[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Page 54583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19419]


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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.

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.

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: Human Monoclonal Antibodies Targeting Glypican-
2 in Neuroblastoma.
    Keywords: Glypican-2, GPC2, Antibody, Immunotoxin, Recombinant 
Immunotoxin, RIT, Chimeric Antigen Receptor, CAR, Antibody-drug 
Conjugate, ADC, bispecific antibody, neuroblastoma.
    Description of Technology: Neuroblastoma is a rare pediatric cancer 
that affects one in every hundred thousand children under the age of 
fifteen in the United States. Current standards of care are 
chemotherapy and surgery, followed by stem-cell treatments, radiation 
and anti-ganglioside antibody therapy, which yield an average three-
year survival rate of 10-45%. This demonstrates a need for more 
effective therapies.
    Glypican-2 (GPC2) is a cell surface protein that has been shown to 
be preferentially expressed on numerous pediatric cancers, including 
neuroblastoma. Due to this preferential expression, GPC2 represents a 
potential candidate for targeted therapy. Researchers at the National 
Cancer Institute's Laboratory of Molecular Biology (NCI LMB) have 
developed and isolated several single domain monoclonal human 
antibodies against GPC2. This technology covers the naked GPC2 
antibodies as well as their use as targeting domains in recombinant 
immunotoxins (RITs) and chimeric antigen receptors (CARs). RITs (using 
clones LH1, LH4, or LH7) and CARs (using LH7) have shown specific 
killing activity against GPC2-expressing cells, suggesting that these 
candidates may be further developed as therapeutics.
    The technology has been validated with in-vitro studies (human 
anti-GPC2 RITs and CARs can bind to, and kill, GPC2-positive tumor 
cells) and the researchers are currently developing mouse models to 
further develop GPC2-targeted therapies.
    Potential Commercial Applications:

--Therapeutic applications include: Unconjugated antibodies, and use as 
targeting moieties for immunoconjugates such as CARs, ADCs, 
immunotoxins, and bispecific antibodies
--Diagnostic agent for detecting and monitoring target-expressing 
malignancies

    Value Proposition:

--First to market potential--No current clinical trials with GPC2-
targeted therapies
--Human antibody with high specificity and binding to targets results 
in less non-specific cell killing, therefore fewer potential side-
effects for the patient
--Small size of single domain antibodies enhances stability, 
solubility, and target recognition

    Development Stage: In-vitro.
    Inventor(s): Mitchell Ho (NCI), et al.
    Intellectual Property: US Provisional Application 62/369,861 (HHS 
Reference No. E-211-2016/0-US-01) filed August 2, 2016, entitled 
``Human Monoclonal Antibodies Targeting Glypican-2 in Neuroblastoma.''
    Collaboration Opportunity: Researchers at the NCI seek parties 
interested in licensing or co-developing GPC2 antibodies and/or 
conjugates.
    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: August 8, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-19419 Filed 8-15-16; 8:45 am]
 BILLING CODE 4140-01-P