MONROVIA, Calif., Oct. 1, 2013 /PRNewswire/ -- Xencor, Inc. today announced that the first patient has been dosed in the Phase 2a part of its ongoing Phase 1b/2a clinical trial of XmAb®5871 in patients with active rheumatoid arthritis. XmAb5871 is the first in Xencor's class of therapeutic antibodies targeting the FcγRIIb pathway in B cells, which shows potential to suppress autoimmune disorders without the side effects caused by B cell depletion.
XmAb5871 is an Fc engineered monoclonal antibody that inhibits B cells by dual targeting CD19 and FcγRIIb. Amgen Inc. and Xencor entered into a collaboration and option agreement for XmAb5871 in December 2010. Under that agreement, Amgen has the option to acquire an exclusive worldwide license to XmAb5871, exercisable at any time before completion of a data review period following our planned subsequent Phase 2b proof-of-concept clinical trial. Xencor leads all research, development, and manufacturing activities for XmAb5871 until that time and is eligible for milestone payments.
"XmAb5871 represents a novel therapeutic strategy for engaging the FcγRIIb pathway to suppress autoimmune responses without B-cell depletion," said Bassil Dahiyat, Ph.D., president and CEO of Xencor. "This Phase 2a rheumatoid arthritis data is intended to inform a larger Phase 2 study and may support the potential use of XmAb5871 in other autoimmune diseases, such as lupus."
The Phase 2a portion of the clinical trial will evaluate biweekly doses of XmAb5871 in approximately 30 rheumatoid arthritis patients with active disease on stable non-biologic DMARD therapy. Endpoints include clinical markers of disease response.
XmAb5871 was well tolerated in the Phase 1a dose escalation part of the trial that enrolled 48 healthy male subjects and inhibited multiple biomarkers of immune function.
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