[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71625-71627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28558]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, 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. 209 and 37 CFR part 404 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.

FOR FURTHER INFORMATION CONTACT: 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.

Device for Vascular Dilation

    Description of Technology: The invention is an enhanced vascular 
dilator that eliminates the vascular injury caused by the size mismatch 
between vascular introducer sheaths and vascular dilators, as the two 
are advanced into a blood vessel. The invention provides a ``shoulder'' 
to match the diameter of the introducer sheath so that there is a 
smooth transition, without size mismatch, between the dilator and the 
introducer sheath. The invention allows the dilator to be withdrawn in 
segments from the introducer sheath. This is especially valuable to 
reduce vascular injury when using large-bore introducer sheaths for 
interventional procedures including transcatheter valves and 
endografts.
    Potential Commercial Applications:
     Caval access.
     Vascular access.
    Competitive Advantages: Non-perforating.
    Development Stage: Prototype.
    Inventors: Robert Lederman (NHLBI), Ozgur Kocaturk (NHLBI), Adam 
Greenbaum (Henry Ford Hospital).
    Intellectual Property: HHS Reference No. E-759-2013/0--US 
Provisional Patent Application 61/890,961 filed 15 October 2013.
    Licensing Contact: Michael Shmilovich; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Heart, Lung, and 
Blood Institute is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize interventional catheter-based procedures to 
reduce vascular injury. For collaboration opportunities, please contact 
Peg Koelble at [email protected].

Her2 Monoclonal Antibodies, Antibody Drug Conjugates, and Site Specific 
Antibody Conjugate Methods

    Description of Technology: Antibody drug conjugates (ADC) can 
demonstrate high efficacy as cancer therapeutics, however, much more 
can be done to improve their efficacy and safety profile. Site-specific 
antibody drug conjugation is a promising way to do this.
    The scientists at the NIH have identified a fully human monoclonal 
antibody, m860, that binds to cell surface-associated Her2 with 
affinity

[[Page 71626]]

comparable to that of Trastuzumab (Herceptin) but to a different 
epitope. In addition, the scientist developed a site-specific glycan 
engineering method to conjugate the antibody to the small molecule drug 
auristatin F. The ADC prepared though this site-specific approach shows 
very good stability, cell surface binding activity and also potent 
specific cell killing activity against Her2 positive cancer cells, 
including Trastuzumab resistant breast cancer cells. This ADC has the 
potential to be developed as a targeted therapeutic for Her2-
overexpressing cancers and this site-specific strategy could be readily 
applied to develop ADCs targeting other cancers that express cell 
surface markers or other disease targets.
    Potential Commercial Applications:
     Therapeutic for the treatment of Her2 positive cancers.
     Method for producing safer and more effective ADCs.
    Competitive Advantages:
     Could be used in combination with Trastuzumab or for 
patients who have developed resistance to Trastuzumab treatment, since 
this antibody targets a different epitope.
     Site specific conjugation provides better efficacy and 
less side effects than ADCs produced using traditional strategies.
     Can be readily applied to develop ADCs targeting other 
cancers that express cell surface markers or other disease targets, 
such as HIV.
    Development Stage:
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Dimiter S. Dimitrov (NCI), Zhu Zhongyu (NCI), Pradman K. 
Qasba (NCI), Boopathy Ramakrishnan (NCI).
    Intellectual Property: HHS Reference No. E-351-2013/0--US 
Provisional Application No. 61/833,732 filed 11 June 2013.
    Licensing Contact: Whitney A. Hastings; 301-451-7337; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate or commercialize 
monoclonal antibodies, ADCs, and methods. For collaboration 
opportunities, please contact John D. Hewes, Ph.D. at 
[email protected].

Non-invasive Early Stage Lung Cancer Diagnostic and Prognostic Assays

    Description of Technology: The present invention provides a unique 
non-invasive diagnostic to detect early stage lung cancer and predict 
patient survival through a simple assay utilizing urine samples. Urine 
samples minimize patient discomfort unlike current early detection 
methods that are highly invasive, such as a biopsy or bronchoscopy, or 
utilize expensive computer tomography (CT) scans that expose patients 
to harmful radiation. Although the sensitivity of low dose CT scans is 
high, the specificity is low, resulting in high false positive rates. 
Utilizing metabolic profiling of urine samples obtained from 1,005 
people, the scientists have developed and validated this unique 
metabolite profile that diagnoses early stage lung cancer and predicts 
patient survival with a high accuracy.
    Potential Commercial Applications:
     Diagnostic test for early stage lung cancer.
     Prognostic test for patient survival.
     Method to help physicians make informed treatment 
decisions.
    Competitive Advantages: Urinary patient samples--no need for 
needles, invasive surgery, or claustrophobic tests.
    Development Stage:
     Early-stage.
     In vivo data available (human).
    Inventors: Curtis Harris (NCI), Majda Haznadar (NCI), Frank 
Gonzalez (NCI), Ewy Mathe (NCI), Kristopher Krausz (NCI), Soumen Manna 
(NCI), and Andrew Patterson (Pennsylvania State University)
    Intellectual Property: HHS Reference No. E-121-2013/0--US Patent 
Application No. 61/845,055 filed 11 July 2013
    Related Technology: HHS Reference No. E-248-2002/0--US Patent 
Application No. 10/533,459 filed 02 May 2005; PCT Application No. PCT/
US2013/055746 filed 20 August 2013
    Licensing Contact: Jennifer Wong, M.S.; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Human Carcinogenesis, is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate or commercialize Non-invasive Urinary 
Biomarkers Highly Predictive of Non-small Cell Lung Cancer Status and 
Survival. For collaboration opportunities, please contact John D. 
Hewes, Ph.D. at [email protected].

Intravenous Water Soluble Formulation of MJC13--A Novel Lead Compound 
for the Treatment of Castrate-Resistant Prostate Cancer

    Description of Technology: Normal prostate growth and maintenance 
is dependent on androgens acting through the androgen receptor (AR). AR 
expression is maintained and plays an important role throughout 
prostate cancer progression. A lead molecule, MJC13, has been 
identified and has higher potency and better selectivity for AR than 
any other compound tested. It has been shown to effectively block AR-
dependent gene expression in cellular models of prostate cancer at 
micromolar concentrations.
    MJC13, although an attractive drug candidate, has low aqueous 
solubility. This has hindered the clinical development of MJC13. 
Scientists at NIH, University of Texas-El-Paso and Texas Southern 
University have developed a water soluble and stable MJC13 liquid 
dosage formulation that is suitable for intravenous administration. The 
solubility of this formulation has increased over 25,000 times compared 
to MJC13 itself. Additionally, a sensitive LC/MS/MS method to analyze 
MJC13 has also been developed, which can detect as little as 1 ng/mL of 
MJC13 in solution or plasma. These studies are of great importance for 
future pre-clinical and clinical studies of MJC13.
    Potential Commercial Applications: Develop MJC13 as a clinical drug 
product for the treatment of castrate-resistant prostate cancer (CRPC), 
in which current treatment options are ineffective.
    Competitive Advantages: Water soluble formulation of the lead 
compound, MJC13, that will enable further pharmacokinetic/
pharmacodynamic studies and clinical studies required for commercial 
development of the drug.
    Development Stage:
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Intellectual Property: HHS Reference No. E-065-2013/0--US 
Provisional Application No. 61/788,716 filed 15 March 2013.
    Related Technology: HHS Reference No. E-162-2009/0--US Patent 
Application No. 13/395,976 filed 14 March 2012.
    Licensing Contact: Eggerton Campbell, Ph.D.; 301-435-5282; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate or commercialize 
this technology with an initial goal of preclinical evaluation and an 
ultimate goal of clinical testing. For collaboration opportunities, 
please contact John D. Hewes, Ph.D. at [email protected].

[[Page 71627]]

Methods of Modulating Chemotherapeutic Cytotoxicity

    Description of Technology: Investigators at the National Cancer 
Institute (NCI) have discovered that blockade of the signalling 
activity of a single cell-surface receptor, CD47, in cancer cells 
results in enhanced sensitivity of cancer cells to chemotherapy 
treatment and in healthy tissues reduces damage to normal cells. Many 
chemotherapeutic agents cause significant cytotoxicity to non-cancer 
(``normal'') cells, resulting in undesirable side-effects and often 
limiting the dose and/or duration of chemotherapy that can be 
administered to a patient. The present invention relates to a method of 
using CD47-modulating compounds in combination with a chemotherapeutic 
agent to increase the efficacy of that agent against inhibiting tumor 
growth. The invention also relates to methods for preventing damage to 
heart tissue associated with the use of anthracycline chemotherapy. The 
current invention builds on the NIH's previous discoveries of 
antibodies, antisense morpholino oligonucleotides, and peptide 
compounds that modulate CD47.
    Potential Commercial Applications: Combination Chemotherapy 
Competitive Advantages:
     Enhance effectiveness of chemotherapeutic agents.
     Limit off target effects on normal tissue.
     Reduces cytotoxicity of normal cells.
     Provides cardioprotection for anthracyclines.
    Development Stage:
     Early-stage.
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: David D. Roberts and David R. Soto Pantoja (NCI).
    Publication: Soto-Pantoja DR, et al. CD47 deficiency confers cell 
and tissue radioprotection by activation of autophagy. Autophagy. 2012 
Nov;8(11):1628-42. [PMID 22874555]
    Intellectual Property: HHS Reference No. E-296-2011/0--US 
Application No. 61/779,587 filed 13 March 2013
    Related Technology: HHS Reference No. E-227-2006/5-
     US Application No. 12/444,364 filed 03 April 2009.
     CA Application No. 2,665,287 filed 05 October 2007.
     EP Application No. 07868382.8 filed 27 March 2009.
     US Application No. 13/546,941 filed 11 July 2012.
     US Application No. 13/546,931 filed 11 July 2012.
    Licensing Contact: Charlene Maddox, Ph.D.; 301-435-4689; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Pathology, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize CD47 targeting therapeutics, 
cardioprotection, autophagy modulation. For collaboration 
opportunities, please contact John D. Hewes, Ph.D. at 
[email protected].

    Dated: November 21, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-28558 Filed 11-27-13; 8:45 am]
BILLING CODE 4140-01-P