[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Pages 44941-44942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18965]



[[Page 44941]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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: 301-496-7057; fax: 301-402-0220. 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: [email protected].
    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 (301) 451-2235 or 
[email protected] 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

[[Page 44942]]

    Licensing Status: Available for licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].
    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 [email protected] 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.
[FR Doc. 2011-18965 Filed 7-26-11; 8:45 am]
BILLING CODE 4140-01-P