[Federal Register Volume 64, Number 3 (Wednesday, January 6, 1999)]
[Notices]
[Pages 903-904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-240]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing:
Therapeutic Respiratory Syncytial Virus Monoclonal Antibodies
AGENCY: National Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
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SUMMARY: Respiratory Syncytial Virus (RSV) is the major cause of
serious viral lower respiratory tract illness in infants and children
worldwide. Research at the National Institutes of Health (NIH) has
resulted in the discovery of several different anti-RSV monoclonal
antibody (MAb) technologies important for the treatment of this
disease. Used separately or in combination, these technologies could
provide the basis for the commercial development of a new anti-RSV
therapeutic. The therapeutic technologies available for licensing
consist of a patented human MAb against RSV, a unpatented panel of
murine MAbs against RSV and patent applications relating to methods of
treating RSV infection utilizing more than one antibody. The human and
murine MAbs bind the F glycoprotein of RSV at different nonoverlapping
epitopes. A product combining the human MAb with a humanized version of
a least one of the murine antibodies may provide an improvement to
current single MAb therapies by reducing the likelihood of the
formation of RSB escape mutants.
ADDRESSES: Questions about these licensing opportunities, copies of the
patent and/or patent applications should be addressed to Peter Soukas,
J.D., Technology Licensing Specialist, Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, Maryland 20852-3804; Telephone: 301/496-7735 ext. 268; Fax:
301/402-0220; E-mail: ps193c@nih.gov. A signed Confidential Disclosure
Agreement will be required to receive copies of the patent application.
SUPPLEMENTARY INFORMATION: 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 USC 207 and 37 CFR Part 404 to achieve
expeditious commercialization of results of federally-funded research
and development. Foreign patented applications are filed on selected
inventions to extend market coverage for companies and may also be
available for licensing.
[[Page 904]]
Human Neutralizing Monoclonal Antibodies to Respiratory Syncytial
Virus and Human Neutralizing Antibodies to Respiratory Syncytial
Virus
Inventors: Robert Chanock, Dennis Burton, Carlos Barbas III, Brian
Murphy, and James Crowe Jr.
Serial Number 08/162,102 filed 10 Dec 93 (with priority to 16 Sep
92) which issued as U.S. Patent Number 5,762,905 on 09 Jun 98 and
Serial Number 08/920,100 filed 26 Aug 97 (divisional of 08/162,102)
This invention is a human monoclonal antibody fragment (Fab)
discovered utilizing phage display technology. It is described in Crowe
et al., P.N.A.S. 91:1386-1390 (1994) and Barbas et al., P.N.A.S.
89:10164-10168 (1992). 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. The invention has been foreign
filed as PCT/US93/08786.
Murine Monoclonal Antibodies Effective To Treat Respiratory
Syncytial Virus
Inventors: Robert Chanock, Brian Murphy, Judy Beeler, and Kathleen
van Wyke Coelingh
Available for licensing through a Biological Materials License
Agreement are the murine MAbs described in Beeler, J. A. et al.
``Neutralization Epitopes of the F Glycoprotein of Respiratory
Syncytial Virus: Effect of Mutation Upon Fusion function,'' J. Virology
63:2941-2950 (1989). The MAbs that are available for licensing are the
following: 1129, 1153, 1142, 1200, 1214, 1237, 1121, 1112, 1269, and
1243. One of these MAbs, 1129, is the basis for a humanized murine MAb
(see U.S. Patent Number 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 patent
5,762,905 (see above for description).
Immunotherapeutic Method of Preventing or Treating Viral
Respiratory Tract Disease
Inventors: Robert Chanock, Gregory Prince, James Young, Brian
Murphy, Val Hemming, Judy Beeler, Kathleen Coelingh Serial Number 08/
479,797 filed 97 Jun 95 (CIP of combined applications 07/555,091 and
07/937,909)
Rather than the use of a single monoclonal antibody to treat lower
respiratory infections, this invention contemplates the use of a
mixture of neutralizing, prophylactic and therapeutic monoclonal
antibodies each directed to a specific epitope on the surface of a
major viral protein (for example, the F glycoprotein of RSV) to treat
infections. Utilizing a mixture of antibodies significantly lessens the
possibility of escape mutants. This invention discloses an improved
method of treating or preventing lower respiratory tract viral diseases
through the administration of multiple neutralizing and therapeutic
antibodies in a small particle aerosol. Prior to this invention, there
has not been a convenient method of administration. Previously, small
children and infants have only been able to use this therapy when
incubated and attached to a ventilator. An aerosol nebulizer is
utilized in this invention. Furthermore, a prophylactic, neutralizing,
and therapeutic combination of various antiviral agents is also
described.
Dated: December 28, 1998.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer.
[FR Doc. 99-240 Filed 1-5-99; 8:45 am]
BILLING CODE 4140-01-M
