[Federal Register Volume 68, Number 44 (Thursday, March 6, 2003)]
[Notices]
[Pages 10744-10745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5210]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Protein 
Biopharmaceuticals for Treatment of HIV Infections

AGENCY: National Institutes of Health, Public Health Service, DHHS.

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 
an exclusive license to practice the invention embodied in United 
States Patent Application 60/339,751 filed December 17, 2001 and its 
foreign equivalents, entitled ``GP41 Inhibitor,'' to Virosys 
Pharmaceuticals, Inc., having a place of business in Redwood Shores, 
CA. The patent rights in this invention 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 May 5, 
2003 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: Susan Ano, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; E-mail: [email protected]; Telephone: (301) 
435-5515; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: This invention relates to a chimeric 
molecule, NCCG-gp41, in which the internal trimeric helical coiled-coil 
of the ectodomain of gp41 is fully exposed and stabilized by both 
fusion to a minimal ectodomain core of gp41 and by engineered 
intersubunit disulfide bonds. NCCG-gp41 inhibits HIV envelope mediated 
cell fusion at nanomolar concentrations with an IC50 of 16 nM. It is 
proposed that NCCG-gp41 targets the exposed C-terminal region of the 
gp41 ectodomain in its pre-hairpin intermediate state, thereby 
preventing the formation of the fusogenic form of the gp41 ectodomain 
that comprises a highly stable trimer of hairpins arranged in a six-
helix bundle. NCCG-gp41 has potential as (a) An HIV therapeutic agent 
that inhibits cell entry; (b) as an AIDS vaccine and; (c) as a 
component of a high throughput screening assay for small molecule 
inhibitors of HIV envelope mediated cell fusion. Antibodies have been 
raised against NCCG-gp41 that inhibit HIV envelope mediated cell 
fusion.
    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 404.7. 
The prospective 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 development of protein

[[Page 10745]]

biopharmaceuticals for the treatment of HIV infections.
    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: February 25, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer.
[FR Doc. 03-5210 Filed 3-5-03; 8:45 am]
BILLING CODE 4140-01-P