[Federal Register Volume 73, Number 17 (Friday, January 25, 2008)]
[Notices]
[Pages 4595-4596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1258]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

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

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 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.

DATES: 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.

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-130-2001/0) provides 
a

[[Page 4596]]

novel 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.

    Dated: January 16, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E8-1258 Filed 1-24-08; 8:45 am]
BILLING CODE 4140-01-P