[Federal Register Volume 64, Number 108 (Monday, June 7, 1999)]
[Pages 30348-30349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14242]



National Institutes of Health

Prospective Grant of Exclusive License: Drug and Method for the 
Therapeutic Treatment of Lymphomas and Leukemias

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.


SUMMARY: This notice in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 
404.7(a)(1)(I) that the National Institutes of Health, Department of 
Health and Human Services, is contemplating the grant of an exclusive 
world-wide license to U.S. Patents and Patent Applications USPA SN: 60/
041,437, entitled: ``Recombinant Antibodies and Immunoconjugates 
Targeted to CD-22 Bearing Cells and Tumors''; USPN 4,892,827, entitled, 
``Recombinant Pseudomonas Exotoxin: Construction of an Active 
Immunotoxin with Low Side Effects''--excluding any foreign equivalents 
corresponding to 4,892,927 (= USSN 06/911,227); USPN 5,747,654, 
entitled, ``Recombinant Disulfide-Stabilized Polypeptide Fragments 
Having Binding Specificity''; USPA SN: 09/002,753, entitled: 
``Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding 
Specificity''; USPA SN: 07/865,722; entitled: ``Recombinant Antibody-
Toxin Fusion Protein''; USPN 5,863,745, entitled: ``Recombinant 
Antibody-Toxin Fusion Protein''; USPN 5,696,237, entitled: 
``Recombinant Antibody-Toxin Fusion Protein''; and USPA SN: 06/005,388, 
entitled: ``Immunotoxin Containing a Disulfide-Stabilized Antibody 
Fragment Joined to a Pseudomonas Exotoxin that does not Require 
Proteolytic Activation'' and corresponding foreign patent applications 
to AlbaPharm, Inc. having an address in Ann Arbor, Michigan. The United 
States of America is an assignee of the patent rights in these 
inventions and the contemplated exclusive license may be limited to the 
use of RFB4 (dsFv)--PE38 [also known as BL22] immunotoxin and relevant 
patents and patent applications for the therapeutic treatment of 
Lymphomas and Leukemias which express the CD22 surface antigen.

DATES: Only written comments and/or applications for a license which 
are received by NIH on or before August 6, 1999 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments and other materials relating to this contemplated exclusive 
license should be directed to: J.R. Dixon, Ph.D., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-
3804. Telephone: (301) 496-7735 ext. 206; Facsimile: (301) 402-0220, E-
Mail: [email protected] A signed Confidentiality Agreement will be 
required to receive copies of any patent applications.

SUPPLEMENTARY INFORMATION: The technology is directed to a RFB4 (dsFv)-
PE38 (also known as: BL22) immunotoxin and to methods and DNA sequences 
to produce disulfide-stabilized (ds) recombinant polypeptide fragments 
to construct the aforementioned immunotoxin. RFB4 is a disulfide-linked 
recombinant immunotoxin fused to PE38, a mutant form of Pseudomonas 
Exotoxin, that binds to CD22--a 135kDa phosphoglycoprotein adhesion 
molecule present on the surface of B-cells. RFB4 is a mouse monoclonal 
antibody that recognizes an external epitope on the CD22 cell surface 
antigen and has no detectable cross-reactivity with any other normal 
cell types. CD22 is a lineage-restricted B-cell antigen that belongs to 
the Ig superfamily and is displayed on chronic B-Lymphocytic Leukemia 
cells and B-cell Non-Hodgkins Lymphoma cells. To kill CD22-positive 
cells, the RFB4 antibody was used to make a recombinant immunotoxin. To 
construct the recombinant PE immunotoxin, the variable portions of the 
heavy and light chains of RFB4 were cloned and the Fv fragments linked 
together by a disulfide bond to form a disulfide stabilized (ds) 
construct. The construct was combined by gene fusion with PE38, a 
truncated version of PE, to form RFB4 (dsFv)-PE38, or BL22.
    The prospective exclusive license will be royalty-bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective

[[Page 30349]]

exclusive license may be granted unless within sixty (60) days from the 
date of this published notice, NIH receives written evidence and 
argument that establishes that the grant of the exclusive license would 
not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 
    Applications for a license [i.e., completed ``Application for 
License to Public Health Service Inventions''] in the field of use of 
the RFB4 (dsFv)-PE38 immunotoxin and the relevant Patents and Patent 
Applications for the therapeutic treatment of Lymphomas and Leukemias 
which express the CD22 surface antigen filed in response to this notice 
will be treated as objections to the grant of the contemplated 
exclusive license. Comments and objections will not be made available 
for public inspection and, to the extent permitted by law, will not be 
subject to disclosure under the Freedom of Information Act, 5 U.S.C. 

    Dated: May 26, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 99-14242 Filed 6-4-99; 8:45 am]