The Company’s flagship candidate, gevokizumab, is a potent monoclonal antibody with unique allosteric modulating properties and the potential to treat patients with a wide variety of inflammatory and other diseases. Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine, and modulates the cellular signaling events that produce inflammation. IL-1 beta has been shown to be involved in diverse array of disease states, including non-infectious uveitis (including Behçet's uveitis), cardiovascular disease, and other auto-inflammatory diseases.
Gevokizumab currently is being studied in a global Phase 3 clinical program, termed EYEGUARD™, which is being conducted by SERVIER and XOMA. This program is designed to determine gevokizumab's ability to treat acute non-infectious uveitis (NIU) in EYEGUARD-A, to prevent disease flares in patients with Behçet's uveitis in EYEGUARD-B, and to prevent disease flares in NIU patients who are controlled with steroids and immunosuppressants in EYEGUARD-C.
XOMA has a Proof-of-Concept (POC) program underway in which the Company is exploring the efficacy and safety of gevokizumab in multiple indications. The Company reported data from a successful Phase 2 study in moderate to severe inflammatory acne in January 2013. XOMA anticipates full results from its two POC studies in patients with erosive osteoarthritis of the hand and data from the National Eye Institute's study of gevokizumab in patients with active non-infectious anterior scleritis later this year. Additionally, the Company recently launched a pilot study in pyoderma gangrenosum, a rare skin ulceration disease. Separately, SERVIER initiated a Phase 2 study to determine gevokizumab's ability to reduce arterial wall inflammation in patients with marked atherosclerotic plaque inflammation and who have experienced an acute coronary syndrome in the previous twelve months, as well as a POC study in polymyositis/dermatomyositis. Information about gevokizumab clinical studies can be found at www.clinicaltrials.gov and www.clinicaltrialsregister.eu.
XOMA’s preclinical pipeline includes the XMet program, which consists of three separate classes of Selective Insulin Receptor Modulators (SIRMs) antibodies: XMet A, XMet S and XMet D. XOMA is developing these antibodies to modulate the insulin receptor in a variety of ways for the potential treatment of diabetes and other metabolic syndromes.
The Company also is developing XOMA 3AB, a three-antibody co-formulation drug product candidate designed to treat botulinum toxin (Type A) poisoning, among the most deadly bioterror threats. XOMA 3AB, currently in Phase 1 testing, is being developed with funding from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
XOMA has two product candidates that are being developed by Novartis: HCD122, a monoclonal antibody to CD40, and LFA102, a monoclonal antibody to the prolactin receptor which is currently in a Phase 1 clinical trial for certain breast and prostate cancers.