[Federal Register Volume 80, Number 3 (Tuesday, January 6, 2015)]
[Notices]
[Page 510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30878]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Her2 Monoclonal 
Antibodies, Antibody Drug Conjugates, and Site Specific Antibody 
Conjugate Methods for the Treatment of Cancer

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 an exclusive patent 
license to HUIYU Pharmaceuticals Co, Ltd located in Neijiang City, 
CHINA to practice the inventions embodied in U.S. Provisional Patent 
Application 61/833,732, filed June 11, 2013 entitled ``Her2-Specific 
Monoclonal Antibodies and Conjugates Thereof'' [HHS Ref. No.: E-351-
2013/0-US-01], and International Application PCT/US2014/041492, filed 
June 9, 2014 entitled ``Her2-Specific Monoclonal Antibodies and 
Conjugates Thereof'' [HHS Ref. No.: E-351-2013/0-PCT-02], any PCT, US 
or foreign applications claiming the benefit of. 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 limited to 
China, and the field of use may be limited to:

    The use of the m860 monoclonal antibodies as mono-specific 
antibodies; or targeting moieties for immunoconjugates, wherein the 
antibodies are conjugated to auristatin F and analogues thereof, for 
the treatment of HER2 positive cancers.


DATES: Only written comments or applications for a license (or both) 
which are received by the NIH Office of Technology Transfer on or 
before February 5, 2015 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Eggerton Campbell, Ph.D. Licensing and 
Patenting Manager, Cancer Branch, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-5282; Facsimile: (301) 
435-4013; Email: [email protected].

SUPPLEMENTARY INFORMATION: These inventions concern Antibody Drug 
Conjugates (ADCs). ADCs can demonstrate high efficacy as cancer 
therapeutics, however, much more can be done to improve their efficacy 
and safety profile. Site-specific antibody drug conjugation is a 
promising way to do this.
    The scientists at the NIH have identified a fully human monoclonal 
antibody, m860, that binds to cell surface-associated Her2 with 
affinity comparable to that of Trastuzumab (Herceptin) but to a 
different epitope. In addition, the scientist developed a site-specific 
glycan engineering method to conjugate the antibody to the small 
molecule drug auristatin F. The ADC prepared though this site-specific 
approach shows very good stability, cell surface binding activity and 
also potent specific cell killing activity against Her2 positive cancer 
cells, including Trastuzumab resistant breast cancer cells. This ADC 
has the potential to be developed as a targeted therapeutic for Her2-
overexpressing cancers.
    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 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 thirty (30) days from the date of 
this published notice.
    Applications for a license in the field of use that are 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 30, 2014.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2014-30878 Filed 1-5-15; 8:45 am]
BILLING CODE 4140-01-P