[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Page 36828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15655]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive License Agreement: Development 
of Bispecific and Multi-Specific Fusion Proteins for the Treatment of 
ROR1 Expressing Human Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 an exclusive license 
agreement to practice the inventions embodied in US Provisional 
Application No. 61/418,550 entitled, ``Chimeric rabbit/human ROR1 
antibodies'' filed December 1, 2010 [HHS Ref. E-039-2011/0-US-01]; PCT 
Application No. PCT/US2011/062670 entitled, ``Chimeric rabbit/human 
ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-PCT-
02]; Australian Patent Application No. 2011336650 entitled, ``Chimeric 
rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-
2011/0-AU-03]; Canadian Patent Application No. 2818992 entitled, 
``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS 
Ref. E-039-2011/0-CA-04]; European Patent Application No. 11791733.6 
entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 
2011 [HHS Ref. E-039-2011/0-EP-05]; and U.S. Patent Application No. 13/
990,977 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed May 
31, 2013 [HHS Ref. E-039-2011/0-US-06] and all related continuing and 
foreign patents/patent applications for the technology family to 
Emergent BioSolutions. 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 use of the Licensed Patent 
Rights to develop, make, have made, sell, have sold, import and export 
bi-specific and multi-specific fusion proteins that are capable of 
eliciting redirected T-cell cytotoxicity for the treatment of human 
receptor tyrosine kinase-like orphan receptor 1 (ROR1) expressing 
cancers, wherein said fusion proteins comprise one or more single-chain 
variable fragment (scFv) ROR1 binding domains from the anti-ROR1 
antibodies designated as R11 or R12, one or more of Licensee's 
proprietary scFv CD3 binding domains, and optionally a fragment 
crystallizable (Fc) domain.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before July 
27, 2015 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: Tyrosine kinase-like orphan receptor 1 
(ROR1) is a signature cell surface antigen for B-cell malignancies, 
most notably, B-cell chronic lymphocytic leukemia (B-CLL) and mantle 
cell lymphoma (MCL) cells, two incurable diseases. The investigators 
have developed a portfolio of chimeric anti-ROR1 monoclonal antibodies 
that selectively target ROR1 malignant B-cells but not normal B-cells. 
These antibodies may be linked to chemical drugs or biological toxins 
thus providing targeted cytotoxic delivery to malignant B-cells while 
sparing normal cells. Moreover, as these antibodies selectively target 
ROR1, they can also be used to diagnose B-cell malignancies.
    The prospective exclusive license will comply with the terms and 
conditions of 35 U.S.C. 209 and 37 CFR part 404. The exclusive license 
may be granted unless within thirty (30) 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 part 404.
    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: June 22, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-15655 Filed 6-25-15; 8:45 am]
 BILLING CODE 4140-01-P