XOMA has built a portfolio of innovative therapeutic antibodies, both in late-stage clinical development and in preclinical research. The Company discovers and develops innovative antibody-based therapeutics that have unique allosteric modulating properties. The lead product candidate, gevokizumab, is a potent, fully humanized allosteric-modulating monoclonal antibody that binds to the inflammatory cytokine interleukin-1 beta (IL-1 β). By targeting IL-1 β, XOMA believes that gevokizumab has the potential to address the underlying inflammatory causes of a wide range of diseases that have been identified as having unmet medical needs.
Today, XOMAs principal activities are centered on the advancement of gevokizumab and the development of its preclinical pipeline.
- Together with its development partner, SERVIER, a leading independent French pharmaceutical company, XOMA initiated three Phase 3 clinical trials evaluating gevokizumab for the treatment of non-infectious intermediate, posterior or pan-uveitis (NIU) and Behçets uveitis, a severe subset of NIU. XOMA is responsible for all of the clinical study sites in the United States, and SERVIER is responsible for all of the clinical study sites outside of the United States. These studies are known as the EYEGUARD program, which includes EYEGUARD-A (patients with active NIU), EYEGUARD-B (patients with Behçets uveitis), and EYEGUARD-C (patients with a history of NIU currently controlled with systemic treatment).
- XOMA is also conducting a gevokizumab clinical trial in pyoderma gangrenosum (PG), a rare ulcerative skin disease. Based upon what the Company believes are compelling pilot study data, XOMA met with the U.S. Food and Drug Administration (FDA) to solicit feedback on a proposed Phase 3 clinical development program and have submitted the final protocol to FDA for final comments. The Phase 3 program is expected to include two double-blind, placebo-controlled clinical studies, each of which is designed to enroll approximately 60 patients with active PG.
- 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.
- XOMA 3AB, an antibody candidate in preclinical development to neutralize the botulinum toxin, among the most deadly bioterrorism threats, under development through funding provided by the National Institutes of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).
XOMA's antibody technology platforms include an unmatched collection of antibody phage display libraries and proprietary Human Engineering, Bacterial Cell Expression (BCE), affinity maturation and manufacturing technologies. BCE is a key breakthrough biotechnology for the discovery and manufacturing of antibodies and other proteins. Overall, 60 pharmaceutical and biotechnology companies have signed BCE licenses, and several licensed product candidates are currently in clinical development. XOMA is entitled to development-related milestones and royalties on antibodies covered under these licenses.
Oct 9, 2014
XOMA Launches XOMA 358 Clinical Development
Oct 6, 2014
The Texas A&M University System and XOMA License Innovative Manufacturing Technology
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