Genmab moves to Phase 2 study with daratumumab in smoldering multiple myeloma

Study will begin enrollment in 2015, evaluate three different dose schedules of daratumumab

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COPENHAGEN, Denmark—Genmab A/S has announced that its collaboration partner, Janssen Biotech, Inc. plans to start a Phase 2 study of daratumumab in smoldering multiple myeloma. The study (SMM2001) will evaluate three different dose schedules of daratumumab for the treatment of smoldering multiple myeloma. The study is expected to start enrolling patients in 2015. Smoldering myeloma, also known as indolent myeloma or asymptomatic myeloma, is a very slow-growing form of the disease, which is characterized by a proliferation of malignant plasma cells and a subsequent overabundance of monoclonal paraprotein (M protein). Smoldering myeloma is a very early phase of myeloma and is devoid of symptoms but detectable via a bone marrow biopsy.
"We are pleased to announce this study, which illustrates that the development plan for daratumumab encompasses all stages of multiple myeloma. Smoldering multiple myeloma is a challenging indication, as physicians will evaluate treating patients at an early stage of the disease, with the intent to extend the period before the disease transitions to symptomatic multiple myeloma," said Jan van de Winkel, Ph.D., Genmab CEO.
The Phase 2 SMM2001 study will be a randomized, open-label, multicenter study and will enroll approximately 120 patients with high risk smoldering multiple myeloma. Patients will be randomized to receive one of three dose schedules of daratumumab. The study will be conducted by Janssen Research & Development LLC, along with Janssen Biotech, a member of the Johnson & Johnson family of companies.
Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma. Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
In 1999, Janssen Biotech, then known as Centocor, became a wholly owned subsidiary of Johnson & Johnson, the worldwide manufacturer and marketer of healthcare products. Since being acquired by Johnson & Johnson, Centocor has increased its annual sales from approximately $500 million to more than $2 billion. During the same period, research and development investment increased from $75 million to more than $300 million. In 2004 Centocor purchased a new manufacturing plant in St. Louis, Missouri, and is currently opening a new manufacturing facility in County Cork, Ireland. In 2008, Centocor, Inc. and Ortho Biotech Inc. merged to form Centocor Ortho Biotech Inc. In June 2011 Centocor Ortho Biotech changed its name to Janssen Biotech, Inc. as part of a global effort to unite the Janssen Pharmaceutical Companies around the world under a common identity.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company currently has one marketed antibody, Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications and daratumumab in late stage clinical development for multiple myeloma. Additionally Genmab has a clinical pipeline with both late and early stage programs. Genmab's technology base consists of validated and proprietary next generation antibody technologies—the DuoBody® platform for generation of bispecific antibodies, and the HexaBody™ platform which creates effector function enhanced antibodies. Genmab's deep antibody expertise is expected to provide a stream of future product candidates. Partnering of selected innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top-tier pharmaceutical and biotechnology companies.

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