Celimmune LLC, a clinical development-stage immunotherapy company focused on treating and preventing autoimmune diseases, announced today that it has licensed a Phase 2-stage, anti-IL-15 monoclonal antibody (AMG 714) from Amgen (NASDAQ: AMGN). Under the provisions of this exclusive license agreement, Celimmune has the rights to develop, manufacture and commercialize AMG 714 on a worldwide basis excluding Japan. Concurrently, Amgen has been granted an exclusive option to reacquire AMG 714, upon completion of additional clinical studies. Financial terms of the agreements are not being disclosed. Celimmune plans to initiate Phase 2 studies of AMG 714 for the treatment of diet non-responsive celiac disease and refractory celiac disease (RCD).
Dr. Francisco Leon, Celimmune's CEO and Chief Medical Officer, stated, "Celiac disease is the only common autoimmune disease without any approved medication. Published literature demonstrates that the gluten-free diet is not a solution for the vast majority of patients. As such, Celimmune is delighted to have an opportunity to license an experimental therapeutic that will test one of the main hypotheses in the pathophysiology of celiac disease, namely that IL-15 plays a central role in RCD and non-responsive celiac disease. IL-15 appears to be an essential, non-redundant, growth factor for those intraepithelial lymphocytes that cause intestinal mucosal atrophy and pathological progression to lymphoma in RCD. IL-15 has been shown to be one of the key factors in the loss of tolerance to food antigens, and also is believed to be involved in Crohn's disease and other autoimmune diseases."
Ashleigh Palmer, Celimmune's Executive Chairman, said, "Our agreement with Amgen underscores Celimmune's distinctive core competence focused on the translational and clinical development of high-potential therapeutics for priority autoimmune and other immunological diseases with high levels of unmet medical and socioeconomic need, including cancer. Celimmune, in partnership with our enabling networks, has deep management experience, proven capabilities and industry leading expertise in developing clinical-stage assets for celiac and other autoimmune diseases. AMG 714 could be the first drug to market for a celiac indication, and there are currently no other drugs in clinical development targeting the IL-15 cytokine. In addition to celiac, AMG 714 could have longer-term expansion and life cycle management opportunities within adjacent gastrointestinal autoimmune diseases."