BREDA, The Netherlands and GHENT, Belgium, May 29, 2014 /PRNewswire/ --
arGEN-X will present full results from the dose-escalation part of a Phase 1 study of ARGX-110, a novel anti-CD70 antibody, in patients with advanced hematological and solid tumors at the 50th annual meeting of the American Society of Clinical Oncology (ASCO; 30 May-3 June, 2014, Chicago, IL, USA).
arGEN-X reported in December 2013 that this study met its translational development goals: all pre-specified biological activity measures (e.g. target saturation, effector functions, immune-modulation) were met. The study also showed that ARGX-110 has a favorable safety profile and identified a dose that was advanced into a larger safety study in patients with a range of hematological and solid tumors. Patient recruitment into this expanded study began in January 2014 in Europe (ClinicalTrials.gov Identifier: NCT01813539) and top-line results are expected in 2015.
The results will be presented in a poster as follows:
Poster Session: Developmental Therapeutics - Immunotherapy
Abstract number: #3023
Poster title: A Phase 1, first-in-human study of ARGX-110, a monoclonal antibody targeting CD70, a receptor involved in immune escape and tumor growth in patients with solid and hematological malignancies.
Date/time: Monday 2 June, 1:15pm-4:15pm, Room S405
Monday 2 June, 4:45pm-6:00pm, Room S406
Presenter: Ahmad Awada, Principal Investigator, Institut Jules Bordet
Authors: A. Awada, C. Rolfo, S. Rottey, L. Ysebrant de Lendonck, W. Schroyens, F. Offner, K. Silence, T. Dreier, M. Moshir, H. de Haard, M. Peeters, D. Bron, A. Thibault, P. Aftimos.
Institut Jules Bordet, Université Libre de Bruxelles, Belgium; Universitair Ziekenhuis Antwerpen, Belgium; Universitair Ziekenhuis Gent, Belgium; arGEN-X BVBA, Belgium.
ARGX-110 is a first-in-class monoclonal antibody that potently blocks CD70-induced tumor proliferation and tumor escape from immune surveillance. In addition, the POTELLIGENT®-enhanced antibody-dependent cellular cytotoxicity (ADCC) of ARGX-110 enables selective destruction of CD70-positive tumor cells. CD70 is overexpressed in the majority of cancer patients tested to date. Expectations of a favourable therapeutic index stem from its virtual absence in healthy tissues.
About the ARGX-110 Study
The Phase 1 study (ClinicalTrials.gov Identifier: NCT01813539) consists of a dose-escalation phase followed by an adaptive safety study conducted in patients with advanced, refractory cancer. The patient enrichment strategy relies on individual tumor screening for CD70 utilizing a reproducible immunohistochemistry method. In addition to traditional clinical and PK/PD endpoints, biomarkers documenting the three modes of action of ARGX-110 are being evaluated. Patient enrolment is planned at approximately 90 CD70-positive patients with either hematological or solid tumors. The study is managed jointly by arGEN-X and a consortium of leading academic institutions in Belgium and France.
arGEN-X is a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases. arGEN-X has generated a clinical pipeline of differentiated antibody candidates using its SIMPLE Antibody™ discovery platform. SIMPLE Antibody™ has a particular strength in addressing novel, complex disease targets that are difficult to access using established antibody technology platforms. Fc engineering technologies - NHance®, ABDEG™ and POTELLIGENT® - further enhance the therapeutic properties of SIMPLE Antibody™ leads in terms of their residence time in the body, their ability to clear disease targets or pathogenic antibodies and their cell-killing potency through Antibody-Dependent Cell-mediated Cytotoxicity (ADCC), respectively. arGEN-X has leveraged its suite of antibody technologies in forging strategic collaborations with pharmaceutical and biotechnology companies to provide new approaches to diseases with unmet medical needs.
For further information, please contact:
Tim Van Hauwermeiren
Chief Executive Officer
Chief Medical Officer
Mark Swallow/David Dible
Citigate Dewe Rogerson
Stern Investor Relations