2011-18965. Government-Owned Inventions; Availability for Licensing

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

Monoclonal Antibodies for Rare Diseases

Description of Technology: Available for licensing are three monoclonal antibodies (mAb) that bind with high specificity and affinity to the tumor cell surface antigen tyrosine kinase-like orphan receptor 1 (ROR1). ROR1 is expressed in chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), two incurable B-cell malignancies that are designated as rare diseases by NIH's Office of Rare Diseases Research. Therapeutics for rare diseases can qualify for orphan drug status and receive expedited review by the FDA. Currently, there are no therapeutic mAbs that target CLL or MCL but not healthy cells.

Investigators from the National Cancer Institute developed chimeric antibodies that selectively target ROR1 malignant B-cells but not normal B-cells. Additionally, this technology allows for mAb derivatives with potentially higher pharmacokinetic and/or pharmacodynamic activity, including humanized mAb in an IgG and IgM format, antibody-drug conjugates, immunotoxins, and bispecific antibodies. These three mAbs have been characterized in vitro for mediating antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, apoptosis, and internalization. Results show that these mAbs bind with high specificity and affinity to three different epitopes on human ROR1, and ROR1-expressing primary CLL cells from untreated CLL patients and MCL cell lines. Moreover, as these antibodies selectively target ROR1, they can also be used to diagnose B-cell malignancies.

Applications:

• Antibody treatments for B-CLL and MCL
• Diagnostics for B-CLL and MCL

Advantages:

• Therapeutics that can qualify for an orphan drug status by the FDA and receive expedited FDA review
• Antibodies that selectively target malignant B-cells and not healthy cells

Development Status: The technology is currently in the pre-clinical stage of development.

Market:

• Global orphan drugs market reached $58.7 billion in 2006 and it is expected to reach $81.8 billion by 2011
• Biologic drugs account for over 60% of the orphan drug market with sales of $35.3 billion in 2006 and it is projected to be worth $53.4 billion by 2011

Inventors: Christoph Rader and Jiahui Yang (NCI)

Relevant Publication: Yang J et al. Therapeutic potential and challenges of targeting receptor tyrosine kinase ROR1 with monoclonal antibodies in B-cell malignancies. PLoS ONE 2011;6(6):e21018. Epub 2011 Jun 15. [PMID: 21698301]

Patent Status: U.S. Provisional Application No. 61/418,550 filed December 1, 2010 (HHS Reference No. E-039-2011/0-US-01)

Licensing Status: Available for licensing.

Licensing Contact: Jennifer Wong; Phone No.: 301-435-4633; E-mail Address: [e-mail].

Collaborative Research Opportunity: The National Cancer Institute, Center for Cancer Research, Experimental Transplantation and Immunology Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize anti-ROR1 monoclonal antibodies and their derivatives. Please contact Dr. Christoph Rader at [phone] or [e-mail] for more information.

Oral Vaccine for Inducing Mucosal Immunity

Description of Technology: Available for licensing is a micro/nanoparticle oral vaccine delivery system that specifically targets the large intestine for vaccine deposition and in situ immune activation, with minimal perturbation in the upper part of the gastrointestinal (GI) tract.

Vaccine delivery to the large intestine has been experimentally demonstrated as an effective means for inducing mucosal immunity against infections transmitted through the recto-genital mucosal area such as sexually transmitted disease as well as fungal and parasitic infections. In this system, the vaccine components are encapsulated by nanometer-sized particles to allow optimal uptake once it reaches the lumen and makes contact with the intestinal mucosal surface. To protect from premature degradation and uptake in the upper GI, these particles are coated within micrometer-sized particles. This coating is designed with a pH- and time-dependent release profile that is optimized for vaccine uptake to occur within the large intestine. This particular feature may also make this technology a potential delivery system for recto-colon cancer therapies.

Applications:

• Vaccine delivery system for inducing mucosal immunity against a variety of infections transmitted through the recto-genital mucosal area
• Potential delivery system for recto-colon cancer therapeutics
• Potential delivery system for recto-colon immunotherapies or controlled drug release

Advantages:

• Oral delivery provides a more practical and less invasive means of vaccine delivery to the large intestine compared to intrarectal or intracolorectal routes
• Delivery system can be used against a variety of diseases transmitted through the recto-genital mucosa
• Proof of concept has been demonstrated in vivo.

Development Status:

• Early-stage
• Pre-clinical
• In vitro data available
• In vivo data available (animal)

Market: Global vaccine market is expected to be worth an estimated $23.8 billion by 2012

Inventors: Qing Zhu (NCI), Jay A. Berzofsky (NCI), James Talton (Nanotherapeutics Inc.)

Relevant Publication: Manuscript submitted, under review.

Patent Status: HHS Reference Number E-132-2009/0 —

• US Application No. 61/238,361 filed 31 Aug 2009
• PCT Application No. PCT/US2010/047338 filed 31 Aug 2010

Licensing Status: Available for licensing.

Licensing Contact: Jennifer Wong; 301-435-4633; [e-mail].

Collaborative Research Opportunity: The Center for Cancer Research, Vaccine Branch, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Oral Delivery of a Vaccine to the Large Intestine to Induce Mucosal Immunity. Please contact John Hewes, Ph.D. at 301-435-3121 or [e-mail] for more information.

Dated: July 21, 2011.

Richard U. Rodriguez,

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