Regulatory Filings • Apr 8, 2015
Regulatory Filings
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arGEN-X Opens Expansion Cohort in Phase 1b Study of ARGX-111 in Patients with MET Amplified Cancers
Breda, The Netherlands / Ghent, Belgium, 8 April - arGEN-X N.V. (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 announced that it has advanced ARGX-111, a best-in-class highly differentiated SIMPLE Antibody(TM) targeting c-MET driven malignancies, into the safety and efficacy expansion part of its Phase 1b study. The objective of the expansion cohort is to further characterize the safety of ARGX-111 in cancer patients with MET amplified tumors, and to evaluate efficacy signals in order to select the indications to be studied in Phase 2 clinical development.
"We are pleased to have selected the dose of ARGX-111 to move forward into safety expansion cohort of the study. We based the selection on the results of the dose escalation portion of the study conducted in patients pre-screened for cancers with over-expression of c-Met," commented Alain Thibault, M.D., Chief Medical Officer at arGEN-X. "Biological activity was illustrated especially in the context of MET amplification. We will recruit these types of patients for the upcoming expansion cohort and we expect to report interim data in the second half of 2016."
The full data from the dose escalation part of the Phase 1b study will be presented at the upcoming 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, 29 May - 2 June, in Chicago, IL, USA.
ARGX-111 is a cMet-targeting human monoclonal SIMPLE Antibody(TM) that modulates all known mechanisms of action of the receptor. As well as best-in-class blocking of both ligand-dependent and independent signaling through c-MET, ARGX-111 benefits from POTELLIGENT®-enhanced Antibody Dependent Cellular Cytotoxicity (ADCC), which drives the immune system to destroy c-MET positive cells of the primary tumor and the circulating tumor cells that are responsible for metastasis; and from NHance®, which drives tissue penetration in the hunt for tumor metastasis. Owing to this unique combination, ARGX-111 has demonstrated superior therapeutic potential in vitro and in vivo in solid and hematological malignancies when compared to established biologic and small molecule-based c-Met therapies.
arGEN-X is a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases. arGEN-X has generated a pipeline of differentiated clinical and preclinical antibody candidates using its SIMPLE Antibody(TM) discovery platform. SIMPLE Antibody(TM) has a particular strength in addressing novel, complex disease targets that are difficult to access using established antibody technology platforms. Proprietary Fc engineering technologies (NHance® and ABDEG(TM)) and POTELLIGENT® technology (licensed from BioWa, Inc.) further enhance the therapeutic properties of SIMPLE Antibody(TM) leads in terms of tissue penetration/residence time in the body, ability to clear disease targets or pathogenic antibodies and cell-killing potency through Antibody-Dependent Cellmediated Cytotoxicity (ADCC), respectively. arGEN-X has leveraged its suite of antibody technologies in forging strategic collaborations with pharmaceutical and biotechnology companies to provide new approaches to diseases with unmet medical needs.
arGEN-X is listed on the Euronext Brussels exchange under the symbol ARGX.
SIMPLE Antibody(TM), NHance® and ABDEG(TM) are trademarks of arGEN-X NV POTELLIGENT® is a trademark of BioWa Inc.
Joke Comijn, Corporate Communications Manager +32 (0)477 77 29 44
Mark Swallow/David Dible Citigate Dewe Rogerson +44 207 282 2948 [email protected]
Beth DelGiacco (US IR) Stern Investor Relations +1 212 362 1200 [email protected]
The contents of this announcement include statements that are, or may be deemed to be, "forwardlooking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes", "estimates", "anticipates", "expects", "intends", "may", "will", or "should", and include statements arGEN-X makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. arGEN-X' actual results may differ materially from those predicted by the forward-looking statements. arGEN-X undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
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