CLS Limited To Initiate Phase 2 Clinical Trials Using Xencor’s Proprietary XmAb Technology

CLS Limited To Initiate Phase 2 Clinical Trials Using Xencor’s Proprietary XmAb Technology

Xencor, a clinical-stage biotech company focussed on designing monoclonal antibodies for the cure of autoimmune diseases and cancer, has been developing several products via an innovative technology called XmAb, which uses the Fc domain of an immunoglobulin (the portion of the antibody that interacts with multiple segments of the immune system) instead of the conventional Fv domain used by most competitors.

So far, eight products designed with this technology have shown the ability to enhance antibody performance, simultaneously maintaining over 99.5% identity in structure and sequence to natural antibodies in preclinical and clinical studies. Some of Xencor’s partners in the pharmaceutical industry include Amgen, Merck, Janssen R&D LLC, Alexion, Novo Nordisk and Boehringer Ingelheim.

The company recently announced in a press release that a Phase 2 clinical trial for CSL362 (now called JNJ-56022473 directed against leukemia) which uses Xencor’s XmAb Cytotoxic Fc Domain has been rolled out by its partner CSL Limited through its licensee Janssen Biotech Inc. A string of products which have been previously designed using this innovative technology include XmAb5871, which completed a Phase 1b/2a clinical trial for the treatment of rheumatoid arthritis and is now in preparation for a clinical trial in an IgG4-related disease in 2015; XmAb7195 which is currently in a Phase 1a developmental stage for the treatment of asthma; and XmAb5574/MOR208 which has been licensed to Morphosys AG and is currently under clinical developmental Phase 2 trials for the treatment of acute lymphoblastic leukemia and non-Hodgkin lymphoma.

Xencor is scheduled to receive an undisclosed milestone payment. Under the terms of an agreement signed in February 2009, Xencor had granted CSL Limited a non-exclusive license to Xencor Cytotoxic Fc Domains to use in CSL programs, including CSL362. As such, Xencor would also become eligible to receive more lump sums and royalties in the future based on product sales.

Commenting on this latest development, Dr. Bassil Dahiyat, Ph.D., president and chief executive officer of Xencor said, “CSL’s program is the third drug candidate using our XmAb technology to start Phase 2 clinical trials. By selectively licensing our XmAb technology, we believe we create value in non-core areas, thus allowing us to focus on advancing our key internal development programs.”