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

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National Institutes of Health, Public Health Service, HHS.




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 inventions embodied in:

1. U.S. Provisional Patent Application S/N 60/329,709 (E-130-2001/0-US-01). PCT/US02/33165 was filed on October 16, 2002 (E-130-2001/0-PCT-01) and converted into 02773789.9 (E-130-2001/0-EP-03) filed in Europe on May 12, 2004, 2002337885 (E-130-2001/0-AU-02) filed in Australia on March 29, 2004, 10/492,729 (E-130-2001/0-US-05) filed in the U.S. on April 15, 2004, divisional application 11/748,992 (E-130-2001/0-US-07) filed in the U.S. on May 15, 2007, and 2,463,931(E-130-2001/0-CA-04) filed in Canada on April 15, 2004; entitled “Broadly Cross-Reactive Neutralizing Antibodies Against Human Immunodeficiency Virus Selected By Env-CD4-Co-Receptor Complex.” Inventor(s): Dimiter S. Dimitrov (NCI), Maxime Moulard (EM), Xiadong Xiao (NCI), Yuuei Shu (NCI), Sanjay K. Phogat (IAVI), Mei-Yun Zhang (NCI), and Dennis Burton (Scripps Inst.)

2. U.S. Provisional Patent Application S/N 60/623,394 (E-251-2004/0-US-01). PCT/US2005/39175 (E-251-2004/0-PCT-02) filed on October 28, 2005 and converted into 2,585,574 (E-251-2004/0-CA-04) filed in Canada on October 28, 2005, 05819487.9 (E-251-2004/0-EP-05) filed in Europe on April 27, 2007, 2005302416 (E-251-2004/0-AU-06) filed in Australia on October 28, 2005, and 11/718,202 (E-251-2004/0-US-03) filed in the U.S. on August 10, 2007; entitled “Novel Broadly Cross-Reactive HIV Neutralizing Human Monoclonal Antibodies Selected From Phage Display Libraries Using Novel Strategy Based On Competitive Antigen Panning.” Inventor(s): Dimiter S. Dimitrov (NCI) and Mei-Yun Zhang (SAIC) to 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.


Only written comments and/or application for a license, which are received by the NIH Office of Technology Transfer on or before March 25, 2008 will be considered.


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:; Telephone: (301) 435-5606; Facsimile: (301) 402-0220.

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The first invention (E-130-2001/0) provides a Start Printed Page 4596novel anti-HIV human monoclonal antibody named X5. This antibody demonstrates promise over conventional anti-HIV antibodies because the X5 antibody exhibits a unique binding activity compared to its counterparts. It has been established that the initial stage of HIV-1 entry into cells is mediated by a complex between the viral envelope glycoprotein (Env) such as gp120-gp41, a receptor CD4 and a co-receptor CCR5. The X5 antibody binds to an epitope on gp120 that is induced by interaction between gp120 and the receptor CD4 and enhanced by the co-receptor CCR5. The X5 antibody also shows strong activity at very low levels (in the range from 0.0001—0.1 Mg/ml concentration based on the particular isolate). Because it is a human antibody, it can be administered directly into patients so that it is an ideal candidate for clinical trials. It also can be easily produced because it was obtained by screening of phage display libraries and its sequence is known. Finally, since it has neutralized all virus envelope glycoproteins, including those from primary isolates of different clades, the epitope is highly conserved and resistance is unlikely to develop. Therefore, this antibody and/or its derivatives including fusion proteins with CD4 are good candidates for clinical development.

The second invention (E-251-2004/0) provides for pharmaceutical compositions of, and methods of using potent cross-reactive human monoclonal antibodies to HIV. Specifically, the invention describes a competitive antigen panning (CAP) method of isolating antibodies that bind to the gp41 subunit of the HIV-1 envelope glycoprotein. Additionally, the invention includes compositions of the aforementioned antibodies and the epitopes recognized by the antibodies. Methods of using the invention in the development of vaccine immunogens for the treatment and prevention of HIV, as well as the detection of HIV in a mammal are also described. The invention has significant implications in the development of HIV inhibitors, vaccines, and research tools for understanding mechanisms of HIV entry. Further development of the disclosed invention may yield novel therapies and methods in the prevention of mother-to-child transmission of HIV, treatment of accidental exposure to HIV, and chronic infection in patients with resistance to current therapies.

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 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.

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Dated: January 16, 2008.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. E8-1258 Filed 1-24-08; 8:45 am]