[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Notices]
[Pages 31700-31701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12291]


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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, Public Health Service, 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 in the U.S. in accordance 
with 35 U.S.C. 207 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.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Immunotoxins With Deletions in Domain II That Remove Immunogenic 
Epitopes With Minimal Loss of Cytotoxic Activity

    Description of Technology: Anti-CD22 immunotoxins consist of a 
disulfide-linked FV (VH/VL) antibody fragment 
recombinantly linked to a toxic moiety capable of killing cells. In 
particular, a 38-kDa active fragment of Pseudomonas exotoxin A (PE38) 
containing three specific domains (domain Ib, domain II and domain III) 
has been used successfully in these immunotoxins. These immunotoxins 
have been shown to have activity against various forms of cancer, such 
as hairy cell leukemia and chronic lymphocytic leukemia, and are

[[Page 31701]]

currently being evaluated in clinical trials.
    This technology involves the development of a less immunogenic form 
of anti-CD22 immunotoxins. Specifically, the inventors have removed all 
of domain Ib and the majority of domain II from the PE38 portion of the 
immunotoxin. The resulting construct maintains a similar cytotoxicity 
to the larger immunotoxin, but with lowered immunogenicity.
    Application: Treatment of cancers associated with the increased 
expression of CD22, such as leukemia and lymphoma.
    Advantages: Less immunogenic immunotoxin results in improved 
cytotoxicity; Targeted therapy decreases non-specific killing of non-
cancerous cells.
    Inventors: Ira Pastan (NCI) et al.
    Patent Status: U.S. Provisional Application No. 60/969,929 filed 09 
Sep 2007 (HHS Reference No. E-292-2007/0-US-01).
    Licensing Contact: David A. Lambertson, PhD; 301-435-4632; 
[email protected].

The Combination of Anti-CD22 Immunotoxins With Standard 
Chemotherapeutic Agents on a Human Burkitt Lymphoma Cell Line

    Description of Technology: The treatment of hematological 
malignancies has been a major public health challenge because patients 
frequently do not respond to conventional therapies with long-term 
complete remission. However, current therapies are associated with 
multiple toxicities, suggesting that new therapies are needed.
    In the past several years immunotoxins have been developed as an 
alternative approach to treat different malignancies. Since 
hematological malignancies are readily accessible via the blood stream, 
immunotoxins represent a viable therapeutic approach. Furthermore, 
immunotoxins have the potential for decreased nonspecific toxicity, 
suggesting these agents could lead to improved cancer therapies.
    This technology relates to new combination therapies using an 
immunotoxin and chemotherapeutic agent. Specifically, the anti-CD22 
immunotoxin HA22 has been used in combination with 4 different 
chemotherapeutic agents: Taxol, cisplatin, etopside and doxorubicin. 
The combinations were shown to have a synergistic effect when examined 
in both in vitro cell models and in vivo animal models. As a result, it 
may be possible for this combination therapy to overcome previous 
shortcomings seen with chemotherapy treatment alone.
    Application: Treatment of cancers associated with the increased 
expression of CD22, such as leukemia and lymphoma.
    Advantages: Uses a combination of agents previously shown to be 
effective in killing cancer cells; Combination of immunotoxins and 
chemotherapeutics showed a synergistic effect, suggesting the 
combination offers distinct advantages of the use of either agent 
alone.
    Inventors: Ira Pastan (NCI) et al.
    Patent Status: PCT Application No. PCT/US2008/002747 filed 28 Feb 
2008 (HHS Reference No. E-132-2007/2-PCT-01).
    Licensing Contact: David A. Lambertson, PhD; 301-435-4632; 
[email protected].

    Dated: May 23, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-12291 Filed 6-2-08; 8:45 am]
BILLING CODE 4140-01-P