[Federal Register Volume 71, Number 107 (Monday, June 5, 2006)]
[Notices]
[Pages 32364-32365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8680]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Co-Exclusive License: Human Monoclonal 
Antibody, Their Fragments and Derivatives as Biotherapeutics for the 
Treatment of HIV Infections

AGENCY: National Institutes of Health, Public Health Service, 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 (NIH), 
Department of Health and Human Services, is contemplating the grant of 
a co-exclusive license to practice the inventions embodied in:
    1. U.S. Provisional Patent Application Serial No. S/N 60/378,406, 
PCT/US03/14905, NIH (DHHS) Ref. No. E-144-2002/1-PCT-02 converted into 
03733940.5 (E-144-2002/1-EP-04) filed in Europe on November 25, 2004, 
and 2003239356 (E-144-2002/1-AU-05) filed in Australia October 29, 
2004, 10/512,966 (E-144-2002/1-US-03) filed in USA October 28, 2004, as 
well as 2485120 (E-144-2002/1-CA-06) filed in Canada May 6, 2003, 
entitled: ``Identification of Novel Broadly Cross-Reactive Neutralizing 
Human

[[Page 32365]]

Monoclonal Antibodies''. Inventor(s): Dimiter S. Dimitrov (NCI) and 
Mei-Yun Zhang (SAIC).
    2. U.S. Patent Application, S/N 60/506,946 (E-316-2003/0-US-01), 
PCT/US2004/31878 (E-316-2003/0-PCT-02) entered the national stage 
filing on March 29, 2006 in USA (E-316-2003/0-US-03), in Canada (E-316-
2003/0-CA-04), in Europe (E-316-2003/0-EP-05), and in Australia (E-316-
2003/0-AU-06), entitled: ``Immunoglobulins With Potent and Broad 
Antiviral Activity''. Inventor(s): Dimiter S. Dimitrov (NCI) and Mei-
Yun Zhang (SAIC) to Virosys Pharmaceuticals Inc. (hereafter Virosys) 
having a place of business in Los Altos Hills, California, and 
Profectus Biosciences, Inc. (hereafter Profectus) having a place of 
business in Baltimore, Maryland. The patent rights in these inventions 
have been assigned to the United States of America.

DATES: Only written comments and/or application for a license, which 
are received by the NIH Office of Technology Transfer on or before 
August 4, 2006 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Sally Hu, Ph.D., M.B.A., Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; E-mail: [email protected]; Telephone: 
(301) 435-5606; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: The first invention (E-144-2002/1-PCT-02) 
describes two single chain fragment variable (scFv) clones, designated 
M6 and M9 that were selected from phage-displayed X5 scFv mutants 
library by panning the library against gp12089.6/IIIB-CD4 
complex using the alternating antigen panning strategy (AAP). M6 and M9 
are stable and have significant improved binding activities to 
gp120IIIB. Both scFvs inhibit more efficiently membrane 
fusion of HIV mediated by envelop glycoproteins of primary HIV isolates 
with a broader spectrum compared to other antibodies such as X5, 
indicating that the scFv form may be a more proper form compared to the 
Fab form for HIV-1 neutralizing antibodies to inhibit virus infection 
and transmission. Furthermore, scFv is a single molecule almost half 
the size of Fab, which makes it more suitable for constructing bivalent 
and multivalent antibodies and antibody fusion proteins. M6 and M9 are 
cross-reactive with HIV-1 isolates so that these antibodies could be 
directly used for therapy of HIV-1 infected individuals. In addition, 
these antibodies can also be used for screening of peptide phage 
display libraries, libraries of Envs, and in general as tools for 
development of HIV vaccines and therapeutics.
    The second invention (E-316-2003) describes methods of inhibiting 
viral infection, such as HIV-1, by administering a fusion protein 
comprising a small size, single chain Fv (scFv) antibody-binding domain 
joined to an Fc region by a long flexible linker. In particular, scFv 
M6 or M9, and their complex with two-domain soluble CD4 are joined to 
Fc by a long flexible linker to provide a new agent for the inhibition 
of HIV infection or immunotherapy of HIV-infected individuals. The Fc 
region provides stability, long half-life, and biological effector 
functions. The scFv-Fc fragment provides antigen recognition and 
neutralizing activity. The small size of the scFv-Fc fusion molecule 
provides easy access to conserved viral epitopes exposed before or 
during viral entry. In addition, these fusion molecules exhibit 
neutralization activity that is higher than that of whole IgGs, and 
comparable to or better than that of scFv. Thus, this invention may 
offer a novel approach to treat and prevent HIV-1 infection and/or 
AIDS, is related to invention E-144-2002/1, and may strengthen the 
company's portfolio of technologies being developed.
    The prospective co-exclusive license will be royalty bearing and 
will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 
404.7. The prospective co-exclusive license may be granted unless, 
within 60 days from the date of this published Notice, 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.
    The field of use may be limited to the development of human 
monoclonal antibodies for use as a therapeutic or preventative in HIV 
infection either alone or in combination with other compounds.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response 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: May 26, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
 [FR Doc. E6-8680 Filed 6-2-06; 8:45 am]
BILLING CODE 4140-01-P