Corporate Overview

Celimmune LLC is a clinical development-stage immunotherapy company focused on treating and preventing immune-mediated diseases, including celiac disease and refractory celiac disease (refractory sprue). Our goal is to develop a portfolio of products and technologies targeting immune-mediated diseases by leveraging our expertise in translational and rapid go/no-go decision clinical development of high-potential therapeutics.

Our lead product candidate – AMG 714 – is a Phase 2 anti-IL-15 monoclonal antibody that we are developing for the treatment of diet non-responsive celiac disease and Type II refractory celiac disease, a rare type of intestinal lymphoma.

Celiac disease is a chronic hereditary systemic autoimmune and inflammatory disease triggered by gluten consumption, which can cause gastrointestinal dysfunction and debilitating symptoms, including nutritional malabsorption. Over the course of a lifetime, 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. Celiac disease is the only common autoimmune disease without any approved medication.

We are developing AMG 714 for celiac disease based on scientific research involving IL-15. 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 Type II refractory celiac disease. 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 immune-mediated diseases.

Based on this understanding, we licensed AMG 714 from Amgen (NASDAQ:AMGN). Under the provisions of an exclusive license agreement, Celimmune has the rights to develop, manufacture and commercialize AMG 714 on a worldwide basis, excluding Japan.