Date: 2017-06-14
Type of
information: Interim results
phase: 1b
Announcement: interim results
Company: Argen-X (Belgium - The Netherlands)
Product: ARGX-110
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor. ARGX-110 is a SIMPLE antibody™) targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors and severe autoimmune diseases. ARGX-110 works in three ways: i) blocks growth of tumor cells, ii) kills cancer cells and iii) restores immune surveillance against tumors (Silence K. et al. mAbs 2014; 6 (2):523-532). ARGX-110 is currently being evaluated in hematological and solid tumors. Preclinical work on ARGX-110 in AML was done in collaboration with the Tumor Immunology Lab of Prof. A. F. Ochsenbein at the University of Bern. Prof. Ochsenbein won the prestigious 2016 Otto Naegeli Prize for their breakthrough research on CD70/CD27 signaling with therapeutic potential for cancer patients.
Disease: relapsed/refractory cutaneous T-cell lymphoma (CTCL)
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On June 14, 2017, argenx presented updated data from its Phase 1b expansion study of ARGX-110 in patients with different subtypes of relapsed/refractory cutaneous T-cell lymphoma (CTCL) and various disease stages, at the International Conference of Malignant Lymphoma (ICML) in Lugano, Italy.
- "Analysis of the skin biopsies continues to strengthen the biological rationale of targeting CD70 with ARGX-110. Clinical activity was observed in patients across different CTCL subtypes (mycosis fungoides, Sézary syndrome, panniculitis-like TCL) and different disease stages whilst the drug shows a favorable safety and tolerability profile," commented Nicolas Leupin, Chief Medical Officer of argenx. "Improved pruritis was observed in some of the patients and will be further monitored to explore ARGX-110 modes of action in skin of CTCL patients."
- • On April 12, 2017, argenx announced the initiation of a Phase II trial of ARGX-110 as a monotherapy in patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL).
- The Phase II clinical trial will enroll up to 10 additional relapsed/refractory CTCL patients, and will be conducted at multiple centers in Europe. The primary endpoints of the trial are safety and efficacy and secondary endpoints include pharmacokinetics and immunogenicity. Interim data are expected by the end of 2017, and we expect to report topline data in the second half of 2018.
Is
general: Yes
