On September 22, 2016 argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today provided highlights from its lead pipeline programs, ARGX-113 and ARGX-110, during its R&D in New York City (Press release, arGEN-X, SEP 22, 2016, View Source [SID:SID1234515303]). Schedule your 30 min Free 1stOncology Demo! "We are very pleased to announce today our strategic plan for driving forward our antibody pipeline through 2017; it includes several important value creating events including two Phase 2 studies in important autoimmune indications for ARGX-113 and two combination studies in serious hematological malignancies for ARGX-110," said Tim Van Hauwermeiren, CEO of argenx. "We’re particularly proud of the speed of our development plan and look forward to continuing to advance our entire pipeline rapidly towards becoming an integrated drug development company."
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Members of argenx management as well as guest speakers Dr. James Howard from the University of North Carolina, Dr. Adrian Newland from The Royal London Hospital, and Dr. Owen O’Connor from Columbia University presented the following program highlights:
ARGX-113
ARGX-113 is a potential breakthrough therapy for the treatment of IgG-mediated autoimmune diseases. It is the Fc-portion of an antibody enhanced by argenx proprietary ABDEG technology to block the recycling receptor FcRn leading to fast depletion of IgGs, including autoimmune disease-causing IgG’s. In June 2016, argenx announced favorable safety and tolerability, and efficacy data from its Phase 1 multiple ascending dose study in healthy volunteers. Early pharmacodynamic results showed selective and potent IgG reduction of up to 85%.
Today, argenx announces further results from the Phase 1 study of ARGX-113, across multiple doses and dosing regimens, and its plan to advance ARGX-113 into Phase 2 studies in myasthenia gravis (MG) and immune thrombocytopenic purpura (ITP). argenx plans to open the MG study before the end of the year and the ITP study shortly thereafter.
ARGX-110
ARGX-110 is a SIMPLE Antibody that potently blocks CD70-induced tumor cell proliferation and tumor escape from immune surveillance. It is currently being studied in an ongoing Phase 1b expansion cohort in patients with relapsed/refractory T-cell lymphoma (TCL).
Today, argenx announced new patient anecdotes from its Phase 1b safety expansion cohort showing a favorable safety profile and biological activity in cutaneous T-cell lymphoma (CTCL) patients, evidenced by biomarker data and clinical disease score. The results established the Phase 2 dose and also refined the biomarkers to be used to assess the ongoing effects of ARGX-110 in TCL patients. The Company presented its plan to study ARGX-110 in two combination studies in TCL and AML, both with the respective standard of care. argenx aims to initiate at least one combination study before the end of the year.