[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Notices]
[Page 51969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22359]


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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 inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing to achieve expeditious 
commercialization of results of federally-funded research and 
development.

FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained 
by emailing the indicated licensing contact at the National Heart, 
Lung, and Blood, Office of Technology Transfer and Development Office 
of Technology Transfer, 31 Center Drive Room 4A29, MSC2479, Bethesda, 
MD 20892-2479; telephone: 301-402-5579. A signed Confidential 
Disclosure Agreement may be required to receive any unpublished 
information.

SUPPLEMENTARY INFORMATION: Technology description follows.

Antibody Targeting Cell Surface Deposited Complement Protein C3d

    Available for licensing and commercial development is a patent 
estate covering anti-C3d antibodies, antibody fragments, and their 
methods of use for killing cancer cells expressing C3d complement 
protein on their surface, and more particularly for the treatment of 
patients with Chronic Lymphocytic Leukemia (CLL); a malignancy of 
mature B-cells and the most common leukemia in the US. The most 
commonly used monoclonal antibodies (mAbs) are of mouse origin that 
have been chimerized or humanized to carry human constant regions 
(typically the human lgG1 isotype), required for the recruitment of 
human effector mechanisms. The complement system consists of soluble 
plasma proteins and is activated upon binding of a mAb to target cells 
resulting in the deposition of complement components on the cell 
surface and formation of the membrane attack complex (MAC), which can 
kill cells inducing lysis. The invention originated from an observation 
during CLL patient treatment with chemotherapy in combination with an 
anti CD20 mAb (e.g., rituximab or ofatumumab). Upon infusion complement 
is deposited on the cell surface of CLL cells, a subset of cells is 
killed, and other cells escape having lost CD20 expression due to a 
process called trogocytosis by which antibody-CD20 complexes are pulled 
of the CLL cell surface by immune cells that bind the Fc-portion of the 
mAb. It has been noted that C3d is stably attached to the CLL cells 
that escape from further rituximab or ofatumumab targeting and remains 
detectable for weeks on these cells. C3d, thus, could serve as a 
neoantigen that could be targeted with anti C3d specific mAbs to kill 
off escaped tumor cells.
    Potential Commercial Applications:
    Development Stage:
     Mouse data available.
    Inventors: Adrian Wiestner, Martin Skarzynski, Christoph Rader (all 
of NHLBI), and Margaret A. Lindorfer, Ronald P. Taylor, and Berengere 
Vire (all of the University of Virginia School of Medicine).
    Relevant Publications:
     Robinson, et al. Blood. 2018 Aug 2;132(5):521-532. doi: 
10.1182/blood-2018-02-830992.
    Intellectual Property: HHS Reference No. E-758-2013-0 and -1; U.S. 
Provisional Patent Application 61/924,967 filed January 8, 2014 
(converted), International Patent Application PCT/US2015/010620 filed 
January 8, 2015 (nationalized), U.S. Patent Application 15/110, 557 
filed January 8, 2015, Canadian Patent Application 2936346 filed 
January 8, 2015, European Patent Application 15701442.4 filed January 
8, 2015, and U.S. Divisional Patent Application 16/047,929 filed 
January 8, 2015.
    Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; 
[email protected].

    Dated: October 4, 2018.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2018-22359 Filed 10-12-18; 8:45 am]
BILLING CODE 4140-01-P