ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 521

Update on the Clinical Phase 1 and Phase 2 Trials Investigating the Fully Human Immunocytokine Dekavil (F8IL10) in Patients with Rheumatoid Arthritis

Mauro Galeazzi1, Gian Domenico Sebastiani2, Jürgen Wollenhaupt3, Jean Dudler4, Christof Specker5, Reinhard Voll6, Pascal Zufferey7, Piercarlo Sarzi Puttini8, Ombretta Viapiana9 and Franziska Bootz10, 1Rheumatology, University Hospital of Siena, Siena, Italy, 2Rheumatology, San Camillo Forlanini Hospital, Roma, Italy, 3Division of Reheumatology, Schoen-Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, 4Rheumatology, Cantonal Hospital Fribourg, Fribourg, Switzerland, 5Rheumatology, St. Josef Krankenhaus, Universitätsklinikum Essen, Esssen, Germany, 6Clinic for Rheumatology and Clinical Immunology, Medical Center University of Freiburg, Freiburg, Germany, 7Department of Rheumatology, University Hospital Lausanne, Lausanne, Switzerland, 8Rheumatology, Luigi Sacco Hospital, Milan, Italy, 9University Hospital Verona, Verona, Italy, 10Clinical Department, Philochem AG (Philogen Group), Otelfingen, Switzerland

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Antibodies, Biologic agents, cytokines and rheumatoid arthritis (RA)

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print
Session Information

Date: Sunday, November 5, 2017

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster I: Comorbidities and Adverse Events; Efficacy and Safety of Small Molecules

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose:

The antibody-based targeted pharmacodelivery of cytokines by means of immunocytokines has the potential to enhance therapeutic activity at the site of disease while sparing healthy tissues. Dekavil (F8IL10) is a fully human immunocytokine consisting of the targeting antibody F8 (specific to EDA) fused to the anti-inflammatory payload interleukin-10. Dekavil is currently in phase 2 clinical development for the treatment of rheumatoid arthritis (RA).

Methods:

Patients diagnosed with RA according to ACR/EULAR classification criteria, who have active disease despite MTX therapy and who failed anti-TNF treatment are the target population.

In a recently completed phase 1b dose escalation study with the aim to explore safety, tolerability and the maximum tolerated dose (MTD), cohorts of 3-6 patients were treated with escalating doses of Dekavil (6-600 μg/kg + MTX). Patients received 4 weekly s.c. injections of Dekavil in combination with a fixed dose of MTX (10-15 mg). Patients willing to continue the treatment had the opportunity to receive 4 additional weekly injections of Dekavil.

The ongoing multicenter, double-blind, placebo-controlled phase 2 trial assesses therapeutic activity by measuring the mean change from baseline of DAS28-CRP. Patients are randomized into two treatment groups (Dekavil 30 or 160 μg/kg plus MTX) and one placebo group (placebo plus MTX). Study participants receive 8 weekly s.c. injections of Dekavil in combination with a fixed dose of MTX (10-15 mg).

Both studies further investigate the possible formation of anti-fusion protein antibodies as well as F8IL10 signature.

Results:

In the phase 1 study, Dekavil was shown to be well tolerated up to the highest investigated dose (600 μg/kg) and an MTD was not reached. In 34 out of 35 patients treated in the phase 1 study, no DLTs, no SAEs and no SUSARs have been reported. One study subject in cohort 9 (450 μg/kg) experienced a DLT (G2 purpura), which was accompanied by a SAE (G2 dyspnea, not drug related). The patient fully recovered within one week after having received corticosteroid treatment. The most frequently observed adverse event was mild injection site reaction and occurred in 60% of the patients. Furthermore, two cases of drug related anemia (G3 and G2; 160 μg/kg and 450 μg/kg, respectively) were reported in this study. All adverse reactions resolved completely. At the first efficacy assessment after 4 cycles of treatment, 36.4% of patients (12/33) revealed ACR responses. The fraction of responding patients increased to 45.8% (11/24) after 8 cycles of treatment. Two patients benefited from a long lasting ACR70 responses for more than 12 months after the last drug administration.

As of May 2017, 23 out of 87 patients have been enrolled in the phase 2 clinical study. Neither SAE nor SUSARs nor treatment-related deaths were recorded so far. An interim analysis performed after 45 patients will allow for a more thorough understanding of the product.

Conclusion:

The currently available data suggest that the biologic agent Dekavil is a safe and well tolerated novel therapeutic approach for the treatment of RA.


Disclosure: M. Galeazzi, None; G. D. Sebastiani, None; J. Wollenhaupt, Abbott, BMS, MSD, Pfizer, UCB, 2,Abbott, BMS, MSD, Pfizer, UCB, 5; J. Dudler, None; C. Specker, None; R. Voll, None; P. Zufferey, None; P. Sarzi Puttini, None; O. Viapiana, None; F. Bootz, Philchem AG (Philogen group), 3.

To cite this abstract in AMA style:

Galeazzi M, Sebastiani GD, Wollenhaupt J, Dudler J, Specker C, Voll R, Zufferey P, Sarzi Puttini P, Viapiana O, Bootz F. Update on the Clinical Phase 1 and Phase 2 Trials Investigating the Fully Human Immunocytokine Dekavil (F8IL10) in Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/update-on-the-clinical-phase-1-and-phase-2-trials-investigating-the-fully-human-immunocytokine-dekavil-f8il10-in-patients-with-rheumatoid-arthritis/. Accessed .
  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to 2017 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/update-on-the-clinical-phase-1-and-phase-2-trials-investigating-the-fully-human-immunocytokine-dekavil-f8il10-in-patients-with-rheumatoid-arthritis/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology