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###### Department of Health and Human Services

###### National Institutes of Health 

# 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-                          ( print 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 109                    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 109                    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