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Clinical Trials

Date: 2017-07-07

Type of information: Presentation of results at a congress

phase: 1b

Announcement: presentation of results at the 3rd Singapore Society of Oncology Annual Scientific Meeting in Singapore

Company: arGEN-X (The Netherlands - Belgium)

Product: ARGX-111

Action mechanism: monoclonal antibody. ARGX-111 is a  fully human antibody specific for c-Met, a receptor tyrosine kinase involved in cell proliferation, angiogenesis and metastasis. c-Met is widely implicated in multiple cancers, including non small cell lung cancer (NSCLC), gastric, prostate and brain tumors. ARGX-111 has been shown in several preclinical models to outperform clinical-stage anti-c-Met antibodies in terms of potency and efficacy.

Disease:

Therapeutic area: Cancer - Oncology

Country: Belgium

Trial details:

The Phase Ib study being undertaken by arGEN-X includes an adaptive dose escalation scheme, to be followed by a safety cohort expansion.  Approximately 35 patients will be enrolled by a consortium of leading academic institutions in Belgium. In addition to traditional clinical and PK endpoints, biomarkers critical to understanding the effect of ARGX-111 on c-Met biology will be researched during the course of the trial.

Latest news:

  • • On July 7, 2017, argenx announced that its abstract covering the complete data set from its Phase Ib study of ARGX-111 in patients with advanced cancers over-expressing the MET protein was selected as part of the Best of ASCO program at the 3rd Singapore Society of Oncology Annual Scientific Meeting in Singapore.
  • The new data from the Phase Ib study continue to show evidence of anti-tumor activity with ARGX-111 at all dose levels and across different indications. Partial response and stable disease were observed, respectively, in one and nine of 24 heavily pretreated patients with MET-positive malignancies, both MET-gene-amplified and with MET overexpression. Treatment-emerging adverse events were reported for all patients, but none of the grade 5 toxicities were related to ARGX-111.
  • • On September 17, 2013, arGEN-X, a clinical stage human monoclonal antibody therapeutics company, has announced the CTA filing of a first-in-man Phase Ib cancer study with ARGX-111, its second proprietary SIMPLE Antibody™ product to enter the clinic this year.
  • The Phase Ib study will enroll patients with tumors that have been pre-screened for over-expression of c-Met. Because of the known role of c-Met activation in promoting the metastatic potential of tumor cells, the study will also document the eradication of those patients\' circulating tumor cells (CTCs), which are known to be precursors of advancing disease.
    • On February 8, 2012, arGEN-X has announced that it has progressed ARGX-111, its third therapeutic candidate, into formal preclinical development. ARGX-111 was selected from a panel of more than 60 antagonistic anti-c-Met antibodies generated from the SIMPLE Antibody™ platform, several of which have specificity for previously unknown epitopes on c-Met. ARGX-111 exhibits the unique ability to block both ligand-dependent and independent receptor activation, while avoiding agonistic activity. In addition, the antibody demonstrates potent cytotoxic effects against c-Met over-expressing tumor cells.

Is general: Yes