    Keywords: Melanoma, GDA, Allograft, Genetically Engineered Mouse, 
immunological response.
    Description of Technology: 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.
    Before testing drugs in humans, drug developers are required to 
demonstrate a reasonable expectation of safety and efficacy by 
performing so-called pre-clinical studies. A key element of such trials 
is the use of animal models,

[[Page 85981]]

typically mice or rats that are selected for demonstrating hallmarks of 
a given disease. For cancer research, while many mouse models exist to 
simulate the response of the cancer to a particular drug, all of the 
current models have some limitations in their ability to fully predict 
the concomitant physiological or immunological response that might 
result when the drug progresses to clinical trials. This is problematic 
both in models in which the cancer spontaneously develops in the animal 
as well as models in which cancerous cells or tumors, i.e., allografts 
(derived from cells of the same organism) or xenografts (derived from 
cells of different organism, usually humans), are transplanted into an 
otherwise cancer-free animal.
    To address these issues, researchers at NCI developed a means of 
more closely simulating in mouse models both melanoma cancer itself and 
the resulting physiological and immunological response by creating a 
genetically engineered mice (GEM)-derived allograft (GDA). This 
allograft both resembles human-like melanoma and has features that will 
stimulate a normal immunological response in the mouse. Thus, when 
transplanted into a host, the resulting tumor-containing mouse may be 
used to test conventional cancer therapies (e.g., chemotherapy and 
radiotherapy), targeted drugs (e.g., kinase inhibitors), and 
immunotherapies with an expectation that the response in the mouse will 
more closely mimic the types of responses expected in humans if the 
therapy progresses to clinical trials. Further this melanoma-based GDA 
approach may represent a new standard for building or improving 
preclinical models of other types of cancer.
    Potential Commercial Applications:
     This is a novel mouse allograft model that provides a 
preclinical model of human-like advanced-stage melanoma.
     This allograft model may be useful for preclinical testing 
of conventional therapies, targeted therapies, and immunotherapies.
    Value Proposition:
     Hgf-tg;Cdk4R24C C57BL/6 mouse-derived melanoma allograft 
with humanized pathogenetics allows adoption of clinically relevant 
procedures and endpoints, facilitating clinical translation.
     Features a constitutively activated MET/MAPK pathway and 
disrupted CDKN2A pathway.
     Expresses typical diagnostic markers of human melanoma 
such as DCT and TRP1.
     Exhibits progression patterns relevant to human disease.
    Development Stage: Basic (Target ID).
    Inventor(s): Chi-Ping Day, Glenn T. Merlino, Zoe Weaver Ohler, 
Rajaa El Meskini, Terry A. Van Dyke (all of NCI), and Thomas 
T[uuml]ting (University Hospital Bonn).
    Intellectual Property: HHS Reference Number E-291-2015/0. This is a 
Research Tool. Following the policy of the National Institutes of 
Health, patent protection will not be sought.
    Publications:

1. Day CP, et al. ``Glowing head'' mice: A genetic tool enabling 
reliable preclinical image-based evaluation of cancers in 
immunocompetent allografts. PLoS One 2014; 9(11):e109956. [PMID 
25369133]
2. Day CP, et al. Preclinical mouse cancer models: A maze of 
opportunities and challenges. Cell. 2015;163(1):39-53. [PMID 26406370]

    Contact Information: Inquiries about licensing, research 
collaborations, and co-development opportunities should be sent to John 
D. Hewes, Ph.D., email: [email protected].

    Dated: November 22, 2016.
John D. Hewes,
Technology Transfer and Patenting Specialist, Technology Transfer 
Center, National Cancer Institute.
[FR Doc. 2016-28624 Filed 11-28-16; 8:45 am]
 BILLING CODE 4140-01-P