04-14750. Government-Owned Inventions; Availability for Licensing: SARS-Related Technologies

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

SARS Coronavirus MVA Vaccines and Therapy

Bernard Moss (NIAID).

U.S. Provisional Application No. 60/558,995 filed 05 Apr 2004 (DHHS Reference No. E-165-2004/0-US-01).

Licensing Contact: Michael Shmilovich; 301/435-5019; [e-mail].

Intranasal or intramuscular inoculations of BALB/c mice with modified vaccinia Ankara (MVA) vector encoding SARS-CoV Spike protein produced serum antibodies that recognized SARS S in ELISA and elicited protective immunity as shown by reduced titers of SARS-CoV in the upper and lower respiratory tracts of mice following challenge. Passive transfer of serum from mice immunized with MVA/S to naive mice also reduced the replication of SARS-CoV in the respiratory tract following challenge, demonstrating the role of antibody to S in protection.

Enhanced Sensitivity ELISA for SARS Diagnostic

Gary J. Nabel et al. (NIAID).

U.S. Provisional Application No. 60/503,508 filed 15 Sep 2003 (DHHS Reference No. E-334-2003/0-US-01).

U.S. Provisional Application No. 60/550,317 filed 08 Mar 2004 (DHHS Reference No. E-334-2003/1-US-01).

Licensing Contact: Michael Shmilovich; 301/435-5019; [e-mail].

Reagents and protocols for extremely sensitive ELISA for use as a SARS diagnostic are described. The ELISA uses recombinant-expressed nucleoprotein (N) or spike (S) glycoprotein from the SARS coronavirus as capture antigens. As little as five (5) days after onset, detection of antibody response is possible. The ELISA described herein is more sensitive than existing technology because of the N and S proteins; existing ELISAs use formalin-inactivated whole virus or peptides.

E-334-2003/1-US-01 also describes DNA Vaccines (CMV/R-SARS-S plasmid) including a nucleic acid encoding the peptide of SARS Spike glycoprotein, the RSV enhancer, the mouse ubiquitin enhancer (mUBB), and the CMV enhancer (Xu et al. 1998 Nature Med. 4: 37-42). Optionally the HTLV-1 R region (Takebe et al. 1988 Mol Cell Biol 8: 466-472) is also included.

Interferon-Alpha SARS Treatment

Kathryn C. Zoon, Renqui Hu, Joseph B. Bekisz (NCI).

U.S. Provisional Application filed 30 Apr 2004 (DHHS Reference No. E-278-2003/0-US-01).

Licensing Contact: Michael Shmilovich; 301/435-5019; [e-mail].

The Public Health Service seeks a licensee to commercialize protein engineered human interferon alphas for treating and/or preventing a SARS-associated coronaviral infection in humans and other relevant mammalian species.

Soluble SARS Coronavirus Spike Protein (S Protein)

Dimiter S. Dimitrov, Xiadong Xiao (NCI).

U.S. Provisional Application No. 60/489,166 filed 21 Jul 2003 (DHHS Reference No. E-228-2003/0-US-01).

Licensing Contact: Michael Shmilovich; 301/435-5019; [e-mail].

The SARS coronavirus is etiologically linked to severe acute respiratory syndrome. Soluble forms of the SARS coronavirus spike protein have been cloned, expressed and characterized, and are available for licensing for use as research reagents, in the development of vaccines and inhibitors of the viral infection, for selection of monoclonal antibodies, and development of kits containing antibodies that bind to the spike protein. The filed patent application additionally claims the associated spike protein polypeptides, peptide fragments, and conserved variants thereof; nucleic acid segments and constructs that encode the spike protein, polypeptides and peptide fragments of the spike protein, and conserved variants thereof and coupled proteins that include the spike protein or a portion thereof and peptidomimetics.

Dated: June 20, 2004.

Steven M. Ferguson,

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