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Notice

Prospective Grant of Exclusive License: Human Monoclonal Antibody Biotherapeutics for the Treatment of HIV Infections

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Information about this document as published in the Federal Register.

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AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

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 60/329,709 filed October 16, 2001 and its foreign equivalents, entitled “Novel Broadly Reactive HIV-Neutralizing Human Antibody Against Receptor-Induced Epitope on gp120,” 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 12, 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: Sally Hu, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Email: hus@od.nih.gov; Telephone: (301) 435-5606; Facsimile: (301) 402-0220.

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SUPPLEMENTARY INFORMATION:

This invention provides a novel anti human antibody named X5. The X5 antibody demonstrates promise over other conventional anti-HIV antibodies because this antibody presents a unique binding activity different than its counterparts. It has been established that the very initial stage of HIV-1 entry into cells is mediated by a complex between the virus envelope glycoprotein (Env) such as gp120-gp41, a receptor CD4 and a co-receptor CCR5. This X5 Start Printed Page 11574antibody binds to an epitope on gp120 that is induced by interaction between gp120 and the receptor CD4. The X5 antibody also shows strong activity at very low levels (μg/ml concentration). Because it is a human antibody, it can be administered directly into patients so that it is an ideal candidate for clinical trials. Finally, since it has neutralized all virus envelope glycoproteins that were tested against it, the epitope is very conserved and resistance is unlikely to develop. Therefore, this antibody and/or its derivatives are a good candidate for clinical development.

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 human monoclonal antibody biotherapeutics 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.

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Dated: February 27, 2003.

Steven M. Ferguson,

Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer.

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[FR Doc. 03-5690 Filed 3-10-03; 8:45 am]

BILLING CODE 4140-01-P