Government-Owned Inventions; Availability for Licensing, 35056-35057 [E7-12337]

Download as PDF 35056 Federal Register / Vol. 72, No. 122 / Tuesday, June 26, 2007 / Notices jlentini on PROD1PC65 with NOTICES Total Emission Detection System for Multi-Photon Microscopy Description of Technology: Available for licensing and commercial development is a novel two-photon microscope system, which would allow improved fluorescent light collection, the use of less excitation power and deeper penetration of tissue and isolated cells. Multi-photon fluorescence microscopy (MPFM) is an imaging technique that can investigate biological processes to sub-cellular resolution at depths of hundreds of microns below the surface of biological tissues. MPFM provides higher resolution imaging of tissues than confocal imaging, but is currently limited by the use of inefficient light collection systems, which lead to detection of only a fraction of the light that is emitted from the sample. The new system consists of an array of mirrors, lenses, and reflecting surfaces designed to collectively maximize the probability of collecting all emitted fluorescent light to a detector, thereby providing enhanced brightness of light detected from the sample and an increase in signal-tonoise ratio (SNR). This increase in SNR can be used to improve time resolution, reduce laser power requirements and reduce photodynamic damage. Applications: Three-dimensional imaging of biological tissues and cells; Three-dimensional imaging of semiconductor integrated circuits. Market: Optical Imaging. Development Status: Late-stage technology. Inventors: Christian A. Combs, Robert S. Balaban, Jay R. Knutson (NHLBI). Patent Status: U.S. Provisional Application No. 60/835,462 filed 04 Aug 2006 (HHS Reference No. E–257– 2005/0–US–01). Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: Chekesha S. Clingman, Ph.D.; 301–435–5018; clingmac@mail.nih.gov Collaborative Research Opportunity: The NHLBI Light Microscopy Core Facility is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize a total emission detection system for multi-photon imaging. Please contact Lili Portilla, Director of the NHLBI Office of Technology Transfer and Development at 301–402–5579 or via e-mail at LILIP@nih.gov for more information. VerDate Aug<31>2005 17:07 Jun 25, 2007 Jkt 211001 Dated: June 19, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7–12335 Filed 6–25–07; 8:45 am] inhibits Hsp90 that would target only client kinase proteins would be an ideal therapeutic agent for cancer treatment. The current invention is a short peptide that inhibits Hsp90 that prevents the recognition and function of client kinase proteins, and promotes the BILLING CODE 4140–01–P degradation of client kinase proteins, while not affecting other non-kinase DEPARTMENT OF HEALTH AND client proteins. HUMAN SERVICES Applications and Modality: Current applications include targeting client National Institutes of Health kinase proteins promoting degradation, and preventing recognition and function Government-Owned Inventions; of the client kinase proteins; restriction Availability for Licensing of Hsp90 inhibition to client kinases that utilize similar Hsp90 recognition AGENCY: National Institutes of Health, sequences to the oncogenic tyrosine Public Health Service, HHS. kinase Hsp90 client ErbB2; and having ACTION: Notice. kinase-specific chaperone inhibitors SUMMARY: The inventions listed below preferentially active as anti-cancer are owned by an agency of the U.S. agents compared to indiscriminate Government and are available for pharmacologic inhibitors of Hsp90. licensing in the U.S. in accordance with Market: 600,000 deaths from cancer 35 U.S.C. 207 to achieve expeditious related diseases were estimated in 2006; commercialization of results of In 2006, cancer drug sales were Federally-funded research and estimated to be $25 billion; There is a development. Foreign patent burgeoning drug market for Hsp90 applications are filed on selected inhibitors for cancer treatment. inventions to extend market coverage Development Status: The technology for companies and may also be available is currently in the preclinical stage of for licensing. development. ADDRESSES: Licensing information and Inventors: Leonard M. Neckers et al. copies of the U.S. patent applications (NCI). Patent Status: U.S. Provisional listed below may be obtained by writing Application No. 60/895,313 filed 16 Mar to the indicated licensing contact at the Office of Technology Transfer, National 2007 (HHS Reference No. E–121–2007/ 0–US–01); U.S. Provisional Application Institutes of Health, 6011 Executive No. 60/909,834 filed 03 Apr 2007 (HHS Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301– Reference No. E–121–2007/1–US–01). Licensing Status: Available for 496–7057; fax: 301–402–0220. A signed Confidential Disclosure Agreement will exclusive and non-exclusive licensing. Licensing Contact: Adaku be required to receive copies of the Nwachukwu, J.D.; 301–435–5560; patent applications. madua@mail.nih.gov. A Novel Discriminatory Small Peptide Collaborative Research Opportunity: Inhibitor of Hsp90 Targeting Oncogenic The NCI Urologic Oncology Branch is Kinases seeking statements of capability or Description of Technology: Heat shock interest from parties interested in protein 90 (Hsp90) is a molecular collaborative research to further chaperone required for stability and develop, evaluate, or commercialize function for many proteins (clients). peptide inhibitor of Hsp90. Please Presently, there are clinical trials contact John D. Hewes, Ph.D. at 301– focusing on small molecule Hsp90 435–3121 or hewesj@mail.nih.gov for inhibitors; however, pharmacologic more information. Hsp90 inhibition causes destabilization, A Novel Treatment for Non-Small Cell ubiquitination and proteasomeLung Cancer Using Mesothelindegradation of all client proteins Targeted Immunotoxins indiscriminately. Description of Technology: Hsp90 was found to be overexpressed Mesothelin is a glycoprotein, whose in tumor cells; thereby making Hsp90 a expression has been largely restricted to promising molecular target for cancer mesothelial cells in normal tissues, therapy. Additionally, some Hsp90dependent client proteins (non-kinases) although epithelial cells of the trachea, tonsil, fallopian tube, and kidney have were identified as putative tumor shown immunoreactivity. Mesothelin suppressors, suggesting that indiscriminate degradation of all Hsp90 has been shown to be expressed in several cancers including pancreatic client proteins is not ideal. Finding a carcinomas, gastric carcinomas and molecular inhibitor that discriminately PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\26JNN1.SGM 26JNN1 Federal Register / Vol. 72, No. 122 / Tuesday, June 26, 2007 / Notices jlentini on PROD1PC65 with NOTICES ovarian carcinomas, and has the potential of being used as a tumor marker and a novel target for the development of new treatments. The technology relates to the finding that some non-small cell lung cancers (NSCLC) express the antigen mesothelin. Targeting the tumors with antibodies or immunotoxins that specifically bind mesothelin can be a potential new treatment for non-small cell lung cancer. The SSIP immunotoxin and its variants that specifically bind to mesothelin can be used for the treatment of NSCLC. Applications and Modality: NSCLC can be treated by targeting mesothelin. Advantage: Anti-mesothelin antibodies and immunotoxins are already available and being tested for several cancers. Development Status: The technology is in pre-clinical stage of development. Inventors: Ira H. Pastan (NCI) et al. Patent Status: U.S. Provisional Application No. 60/891,923 filed 27 Feb 2007 (HHS Reference No. E–120–2007/ 0–US–01), entitled ‘‘Treatment of NonSmall Cell Lung Cancer with Mesothelin-Targeted Immunotoxins.’’ Licensing Status: Available for exclusive and non-exclusive licensing. Licensing Contact: Jesse S. Kindra, J.D.; 301–435–5559; kindraj@mail.nih.gov Collaborative Research Opportunity: The National Cancer Institute’s Laboratory of Molecular Biology is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize anti-mesothelin antibodies and immunotoxins. Please contact John D. Hewes, Ph.D. at 301–435–3121 or hewesj@mail.nih.gov for more information. A Gene Expression Profile That Predicts Ovarian Cancer Patient Response to Chemotherapy Description of Technology: Ovarian cancer is a poor prognosis disease that remains the most lethal of all gynecologic malignancies. Warning symptoms do not occur until the tumor has already spread beyond the ovary, resulting in diagnosis at an advanced stage. As a result, there is a poor patient prognosis with only fifteen percent of women possessing advanced stage disease surviving for five years. Despite an initial clinical response of 80% to surgery and chemotherapy, most patients experience tumor recurrence within two years of treatment. The overwhelming majority of these patients will eventually develop chemoresistant disease and die. VerDate Aug<31>2005 17:07 Jun 25, 2007 Jkt 211001 Available for licensing are two gene signatures. One gene signature can predict whether a patient will initially respond to standard platinum-paclitaxel chemotherapy, but will relapse within six months of completing treatment. A second gene signature identifies patients who will show no response to therapy. This methodology may enable clinicians to identify patients who may be candidates for additional and/or novel chemotherapy drugs, and effectively choose appropriate cancer treatment. A unique feature of this signature is its derivation from pure, microdissected isolates of ovarian tumor cells, rather than undissected tissue. By utilizing this approach, the resulting gene list is specific to the cell type that causes the disease. Applications: Method to detect if an ovarian cancer patient is sensitive to treatment with chemotherapeutic agents; Method to evaluate ovarian cancer patient chemoresponsiveness; Diagnostic tool to aid clinicians in determining appropriate cancer treatment; Methods to treat ovarian cancer identified by chemoresistant biomarkers compositions. Market: Ovarian cancer is the fourth most common form of cancer in the U.S.; Ovarian cancer is three times more lethal than breast cancer; 15,310 deaths in the U.S. in 2006. Development Status: The technology is currently in the pre-clinical stage of development. Inventors: Michael J. Birrer (NCI) et al. Publication: SC Mok et al. Biomarker discovery in epithelial ovarian cancer by genomic approaches. Adv Cancer Res. 2007;96:1–22. Patent Status: U.S. Provisional Application No. 60/899,942 filed 06 Feb. 2007 (HHS Reference No. E–060– 2007/0–US–01). Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: Jennifer Wong; 301/435–4633; wongje@mail.nih.gov. Potent, Easy to Use Targeted Toxins as Anti-Tumor Agents Description of Technology: The invention discloses synthesis and use of novel derivatives of 2-[2′-(2aminoethyl)-2-methyl-ethyl]-1,2dihydro-6-methoxy-3H-dibenz[de,h]isoquinoline-1,3-dione as targeted anti-tumor agents. The use of targeted toxin conjugates with anti-cancer antibodies, such as herceptin, is increasing. Based on a comparison with the structurally complex toxins, such as DM1, available in the market, these novel toxins are more stable in circulation, thus making the toxinconjugates more tumor-selective and PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 35057 less toxic. As such, these compounds are superior alternatives to the existing toxins. The invention describes a potent and easy to synthesize toxin that can be used for generating a variety of prodrugs. These compounds can be attached to a ligand that recognizes a receptor on cancer cells, or to a peptide that is cleaved by tumor-specific proteases. The compounds are topoisomerase inhibitors and are mechanistically different from DM1 that targets tubulin. The structure of the toxin allows it to be modified with a peptide linker that is stable, but rapidly cleaved in lysosomes after the compound is specifically taken up by cancer cells. Applications: The compounds can be used for preparation of a variety of potent anti-cancer agents with low systemic toxicity. Advantages: Easy to prepare; Structural features make these compounds more stable in circulation; Toxin conjugates are more tumorselective and less toxic. Benefits: 600,000 cancer deaths occurred in 2006 in spite of advances in cancer therapeutics. A major limitation of current therapeutics is their toxic side effects. This technology can effectively treat cancer with low systemic toxicity and thus improve overall survival and quality of life of patients suffering from cancer. The current cancer chemotherapeutic market is valued at $42 billion and expected to grow. Inventors: Nadya I. Tarasova, Marcin D. Dyba, Christopher J. Michejda (NCI). Development Status: In vitro studies are completed and in vivo animal model studies are ongoing. Patent Status: U.S. Provisional Application No. 60/844,027 filed 12 Sep. 2006 (HHS Reference No. E–160– 2006/0–US–01). Licensing Contact: Mojdeh Bahar, J.D.; 301/435–2950; baharm@mail.nih.gov. Dated: June 19, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7–12337 Filed 6–25–07; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Heart, Lung, and Blood Institute Special Emphasis E:\FR\FM\26JNN1.SGM 26JNN1

Agencies

[Federal Register Volume 72, Number 122 (Tuesday, June 26, 2007)]
[Notices]
[Pages 35056-35057]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-12337]


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

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.

A Novel Discriminatory Small Peptide Inhibitor of Hsp90 Targeting 
Oncogenic Kinases

    Description of Technology: Heat shock protein 90 (Hsp90) is a 
molecular chaperone required for stability and function for many 
proteins (clients). Presently, there are clinical trials focusing on 
small molecule Hsp90 inhibitors; however, pharmacologic Hsp90 
inhibition causes destabilization, ubiquitination and proteasome-
degradation of all client proteins indiscriminately.
    Hsp90 was found to be overexpressed in tumor cells; thereby making 
Hsp90 a promising molecular target for cancer therapy. Additionally, 
some Hsp90-dependent client proteins (non-kinases) were identified as 
putative tumor suppressors, suggesting that indiscriminate degradation 
of all Hsp90 client proteins is not ideal. Finding a molecular 
inhibitor that discriminately inhibits Hsp90 that would target only 
client kinase proteins would be an ideal therapeutic agent for cancer 
treatment.
    The current invention is a short peptide that inhibits Hsp90 that 
prevents the recognition and function of client kinase proteins, and 
promotes the degradation of client kinase proteins, while not affecting 
other non-kinase client proteins.
    Applications and Modality: Current applications include targeting 
client kinase proteins promoting degradation, and preventing 
recognition and function of the client kinase proteins; restriction of 
Hsp90 inhibition to client kinases that utilize similar Hsp90 
recognition sequences to the oncogenic tyrosine kinase Hsp90 client 
ErbB2; and having kinase-specific chaperone inhibitors preferentially 
active as anti-cancer agents compared to indiscriminate pharmacologic 
inhibitors of Hsp90.
    Market: 600,000 deaths from cancer related diseases were estimated 
in 2006; In 2006, cancer drug sales were estimated to be $25 billion; 
There is a burgeoning drug market for Hsp90 inhibitors for cancer 
treatment.
    Development Status: The technology is currently in the preclinical 
stage of development.
    Inventors: Leonard M. Neckers et al. (NCI).
    Patent Status: U.S. Provisional Application No. 60/895,313 filed 16 
Mar 2007 (HHS Reference No. E-121-2007/0-US-01); U.S. Provisional 
Application No. 60/909,834 filed 03 Apr 2007 (HHS Reference No. E-121-
2007/1-US-01).
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: Adaku Nwachukwu, J.D.; 301-435-5560; 
madua@mail.nih.gov.
    Collaborative Research Opportunity: The NCI Urologic Oncology 
Branch is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize peptide inhibitor of Hsp90. Please contact John D. Hewes, 
Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more information.

A Novel Treatment for Non-Small Cell Lung Cancer Using Mesothelin-
Targeted Immunotoxins

    Description of Technology: Mesothelin is a glycoprotein, whose 
expression has been largely restricted to mesothelial cells in normal 
tissues, although epithelial cells of the trachea, tonsil, fallopian 
tube, and kidney have shown immunoreactivity. Mesothelin has been shown 
to be expressed in several cancers including pancreatic carcinomas, 
gastric carcinomas and

[[Page 35057]]

ovarian carcinomas, and has the potential of being used as a tumor 
marker and a novel target for the development of new treatments.
    The technology relates to the finding that some non-small cell lung 
cancers (NSCLC) express the antigen mesothelin. Targeting the tumors 
with antibodies or immunotoxins that specifically bind mesothelin can 
be a potential new treatment for non-small cell lung cancer. The SSIP 
immunotoxin and its variants that specifically bind to mesothelin can 
be used for the treatment of NSCLC.
    Applications and Modality: NSCLC can be treated by targeting 
mesothelin.
    Advantage: Anti-mesothelin antibodies and immunotoxins are already 
available and being tested for several cancers.
    Development Status: The technology is in pre-clinical stage of 
development.
    Inventors: Ira H. Pastan (NCI) et al.
    Patent Status: U.S. Provisional Application No. 60/891,923 filed 27 
Feb 2007 (HHS Reference No. E-120-2007/0-US-01), entitled ``Treatment 
of Non-Small Cell Lung Cancer with Mesothelin-Targeted Immunotoxins.''
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: Jesse S. Kindra, J.D.; 301-435-5559; 
kindraj@mail.nih.gov
    Collaborative Research Opportunity: The National Cancer Institute's 
Laboratory of Molecular Biology is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize anti-mesothelin antibodies and 
immunotoxins. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
hewesj@mail.nih.gov for more information.

A Gene Expression Profile That Predicts Ovarian Cancer Patient Response 
to Chemotherapy

    Description of Technology: Ovarian cancer is a poor prognosis 
disease that remains the most lethal of all gynecologic malignancies. 
Warning symptoms do not occur until the tumor has already spread beyond 
the ovary, resulting in diagnosis at an advanced stage. As a result, 
there is a poor patient prognosis with only fifteen percent of women 
possessing advanced stage disease surviving for five years. Despite an 
initial clinical response of 80% to surgery and chemotherapy, most 
patients experience tumor recurrence within two years of treatment. The 
overwhelming majority of these patients will eventually develop 
chemoresistant disease and die.
    Available for licensing are two gene signatures. One gene signature 
can predict whether a patient will initially respond to standard 
platinum-paclitaxel chemotherapy, but will relapse within six months of 
completing treatment. A second gene signature identifies patients who 
will show no response to therapy. This methodology may enable 
clinicians to identify patients who may be candidates for additional 
and/or novel chemotherapy drugs, and effectively choose appropriate 
cancer treatment. A unique feature of this signature is its derivation 
from pure, microdissected isolates of ovarian tumor cells, rather than 
undissected tissue. By utilizing this approach, the resulting gene list 
is specific to the cell type that causes the disease.
    Applications: Method to detect if an ovarian cancer patient is 
sensitive to treatment with chemotherapeutic agents; Method to evaluate 
ovarian cancer patient chemoresponsiveness; Diagnostic tool to aid 
clinicians in determining appropriate cancer treatment; Methods to 
treat ovarian cancer identified by chemoresistant biomarkers 
compositions.
    Market: Ovarian cancer is the fourth most common form of cancer in 
the U.S.; Ovarian cancer is three times more lethal than breast cancer; 
15,310 deaths in the U.S. in 2006.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Michael J. Birrer (NCI) et al.
    Publication: SC Mok et al. Biomarker discovery in epithelial 
ovarian cancer by genomic approaches. Adv Cancer Res. 2007;96:1-22.
    Patent Status: U.S. Provisional Application No. 60/899,942 filed 06 
Feb. 2007 (HHS Reference No. E-060-2007/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
wongje@mail.nih.gov.

Potent, Easy to Use Targeted Toxins as Anti-Tumor Agents

    Description of Technology: The invention discloses synthesis and 
use of novel derivatives of 2-[2'-(2-aminoethyl)-2-methyl-ethyl]-1,2-
dihydro-6-methoxy-3H-dibenz-[de,h]isoquinoline-1,3-dione as targeted 
anti-tumor agents. The use of targeted toxin conjugates with anti-
cancer antibodies, such as herceptin, is increasing. Based on a 
comparison with the structurally complex toxins, such as DM1, available 
in the market, these novel toxins are more stable in circulation, thus 
making the toxin-conjugates more tumor-selective and less toxic. As 
such, these compounds are superior alternatives to the existing toxins.
    The invention describes a potent and easy to synthesize toxin that 
can be used for generating a variety of prodrugs. These compounds can 
be attached to a ligand that recognizes a receptor on cancer cells, or 
to a peptide that is cleaved by tumor-specific proteases. The compounds 
are topoisomerase inhibitors and are mechanistically different from DM1 
that targets tubulin.
    The structure of the toxin allows it to be modified with a peptide 
linker that is stable, but rapidly cleaved in lysosomes after the 
compound is specifically taken up by cancer cells.
    Applications: The compounds can be used for preparation of a 
variety of potent anti-cancer agents with low systemic toxicity.
    Advantages: Easy to prepare; Structural features make these 
compounds more stable in circulation; Toxin conjugates are more tumor-
selective and less toxic.
    Benefits: 600,000 cancer deaths occurred in 2006 in spite of 
advances in cancer therapeutics. A major limitation of current 
therapeutics is their toxic side effects. This technology can 
effectively treat cancer with low systemic toxicity and thus improve 
overall survival and quality of life of patients suffering from cancer. 
The current cancer chemotherapeutic market is valued at $42 billion and 
expected to grow.
    Inventors: Nadya I. Tarasova, Marcin D. Dyba, Christopher J. 
Michejda (NCI).
    Development Status: In vitro studies are completed and in vivo 
animal model studies are ongoing.
    Patent Status: U.S. Provisional Application No. 60/844,027 filed 12 
Sep. 2006 (HHS Reference No. E-160-2006/0-US-01).
    Licensing Contact: Mojdeh Bahar, J.D.; 301/435-2950; 
baharm@mail.nih.gov.

    Dated: June 19, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-12337 Filed 6-25-07; 8:45 am]
BILLING CODE 4140-01-P

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