[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