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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. 

## Molecules for Studying Cellular Immune Responses to Vaccines and Therapeutics 

*Description of Technology:*                     HLA molecules are indispensable and invaluable tools for efficient vaccine research and development. Infectious diseases are the second leading cause of death among adults and the most prominent cause of death in infants and children worldwide. Thus, rapid availability of prophylactic vaccines for cancers and infectious diseases such as HIV, HPV, influenza and diarrheal and respiratory diseases is a world-wide health concern.                 

Available for licensing is a large variety of cell lines, each expressing a particular HLA molecule and the plasmids encoding them, including soluble HLAs. This technology has broad application for development of vaccines and immunotherapeutics. HLA molecules can be used to characterize HLA-peptide binding and elucidate the process of both antigen and tumor cell peptide-processing and presentation. In addition to wild-type HLA molecules, available for licensing are HLAs containing point-mutations in the peptide binding regions. The mutated HLAs can be used to evaluate key peptide interactions. Additionally, soluble HLA molecules are useful for elucidating the structural details of HLAs and HLA-peptide complexes through crystallographic studies, which can be used to aid in vaccine design. Thus, the present technology has the potential to lend insight into immune recognition and identification of immunogenic epitopes for the systematic design of peptide and protein subunit vaccines for cancers and infectious diseases. Furthermore, this technology has application in the development of therapies for autoimmune and related immunological diseases, including those associated with organ transplantation. 

*Applications:*                     (1) Identification/Quantification of T cell responses to specific antigens including vaccine antigens; (2) Identification of T cell                           ( print page 51838)                        responses in patients with autoimmune diseases; (3) Development of vaccines candidates for cancer and infectious diseases; (4) Organ transplant diagnostics and immunotherapeutics.                 

*Inventors:*                     William Biddison, Richard Turner, Susan Gagnon (NINDS).                 

*Relevant Publications:*

1. TK Baxter, SJ Gagnon, RL Davis-Harrison, JC Beck, AK Binz, RV Turner, WE Biddison. Strategic mutations in the class I major histocompatibility complex HLA-A2 independently affect both peptide binding and T cell receptor recognition. J. Biol. Chem. 2004 Jul 9; 279(28):29175-29184. 

2. BM Baker, RV Turner, SJ Gagnon, DC Wiley, WE Biddison. Identification of a crucial energetic footprint on the alpha1 helix of human histocompatibility leukocyte antigen (HLA)-A2 that provides functional interactions for recognition by tax peptide/HLA-A2-specific T cell receptors. J. Exp. Med. 2001 Mar 5; 193(5):551-562. 

*Patent Status:*                     HHS Reference Nos. E-251-2006/0 and E-251-2006/1—Biological Materials.                 

*Licensing Status:*                     Available for licensing through Biological Materials License Agreements.                 

*Licensing Contact:*                     Susan Ano, Ph.D.; 301/435-5515;                     *anos@mail.nih.gov.*

## Neutralizing Monoclonal Antibodies to Botulinum Neurotoxin A 

*Description of Technology:*                     Available for licensing from the NIH are two chimpanzee-derived monoclonal antibodies (mAbs) against botulinum neurotoxin type A (BoNT/A). These mAbs can be developed for prevention, therapy, or diagnosis of BoNT/A. Use of this technology represents a significant improvement over the existing therapy of supportive care and treatment with equine antitoxin polyclonal antibodies.                 

*Potential Applications of Technology:*                     (1) Emergency prophylaxis against BoNT/A outbreak (natural or biodefense-related); (2) Therapeutic against BoNT/A; (3) Rapid Diagnosis of BoNT/A; (4) Therapeutic against overdosage of BoNT/A as used in clinical treatments.                 

*Advantages of Existing Therapies:*                     (1) No anticipated side effects compared to currently utilized equine antitoxin polyclonal antibodies; (2) Monoclonal instead of polyclonal.                 

*Inventors:*                     Robert H. Purcell et al. (NIAID).                 

*Patent Status:*                     HHS Reference No. E-180-2006/0—Research Tool.                 

*Licensing Status:*                     Available for non-exclusive licensing.                 

*Licensing Contact:*                     Susan Ano, Ph.D.; 301/435-5515;                     *anos@mail.nih.gov.*

Dated: August 25, 2006.

Steven M. Ferguson,

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

[FR Doc. 06-7331 Filed 8-30-06; 8:45 am]

BILLING CODE 4140-01-P