Accessibility Statement Skip Navigation
  • Why PRWeb
  • How It Works
  • Who Uses It
  • Pricing
  • Login
  • GDPR
  • Create a Free Account
Return to PRWeb homepage
  • News
  • Resources
  • Contact
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
      • Multimedia Gallery

      • All Multimedia
      • All Photos
      • All Videos
  • Business & Money
      • Auto & 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
      • View All Auto & Transportation

      • 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
      • View All Business Technology

      • Entertain­ment & Media

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

      • 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
      • View All Financial Services & Investing

      • 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
      • View All General Business

  • Science & Tech
      • 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
      • View All Consumer Technology

      • Energy & Natural Resources

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

      • Environ­ment

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

      • 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
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

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

  • Lifestyle & Health
      • 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
      • View All Consumer Products & Retail

      • Entertain­ment & Media

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

      • 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
      • View All Health

      • Sports

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

      • Travel

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

  • Policy & Public Interest
      • 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
      • View All Policy & Public Interest

  • People & Culture
      • 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
      • View All People & Culture

  • Hamburger menu
  • Cision PRWeb provides efficient communication tools to continuously engage with target audiences across multiple online channels
  • Create a Free Account
    • ALL CONTACT INFO
    • Contact Us


      11AM ET Sunday – 8PM ET Friday

  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR
  • News in Focus
    • Browse All News
    • Multimedia Gallery
  • 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
  • RSS
  • GDPR
  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR
  • Send a Release
  • Sign up
  • Log in
  • Resources
  • RSS
  • GDPR

Actuate Therapeutics Announces Primary Endpoint Met In Phase 2 Study In Pancreatic Cancer
  • USA - English

Elraglusib Results in 57% Disease Control Rate and 39% Objective Response Rate in Combination with Gemcitabine/Abraxane in First Line Treatment of Pancreatic Cancer


News provided by

Actuate Therapeutics, Inc.

Oct 28, 2021, 07:55 ET

Share this article

Share toX

Share this article

Share toX

CHICAGO and FORT WORTH, Texas, Oct. 28, 2021 /PRNewswire-PRWeb/ -- Actuate Therapeutics, Inc. (Actuate), a clinical stage biopharmaceutical company, today announced that their Phase 2 open-label single arm study of elraglusib (9-ING-41) plus gemcitabine/nab-paclitaxel treatment met its primary endpoint for clinical response in patients with advanced pancreatic cancer in the first-line setting. Thirteen of the initial twenty-three sequentially enrolled evaluable patients in that study demonstrated positive responses to the combination therapy, including two patients with confirmed complete responses (CRs), seven with confirmed partial responses (PRs), and four patients with stable disease of 4 or more cycles, for a disease control rate of 57 percent, which exceeded the prespecified statistical threshold for clinical success in the study.

This trial is the Part 3 expansion arm of the 1801 trial evaluating elraglusib, a novel, small molecule inhibitor of glycogen synthase kinase-3 beta (GSK-3β), in adult and pediatric patients with advanced cancer (NCT03678883, EudraCT#:2018-003739-32).

Expanding upon the successful single arm trial, the company also announced initiation of an international phase 2 randomized controlled trial of elraglusib in combination with gemcitabine/nab-paclitaxel for first line treatment of patients with advanced pancreatic cancer.

"Based on the very encouraging responses seen in the single arm study, we are very pleased to have enrolled the first patients on the randomized controlled clinical study that Actuate consequently and immediately opened. This randomized Phase 2 clinical trial is designed to evaluate first-line treatment with elraglusib when dosed once weekly versus twice weekly in combination with gemcitabine/nab-paclitaxel, versus gemcitabine/nab-paclitaxel alone" said Dr. Benedito Carneiro, Brown University's principal investigator on the 1801 study. "This study will help define the dosing regimen for elraglusib to take forward in registration studies for first line treatment of pancreatic cancer, a notoriously difficult to treat disease. We are also excited to open our investigator-initiated study of elraglusib in patients with refractory soft tissue sarcomas."

"We initially focused on elraglusib as a promising therapy for patients with pancreatic cancer based on pre-clinical data of its single agent activity and synergy with gemcitabine", said Dr. Anwaar Saeed, principal investigator on the 1801 study at the University of Kansas Cancer Center. "As the clinical data on elraglusib has evolved, so has appreciation of GSK-3β inhibition as an immunomodulatory approach in cancer therapy. I am thus very excited to open our investigator-initiated study of elraglusib, gemcitabine/nab-paclitaxel and an anti-PD-1 checkpoint inhibitor in patients with metastatic pancreatic cancer in which we hope to mirror the pre-clinical data on elraglusib's stimulation of NK and T cell effector function and its synergy with checkpoint inhibitors."

"We have observed significant durable responses and a favorable safety profile in patients on elraglusib studies. We are looking forward to enrolling on the randomized study for patients with metastatic pancreatic cancer" said Dr. Devalingam Mahalingam, principal investigator on the 1801 study at Northwestern University. "In addition to its anti-neoplastic and immunomodulatory activity, elraglusib has very potent anti-fibrotic activity in a range of standard pre-clinical models. This may be an important mode of action in a spectrum of adult and pediatric cancers. With my focus on improving the prognosis of patients with GI malignancies, I am particularly interested in conducting an investigator-initiated study in advanced hepatocellular cancer where elraglusib's modes of action may be of benefit."

"Our investigators' satisfaction with the number and durability of responses that patients with advanced pancreatic cancer experienced in the single arm study encouraged us to very rapidly advance to an international randomized controlled study" said Daniel Schmitt, Actuate's President & CEO. "Enrollment of patients in the Phase 2 randomized study represents a major advance in the elraglusib program. With the FDA's recent granting of Fast Track Status for elraglusib for treatment of pancreatic cancer, there is a clear and potentially accelerated path to follow for registration."

About Actuate Therapeutics, Inc.
Actuate is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics for cancers and inflammatory diseases. In addition to this randomized controlled study, Actuate is executing Phase 2 clinical trial for the treatment of myelofibrosis, a Phase 1/2 trial for neuroblastoma in pediatric patients, and a Phase 2 trial in salivary gland carcinomas. The company is also planning additional clinical studies of elraglusib in other cancers including studies for front line treatment of advanced pancreatic cancer both in combination with FOLFIRINOX, and with a checkpoint inhibitor containing regimen. For additional information, please visit the Company's website at http://www.actuatetherapeutics.com

Media Contact

Public Relations Dept., Actuate Therapeutics, Inc., +1 (847) 986-4190, [email protected]

SOURCE Actuate Therapeutics, Inc.

Related Links

http://www.actuatetherapeutics.com

Modal title

Contact PRWeb

  • 11AM ET Sunday – 8PM ET Friday
  • Contact Us

About PRWeb

  • About PRWeb
  • Partners
  • Partnership Programs
  • Editorial Guidelines
  • Resources

Why PRWeb

  • Why PRWeb
  • How It Works
  • Who Uses It
  • Pricing

Accounts

  • Create a Free Account
  • Log in
  • Contact Us

Do not sell or share my personal information:

  • Submit via [email protected] 
  • Call Privacy toll-free: 877-297-8921

Contact Cision

Products

About

My Services
  • All News Releases
  • Online Member Center
  • ProfNet
Cision Distribution Helpline
888-776-0942
  • Legal
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 Cision US Inc.