[Federal Register Volume 65, Number 19 (Friday, January 28, 2000)]
[Notices]
[Page 4563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1931]


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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, DHHS.

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 in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally funded research and development.

ADDRESSES:  Licensing information and a copy of the U.S. patent 
application referenced below may be obtained by contacting Elaine Gese 
at the Office of Technology Transfer, National Institutes of Health, 
6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; 
Telephone: 301/496-7056 ext. 282; Fax: 301/402-0220; E-mail: 
[email protected]. A signed Confidential Disclosure Agreement is required 
to receive a copy of any patent application.

Variants of Humanized Anti-Carcinoma Monoclonal Antibody CC49

Syed V. Kashmiri (NCI), Eduardo A. Padlan (NIDDK), Jeffrey Schlom (NCI)
U.S. Provisional Patent Applications 60/106,534 filed 31 Oct 1998 and 
60/106,757 filed 02 Nov 1998

    The invention embodied in these two patent applications describes 
the humanization of a murine anti-carcinoma antibody which has been 
shown to react with Tumor Associated Glycoprotein 72 (TAG-72), an 
antigen which is expressed on human breast, colorectal, and other 
carcinomas. The humanization process, which renders the antibody 
minimally immunogenic to humans, has been accomplished by a method 
different from the current procedure for the humanization of a rodent 
antibody which is based on grafting all the Complementarity Determining 
Residues (CDRs) of a rodent antibody onto a human antibody framework. 
This new humanization protocol involves identifying the Specificity 
Determining Residues (SDRs), the amino acid residues in the 
hypervariable regions of an antibody that are most critical for antigen 
binding activity. The CDRs, which are found not to contain SDRs and 
hence are dispensable for antigen binding activity, are not grafted 
onto the human antibody frameworks. Rather, only the SDRs of the 
essential CDRs are transferred to the human antibody molecule. The 
resulting molecule is believed to elicit an immune response in humans 
which is significantly less than that elicited through administration 
of other humanized antibodies.
    Embodied in the current invention are methods of identifying the 
SDRs, and of rendering any antibody minimally immunogenic in humans by 
transferring the SDRs of the antibody to a human antibody framework. 
The resulting humanized antibodies, including CDR variants therof 
(including a CH2 deleted version), are also embodied in the invention, 
as are methods of using the antibodies for therapeutic and diagnostic 
purposes.

    Dated: January 20, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 00-1931 Filed 1-27-00; 8:45 am]
BILLING CODE 7555-01-M