arGEN-X and The Leukemia & Lymphoma Society Partner on Treatment of Waldenström’s Macroglobulinemia

Date: 11/06/2014

10 June 2014, Breda, the Netherlands / Ghent, Belgium – arGEN-X today announced it has entered into a partnership with The Leukemia & Lymphoma Society (LLS) in which both parties will contribute to the funding of a Phase 2 clinical study of the Company’s lead candidate, ARGX-110, in patients with refractory Waldenström’s macroglobulinemia (WM). ARGX-110 is a novel anti-CD70 antibody created by arGEN-X which is currently being evaluated across a range of hematological and solid cancers in a Phase 1b study in Europe.

We are extremely pleased to collaborate with LLS to evaluate the potential of ARGX-110 in patients with WM. In preclinical studies the compound showed broad therapeutic potential against CD70-positive lymphomas, and we hope to demonstrate a similar therapeutic  benefit in the clinic with this initial Phase 2 study,” said Alain Thibault, arGEN-X’ Chief Medical Officer. “This collaboration is an important milestone for the development of ARGX-110 as it allows us to work with premier oncology centers in the U.S. We look forward to advancing this program with LLS in a patient population that is still in need of new treatment options.”

Under the agreement, both parties will contribute funding, of up to $2.2 million and totaling $4.5 million, with LLS funding coming through its Therapy Acceleration Program (TAP), a strategic initiative to speed the development of therapies that have the potential to change the standard of care for patients with hematological cancers. arGEN-X plans to submit an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the second half of 2014. The study is expected to begin in the second half of 2014, and will be led by Dr. Steven P. Treon, MD, PhD, Director of the Bing Center for Waldenström’s macroglobulinemia at Harvard Medical School (Cambridge, MA, USA).

“WM is a rare blood cancer that, despite significant progress, still remains incurable,” said Lee Greenberger, Ph.D, LLS’s Chief Scientific Officer. “Nevertheless, understanding the molecular basis of WM, including the role of CD70, has increased dramatically in the recent years. These new findings offer the possibility that novel targeted therapies, such as ARGX-110, could change treatment outcomes in the future. Based on preclinical and initial clinical data with ARGX-110, we believe ARGX-110 has potential to benefit patients with WM, and we are very pleased to be a part of this development program.”