[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]]
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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.
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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