[Federal Register Volume 81, Number 129 (Wednesday, July 6, 2016)]
[Notices]
[Page 44032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15898]


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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, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is co-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.

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: Shark Antibodies that Target Tumor and Viral 
Antigens.
    Description of Technology: Shark V-NAR (Variable New Antigen 
Receptor) antibodies are an emerging class of therapeutic candidates. 
As single domain (heavy chain) antibodies with an extensive antigen-
binding repertoire, shark V-NAR antibodies may provide advantages over 
traditional antibodies. Specifically, the smaller size of shark V-NAR 
antibodies may provide increased solubility, thermal stability, 
refolding capacity, and the ability to recognize epitopes that are 
sterically hindered from recognition by larger antibodies, but without 
loss of specificity in antigen-binding.
    Researchers at the National Cancer Institute's Laboratory of 
Molecular Biology (NCI LMB) have developed an immunological platform 
that includes the development of a shark V-NAR antibody phage display 
library, isolation of specific antibodies that bind to several tumor 
and viral antigens from the library, and the development of the 
specific antibodies for treatment of cancer or viral infection. 
Specific antibody targets for binders include tumor-specific antigens 
(GPC3 [Clone F1], PD1 [Clone A1], HER2 [Clones A6/A7]), and viral 
antigens (MERS [Clones A3, A7, A8, B4, and B5] and SARS [Clone O1]).
    Anti-glypican 3 (GPC3) V-NAR, Clone F1, is an antibody of immediate 
interest since it has already shown specific binding to GPC3-expressing 
tumor cells in vitro. Thus, anti-GPC3 V-NAR represents a viable 
candidate for development of an antibody-toxin/drug conjugate (ADC and 
immunotoxin), a bispecific antibody or a chimeric antigen receptor 
(CAR) against GPC3-expressing tumor cells.
    Potential Commercial Applications:
 Therapeutic Uses
[cir] Use as unconjugated antibodies
[cir] Use as targeting moieties for immunoconjugates such as CARs, 
ADCs, Immunoconjugates, bispecific antibodies, etc.
 Diagnostic agent for detecting and monitoring target-
expressing malignancies
    Value Proposition:
 Potential to be first to market with high specificity and 
binding to targets resulting in less non-specific cell killing, 
therefore fewer potential side-effects for the patient
 Small size of antibodies enhances stability, solubility, and 
target recognition
    Development Stage:
 In-vitro data--Shark/Human anti-GPC3 chimera can bind to GPC3-
positive tumor cells
 In-vivo testing
    Inventor(s): Mitchell Ho (NCI), et al.
    Intellectual Property: US Provisional Application 62/334,194 (HHS 
Reference No. E-113-2016/0-US-01) filed May 10, 2016 entitled 
``Variable New Antigen Receptor (VNAR) Antibodies and Antibody 
Conjugates Targeting Tumor and Viral Antigens''.
    Collaboration Opportunity: Researchers at the NCI seek parties 
interested in licensing or co-developing shark V-NAR antibodies and/or 
conjugates for cancer therapeutics and/or diagnostics.
    Contact Information: Requests for copies of the patent application 
or inquiries about licensing, research collaborations, and co-
development opportunities should be sent to John D. Hewes, Ph.D., 
email: [email protected].

    Dated: June 28, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-15898 Filed 7-5-16; 8:45 am]
 BILLING CODE 4140-01-P