- Preliminary results from an open-label pilot Phase 2 study assessing Xencor's (NASDAQ:XNCR) lead product candidate XmAb5871 in patients with active IgG4-related disease (IgG4-RD) showed a positive treatment effect in most patients. The data were presented at the American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting in Washington, D.C.
- Nine of 11 of patients who received an initial intravenous (IV) dose of XmAb5871 achieved a response within two weeks which generally deepened over time. Responses are measured by a scale called IgG4-RD Responder Index.
- XmAb5871 is being administered every other week. No serious adverse events (AEs) have been reported. Treatment-related AEs (TRAEs) have occurred in five patients. TRAEs occurring in more the one patient were abdominal pain/discomfort (n=3) and mild headache (n=2). There was one discontinuation due to a moderate hypersensitivity reaction following the fifth infusion which resolved without medical management. The subject was later found to have developed anti-drug antibodies.
- Two other subjects discontinued prior to receiving all 12 planned infusions. One had an initial response to therapy that was lost and one failed to respond at all.
- XmAb5871 is a monoclonal antibody that targets CD19, specifically TcyRIIb, a receptor that inhibits B cell function without killing the cells. Inhibiting the function of B cells is a proven approach to treating many autoimmune diseases.
- IgG4-RD is an autoimmune disorder characterized by chronic inflammation, specifically tissue infiltration with lymphocytes (includes B cells) and IgG-4-secreting plasma cells. It is a relapsing-remitting condition associated with varying degrees of fibrosis. It can lead to organ failure if untreated, although it usually responds well to oral steroids. The specific prevalence is unknown but it is rare, occurring in 2.8 - 10.8/million according to one study conducted in Japan.
- Complete results should be available in 2017.
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