• Resources
  • Blog
  • Journalists
  • Log In
  • Sign Up
  • Data Privacy
  • Send a Release
Cision PR Newswire: news distribution, targeting and monitoring home
  • News
  • Products
    • Overview
    • Distribution by PR Newswire
    • Cision Communications Cloud®
    • Cision IR
    • Sponsored Placement
    • All Products
  • Contact
    • General Inquiries
    • Request a Demo
    • Editorial Bureaus
    • Partnerships
    • Media Inquiries
    • Worldwide Offices

 

When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All News Releases
      • All Public Company
      • English-only
      • News Releases Overview

      • Multimedia Gallery

      • All Multimedia
      • All Photos
      • All Videos
      • Multimedia Gallery Overview

      • Trending Topics

      • All Trending Topics
  • Business & Money
      • Auto & Transportation

      • All Automotive & Transportation
      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation
      • Auto & Transportation Overview

      • View All Auto & Transportation

      • Business Technology

      • All Business Technology
      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • Business Technology Overview

      • View All Business Technology

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Financial Services & Investing

      • All Financial Services & Investing
      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • Financial Services & Investing Overview

      • View All Financial Services & Investing

      • General Business

      • All General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News
      • General Business Overview

      • View All General Business

  • Science & Tech
      • Consumer Technology

      • All Consumer Technology
      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • Consumer Technology Overview

      • View All Consumer Technology

      • Energy & Natural Resources

      • All Energy
      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities
      • Energy & Natural Resources Overview

      • View All Energy & Natural Resources

      • Environ­ment

      • All Environ­ment
      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • Environ­ment Overview

      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • All Heavy Industry & Manufacturing
      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • Heavy Industry & Manufacturing Overview

      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • All Telecomm­unications
      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • Telecomm­unications Overview

      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • All Consumer Products & Retail
      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • Consumer Products & Retail Overview

      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Health

      • All Health
      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • Health Overview

      • View All Health

      • Sports

      • All Sports
      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • Sports Overview

      • View All Sports

      • Travel

      • All Travel
      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • Travel Overview

      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • All Policy & Public Interest
      • Advocacy Group Opinion
      • Animal Welfare
      • Congressional & Presidential Campaigns
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy
      • U.S. State Policy
      • Policy & Public Interest Overview

      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • All People & Culture
      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • People & Culture Overview

      • View All People & Culture

      • In-Language News

      • español
      • português
      • Česko
      • Danmark
      • Deutschland
      • España
      • France
      • Italia
      • Nederland
      • Norge
      • Polska
      • Portugal
      • Россия
      • Slovensko
      • Suomi
      • Sverige
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • Sponsored Placement
  • All Products
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • PR Newswire: news distribution, targeting and monitoring
  • Send a Release
    • ALL CONTACT INFO
    • Contact Us

      888-776-0942
      from 8 AM - 10 PM ET

  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • News in Focus
    • Browse All News
    • Multimedia Gallery
    • Trending Topics
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • All Products
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR

EDO Announces Next Milestone for Tinostamustine (EDO-S101) as First-In-Human Solid Tumor Study Begins

EDO (PRNewsFoto/Mundipharma EDO GmbH) (PRNewsFoto/Mundipharma EDO GmbH)

News provided by

Mundipharma EDO GmbH (EDO)

Oct 09, 2017, 19:01 ET

Share this article

Share this article


BASEL, Switzerland, October 10, 2017 /PRNewswire/ --

Mundipharma EDO GmbH (EDO) has begun a US Phase 1/2 clinical study for tinostamustine (EDO-S101) in patients with advanced solid tumors at Stanford University, Cedars Sinai Medical Center (Los Angeles) and The Mayo Clinic (Scottsdale). The news follows the announcement last year of the first-in-human study for tinostamustine in relapsed/refractory hematological malignancies.

Tinostamustine: a first-in-class alkylating deacetylase inhibiting molecule (AK-DACi) (PRNewsFoto/Mundipharma EDO GmbH (EDO))
Tinostamustine: a first-in-class alkylating deacetylase inhibiting molecule (AK-DACi) (PRNewsFoto/Mundipharma EDO GmbH (EDO))

     (Logo: http://photos.prnewswire.com/prnh/20150731/252073LOGO )

     (Photo: http://mma.prnewswire.com/media/569969/EDO_Molecules.jpg )

The initial phase of the new study has been designed to determine the safety, tolerability, maximum dose and optimal dosing schedule of tinostamustine as a single agent in patients with solid tumors, who have progressed after at least one line of therapy and no other standard therapy with proven clinical benefit is available. It will also investigate the pharmacokinetic profile. The study will then expand to evaluate toxicity and response rates in selected relapsed/refractory solid tumors including: small cell lung cancer (SCLC); soft tissue sarcoma (STS) or non-KIT gastrointestinal stromal tumors (GIST); triple negative breast cancer (TNBC); and ovarian cancer.

Although an effective option for some cancer patients, traditional DNA-damaging therapies have certain limitations which can result in resistance, for example, a failure to gain access to the DNA strands to break them or an inability to counteract the DNA repair mechanisms within cancer cells.[1]

Tinostamustine (EDO-S101) is an AK-DACi (a first-in-class alkylating deacetylase inhibiting molecule) that, in preclinical studies, has been shown to improve access to the DNA strands within cancer cells, break them and counteract damage repair.[2]-[4] Preclinical studies suggest that these complementary and simultaneous modes of action have the potential to overcome resistance.[4],[5]

Preclinical experiments in solid tumors show that tinostamustine exhibits efficacy in most SCLC cell lines, including those that are resistant to doxorubicin.[5],[6] Activity has also been established in
preclinical studies for STS, TNBC and ovarian cancer.[6]

Dr. Thomas Mehrling, CEO of EDO commented: "Following the initial Phase 1 study in hematological malignancies, I am delighted that EDO is now embarking on a further clinical trial in solid tumors. People with advanced solid tumors can become resistant to treatment and often have a relatively poor chance of survival. Breaking through resistance is essential if we are to continue to address
unmet needs in oncology. This is a key step in the investigation of a first-in-class treatment, which we hope will prove a vital addition for patients with limited current options."

About EDO  
EDO is focused on the preclinical and clinical development of treatments for cancer types where there are currently limited options for patients. EDO supports the rapid development of innovative new treatments from initial concept right through to the late stages of clinical development.

EDO is part of the Mundipharma global network of privately-owned independent associated companies, which operate in over 120 countries worldwide.

For further information, please visit http://www.edoncology.com

About the study 
The primary objective of the Phase 1/2 multicenter, clinical trial is to assess the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of tinostamustine as a single agent in patients with solid tumors who have progressed after at least one line of therapy and no other standard therapy with proven clinical benefit is available. MTD will be established for two administration schedules. The secondary objective will be to establish the pharmacokinetic (PK) profile of tinostamustine. There will be an exploratory objective to correlate the extent of gene expression changes in tumor samples with anti-tumor activity. The study will take place at Stanford University, Cedars Sinai Medical Center (Los Angeles) and The Mayo Clinic (Scottsdale).

In the second phase, the study will expand into selected solid tumor cohorts including: relapsed SCLC; relapsed STS or non-KIT GIST; relapsed/refractory TNBC; and relapsed/refractory ovarian cancer. The primary objective of Phase 2 will be to assess objective response rate (ORR) and clinical benefit rate (CBR). The secondary objectives will include safety, progression-free survival, overall survival, duration of response and PK profiles.

For further information about the study please visit: http://www.clinicaltrials.gov

About Solid Tumours 
Patients with advanced stage SCLC have a low chance of survival (8% relative 5-year survival rate for Stage III and 2% for Stage IV).[7]

Approximately 16% of patients with STS have advanced stage (metastatic) disease. For these patients, the relative 5-year survival rate is 16%.[8]

TNBC tends to be more aggressive than other types of breast cancer, is more likely to spread beyond the breast and more likely to recur after treatment. Relative 5-year survival rates are lower for TNBC than for other types of breast cancer. TNBC is not a good candidate for hormonal therapy or HER2 targeting treatments.[9]

Ovarian cancer is the seventh most common cause of cancer-related deaths in women worldwide.[10] Relative 5-year survival rates vary significantly depending on cancer stage. The outlook is worse for those with advanced ovarian cancer.[11]

References  

  1. Cheung-Ong K, et al. DNA-Damaging Agents in Cancer Chemotherapy: Serendipity and Chemical Biology. Chemistry & Biology 2013;20:648-59.
  2. López-Iglesias AA. The Alkylating Histone Deacetylase Inhibitor Fusion Molecule Edo-S101 Displays Full Bi-Functional Properties in Preclinical Models of Hematological Malignancies. Blood 2014; 124: (21). https://ash.confex.com/ash/2014/webprogram/Paper72121.html
  3. López-Iglesias AA. preclinical antimyeloma activity of EDO-S101 (bendamustine-vorinostat fusion molecule) through DNA-damaging and HDACi effects. 15th International Myeloma Workshop. 23−26 September 2015. Rome, Italy.
  4. Di Filippi R, et al. The First-In-Class Alkylating Histone Deacetylase Inhibitor (HDACi) Fusion Molecule EDO-S101 Exerts Potent Preclinical Activity Against Tumor Cells of Hodgkin Lymphoma (HL) Including Bendamustine Resistant Clones. 57th Annual Meeting and Exposition of the American Society of Hematology (ASH), 6 December 2015.
  5. Yan S, Xu K, Lin J, et al. Synergistic inhibition of tumor growth and overcoming chemo-resistance by simultaneously targeting key components in DNA damage/repair, epigenetic, and putative cancer stem cell signaling pathways using novel dual-functional DNA-alkylating/HDAC inhibitor and tumor suppressor gene nanoparticles in lung cancer. Cancer Research 2012;72( Suppl 1): Abstract 2741.
  6. Mundipharma EDO GmbH Data on file.

https://ash.confex.com/ash/2014/webprogram/Paper70113.html

  1. National Cancer Institute SEER Database (1988-2001). American Cancer Society website. Last accessed April 2017: https://www.cancer.org/cancer/small-cell-lung-cancer/detection-diagnosis-staging/survival-rates.html
  2. National Cancer Institute. American Cancer Society website: Last accessed April 2017: https://www.cancer.org/cancer/soft-tissue-sarcoma/detection-diagnosis-staging/survival-rates.html
  3. Breastcancer.org website. Last accessed April 2017: http://www.breastcancer.org/symptoms/diagnosis/trip_neg/behavior
  4. Jemal A, et al. Global Cancer Statistics. Ca Cancer J Clin 2011;61:69-90.
  5. National Cancer Institute SEER database (2004-2010). American Cancer Society website. Last accessed April 2017: https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/survival-rates.html

SOURCE Mundipharma EDO GmbH (EDO)

Modal title

Contact Cision

  • Cision Distribution 888-776-0942
    from 8 AM - 9 PM ET

  • Chat with an Expert
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices

Products

  • Cision Communication Cloud®
  • For Marketers
  • For Public Relations
  • For IR & Compliance
  • For Agency
  • For Small Business
  • All Products

About

  • About PR Newswire
  • About Cision
  • Become a Publishing Partner
  • Become a Channel Partner
  • Careers
  • COVID-19 Resources
  • Accessibility Statement
  • Asia
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Mexico
  • Middle East
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

My Services

  • All New Releases
  • Online Member Center
  • ProfNet

Contact Cision

Products

About

My Services
  • All News Releases
  • Online Member Center
  • ProfNet
Cision Distribution Helpline
888-776-0942
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2022 Cision US Inc.