Breda, the Netherlands / Ghent, Belgium and White Plains, NY, USA (June 10, 2014) - arGEN-X, a clinical stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, 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 Waldenstrom'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 Waldenstrom'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."
ARGX-110 is a SIMPLE antibody(TM) targeting CD70, an immune checkpoint target involved in hematological malignancies (lymphomas and leukemias), several solid tumors and autoimmune diseases. ARGX-110 works in three ways: i) blocks growth of tumor cells, ii) kills cancer cells and iii) activates the patients' immune system against the tumor. ARGX-110 is currently being evaluated across a range of hematological and solid tumors in a Phase 1b study in Europe.
About Waldenstrom's macroglobulinemia
Waldenstrom's macroglobulinemia is a rare type of B-cell lymphoma in which overactive CD70 signaling contributes to tumor growth. While most patients respond to combinations of cytotoxic and/or targeted therapy (small molecules or biologics), recurrence is common, defining an unmet medical need for a significant number of patients.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society (R) (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, multiple myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.
Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.