[Federal Register Volume 64, Number 108 (Monday, June 7, 1999)]
[Notices]
[Pages 30349-30350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14243]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Drug and Method for the 
Therapeutic Treatment of Leukemia, Lymphoma, Hair Cell Leukemia, 
Hodgkin's Disease and Other Hematologic Malignancies Plus to Prevent 
and Treat Graft-versus-Host Disease and Allograft Rejection

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

ACTION: Notice.

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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 USPN 
4,892,827, entitled, ``Recombinant Pseudomonas Exotoxin: Construction 
of an Active Immunotoxin with Low Side Effects''--excluding any foreign 
equivalents corresponding to 4,892,827 (= 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: 60/005,388, 
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. of 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 an anti-
Tac(dsFv)--PE38 based immunotoxin and/or anti-Tac(Fc)--PE38 immunotoxin 
and relevant patents and patent applications for the therapeutic 
treatment of refractory Leukemia, Lymphoma, Hairy Cell Leukemia, 
Hodgkin's disease and other hematologic malignancies and for the 
treatment of Graft-versus-Host Disease and Allograft Rejection.

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 the contemplated licenses 
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 of the patent applications.

SUPPLEMENTARY INFORMATION: The technology is directed to an anti-Tac 
(dsFv)-PE38 and/or anti-Tac(Fv)-PE38 immunotoxin for the therapeutic 
treatment of refractory Leukemia, Lymphoma, Hairy Cell Leukemia, 
Hodgkin's disease and other hematologic malignancies. Ani-Tac(dsFv)-
PE38 and anti-Tac(scFv)-PE38 are recombinant immunotoxins composed of a 
disulfide-stabilized (ds) or a single chain Fv form of the anti-Tac 
(anti-CD25) monoclonal antibody which binds to the  subunit of 
the IL2 receptor (also called P55, Tac, or CD25), fused to PE38, a 
mutant form of Pseudomonas Exotoxin A which has ADP ribosylating 
activity and the ability to translocate across a cell membrane. Anti-
Tac-(dsFv)PE38 or anti-Tac(scFv)-PE38 immunotoxins are very cytotoxic 
to normal or malignant cells expressing this IL2 receptor. The 
technology is also directed to methods and DNA sequences to produce 
disulfide-stabilized (ds) or single-chain (sc) recombinant polypeptide 
fragments to construct the aforementioned immunotoxins. Anti-Tac is a 
monoclonal antibody fused to PE38, a mutant form of Pseudomonas 
Exotoxin, that binds to the CD25 surface antigen. To kill CD25-positive 
cells, the anti-Tac antibody was used to make a recombinant 
immunotoxin. To construct the recombinant PE immunotoxin, the variable 
portions of the heavy and light chains of anti-Tac could be 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 an anti-Tac(dsFv)-
PE38 or anti-Tac(scFv)-PE38 immunotoxin.
    The technology is also directed to an anti-Tac(dsFv)-PE38 and anti-
Tac(scFv)-PE38 immunotoxin for: (1) the prevention of Graft-versus Host 
Disease (``GVHD'') by purging bone marrow of potentially recipient-
reactive donor T-cells, (2) the treatment of Graft-versus Host Disease 
by i.v. administration, and (3) the treatment or prevention of 
allograft rejection.
    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 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 404.7.
    Applications for a license [i.e., completed Application for License 
to Public Health Service Inventions] in the field of use of the anti-
Tac(dsFv)-PE38 and/or anti-Tac(scFv)-PE38 immunotoxin and the relevant 
Patent Applications for the therapeutic treatment of refractory 
Leukemia, Lymphoma, Hairy Cell Leukemia, Hodgkin's disease and other 
hematologic malignancies and for the treatment of Graft-versus-Host 
Disease and Allograft Rejection 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. 552.


[[Page 30350]]


    Dated: May 26, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 99-14243 Filed 6-4-99; 8:45 am]
BILLING CODE 4140-01-M