[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Notices]
[Pages 36936-36937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13499]


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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 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: Therapeutic antibody-drug conjugates targeting 
CD56-positive tumors.
    Description of Technology: CD56, also known as neural cell adhesion 
molecule (NCAM), is a glycoprotein that plays an important role in 
normal physiological functions. It is expressed in low levels in normal 
cells such as neurons, glia, skeletal muscle and natural killer cells 
but is highly expressed on a variety of cancerous cells including 
neuroblastoma, small-cell lung cancer, and multiple myeloma. In 
neuroblastoma, patients undergo a very aggressive treatment regimen 
that still results in a high mortality rate. Many neuroblastomas have 
increased expression of CD56 which represents a possible therapeutic 
target for these aggressive and hard to treat cancers.
    Researchers at the National Cancer Institute's Cancer and 
Inflammation Program, in collaboration with the Children's Hospital of 
Philadelphia (CHOP), have developed antibody-drug conjugates (ADC) that 
incorporate one of two novel human CD56 antibodies, known as m900 and 
m906, in combination with a known cytotoxic drug, pyrrolobenzodiazepine 
(PBD). Other PBD-ADCs have demonstrated the ability to overcome 
resistance in some multi-drug resistant cancers which could present 
additional benefits for the ADCs of the current invention. The m900 and 
m906 ADCs have been shown to induce cell death and CD56 down regulation 
in vitro in four different CD56-positive neuroblastoma cell lines. 
Preliminary studies in animals have also shown promising results, and 
additional in vivo work is ongoing.
    Potential Commercial Applications:

--Therapeutic for the treatment of neuroblastoma
--Therapeutic for the treatment of other CD56-positive cancers 
including small cell lung cancer, multiple myeloma, pancreatic cancer, 
ovarian cancer, acute myeloid leukemia, NK-T lymphoma, and 
neuroendocrine cancer

    Value Proposition:

--Fully human antibodies (m900 or m906) targeting CD56 may offer 
improved properties over the humanized antibody IMGN901

    Development Stage: Pre-clinical (in vivo validation).
    Inventor(s): Dimiter S. Dimitrov (NCI), Yang Feng (NCI), Zhongyu 
Zhu (NCI), John M. Maris (Children's Hospital of Philadelphia).
    Intellectual Property: HHS Reference No. E-221-2015/0-US-01. US 
Provisional Application No. 62/199,707, filed July 31, 2015 entitled 
``ANTIBODY-DRUG CONJUGATES FOR TARGETING CD56-POSITIVE TUMORS''.
    Publications: Feng, Y, et al. Differential killing of CD56-
expressing cells by drug-conjugated human antibodies targeting 
membrane-distal and membrane-proximal non-overlapping epitopes. mAbs, 
2016;

[[Page 36937]]

24:1-12. DOI: 10.1080/19420862.2016.1155014.
    Related Technologies: E-142-2014 (CD56-targeting antibodies and 
related CARs).
    Collaboration Opportunity: Researchers at the NCI seek licensing 
and/or co-development research collaborations for development of 
antibody-drug conjugates for the treatment of cancer.
    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 2, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-13499 Filed 6-7-16; 8:45 am]
BILLING CODE 4140-01-P