• Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Data Privacy
  • Sign Up
  • Send a Release
Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • News
  • Products
    • Overview
    • Content Distribution
    • Multimedia Services
    • Disclosure Services
    • Cision Communications Cloud®
  • Contact
    • General Enquiries
    • Media Enquiries
    • Partnerships
    • 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 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
      • Stock Offering
      • Stock Split
      • Venture Capital


      • View All Financial Services & Investing
      • 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 & 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
  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Worldwide Offices
  • 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

  • Log In
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • GDPR
  • News in Focus
    • Browse News Releases
    • Regulatory News
    • 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
    • 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
  • Log In
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • GDPR
  • Overview
  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®
  • Log In
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • GDPR
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Worldwide Offices
  • Log In
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • GDPR

Alkermes Advances ALKS 4230 into Monotherapy Expansion Phase of ARTISTRY-1 in Patients With Renal Cell Carcinoma or Melanoma

Alkermes plc Logo

News provided by

Alkermes plc

12 Jun, 2019, 12:00 BST

Share this article

Share this article


-- Initiation of Monotherapy Efficacy Evaluation Follows Selection of Recommended Phase 2 Dose in Dose-Escalation Stage --

-- Proof-of-Mechanism Demonstrated by Desired Expansion of Tumor-Killing Immune Cells
While Avoiding Activation of Immunosuppressive Cells --

DUBLIN, June 12, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the initiation of the monotherapy expansion stage of its ARTISTRY-1 clinical trial to evaluate the efficacy, safety and tolerability of ALKS 4230 in treating patients with renal cell carcinoma or melanoma. Initiation of this portion of the ongoing study follows the identification of 6 µg/kg/day administered intravenously as the recommended monotherapy dose of ALKS 4230 to evaluate in these select tumor types. The maximum tolerated dose of ALKS 4230 has not yet been reached, and the dose-escalation stage of the ARTISTRY-1 study is continuing. ALKS 4230 is a novel, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex.

"At the 6 µg/kg/day dose, data from the dose-escalation stage of ARTISTRY-1 demonstrated the tolerability profile we set out to achieve for ALKS 4230, along with desired lymphocyte cell expansion without corresponding Treg activation. This validates our design rationale for ALKS 4230, and we now look forward to progressing into the expansion stage to evaluate ALKS 4230 as monotherapy in select tumor types," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "We plan to present the first efficacy data from across the ALKS 4230 development program at a medical meeting later this year, pending conference acceptance."

Selection of the recommended phase 2 dose of ALKS 4230 as monotherapy was made following the completion of five dose-escalation cohorts, spanning a dose range of 0.1 µg/kg/day to 6 µg/kg/day, in 36 patients who were refractory to prior administered therapies known to demonstrate clinical benefit. Data from the completed cohorts demonstrated dose-dependent pharmacodynamic effects on circulating natural killer (NK) cells and CD8+ T cells, and minimal and non-dose dependent effects on immunosuppressive regulatory T cells (Tregs). The newly initiated monotherapy expansion stage will assess objective efficacy measures of ALKS 4230 administered intravenously daily for five consecutive days in up to 105 patients refractory to prior administered therapies with renal cell carcinoma or melanoma, two tumor types for which high-dose IL-2 has demonstrated durable anti-tumor responses as a monotherapy treatment.1   

Data from the initial four cohorts of the dose-escalation stage of ARTISTRY-1 were presented at the 2018 Society for Immunotherapy of Cancer (SITC) Annual Meeting. Treatment with ALKS 4230 at 3 µg/kg/day resulted in a dose-dependent increase in circulating NK cells and CD8+ T cells with a near 4-fold and 2-fold expansion, respectively, and minimal, non-dose-dependent change in Tregs. Further effector-cell expansion was observed in cohort 5 at the 6 µg/kg/day dose, with minimal increase in circulating Tregs. No dose-limiting toxicities were observed in cohort 5. Fever and chills were the most common treatment-related adverse events (AEs) for ALKS 4230 across all cohorts, and the safety profile observed with ALKS 4230 was consistent with the known profile of cytokine therapy.

About ALKS 4230  
ALKS 4230 is a novel, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Program 
ARTISTRY is an Alkermes-sponsored clinical program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1/2 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, the newly initiated monotherapy expansion stage and an ongoing combination therapy stage with the PD-1 inhibitor KEYTRUDA® (pembrolizumab) in patients with select advanced solid tumors.

ARTISTRY-2 is an ongoing phase 1/2 study of ALKS 4230 administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules.

About Alkermes 
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases and oncology. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction, multiple sclerosis and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

Note Regarding Forward-Looking Statements 
Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic value of ALKS 4230; clinical development plans for ALKS 4230, including details of the ongoing ARTISTRY-1 and ARTISTRY-2 phase 1/2 studies and the company's plans for presentation of data relating to the ARTISTRY development program. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond the company's control, which could cause actual results to differ materially from those expressed or implied in the forward-looking statements. These risks and uncertainties include, among others, whether preclinical and early clinical results for ALKS 4230, as a monotherapy or in combination with pembrolizumab, will be predictive of future clinical study results; whether ALKS 4230, as a monotherapy or in combination, could be shown to be unsafe or ineffective; whether future clinical trials or future stages of ongoing clinical trials for ALKS 4230, as a monotherapy or in combination, will be initiated or completed on time or at all; changes in the cost, scope and duration of development activities for ALKS 4230; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2018 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

KEYTRUDA® is a registered trademark of Merck & Co., Inc.

1 Rosenberg S. A. (2014). IL-2: the first effective immunotherapy for human cancer. Journal of immunology (Baltimore, Md.: 1950), 192(12), 5451–5458. doi:10.4049/jimmunol.1490019

Alkermes Contacts: 
For Investors: Sandy Coombs, +1 781 609 6377
For Media: Gretchen Murphy, +1 781 609 6419

Logo - http://mma.prnewswire.com/media/616416/Alkermes_plc_Logo.jpg

Related Links

http://www.alkermes.com

SOURCE Alkermes plc

Modal title

Also from this source

Alkermes to Take Part in SVB Leerink 10th Annual Global...


Alkermes plc Reports Financial Results for the Fourth Quarter and ...

Explore

More news releases in similar topics

  • Medical Pharmaceuticals
  • Health Care & Hospitals
  • Clinical Trials & Medical Discoveries

    Contact PR Newswire

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

    • General Enquiries
    • Media Enquiries
    • Partnerships
    • Worldwide Offices

    Products

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

    About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers

    • Asia
    • Brazil
    • Canada
    • Czech
    • Denmark
    • Finland
    • France
    • Germany
    • India
    • Israel
    • Mexico
    • Middle East
    • Netherlands
    • Norway
    • Poland
    • Portugal
    • Russia
    • Slovakia
    • Spain
    • Sweden
    • United States

    My Services

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

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 © 2021 PR Newswire Europe Limited. All Rights Reserved. A Cision company.