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


      • Entertain­ment & Media Overview
      • 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
      • Stock Offering
      • Stock Split
      • Venture Capital


      • Financial Services & Investing Overview
      • General Business
      • All General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • 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
  • 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
      • 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
      • Environ­ment
      • All Environ­ment
      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters


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


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


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


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


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


      • People & Culture Overview
      • 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
  • 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
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Policy & Public Interest
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • People & Culture
    • People & Culture
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • 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

Innovent Announces First Patient Dosed in Phase 2 Pivotal Trial of IBI310 (CTLA-4) combined with TYVYT® (sintilimab injection) for the treatment of second-line or above Advanced Cervical Cancer


News provided by

Innovent Biologics

Dec 10, 2020, 19:57 ET

Share this article


SAN FRANCISCO and SUZHOU, China, Dec. 10, 2020 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, today announces that the first patient has been successfully enrolled and dosed in the randomized, double-blind, phase 2 multi-center clinical trial (NCT04590599) evaluating its IBI310 (anti CTLA-4 monoclonal antibody) in combination with TYVYT® (sintilimab injection) for the treatment of patients with second-line or above advanced cervical cancer.

The trial is a randomized, double-blind, controlled, parallel cohort phase 2 clinical trial evaluating the efficacy and safety of IBI310 versus placebo, in combination with TYVYT® (sintilimab injection), for advanced cervical cancer patients who have failed first and later line or intolerant of platinum-based chemotherapy. This clinical trial plans to enroll 174 patients with advanced cervical cancer.

Primary Investigator of the study, Professor Ding Ma of Tongji Hospital affiliated to Huazhong University of Science and Technology, stated:" Cervical cancer is the 4th most common malignant tumor among women in the world. in China, it ranks the 6th highest incidence rate (154/100,000) and 8th highest mortality rate (69/100,000) across tumor types. Treatment option of advanced cervical cancer is limited. The five-year survival rate of Stage IVb cervical cancer is still at a low level of less than 17%. Currently there is no standard treatment for patients with advanced cervical cancer who have failed platinum-based chemotherapy, representing a huge unmet clinical need. In recent years, immune checkpoint inhibitors have brought new hope to such patient population. We hope to explore the therapeutic value of the regimen of IBI310 in combination with TYVYT® (sintilimab injection) as second-line or above treatment for patients with advanced cervical cancer."

Dr. Hui Zhou, Vice President and Head of Medical Sciences and Oncology Strategy of Innovent, stated: "CTLA-4 is an important immunosuppressive receptor. Currently, only one antibody drug targeting CTLA-4 has been approved and marketed globally, though lots of clinical trials on CTLA-4 targeted drugs have been conducted. So far there is no CTLA-4 targeted drug approved in China. With the most advanced progress in clinical development in China, IBI310 in combination with TYVYT® (sintilimab injection) has shown promising preliminary anti-tumor potential value. We will evaluate the efficacy of IBI310 combined with TYVYT® (sintilimab injection) in the phase II trial and we hope to provide more effective treatment to benefit patients and their families."

About IBI310

IBI310 is a recombinant fully-human monoclonal antibody against cytotoxic T lymphocytic associated antigen 4 (CTLA-4). IBI310 can interfere with the binding of CTLA-4 and CD80/CD86 on antigen presenting cells, thereby blocking the inhibitory effect on T cell activation. IBI310 can promote the activation and amplification of T cells, and enhance the anti-tumor ability of the immune system.

CTLA-4 provides a new approach for immunotherapy in many diseases, including tumors. Innovent has announced the preliminary results of the Phase 1 clinical trial about anti-CTLA-4 monoclonal antibody (NCT03545971) at the 56th Annual American Society of Clinical Oncology (ASCO) (Online Publication, Abstract No. 302489). Phase II/III clinical studies of IBI310 combined with TYVYT® (sintilimab injection) for multiple tumors are ongoing.

About TYVYT® (Sintilimab Injection)

TYVYT® (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT® (sintilimab injection) is the only PD-1 inhibitor included in the new Catalogue of the National Reimbursement Drug List (NRDL). In April 2020, the NMPA accepted the sNDA for TYVYT® (sintilimab injection) in combination with ALIMTA® (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with nonsquamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT® (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT® (sintilimab injection) in combination with GEMZAR® (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In September 2020, TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab biosimilar injection) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of overall survival and progression-free survival in an interim analysis of the Phase 3 ORIENT-32 study.

TYVYT® (sintilimab injection) is a fully human immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for TYVYT® (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. This includes global clinical research studies on TYVYT® (sintilimab injection).

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, metabolic, autoimmune and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 23 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with four products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) – officially approved for marketing in China, four assets in Phase 3 or pivotal clinical trials, and additional 15 molecules in clinical trials. TYVYT® is the only PD-1 inhibitor included in the NRDL.

Innovent has built an international team with expertise in cutting-edge biological drug development and commercialization. The company has also entered into strategic collaborations with Eli Lilly and Company, Roche, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. For more information, please visit: www.innoventbio.com.

Note:

TYVYT® (sintilimab injection) is not an approved product in the United States.
BYVASDA® (bevacizumab biosimilar injection) is not an approved product in the United States.
SULINNO® (adalimumab biosimilar injection) is not an approved product in the United States.

TYVYT® (sintilimab injection, Innovent)
BYVASDA® (bevacizumab biosimilar injection, Innovent)
SULINNO® (adalimumab biosimilar injection, Innovent)
HALPRYZA® (rituximab biosimilar injection, Innovent)

ALIMTA® and GEMZAR® are trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

SOURCE Innovent Biologics

Modal title

Also from this source

Innovent Announces NMPA Acceptance of a Supplemental New Drug...


Innovent Announces NMPA Granted New Indication Approvals for...

Explore

More news releases in similar topics

  • Pharmaceuticals
  • Health Care & Hospitals
  • Medical Pharmaceuticals

    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 © 2021 Cision US Inc.