Products in Clinical Development:
Gained initial results from Phase 1 SAD study in healthy volunteers Showed compound to be safe and well-tolerated across all doses. Pharmacokinetic (PK) profiles were consistent with expectations and promising PD effects were seen relating to speed, depth and duration of IgG reduction.
Defined doses for MAD escalation. Top line data from Phase 1 MAD study are expected by July 2016.
T-cell lymphoma (TCL):
Phase 1b safety expansion cohort ongoing in patients with relapsed/refractory TCL.
Presented topline Phase 1 clinical data at workshop in conjunction with the American Society of Hematology (ASH) Annual Meeting showing evidence of early biologic activity.
Will present interim data of the study by mid-2016 and top-line data will by the end of the year.
Acute myeloid leukemia (AML):
Presented preclinical data on ARGX-110 in AML models at ASH (Dec 2015) by argenx collaborators from the University of Bern, Switzerland.; combined preclinical data in chronic myelogenous leukemia (CML) and AML offer strong biology rationale to target leukemic stem cells by blocking the CD70/CD27 pathway.
·Nasopharyngeal carcinoma (NPC):
Enrolled 6 patients in ongoing Phase 1 safety expansion cohort with Stage 4 NPC patients.
Phase 1b safety expansion cohort ongoing in MET-amplified, end-stage cancer patients.
Presented Preliminary results from Phase 1b trial of ARGX-111 at American Society of Clinical Oncology (ASCO) Annual Meeting (Chicago, May 29) and were consistent with preclinical observations including depletion of circulating tumor cells and a strong safety profile.
Opened three clinics in South Korea, bringing total number of clinical sites to eight.
Will present interim data of Phase 1b safety expansion cohort by mid- 2016.
Products in Preclinical Development
In-licensed asset from de Duve Institute/Universite Catholique de Louvain (UCL) through Innovative Access Program.
Published therapeutic potential of ARGX-115 to inhibit immune checkpoint GARP in Science Translational Medicine .
Collaborations and grants
Announced dosing of first healthy volunteer by partner Bird Rock Bio (formerly RuiYi) with gerilimzumab (ARGX-109), a novel SIMPLE Antibody TM neutralizing the IL-6 cytokine for treatment of autoimmune disorders, including rheumatoid arthritis. argenx generated antibody in late 2012 and licensed worldwide development and commercialization rights to Bird Rock Bio.
Launched Innovative Access Program extending reach of proprietary SIMPLE Antibody TM platform to academic centers of excellence and emerging biotech companies.
Initiated new multi-product commercial license agreement with Lonza for proprietary GS Xceed TM System for creation and development of cell lines to be utilized in manufacture of biopharmaceuticals.
Announced alliance with LEO Pharma to develop innovative antibody-based solutions for treatment of chronic inflammation underlying many skin conditions; first milestone payment, for selecting the lead cell line for manufacture of the licensed SIMPLE Antibody TM candidate, was received in January.
Received EUR 1.6 million grant from Institute for the Promotion of Innovation by Sciences and Technology in Flanders (IWT) to advance application of proprietary NHance® technology platform.
Continued execution of IP strategy with multiple grants and notices of allowance for SIMPLE Antibody TM platform (U.S, EU) and ARGX-111 program (Japan, EU) - 13 patents granted and 104 pending patents.
Appointed Nicolas Leupin, MD, MBA, as Chief Medical Officer. Dr. Nicolas Leupin most recently held senior clinical development positions at Celgene as European clinical lead for lenalidomide. Prior to his move into the pharmaceutical industry, Dr. Leupin spent several years as a hematologist/oncologist at the Cancer Center of the Lausanne University Hospital and Bern University Hospital.
Announced several Board of Directors changes including the appointment of Dr. J. Donald deBethizy as Non-executive Director and the resignation of Non-executive Directors Dr. Bruno Montanari, Dr. Harrold van Barlingen and Michael Sheffery. Dr. Pam Klein agreed to serve as an advisor to the Board and Christina Takke having left Forbion Capital Partners now serves as an independent Non-executive board member within the meaning of the Dutch Corporate Governance Code (provision III.2.2).
Increased headcount to 49 persons in support of the expansion of the business.