USA-based biotech company Amgen (Nasdaq: AMGN) has licensed a Phase II-stage anti-interleukin (IL)-15 monoclonal antibody, AMG 714, to Celimmune, a recently-established US start-up.
Celimmune has the rights to develop, manufacture and commercialize AMG 714 globally, excluding Japan, while Amgen has been granted an exclusive option to reacquire the therapy upon completion of additional clinical study. Financial terms have not been disclosed. Celimmune plans to start Phase II studies in the treatment of diet non-responsive celiac disease and refractory celiac disease.
Francisco Leon, chief executive and chief medical officer of Celimmune, said: "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."
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