Notice (B): Government-Owned Inventions; Availability for Licensing

Federal Register: October 3, 2008 (Volume 73, Number 193)              
                  Page 57637-57638

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

ACTION: Notice.

SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Murine Monoclonal Antibodies Effective To Treat Respiratory Syncytial 
Virus

    Description of Technology: Available for licensing through a 
Biological Materials License Agreement are the murine MAbs described in 
Beeler et al, ``Neutralization epitopes of the F glycoprotein of 
respiratory syncytial virus: effect of mutation upon fusion function,'' 
J Virol. 1989 Jul;63(7):2941-

[[Page 57638]]

2950. The MAbs that are available for licensing are the following: 
1129, 1153, 1142, 1200, 1214, 1237, 1112, 1269, and 1243. One of these 
MAbs, 1129, is the basis for a humanized murine MAb (see U.S. Patent 
5,824,307 to humanized 1129 owned by MedImmune, Inc.), recently 
approved for marketing in the United States. MAbs in the panel reported 
by Beeler et al. have been shown to be effective therapeutically when 
administered into the lungs of cotton rats by small-particle aerosol. 
Among these MAbs several exhibited a high affinity (approximately 
10\9\M-1) for the RSV F glycoprotein and are directed at 
epitopes encompassing amino acid 262, 272, 275, 276 or 389. These 
epitopes are separate, nonoverlapping and distinct from the epitope 
recognized by the human Fab of U.S. Patent 5,762,905 owned by The 
Scripps Research Institute.
    Applications: Research and drug development for treatment of 
respiratory syncytial virus.
    Inventors: Robert M. Chanock, Brian R. Murphy, Judith A. Beeler, 
and Kathleen L. van Wyke Coelingh (NIAID).
    Patent Status: HHS Reference No. B-056-1994/1--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for non-exclusive licensing under a 
Biological Materials License Agreement.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.

Neutralizing Monoclonal Antibodies to Respiratory Syncytial Virus

    Description of Technology: Respiratory syncytial virus (RSV) is the 
most common cause of bronchiolitis and pneumonia among infants and 
children under 1 year of age. Illness begins most frequently with 
fever, runny nose, cough, and sometimes wheezing. During their first 
RSV infection, between 25% and 40% of infants and young children have 
signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% require 
hospitalization. Most children recover from illness in 8 to 15 days. 
The majority of children hospitalized for RSV infection are under 6 
months of age. RSV also causes repeated infections throughout life, 
usually associated with moderate-to-severe cold-like symptoms; however, 
severe lower respiratory tract disease may occur at any age, especially 
among the elderly or among those with compromised cardiac, pulmonary, 
or immune systems.
    This invention is a human monoclonal antibody fragment (Fab) 
discovered utilizing phage display technology. The neutralizing 
monoclonal antibody was isolated and its binding site was identified. 
Fab F2-5 is a broadly reactive fusion (F) protein-specific recombinant 
Fab generated by antigen selection from a random combinatorial library 
displayed on the surface of filamentous phage. In an in vitro plaque-
reduction test, the Fab RSVF2-5 neutralized the infectivity of a 
variety of field isolates representing viruses of both RSV subgroups A 
and B. The Fab recognized an antigenic determinant that differed from 
the only other human anti-F monoclonal antibody (RSV Fab 19) described 
thus far. A single dose of 4.0 mg of Fab RSVF2-5/kg of body weight 
administered by inhalation was sufficient to achieve a 2000-fold 
reduction in pulmonary virus titer in RSV-infected mice. The antigen-
binding domain of Fab RSVF2-5 offers promise as part of a prophylactic 
regimen for RSV infection in humans.
    Application: Respiratory Syncytial Virus prophylaxis/therapeutic.
    Development Stage: The antibodies have been synthesized and 
preclinical studies have been performed.
    Inventors: Brian Murphy (NIAID), Robert Chanock (NIAID), James 
Crowe (NIAID), et al.
    Publication: JE Crowe et al. Isolation of a second recombinant 
human respiratory syncytial virus monoclonal antibody fragment (Fab 
RSVF2-5) that exhibits therapeutic efficacy in vivo. J Infect Dis. 1998 
Apr;177(4):1073-1076.
    Patent Status: HHS Reference No. E-001-1996/0--U.S. and Foreign 
Rights Available.
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.

Human Neutralizing Monoclonal Antibodies to Respiratory Syncytial Virus 
and Human Neutralizing Antibodies to Respiratory Syncytial Virus

    Description of Technology: This invention is a human monoclonal 
antibody fragment (Fab) discovered utilizing phage display technology. 
It is described in Crowe et al. , Proc Natl Acad Sci USA. 1994 Feb 
15;91(4):1386-1390 and Barbas et al. , Proc Natl Acad Sci USA. 1992 Nov 
1;89(21):10164-10168. This MAb binds an epitope on the RSV F 
glycoprotein at amino acid 266 with an affinity of approximately 
10\9\M-1. This MAb neutralized each of 10 subgroup A and 9 
subgroup B RSV strains with high efficiency. It was effective in 
reducing the amount of RSV in lungs of RSV-infected cotton rats 24 
hours after treatment, and successive treatments caused an even greater 
reduction in the amount of RSV detected.
    Applications: Research and drug development for treatment of 
respiratory syncytial virus.
    Inventors: Robert M. Chanock (NIAID), Brian R. Murphy (NIAID), 
James E. Crowe Jr. (NIAID), et al.
    Patent Status: U.S. Patent 5,762,905 issued 09 Jun 1998 (HHS 
Reference No. E-032-1993/1-US-01); U.S. Patent 6,685,942 issued 03 Feb 
2004 (HHS Reference No. E-032-1993/1-US-02); U.S. Patent Application 
No. 10/768,952 filed 29 Jan 2004 (HHS Reference No. E-032-1993/1-US-
03).
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
soukasp@mail.nih.gov.

     Dated: September 26, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E8-23437 Filed 10-2-08; 8:45 am]

BILLING CODE 4140-01-P