Xencor Initiates Phase 1b Trial Of Subcutaneous Formulation Of Xmab7195
MONROVIA, Calif., Sept. 15, 2016 /PRNewswire/ -- Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, today announced that the first patient has been dosed in a Phase 1b multi-dose trial of subcutaneously administered XmAb®7195, a potential treatment for allergic disease.
"A previously completed Phase 1a study of intravenous administration of XmAb7195 has shown potent suppression of IgE, in particular demonstrating the rapid clearance of IgE from the circulation, while being generally well tolerated by patients," said Paul Foster, M.D., chief medical officer at Xencor. "We expect to report interim data from this Phase 1b subcutaneous trial in 2017."
Complete data results from a Phase 1a, first-in-human study for IV administration of XmAb7195 were presented at the American Thoracic Society (ATS) 2016 International Conference in May 2016. Data showed that IV XmAb7195 was generally well tolerated with transient, asymptomatic thrombocytopenia reported at doses 2.0 mg/kg, and induced rapid and extensive depletion of serum IgE at all doses tested, including in high IgE subjects.
The poster is available on the Events and Presentations page of Xencor's website under "Archived Scientific Presentations" at http://investors.xencor.com/events.cfm.
For more information about this Phase 1b subcutaneous XmAb7195 clinical trial please visit to www.clinicaltrials.gov (identifier: NCT02881853).
About XmAb®7195
A first in class monoclonal antibody that targets IgE with its variable domain and uses Xencor's XmAb® Immune Inhibitor Fc domain to target FcgRIIb, resulting in three distinct mechanisms of action for reducing IgE levels for the potential treatment of allergic disease. XmAb7195 acts by 1) sequestering free IgE to block IgE signaling, 2) suppressing B-cell differentiation into IgE-secreting plasma cells, and 3) clearing IgE from circulation. Total IgE reduction differentiates XmAb7195 from other anti-IgE therapeutic antibodies that actually increase total IgE levels. Because total IgE assays, unlike free IgE assays, are readily available to clinicians, the effect of XmAb7195 on total IgE levels could enable for the first time simple monitoring, and potentially adjustment, of anti-IgE therapy.
About Xencor's XmAb® Immune Inhibitor Technology
FcRIIb (IIb), also called CD32b, is a receptor for Fc domains on B cells and other immune cells. When engaged, the IIb receptor blocks immune activation pathways and traffics bound soluble antigens out of circulation. Xencor has discovered a series of Fc domain variants with up to a 400-fold increase in binding affinity to FcRIIb derived from just two amino acid changes. These XmAb® Immune Inhibitor Fc domains greatly heighten the properties of IIb receptor engagement and have potential as building blocks for drug candidates in autoimmune, allergic and inflammatory diseases.
About Xencor, Inc.
Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer. Currently, 10 candidates engineered with Xencor's XmAb® technology are in clinical development internally and with partners. Xencor's internal programs include: XmAb5871 in Phase 2 development for the treatment of IgG4-Related Disease, and also for the treatment of Systemic Lupus Erythematosus; XmAb7195 in Phase 1 development for the treatment of asthma and allergic diseases; XmAb14045 in Phase 1 development for acute myeloid leukemia; and XmAb13676 for B-cell malignancies and XmAb18087 for the treatment of neuroendocrine tumors, both in pre-clinical development. Xencor's XmAb antibody engineering technology enables small changes to the structure of monoclonal antibodies resulting in new mechanisms of therapeutic action. Xencor partners include Novartis, Amgen, MorphoSys, Merck, CSL/Janssen, Alexion, Novo Nordisk and Boehringer Ingelheim. For more information, please visit www.xencor.com.
Forward Looking Statements:
Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of applicable securities laws, including the quotation from Xencor's officer and any expectations relating to its business, research and development programs, including ongoing clinical trials of XmAb7195, and the XmAb bispecific antibody technology, including XmAb14045, XmAb13676, and XmAb18087, partnering efforts or its capital requirements. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks described in Xencor's public securities filings. All forward-looking statements are based on Xencor's current information and belief as well as assumptions made by Xencor. Readers are cautioned not to place undue reliance on such statements and Xencor disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE Xencor, Inc.
