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Government-Owned Inventions; Availability for Licensing

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AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

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 Start Printed Page 31701currently 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; lambertsond@mail.nih.gov.

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; lambertsond@mail.nih.gov.

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Dated: May 23, 2008.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. E8-12291 Filed 6-2-08; 8:45 am]

BILLING CODE 4140-01-P