Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • 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 Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & 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 & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & 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 & Recapitalisation
      • 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 & 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 & 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 & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & 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 & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • 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 & 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 & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • 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

  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • 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
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

Dragonfly Therapeutics Announces the Presentation of Phase 1 DF1001 TriNKET® Dose Escalation Results at ASCO 2023 Annual Meeting

This image opens in the lightbox

News provided by

Dragonfly Therapeutics, Inc.

05 Jun, 2023, 14:13 GMT

Share this article

Share toX

Share this article

Share toX

In the ASCO Developmental Therapeutics – Immunotherapy Session, Dr. Howard Safran presents encouraging data on Dragonfly's phase 1/2 study of DF1001, an immune engaging TriNKET® targeting HER2 in patients with advanced solid tumors.

WALTHAM, Mass., June 5, 2023 /PRNewswire/ -- Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, announces the first presentation of its DF1001 TriNKET immune engager clinical data at the ASCO 2023 Annual Meeting in Chicago. The presentation, given by lead investigator Dr. Howard P. Safran, Chief of Hematology/Oncology at the Lifespan Cancer Institute and Medical Director for the Brown University Oncology Group, describes Dragonfly's Phase 1/2 clinical trial of its DF1001 HER2-targeting TriNKET®, a first-in-human study exploring the safety, tolerability, and preliminary biological and clinical activity of DF1001.

Continue Reading
This image opens in the lightbox
Dr. Howard P. Safran, Chief of Hematology/Oncology at the Lifespan Cancer Institute and Medical Director for the Brown University Oncology Group at the ASCO 2023 Annual Meeting

"I am glad to now share that Dragonfly's DF1001 has completed safety evaluation and reached its Phase 2 dose with 67% of patient paired biopsies showing pharmacodynamic response, and clear signs of clinical benefit in both monotherapy and in combination," said Dr. Safran. "We have not seen toxicity nor hit a Maximum Tolerated Dose, and we are seeing encouraging clinical efficacy signals in a heavily pretreated heterogeneous population of patients with advanced cancer. Single agent activity was seen in both HER2 high and HER2 low patients who previously progressed on prior HER2 directed therapies."

As of the April 14th data cutoff for ASCO presentation, Dragonfly has treated 106 patients with DF1001 monotherapy. DF1001 was safe and well tolerated as monotherapy at biweekly doses up to 15 mg/kg and has successfully progressed through Phase 1 combinations with both nivolumab and nab-paclitaxel. There have been no DLTs with DF1001 during the monotherapy dose-escalation phase.

DF1001 pharmacodynamic activity was demonstrated in 67% (28/42) of paired biopsies in monotherapy.

Preclinical data shows TriNKETs directly and indirectly stimulate NK cells, γδ T cells, and CD8+ T cells. The biopsies, collected before and 4-6 weeks after patients started DF1001 treatment, showed a trend of increased infiltration with CD8+ T-cells and/or NK cells in the tumor, demonstrating proof of concept.   

DF1001 yielded promising anticancer activity associated with immune cell infiltration and activation in tumors of heavily pretreated patients - who had received up to 16 lines of prior therapy and with both HER2 low and HER2 high expressing cancers.

DF1001 has generated RECIST responders as a monotherapy in heavily pretreated patients with Metastatic Breast Cancer (MBC), Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC) and Gastro Esophageal Cancer.

At active dose ranges, twenty-five percent of MBC patients (the majority of whom were HER2 low) showed a clinical response, even when treated with an average of six lines of prior therapy.

"We are very encouraged by this Phase 1 DF1001 TriNKET data, which confirm Dragonfly's preclinical studies showing TriNKETs' remarkably appealing safety profile, and notable efficacy including in low- and heterogeneous HER2 expression environments," said Joseph Eid, Dragonfly's President of R&D, "we look forward to our Phase 2 signal-seeking expansion trials, which have begun already in monotherapy and in combination with other therapies in defined patient populations, and in earlier lines of therapy."

DF1001 has also shown clinical benefit including RECIST responses in combination with nivolumab or nab paclitaxel.

Clinical trial sites are open in the U.S., France, Belgium, Denmark and The Netherlands.

Additional information about the trial, including eligibility criteria, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT04143711).

There are six Dragonfly developed drugs in the clinic – including DF1001. 

About DF1001

DF1001 is an investigational first-in-class immune engaging drug candidate targeting HER2 that drives immune activation in solid tumors. DF1001 stimulates co-activating NK receptors, where NKG2D and CD16 co-stimulation yields distinctive and potent NK cell, γδ T cell, and CD8+ T cell activation. DF1001 is being evaluated in adult patients for the treatment of advanced solid HER2-positive tumors. DF1001 was discovered and developed using Dragonfly's TriNKET Platform. DF1001 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF1001 is the most advanced in a pipeline of TriNKETs that Dragonfly is developing to address high unmet needs for patients across a broad range of disease areas.

About Dragonfly's TriNKET® Platform

Dragonfly's TriNKET Platform is the basis for a portfolio of novel therapeutics that are designed as natural combinations harnessing NK cells, γδ T cells, CD8+ T cells and other cells of the innate and adaptive immune system, which when activated cause cancer cell cytolysis and provide a unique therapeutic window beyond current therapies for treatment of cancer and chronic inflammatory diseases.

About Dragonfly

Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing therapies that use its novel bispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly-owned clinical assets and multiple assets in the clinic with partners, Dragonfly has a deep pipeline of wholly-owned preclinical candidates developed using its proprietary platforms as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas. 

For more information visit: 
www.dragonflytx.com 
https://www.linkedin.com/company/dragonfly-therapeutics-inc./ 
https://twitter.com/dragonflytx 

DRAGONFLY MEDIA CONTACT: 
Anne Deconinck | anne@dragonflytx.com 

Photo - https://mma.prnewswire.com/media/2093025/Dragonfly_ASCO_Dr_Howard_Safran.jpg
Logo - https://mma.prnewswire.com/media/390962/Dragonfly_Therapeutics_Logo.jpg 

Modal title

Also from this source

Dragonfly Therapeutics to Present Preclinical Data on Clinical-Stage DF6215, its Engineered IL-2R alpha-active Agonist, and DF9001, its EGFR-targeting TriNKET®, at the Society for Immunotherapy of Cancer (SITC) Annual Conference

Dragonfly Therapeutics to Present Preclinical Data on Clinical-Stage DF6215, its Engineered IL-2R alpha-active Agonist, and DF9001, its EGFR-targeting TriNKET®, at the Society for Immunotherapy of Cancer (SITC) Annual Conference

Dragonfly Therapeutics, Inc., a clinical-stage biotechnology company developing novel immunotherapies, today announced the company will deliver...

More Releases From This Source

Explore

Health Care & Hospitals

Health Care & Hospitals

Medical Pharmaceuticals

Medical Pharmaceuticals

Biotechnology

Biotechnology

Pharmaceuticals

Pharmaceuticals

News Releases in Similar Topics

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.