[Federal Register Volume 78, Number 68 (Tuesday, April 9, 2013)]
[Notices]
[Pages 21131-21132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08148]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of An Exclusive Evaluation Option License: Pre-
clinical Evaluation of Anti-tyrosine Kinase-like Orphan Receptor 1 
Immunotoxins for the Treatment of Human Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is 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 license to practice the inventions embodied in U.S. Patent 
Application 61/172,099 entitled ``Anti-human ROR1 Antibodies'' [HHS 
Ref. E-097-2009/0-US-01], U.S. Patent Application 60/703,798 entitled 
``Mutated Pseudomonas Exotoxins with Reduced Antigenicity'' [HHS Ref. 
E-262-2005/0-US-01], U.S. Patent Application 60/969,929 entitled 
``Deletions in Domain II of Pseudomonas Exotoxin A that Remove 
Immunogenic Epitopes with Affecting Cytotoxic Activity'' [HHS Ref. E-
292-2007/0-US-01], U.S. Patent Application 61/241,620 entitled 
``Improved Pseudomonas Exotoxin A with Reduced Immunogenicity'' [HHS 
Ref. E-269-2009/0-US-01], U.S. Patent Application 61/483,531 entitled 
``Recombinant Immunotoxin Targeting Mesothelin'' [HHS Ref. E-117-2011/
0-US-01], U.S. Patent Application 61/495,085 entitled ``Pseudomonas 
Exotoxin A with Less Immunogenic T-Cell/or B-Cell Epitopes'' [HHS Ref. 
E-174-2011/0-US-01], U.S. Patent Application 61/535,668 entitled 
``Pseudomonas Exotoxin A with Less Immunogenic B-Cell Epitopes'' [HHS 
Ref. E-263-2011/0-US-01], and all related continuing and foreign 
patents/patent applications for the technology family, to SPEED 
BioSystems, LLC. The patent rights in these inventions have been 
assigned to the Government of the United States of America.
    The prospective exclusive evaluation option license territory may 
be worldwide and the field of use may be limited to pre-clinical 
evaluation of lead therapeutic candidates for the development and use 
of anti-tyrosine kinase-like orphan receptor 1 (ROR1) targeted 
immunotoxins for the treatment of human ROR1 expressing cancers, 
wherein the immunotoxin comprises an anti-ROR1 antibody designated as 
2A2 and Pseudomonas exotoxin A (PE). Upon expiration or termination of 
the exclusive evaluation option license, SPEED will have the right to 
execute an exclusive patent commercialization license which will 
supersede and replace the exclusive evaluation option license with no 
broader territory than granted in the exclusive evaluation option 
license and the field of use will be commensurate with the commercial 
development plan at the time of conversion.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
April 24, 2013 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments, and other materials relating to the contemplated exclusive 
evaluation option license should be directed to: Jennifer Wong, M.S., 
Senior Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-4633; Facsimile: (301) 
402-0220; Email: [email protected].

SUPPLEMENTARY INFORMATION: This invention concerns anti-ROR1 
immunotoxin comprising an anti-ROR1 antibody designated as 2A2 and PE 
as a treatment for human ROR1 expressing cancers. The immunotoxin will 
comprise a chimeric mouse anti-human receptor tyrosine kinase-like 
orphan receptor 1 monoclonal antibody whereas the immunotoxin will have 
a toxin domain derived from PE. PE toxin's domain have been modified in

[[Page 21132]]

various ways in order to reduce the immunogenicity of the molecule to 
improve its therapeutic value while at the same time maintaining the 
toxin's ability to trigger cell death. The immunotoxin provides 
targeted cytotoxic delivery to cancer cells while sparing normal cells 
thereby resulting in therapies with fewer side effects.
    The prospective exclusive evaluation option license is being 
considered under the small business initiative launched on October 1, 
2011and will comply with the terms and conditions of 35 U.S.C. 209 and 
37 CFR 404.7. The prospective exclusive evaluation option license, and 
a subsequent exclusive patent commercialization license, may be granted 
unless within fifteen (15) days from the date of this published notice, 
the NIH receives written evidence and argument that establishes that 
the grant of the license would not be consistent with the requirements 
of 35 U.S.C. 209 and 37 CFR 404.7.
    Any additional, properly filed, and complete applications for a 
license in the field of use filed in response to this notice will be 
treated as objections to the grant of the contemplated exclusive 
evaluation option license. Comments and objections submitted to this 
notice will not be made available for public inspection and, to the 
extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: April 2, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-08148 Filed 4-8-13; 8:45 am]
BILLING CODE 4140-01-P