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Company to develop AMG 714 for the treatment of diet non-responsive celiac disease and refractory celiac disease (celiac disease-triggered T-cell lymphoma)
Lebanon, NJ and Bethesda, MD, Mar.2, 2015 — 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 the intraepithelial lymphocytes, which cause intestinal mucosal atrophy and the progression to lymphomain RCD. IL-15 has been shown to be one of the key factors in the loss of tolerance to food antigens in celiac disease, 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.”
Celiac disease is a chronic hereditary systemic autoimmune and inflammatory disease triggered by gluten consumption. Celiac disease is characterized by damage to the lining of the small intestine, causing gastrointestinal dysfunction and debilitating symptoms. Nutritional malabsorption can lead to a failure to thrive in children and anemia and osteopenia in adults. Over the course of a life time, untreated or poorly managed celiac disease is often associated with deteriorating general health, multiple serious intestinal and extra-intestinal medical complications, and increased morbidity and mortality. Currently 1% of Western and 0.5% of Asian populations suffer from celiac disease and diagnosed prevalence is expected to increase dramatically with improved diagnostic tools and clinical awareness.
Celimmune LLC, a clinical development-stage immunotherapy company focused on treating and preventing autoimmune diseases, began operating in February 2015 and is headquartered in Bethesda, Maryland. Celimmune will initially focus its distinctive core competence in translational medicine, immunotherapy clinical development and commercialization on combating celiac disease and other serious autoimmune diseases.