[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Notices]
[Page 77517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30259]



[[Page 77517]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive Commercialization 
License: 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 and 37 CFR 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of a start-up exclusive 
commercialization 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 No. 13/990,977 
entitled, ``Chimeric Rabbit/Human ROR1 Antibodies'' filed June 7, 2013 
[HHS Ref. No. E-039-2011/0], 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 any PCT, US or foreign applications 
claiming benefit of the technology families, to Magnifygen, Inc. The 
patent rights in these inventions have been assigned to the Government 
of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the development and use of 
immunotoxins comprising an anti-tyrosine kinase-like orphan receptor 1 
monoclonal antibody designated as 2A2, R11, R12, or Y31 and Pseudomonas 
exotoxin A for the treatment of human cancers as claimed within the 
scope of the Licensed Patent Rights. For avoidance of doubt, the 
Licensed Field of Use excludes the development of antibody-drug 
conjugates and bispecific antibodies comprising said antibodies.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
January 8, 2015 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments, and other materials relating to the contemplated exclusive 
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-ROR1immunotoxin 
comprising an anti-ROR1antibody designated as 2A2, R11, R12 or Y31 and 
Pseuodomonas Exotoxin A (PE) as 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 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 start-up exclusive commercialization license is 
being considered under the small business initiative launched on 
October 1, 2011 and will comply with the terms and conditions of 35 
U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may 
be granted unless 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 part 404 within fifteen 
(15) days from the date of this published notice.
    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 
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: December 19, 2014.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2014-30259 Filed 12-23-14; 8:45 am]
BILLING CODE 4140-01-P