argenx enters Phase II trial of CTCL drug

argenx has initiated a Phase II trial of ARGX-110 as a monotherapy in patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL). 

The company said that the Phase II clinical trial will enroll up to 10 additional relapsed/refractory CTCL patients, and will be conducted at multiple centers in Europe. Interim data are expected by the end of 2017, and the company expects to report topline data in the second half of 2018.

“We have previously observed evidence of biological activity and a promising safety profile in several CD70-positive CTCL patients treated in an ongoing Phase I safety-expansion cohort, resulting in several patients with partial response or stable disease. Based on these preliminary results, we opted to further evaluate ARGX-110 as a monotherapy in an exploratory Phase II study to demonstrate the intrinsic activity of the drug in relapsed/refractory CTCL patients and to broaden our efficacy database,” commented Nicolas Leupin, CMO of argenx. “This marks the second Phase 1/2 study of ARGX-110 with the first having launched in December 2016 as a combination therapy with standard of care in AML.”